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Comparative Effectiveness Review

Number 203

Attention Deficit
Hyperactivity Disorder:
Diagnosis and
Treatment in Children
and Adolescents

e
Comparative Effectiveness Review
Number 203

Attention Deficit Hyperactivity Disorder: Diagnosis


and Treatment in Children and Adolescents

Prepared for:
Agency for Healthcare Research and Quality
U.S. Department of Health and Human Services
5600 Fishers Lane
Rockville, MD 20857
www.ahrq.gov

Contract No. 290-2015-00004-I

Prepared by:
Duke Evidence-based Practice Center
Durham, NC

Investigators:
Alex R. Kemper, M.D., M.P.H, M.S.
Gary R. Maslow, M.D., M.P.H.
Sherika Hill, M.H.A., Ph.D.
Behrouz Namdari, M.D.
Nancy M. Allen LaPointe, Pharm.D., M.H.S.
Adam P. Goode, D.P.T., Ph.D.
Remy R. Coeytaux, M.D., Ph.D.
Deanna Befus, B.A., B.S.N.
Andrzej S. Kosinski, Ph.D.
Samantha E. Bowen, Ph.D.
Amanda J. McBroom, Ph.D.
Kathryn R. Lallinger, M.S.L.S.
Gillian D. Sanders, Ph.D.

AHRQ Publication No. 18-EHC005-EF


January 2018
Key Messages
Purpose of Review
To update a previous review by comparing strategies to diagnose, treat, and monitor children and
adolescents with attention deficit hyperactivity disorder (ADHD).
Key Messages
• Evidence was insufficient on imaging or electroencephalogram to diagnose ADHD in
children 7–17 years of age.
• Little evidence adds to the 2011 report that found that methylphenidate is effective for
children under age 6 with ADHD and that psychostimulants can be effective for children
6–12 years of age.
• Atomoxetine had slightly higher gastrointestinal effects than methylphenidate.
• Cognitive behavioral therapy may improve ADHD symptoms among children 7–17 years
of age.
• Child or parent training improved ADHD symptoms among children 7–17 years of age
but did not change academic performance.
• Omega-3/6 supplementation made no difference in ADHD symptoms.
• Future studies are needed to evaluate diagnosis, monitoring, and long-term outcomes for
children and adolescents with ADHD managed in usual care settings.

ii
This report is based on research conducted by the Duke Evidence-based Practice Center (EPC)
under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD
(Contract No. 290-2015-00004-I). The findings and conclusions in this document are those of the
authors, who are responsible for its contents; the findings and conclusions do not necessarily
represent the views of AHRQ. Therefore, no statement in this report should be construed as an
official position of AHRQ or of the U.S. Department of Health and Human Services.

None of the investigators have any affiliations or financial involvement that conflicts with
the material presented in this report.

The information in this report is intended to help health care decisionmakers—patients and
clinicians, health system leaders, and policymakers, among others—make well-informed
decisions and thereby improve the quality of health care services. This report is not intended to
be a substitute for the application of clinical judgment. Anyone who makes decisions concerning
the provision of clinical care should consider this report in the same way as any medical
reference and in conjunction with all other pertinent information, i.e., in the context of available
resources and circumstances presented by individual patients.

This report is made available to the public under the terms of a licensing agreement between the
author and the Agency for Healthcare Research and Quality. This report may be used and
reprinted without permission except those copyrighted materials that are clearly noted in the
report. Further reproduction of those copyrighted materials is prohibited without the express
permission of copyright holders.

AHRQ or U.S. Department of Health and Human Services endorsement of any derivative
products that may be developed from this report, such as clinical practice guidelines, other
quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.

This report may periodically be assessed for the currency of conclusions. If an assessment is
done, the resulting surveillance report describing the methodology and findings will be found on
the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on the
title of the report.

Persons using assistive technology may not be able to fully access information in this report. For
assistance contact [email protected].

Suggested citation: Kemper AR, Maslow GR, Hill S, Namdari B, Allen LaPointe NM, Goode
AP, Coeytaux RR, Befus D, Kosinski AS, Bowen SE, McBroom AJ, Lallinger KR, Sanders GD.
Attention Deficit Hyperactivity Disorder: Diagnosis and Treatment in Children and Adolescents.
Comparative Effectiveness Review No. 203. (Prepared by the Duke University Evidence-based
Practice Center under Contract No. 290-2015-00004-I.) AHRQ Publication No. 18-EHC005-EF.
Rockville, MD: Agency for Healthcare Research and Quality; January 2018. Posted final reports
are located on the Effective Health Care Program search page.
DOI: https://doi.org/10.23970/AHRQEPCCER203.

iii
Preface
The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based
Practice Centers (EPCs), sponsors the development of systematic reviews to assist public- and
private-sector organizations in their efforts to improve the quality of health care in the United
States. These reviews provide comprehensive, science-based information on common, costly
medical conditions, and new health care technologies and strategies.
Systematic reviews are the building blocks underlying evidence-based practice; they focus
attention on the strength and limits of evidence from research studies about the effectiveness and
safety of a clinical intervention. In the context of developing recommendations for practice,
systematic reviews can help clarify whether assertions about the value of the intervention are
based on strong evidence from clinical studies. For more information about AHRQ EPC
systematic reviews, see www.effectivehealthcare.ahrq.gov/reference/purpose.cfm.
AHRQ expects that these systematic reviews will be helpful to health plans, providers,
purchasers, government programs, and the health care system as a whole. Transparency and
stakeholder input are essential to the Effective Health Care Program. Please visit the Web site
(www.effectivehealthcare.ahrq.gov) to see draft research questions and reports or to join an
email list to learn about new program products and opportunities for input.
If you have comments on this systematic review, they may be sent by mail to the Task Order
Officer named below at: Agency for Healthcare Research and Quality, 5600 Fishers Lane,
Rockville, MD 20857, or by email to [email protected].

Gopal Khanna, M.B.A. Arlene S. Bierman, M.D., M.S.


Director Director
Agency for Healthcare Research and Quality Center for Evidence and Practice
Improvement
Agency for Healthcare Research and Quality

Stephanie Chang, M.D., M.P.H. Suchitra Iyer, Ph.D.


Director Task Order Officer
Evidence-based Practice Center Program Center for Evidence and Practice
Center for Evidence and Practice Improvement Improvement
Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality

iv
Acknowledgments
The authors thank Naomi Davis, Ph.D., for providing clinical expertise; Megan von Isenburg,
M.S.L.S., for help with the literature search and retrieval; Robyn E. Schmidt, B.A., for assistance
with project coordination; and Rebecca N. Gray, D.Phil., and Liz Wing, M.A., for editorial
assistance.

Key Informants
In designing the study questions, the EPC consulted several Key Informants who represent the
end-users of research. The EPC sought the Key Informant input on the priority areas for research
and synthesis. Key Informants are not involved in the analysis of the evidence or the writing of
the report. Therefore, in the end, study questions, design, methodological approaches, and/or
conclusions do not necessarily represent the views of individual Key Informants.

Key Informants must disclose any financial conflicts of interest greater than $10,000 and any
other relevant business or professional conflicts of interest. Because of their role as end-users,
individuals with potential conflicts may be retained. The TOO and the EPC work to balance,
manage, or mitigate any conflicts of interest.

The list of Key Informants who provided input to this report follows:

Barry Anton, Ph.D., A.B.P.P. Laurence Greenhill, M.D.


Rainier Behavioral Health Columbia University Medical Center
Tacoma, WA New York, NY

William Barbaresi, M.D., FAAP Aaron Lopata, M.D., M.P.P.


Boston Children’s Hospital Health Resources and Services Administration
Boston, MA Maternal and Child Health Bureau
Rockville, MD
Coleen Boyle, Ph.D., M.S.Hyg.
Centers for Disease Control and Prevention Doris Lotz, M.D., M.P.H.
Atlanta, GA Chief Medical Officer
New Hampshire Department of Health and
Teka Dempson Human Services
National Federation of Families for Children’s Concord, NH
Mental Health
Durham, NC Mark Wolraich, M.D.
University of Oklahoma Health Sciences
Theodore Ganiats, M.D. Center
University of Miami Oklahoma City, OK
Miami, FL

v
Technical Expert Panel
In designing the study questions and methodology at the outset of this report, the EPC consulted
several technical and content experts. Broad expertise and perspectives were sought. Divergent
and conflicting opinions are common and perceived as healthy scientific discourse that results in
a thoughtful, relevant systematic review. Therefore, in the end, study questions, design,
methodologic approaches, and/or conclusions do not necessarily represent the views of
individual technical and content experts.

Technical Experts must disclose any financial conflicts of interest greater than $10,000 and any
other relevant business or professional conflicts of interest. Because of their unique clinical or
content expertise, individuals with potential conflicts may be retained. The TOO and the EPC
work to balance, manage, or mitigate any potential conflicts of interest identified.

The list of Technical Experts who provided input to this report follows:

Coleen Boyle, Ph.D., M.S.Hyg.*


Centers for Disease Control and Prevention Susanna Visser, M.S., Dr.Ph.*
Atlanta, GA Centers for Disease Control and Prevention
Atlanta, GA
Theodore Ganiats, M.D.
University of Miami Mark Wolraich, M.D.*
Miami, FL University of Oklahoma Health Sciences
Center
Laurence Greenhill, M.D.* Oklahoma City, OK
Columbia University Medical Center
New York, NY Julie Zito, Ph.D.*
University of Maryland
William E. Pelham, Jr., Ph.D.* Baltimore, MD
Florida International University
Miami, FL

Erin Schoenfelder Gonzalez, Ph.D.*


Seattle Children’s Hospital
Seattle, WA

*Provided input on Draft Report.

vi
Peer Reviewers
Prior to publication of the final evidence report, EPCs sought input from independent Peer
Reviewers without financial conflicts of interest. However, the conclusions and synthesis of the
scientific literature presented in this report do not necessarily represent the views of individual
reviewers.

Peer Reviewers must disclose any financial conflicts of interest greater than $10,000 and any
other relevant business or professional conflicts of interest. Because of their unique clinical or
content expertise, individuals with potential nonfinancial conflicts may be retained. The TOO
and the EPC work to balance, manage, or mitigate any potential nonfinancial conflicts of interest
identified.

The list of Peer Reviewers follows:

Charles J. Homer, M.D., M.P.H.


Harvard TH Chan School of Public Health
Boston, MA

Peter Jensen, M.D.


Mayo Clinic
Rochester, MN

vii
Attention Deficit Hyperactivity Disorder: Diagnosis
and Treatment in Children and Adolescents
Structured Abstract
Objectives. Attention deficit hyperactivity disorder (ADHD) is a common pediatric
neurobehavioral disorder often treated in the primary care setting. This systematic review
updates and extends two previous Agency for Healthcare Research and Quality (AHRQ)
systematic evidence reviews and focuses on the comparative effectiveness of methods to
establish the diagnosis of ADHD, updates the comparative effectiveness of pharmacologic and
nonpharmacologic treatments, and evaluates different monitoring strategies in the primary care
setting for individuals from birth through 17 years of age.

Data sources. We searched PubMed®, Embase®, PsycINFO®, and the Cochrane Database of
Systematic Reviews for relevant English-language studies published from January 1, 2011,
through November 7, 2016.

Review methods. Two investigators screened each abstract and full-text article for inclusion,
abstracted the data, and performed quality ratings and evidence grading. Random-effects models
were used to compute summary estimates of effects when sufficient data were available for
meta-analysis.

Results. Evidence was contributed from 103 articles describing 90 unique studies. Twenty-one
studies related to diagnosis, 69 studies related to treatment, and no studies were identified on
monitoring. The Attention and Executive Function Rating Inventory and Childhood Executive
Functioning Inventory performed better than the Cambridge Neuropsychological Test
Automated Battery for the diagnosis of ADHD for ages 7–17 years (strength of evidence
[SOE]=low). Evidence was insufficient on the use of electroencephalography (EEG) or
neuroimaging to establish the diagnosis of ADHD for ages 7–17 years. No studies directly
assessed the harms to children labeled as having ADHD. Limited additional evidence published
since the original 2011 report was available on ADHD medications approved by the Food and
Drug Administration (FDA) compared with placebo or compared to different FDA-approved
ADHD medications (SOE=insufficient). For atomoxetine and methylphenidate, the most
commonly reported adverse events were somnolence and mild gastrointestinal problems.
Atomoxetine had slightly higher gastrointestinal effects than methylphenidate (SOE=low).
Cognitive behavioral therapy improved ADHD symptoms (SOE=low). Child or parent training
improved ADHD symptoms (SOE=moderate) but made no difference in academic performance
(SOE=low). Omega-3/6 fatty acid supplementation made no difference in ADHD symptoms
(SOE=moderate). Across all treatments, little evidence was reported on the risk of serious
adverse events, including cardiovascular risk.

Conclusions. The 2011 AHRQ systematic review highlighted the benefit of psychostimulants for
children 6–12 years of age with ADHD for up to 24 months and found that adding
psychosocial/behavioral interventions to psychostimulants is more effective than
psychosocial/behavioral interventions alone for children with ADHD and oppositional defiant
disorder. This targeted update found insufficient evidence regarding new approaches to the

viii
diagnosis (e.g., EEGs, neuroimaging). Little is known about the impact of being labeled as
having ADHD. Although cognitive behavioral therapy or child or parent training may decrease
symptoms of ADHD, more information is needed regarding the relative benefit of these
approaches compared to, or combined with, medication treatment. Omega-3/6 supplementation
does not appear to improve ADHD outcomes. No information was identified regarding the
optimal strategy for monitoring after diagnosis.

ix
Contents
Introduction ................................................................................................................................... 1
Background ................................................................................................................................. 1
Population ............................................................................................................................... 1
Diagnosis................................................................................................................................. 2
Treatment Strategies ............................................................................................................... 2
Monitoring Strategies With Intermediate Outcomes .............................................................. 3
Long-Term Outcomes ............................................................................................................. 3
Key Findings From 2011 Report ............................................................................................ 4
Scope and Key Questions ........................................................................................................... 5
Scope of This Review ............................................................................................................. 5
Key Questions ......................................................................................................................... 6
Organization of This Report ....................................................................................................... 8
Methods .......................................................................................................................................... 9
Topic Refinement and Review Protocol ..................................................................................... 9
Literature Search Strategy........................................................................................................... 9
Search Strategy ....................................................................................................................... 9
Inclusion and Exclusion Criteria........................................................................................... 10
Study Selection ..................................................................................................................... 15
Data Extraction ..................................................................................................................... 16
Quality Assessment of Individual Studies ................................................................................ 16
Data Synthesis ........................................................................................................................... 17
Strength of the Body of Evidence ............................................................................................. 18
Applicability ............................................................................................................................. 20
Peer Review and Public Commentary ...................................................................................... 20
Results .......................................................................................................................................... 21
Results of Literature Searches .................................................................................................. 21
Description of Included Studies: Overview .............................................................................. 23
Key Question 1: ADHD Diagnosis ........................................................................................... 26
Description of Included Studies ............................................................................................ 34
Key Points ............................................................................................................................. 34
Detailed Synthesis—Diagnosis ............................................................................................. 34
Strength of Evidence—Diagnosis ......................................................................................... 35
Key Question 2: ADHD Treatment .......................................................................................... 38
Description of Included Studies ............................................................................................ 38
Key Point for Pharmacologic Versus Placebo/Usual Care ................................................... 38
Detailed Synthesis—Pharmacologic Versus Placebo/Usual Care ........................................ 38
Findings in Relation to What Is Already Known—Pharmacologic Versus Placebo/Usual
Care ....................................................................................................................................... 41
Strength of Evidence—Pharmacologic Versus Placebo/Usual Care .................................... 42
Key Points for Pharmacologic Versus Pharmacologic ......................................................... 45
Detailed Synthesis—Pharmacologic Versus Pharmacologic................................................ 45
Findings in Relation to What Is Already Known—Pharmacologic Versus Pharmacologic 47
Strength of Evidence—Pharmacologic Versus Pharmacologic ............................................ 48
Key Points for Pharmacologic Versus Nonpharmacologic .................................................. 51

x
Detailed Synthesis—Pharmacologic Versus Nonpharmacologic ......................................... 51
Findings in Relation to What Is Already Known—Pharmacologic Versus
Nonpharmacologic ................................................................................................................ 53
Strength of Evidence—Pharmacologic Versus Nonpharmacologic ..................................... 53
Key Points for Nonpharmacologic Versus Nonpharmacologic/Placebo .............................. 56
Detailed Synthesis—Overview ............................................................................................. 57
Detailed Synthesis—Neurofeedback .................................................................................... 57
Strength of Evidence—Neurofeedback ................................................................................ 58
Detailed Synthesis—Cognitive Training .............................................................................. 60
Findings in Relation to What Is Already Known—Cognitive Training ............................... 61
Strength of Evidence—Cognitive Training .......................................................................... 61
Detailed Synthesis—Cognitive Behavioral Therapy ............................................................ 63
Strength of Evidence—Cognitive Behavioral Therapy ........................................................ 63
Detailed Synthesis—Child or Parent Training or Behavioral Interventions ........................ 65
Findings in Relation to What Is Already Known—Child or Parent Training or Behavioral
Interventions ......................................................................................................................... 67
Strength of Evidence—Child or Parent Training or Behavioral Interventions..................... 67
Detailed Synthesis—Omega-3/6 Fatty Acid Supplementation............................................. 69
Findings in Relation to What Is Already Known—Omega-3 Fatty Acid Supplementation. 71
Strength of Evidence—Omega-3 Supplementation .............................................................. 71
Detailed Synthesis—Herbal Interventions or Dietary Approaches ...................................... 74
Strength of Evidence—Herbal Interventions or Dietary Approaches .................................. 75
Detailed Synthesis—Other Approaches ............................................................................... 77
Findings in Relation to What Is Already Known—Other Approaches ................................ 77
Strength of Evidence—Other Approaches............................................................................ 77
Key Question 3: ADHD Monitoring ........................................................................................ 79
Discussion..................................................................................................................................... 80
Key Findings and Strength of Evidence ................................................................................... 80
KQ 1: ADHD Diagnosis ....................................................................................................... 80
KQ 2: ADHD Treatment ....................................................................................................... 80
Findings in Relation to What Is Already Known...................................................................... 84
Applicability ............................................................................................................................. 89
Implications for Clinical and Policy Decisionmaking ............................................................... 90
Limitations of the Systematic Review Process ......................................................................... 91
Research Recommendations ..................................................................................................... 91
KQ 1: ADHD Diagnosis Research Gaps .............................................................................. 92
KQ 2: ADHD Treatment Research Gaps .............................................................................. 92
KQ 3: ADHD Monitoring Research Gaps ............................................................................ 93
Conclusions ............................................................................................................................... 93
References .................................................................................................................................... 94
Acronyms and Abbreviations .................................................................................................. 109

Tables
Table 1. Inclusion and exclusion criteria ...................................................................................... 10
Table 2. Definition of quality assessment ratings ......................................................................... 16

xi
Table 3. Required domains: Definitions and scores ..................................................................... 18
Table 4. Definition of strength of evidence grades ....................................................................... 20
Table 5. Ages of individuals represented in included ADHD studies .......................................... 23
Table 6. Description of available tools for ADHD assessment .................................................... 27
Table 7. Strength of evidence for major outcomes—diagnosis .................................................... 36
Table 8. Strength of evidence for major outcomes—labeling/stigma .......................................... 37
Table 9. Strength of evidence for major outcomes—comparisons between pharmacologic and
placebo/usual care treatments ....................................................................................................... 43
Table 10. Strength of evidence for major outcomes—comparisons of pharmacologic treatments
....................................................................................................................................................... 49
Table 11. Characteristics of included studies ............................................................................... 51
Table 12. Strength of evidence for major outcomes—comparisons between pharmacologic and
nonpharmacologic treatments ....................................................................................................... 54
Table 13. Strength of evidence for major outcomes—neurofeedback ......................................... 59
Table 14. Strength of evidence for major outcomes—cognitive training ..................................... 62
Table 15. Strength of evidence for major outcomes—cognitive behavioral therapy ................... 64
Table 16. Strength of evidence for major outcomes—child or parent training or behavioral
interventions .................................................................................................................................. 68
Table 17. Strength of evidence for major outcomes—omega-3 fatty acid supplementation........ 72
Table 18. Strength of evidence for major outcomes—herbal interventions or dietary approaches
....................................................................................................................................................... 76
Table 19. Strength of evidence for major outcomes—other approaches ...................................... 78
Table 20. Summary strength of evidence for major outcomes for KQ 2 ...................................... 82
Table 21. Differences in scope between the 2011 and current evidence reports .......................... 85
Table 22. Potential issues with applicability of included studies for Key Question 1.................. 89
Table 23. Potential issues with applicability of included studies for Key Question 2.................. 90
Figures
Figure 1. Analytic framework for ADHD....................................................................................... 7
Figure 2. Literature flow diagram ................................................................................................. 22
Figure 3. Meta-analysis for effects of omega-3/6 supplementation compared with placebo—
parent ratings ................................................................................................................................. 70
Figure 4. Meta-analysis for effects of omega-3/6 supplementation compared with placebo—
teacher ratings ............................................................................................................................... 70
Appendixes
Appendix A. Exact Search Strings
Appendix B. Data Abstraction Elements
Appendix C. List of Included Studies
Appendix D. List of Excluded Studies
Appendix E. Key to Included Primary and Companion Articles
Appendix F. Characteristics of Included Studies
Appendix G. Overview of Included Studies
Appendix H. Data Tables

xii
Introduction
Background
Attention deficit hyperactivity disorder (ADHD) is a common neurobehavioral disorder, with
about 11 percent of children ages 4 through 17 having been diagnosed.1 In the United States,
there are significant geographical variations in the rate of diagnosis and treatment, and the
prevalence has increased over time.1, 2 The most recent Diagnostic and Statistical Manual of
Mental Disorders (DSM-5)3 has revised the diagnostic criteria for ADHD. To be diagnosed with
ADHD, a child or younger adolescent needs to meet six out of nine possible inattentive
symptoms (such as failing to give close attention to details or being easily distracted) and/or six
out of nine possible hyperactivity/impulsivity symptoms (such as being “on the go” or difficulty
waiting their turn). Also, symptoms need to be present for at least 6 months, occur in at least two
different settings, be present before 12 years of age, and not be better explained by another
disorder. For older adolescents and adults, the number of required symptoms per category is
reduced to five out of nine. ADHD has three presentations: (1) predominantly inattentive, (2)
predominantly hyperactive/impulsive, and (3) combined, based on how many symptoms in each
diagnostic category an individual meets. ADHD that does not clearly fall into these categories
can be referred to as ADHD-Not Otherwise Specified.
Psychostimulants can be effective in reducing distractibility, improving sustained attention,
reducing impulsive behaviors, and improving activity level.4 Nonpharmacologic therapies (e.g.,
behavioral therapy, psychotherapy, psychosocial interventions, and complementary and
alternative medicine interventions), either alone or in combination with medication management,
could potentially address core symptoms of ADHD or the long-term impairments that are
associated with the disorder. Understanding the role of nonpharmacologic therapies can be
challenging because they encompass a broad range of approaches to care, ranging from highly
structured behavioral interventions to complementary medicines.
Despite growing research on treatment for ADHD and awareness of the condition’s course of
illness, important questions remain about ADHD diagnosis and management. Ensuring
appropriate diagnosis and avoidance of misdiagnosis is a key concern for clinical practice. For
treatment, Key Questions include how to best tailor therapy to individuals based on their
characteristics (e.g., age, sex, ADHD symptoms, comorbid conditions, prior and current therapy)
and how to efficiently and effectively monitor individuals with ADHD over time.

Population
This systematic review focuses on children through 17 years of age, categorized to reflect
broad developmental stages (less than 4 years, 4 through 6 years, 7 through 12 years, and 13
through 17 years). We explored the impact of ADHD and its treatment and monitoring strategies
in several subgroups of interest. These include sex because the clinical presentation can vary as
can the response to therapy.5
Many risk factors have been associated with ADHD, including prenatal factors (e.g., tobacco
use, alcohol use, substance abuse), perinatal factors (e.g., low birth weight, prematurity), and
early postnatal factors (e.g., lead exposure, social environment).6 Also, family history of ADHD
and specific genetic conditions (e.g., Fragile X syndrome) can be associated with ADHD. We
evaluated these subpopulations by stratifying outcomes based on common these risk factors
when available.

1
Diagnosis
ADHD diagnosis is based on clinician assessment to determine whether the criteria described
in the DSM are met. For this review, studies based on the DSM-5 or DSM-IV criteria were
included. Rating scales, which can be completed by parents, teachers, and/or patients, are used to
evaluate the presence of each of the 18 symptoms as well as the degree of impairment that results
from symptoms. Rating scale data are integrated with a clinical interview to determine the onset,
course, duration, and impairment associated with symptoms. In addition, screening and clinical
evaluation of potential comorbid psychiatric conditions is a key part of the diagnostic process.
Important questions remain about the accuracy of this approach in primary care settings. A
particular challenge in primary care has been the lack of adequate time and expertise to
distinguish ADHD from other conditions that may appear similar (e.g., anxiety, conduct
disorders, speech or language delay, other developmental disorders) and to determine whether
another condition may better explain ADHD symptoms or is present as a comorbid diagnosis.7
Although most previous research has relied on interviews and rating scales for diagnosis, the
U.S. Food and Drug Administration (FDA) has recently approved a new device “to aid in the
diagnosis of ADHD.”8 The Neuropsychiatric Electroencephalograph [EEG]-Based Assessment
Aid (NEBA; NEBA Health, Augusta, GA) was approved to provide clinical support for an
ADHD diagnosis in patients ages 6–17 years but is not intended to replace the clinical
evaluation.8 There is significant interest in the use of tests to either supplement or replace the
standard methods of diagnosis used in the primary care setting.

Adverse Effects of Diagnosis


Being diagnosed with ADHD can lead to “labeling harms,” which can lead to stigma,
reduced self-esteem, or reduced future educational attainment or career opportunities.9-11
Misdiagnosis can lead to overdiagnosis or underdiagnosis and can also miss conditions that can
be similar in appearance to ADHD (e.g., anxiety, conduct disorders, speech or language delay,
other medical disorders/diseases, or other developmental disorders) that may warrant a different
course of treatment.

Treatment Strategies
Treatment strategies for ADHD can be divided into pharmacologic and nonpharmacologic
therapies. The main categories of pharmacologic therapies include stimulants, selective
norepinephrine reuptake inhibitors, alpha-2 agonists, and antidepressants. Nonpharmacologic
therapies include psychosocial interventions, behavioral interventions, school interventions,
cognitive training therapies, learning training, biofeedback or neurofeedback, parent behavior
training (i.e., training parents to reduce unwanted behaviors, foster desired behaviors and
interactions, and improve family relationships), dietary supplements (e.g., omega-3 fatty acids,
vitamins, herbal supplements, probiotics), elimination diets, vision training, and chiropractic
treatment. For the first line of therapy, the American Academy of Pediatrics (AAP) recommends
behavior therapy for children 4–5 years of age and preferably both behavior therapy and FDA-
approved medications for children 6–18 years of age.12

2
Adverse Effects of Treatment
Adverse effects associated with pharmacologic treatment can include changes in appetite,
growth suppression,13 weight decrease, sleep disturbance, gastrointestinal symptoms, elevated
blood pressure, increased heart rate, risk of sudden cardiac death, cardiac arrhythmias,
conduction abnormalities, tics or other movement disorders, behavior changes, hallucination,
aggression, suicide (attempted or completed), and suicidal ideation. Importantly, suicide and
suicidal ideation can be both an adverse effect of treatment and an ADHD-related health
outcome. Treatment can also lead to personality changes or loss of spontaneity as perceived by
the treated individual, family members, or other close acquaintances.
Individuals who are initially misdiagnosed may be overtreated, and those who have
inadequate monitoring may be overtreated or undertreated. Overtreatment leads to risk of
treatment with no or little potential benefit. Because many of the pharmacologic treatments are
controlled substances, overtreatment could also lead to abuse of a drug to which the treated
individual might not otherwise have access.14 Although reduction of ADHD symptoms can
improve family functioning, the need to provide treatments can potentially also lead to parental
stress, and depending on the specific treatment, there may be significant time demands,
opportunity, or financial costs.

Monitoring Strategies With Intermediate Outcomes


After a child is diagnosed with ADHD and an initial treatment strategy is determined, a
monitoring strategy is applied to ensure that outcomes are evaluated over time and modification
to treatments are made when needed. Stimulant prescription refills are often required monthly,
which can also support the need for frequent re-evaluations. Several instruments are available to
monitor treatment response and adverse effects over time, including the Vanderbilt scales, the
Conners scales, and the Swanson, Nolan, and Pelham Revision (SNAP-IV) rating scales.15-17
Monitoring also includes assessment of any adverse effects of treatment. There are variations in
the frequency of monitoring, often based on the age of the child, the specific treatment, duration
of treatment, previous symptoms and comorbid conditions, and family and health care provider
preferences. Rating scale results are intermediate monitoring outcomes associated with the
outcomes described below.

Long-Term Outcomes
Outcomes associated with ADHD in childhood are based on measures of performance and/or
functional impairment. In childhood and adolescence, individuals with ADHD are at risk for
lower academic performance (e.g., grades, scores on standardized tests), lower rates of
graduation from high school, higher rates of grade retention, and higher rates of school
suspension. In adulthood, outcomes may include limited workforce participation and/or difficulty
maintaining a steady job. Throughout the lifespan, social outcomes associated with ADHD may
include problematic peer and family relationships. Individuals with ADHD are also at risk for
negative outcomes associated with risk-taking behaviors such as motor vehicle collisions or other
accidents, substance use (e.g., higher rates of smoking, more difficulty quitting smoking), and
unprotected sexual activity. Mental health outcomes that are associated with ADHD include
higher rates of mood disorders, depression or anxiety, higher likelihood of having self-injurious
nonsuicidal behavior, suicide (attempted or completed), suicidal ideation, and risk of mortality.
Because these long-term outcomes can be associated with the known course of illness for

3
ADHD, with commonly occurring comorbid conditions or in some cases with ADHD treatment,
it can be difficult to fully assess and predict long-term outcomes for individuals with ADHD.

Key Findings From 2011 Report


This review updates previous Agency for Healthcare Research and Quality (AHRQ) reports
focused on ADHD treatment. This most recent report from 2011 focused on (1) pharmacologic
treatments for children under 6 years of age with ADHD and a disruptive behavior disorder; (2)
long-term comparative safety and effectiveness of various treatment options for children 6 years
of age or older with ADHD; and (3) prevalence of ADHD and rates of diagnosis and treatment
for ADHD. The 2011 report concluded that high strength of evidence (SOE) supported parent
behavior training and low SOE supported methylphenidate (MPH) for improving the behavior of
children aged 6 years or younger. The 2011 report also concluded that there was sparse evidence
at the time regarding long-term outcomes following interventions for ADHD, but that treatment
for 12 to 24 months with MPH or atomoxetine appeared to be associated with improvements in
symptomatic behavior. This current systematic review builds on the 2011 report and also
examines evidence on the diagnosis of ADHD. This report was developed to synthesize
information for clinicians, scientists, and families with children with ADHD or with children
suspected to have ADHD about the accuracy of diagnostic strategies and the harms and benefits
of establishing the diagnosis and treating the condition.
Although different in scope, the current report primarily builds on the foundation of the 2011
report.4 Key findings of that report included:
• Parent behavioral interventions show benefit for ADHD symptoms for children younger
than 6 years of age (high SOE).
• MPH is efficacious and generally safe for the treatment of ADHD symptoms for children
younger than 6 years (low SOE). However, the studies are of short duration (lasting days
to weeks).
• Psychostimulants provide control of ADHD symptoms and are well tolerated in children
6 years and older.
• Combined medication and behavioral treatment are effective in treating ADHD plus
oppositional defiant disorder symptoms, primarily in boys 7–9 years of age with
primarily combined type of ADHD.
• Sparse evidence at the time regarding long-term outcomes following interventions for
ADHD, but treatment for 12 to 24 months with MPH or atomoxetine appeared to be
associated with improvements in symptomatic behavior.

4
Scope and Key Questions
Scope of This Review
This review focuses on the diagnosis and management of ADHD within the primary care
practice setting or other settings in which care can be coordinated by primary care providers
(e.g., in partnership with community-based psychologists or psychiatrists). Although treatment of
ADHD in childhood and adolescence is the focus, this review also evaluates outcomes in
adulthood from treatment that occurs during childhood or adolescence.
Our review updates a 2011 review that focused on the effectiveness of ADHD treatment in
at-risk preschoolers, the long-term effectiveness of ADHD treatment in all ages, and the
variability in ADHD prevalence, diagnosis, and treatment.4 The current review builds on this
2011 report and addresses important gaps in knowledge related to the diagnosis of ADHD,
concerns about labeling with ADHD, and conflicting literature about the effectiveness of
treatment.

Rationale and Context


DSM-5 Criteria for Diagnosis
The DSM-5 criteria are the gold standard for the diagnosis of ADHD. However, most of the
previous studies were developed before the release of these criteria, which were released in 2013.
Compared with the DSM-IV, the DSM-5 criteria allow some symptoms to appear prior to 12
years of age compared with 7 years of age, so more adolescents fulfill the criteria. In addition,
DSM-5 permits the co-occurrence of autism spectrum disorder with the diagnosis of ADHD,
whereas these disorders could not be co-diagnosed in DSM-IV. The DSM-5 criteria emphasize
the life-long, chronic nature of ADHD and the need to monitor individuals over time.

Patient Preferences
There are differences in patient and family preferences related to both pharmacologic and
nonpharmacologic treatment18 and potential outcomes. These treatment preferences have been
shown to be associated with treatment initiation and choice. Findings from this systematic review
are intended to help inform patient and family decisions based on the benefits and harms of
specific treatments.

Other Factors
Two previous AHRQ evidence reports have addressed ADHD.4,19 Because of the number of
studies related to ADHD, this report builds on these previous reports with specific attention to
issues related to diagnosis, treatment, and management of children and adolescents. In the period
since the 2011 publication of the AAP clinical practice guideline,12 new medication formulations
have become available (e.g., MPH transdermal system and suspension, lisdexamfetamine,
amphetamine sulfate tablets, and dextroamphetamine sulfate tablets), and the DSM-5 has been
released, increasing clinical and decisionmaking uncertainty. A separate report on disruptive
behavior disorder is nearly complete and was therefore not targeted in this systematic review.
However, we do include disruptive behavior specifically related to ADHD.

Cost
Cost assessment was not included in this review.

5
Key Questions
The specific Key Questions (KQs) addressed in this review are listed below, and Figure 1
displays the analytic framework that guided our work.
• KQ 1: For the diagnosis of ADHD:
a. What is the comparative diagnostic accuracy of approaches that can be used in the
primary care practice setting or by specialists to diagnose ADHD among
individuals younger than 7 years of age?
b. What is the comparative diagnostic accuracy of EEG, imaging, or approaches
assessing executive function that can be used in the primary care practice setting
or by specialists to diagnose ADHD among individuals aged 7 through 17?
c. For both populations, how does the comparative diagnostic accuracy of these
approaches vary by clinical setting, including primary care or specialty clinic, or
patient subgroup, including age, sex, or other risk factors associated with ADHD?
d. What are the adverse effects associated with being labeled correctly or incorrectly
as having ADHD?
• KQ 2: What are the comparative safety and effectiveness of pharmacologic and/or
nonpharmacologic treatments of ADHD in improving outcomes associated with ADHD?
How do these outcomes vary by presentation (inattentive, hyperactive/impulsive, and
combined) or other comorbid conditions? What is the risk of diversion of pharmacologic
treatment?
• KQ 3: What are the comparative safety and effectiveness of different monitoring
strategies to evaluate the effectiveness of treatment or changes in ADHD status (e.g.,
worsening or resolving symptoms)?
The analytic framework presented in Figure 1 illustrates the population, interventions,
outcomes, and adverse effects that guided the literature search and synthesis. This figure shows
how individuals through 17 years of age without ADHD may be diagnosed and treated for
ADHD, and how treatment is associated with a range of potential adverse effects and outcomes.4
KQ 1 evaluates the comparative accuracy of approaches used to diagnose ADHD, including how
the diagnostic accuracy varies by setting, patient subgroup, or other risk factors. For children
younger than 7 years, we included any method available to primary care clinicians (KQ 1a).
However, for children 7 through 17 years, we focused on novel approaches only because other
reports have assessed the standard screening instruments used for older children. Although the
studies were not restricted to primary care settings, the methods have to be ones available
directly or easily upon referral to primary care clinicians based on feedback from the Technical
Expert Panel and internal clinical experts. KQ 1 also addresses adverse effects of ADHD
diagnosis. KQ 2 considers the comparative safety and effectiveness of pharmacologic and
nonpharmacologic treatments for ADHD and how the outcomes vary by presentation or other
comorbid conditions. KQ 2 also addresses adverse effects of ADHD treatment. KQ 3 considers
the comparative safety and effectiveness of different monitoring strategies to evaluate the
effectiveness of treatment or changes in ADHD status over time.

6
Figure 1. Analytic framework for ADHD

MONITORING KQ 3 Final Outcomes


• Academic performance
• Workforce participation
Individuals • Quality of peer relationships
birth–17 years of • Divorce/relationship status
age without ADHD • Motor vehicle collisions or other
Intermediate Outcomes accidents
diagnosis
• Standardized symptom scores • Motor vehicle violations
• Clinical setting
• Progress toward patient- • Risk-taking behaviors
• Age DIAGNOSIS KQ 1 TREATMENT KQ 2
ADHD Diagnosis identified goals • Incarceration or other legal
• Sex
• Acceptability of treatment system involvement
• Race/ethnicity • Pharmacologic • Functional impairment • Obesity
• Socioeconomic • Nonpharmacologic • Changes in treatment or dose • Tobacco use
status
• Insurance status • Substance abuse
• Geographic KQ 1 KQ 2 • Mood disorders
Adverse Effects of Treatment • Depression or anxiety
location
• Appetite changes • Self-injurious nonsuicidal behavior
• Risk factors Adverse Effects of
• Growth suppression • Suicide (attempted/completed)
• Presentation Diagnosis
• Weight decrease • Suicidal ideation
• Comorbidities • Labeled correctly
• Sleep disturbance • Mortality
or incorrectly
• Gastrointestinal symptoms
• Elevated blood pressure
• Increased heart rate
• Sudden cardiac death
• Cardiac arrhythmias
• Conduction abnormalities
• Tics or other movement disorders
• Behavior changes
• Hallucination
• Aggression
• Suicide (attempted/completed)
• Suicidal ideation
• Overtreatment
• Diversion
• Parental stress
• Personality change
• Time demands/opportunity cost
• Loss of spontaneity

7
Organization of This Report
The remainder of the review first presents our methods followed by an overview of the
results of the updated systematic review. Each results section also describes “Findings in
Relation to What Is Known” to provide appropriate context for the reader. We then synthesize
the literature and provide summary tables and SOE grades for the outcomes. The discussion
section offers our conclusions, summarizes our findings, and provides other information relevant
to interpreting this work for clinical practice and future research. Within the discussion we also
include a summary table of how this updated systematic review compares and contrast to the
2011 AHRQ report in terms of the KQs addressed, populations and outcomes of interest, and the
findings of the review.
Appendix A contains the exact search strings for the literature searches. Appendix B presents
the data elements abstracted from the included studies. Appendix C lists the included studies.
Appendix D lists the excluded studies and the reason for exclusion. Appendix E provides a key
to the primary and companion articles. Appendix F presents details on the study characteristics
of included studies. Appendix G presents an overview of included studies. Appendix H presents
detailed data tables for the different outcomes and comparisons of interest.
A list of acronyms and abbreviations is at the end of this report.

8
Methods
For this comparative effectiveness review, we followed the methods from the Agency for
Healthcare Research and Quality (AHRQ)’s Methods Guide for Effectiveness and Comparative
Effectiveness Reviews (hereafter referred to as the Methods Guide) for the Evidence-based
Practice Center (EPC) program.20 We sought feedback regarding the conduct of the work (such
as development of search strategies and identifying outcomes of key importance) from the Task
Order Officer and the Technical Expert Panel. Our methods map to the Preferred Reporting
Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist.21 All methods and
analyses were determined a priori.

Topic Refinement and Review Protocol


During topic refinement, we engaged in a public process to develop a draft and final protocol
for the review. We generated an analytic framework, preliminary Key Questions (KQs), and
preliminary inclusion/exclusion criteria in the form of PICOTS (populations, interventions,
comparators, outcomes, timing, settings). Initially a panel of 9 key informants representing
medical professionals with expertise in areas of family medicine, child and adolescent
psychiatry, psychology, and pediatrics; payers; Federal agencies; and patients/caregivers gave
input on the KQs to be examined; these KQs were posted on AHRQ’s Effective Health Care
(EHC) Web site for public comment from June 17, 2015, to July 8, 2015, and were revised to
refine the scoping for KQ 1 and KQ 2, clarify the exclusion of pre–post studies, and update the
grey literature to be searched. These revisions were made prior to seeing the results of any
studies.
We then drafted a protocol for the systematic review and recruited a panel of technical
experts to provide clinical content and methodological expertise throughout the development of
the review. This panel included medical professional and Federal agency representation similar
to that of the key informant group. The finalized protocol is posted on the EHC Web site
(www.effectivehealthcare.ahrq.gov). The PROSPERO registration is CRD42016029134.

Literature Search Strategy


Search Strategy
To identify relevant published literature, we searched MEDLINE® (via PubMed), Embase®,
PsycINFO®, and the Cochrane Database of Systematic Reviews (CDSR), limiting the search to
studies conducted in children 17 years of age and younger and published from January 1, 2009,
to November 7, 2016. These databases were selected based on internal expert opinion that they
would identify most of the relevant literature on this topic and following prior related systematic
reviews. We believe that the evidence published from 2009 forward both represents the current
standard of care for the population of interest in this review and allows this report to build on the
previous systematic review published in 2011 (which included literature through May 31, 2010).4
We used a combination of medical subject headings and title and abstract keywords, focusing
on terms to describe the relevant population and interventions of interest. Exact search strings
used for each KQ are in Appendix A. Where possible, we used existing validated search filters.
An experienced search librarian guided all searches. We supplemented the electronic searches
with a manual search of citations from a set of key primary and review articles.22-79 The
reference list for identified pivotal articles was hand-searched and cross-referenced against our

9
database, and additional relevant manuscripts were retrieved. All citations were imported into an
electronic bibliographical database (EndNote® Version X7; Thomson Reuters, Philadelphia, PA).
To identify relevant gray literature, the EPC Scientific Resource Center made requests to
drug and device manufacturers for scientific information packets solicited through the AHRQ
EHC Web site. We also searched study registries for relevant articles from completed studies.
Gray literature databases included ClinicalTrials.gov, the World Health Organization
International Clinical Trials Registry Platform search portal, and the National Guidelines
Clearinghouse.
As an additional step in identifying adverse effects of interest, we reviewed the known
adverse effects of attention deficit hyperactivity disorder (ADHD) medications monitored by the
Food and Drug Administration (FDA).80 As a result of that assessment, we added two additional
outcomes to consideration for this review: chemical leukoderma and priapism.

Inclusion and Exclusion Criteria


We specified our inclusion and exclusion criteria based on the PICOTS (Populations,
Interventions, Comparators, Outcomes, Timing, Settings) identified in topic refinement. Table 1
specifies inclusion and exclusion criteria.
Table 1. Inclusion and exclusion criteria

PICOTS
Inclusion Criteria Exclusion Criteria
Element
Populations KQ 1: Individuals birth through 17 years of age without Individuals 18 years of age or older.
the diagnosis of ADHD, divided by subquestion as Note that studies with individuals
follows: greater than 18 years of age are
• KQ 1a considers the initial diagnosis of individuals included as long as findings are
under 7 years of age. reported separately for individuals 18
years and under, or if the mean patient
• KQ 1b considers the initial diagnosis of individuals age plus the standard deviation is not
through 17 years of age using EEG, imaging, or greater than 21 years of age. Also note
executive function approaches. that for long-term studies, the age of
• KQs 1c and 1d considers both populations. the individuals may be greater than 18,
but these studies are only considered
KQ 2: Individuals birth through 17 years of age with a for inclusion if the age at enrollment in
diagnosis of ADHD the study was 18 years or younger.

KQ 3: Individuals birth through 17 years of age who


Administrative claims data used for
have previously begun treatment for ADHD
diagnosis of ADHD
Subgroups of interest for KQs 1-3:
• The general population of children and
adolescents: ages less than 4, 4–6, 7–12, and 13–
17 years
• When data are available, findings are separately
evaluated by sex or specific risk factors (prenatal
tobacco, alcohol, or substance abuse; prematurity
or low birth weight; and family history); ADHD
presentation; comorbidity; race/ethnicity;
socioeconomic status; insurance status;
geographic location

10
Interventions KQ 1: Any standard ADHD diagnostic strategy, KQ 1: Validation studies or diagnosis
including clinician interview or standardized instrument conducted using a nonvalidated
(e.g., Vanderbilt scales, the Conner scales, and the instrument
SNAP-IV rating score) for individuals under 7 years of
age. The use of EEG-based systems, imaging, or
assessment of executive function were evaluated in the KQ 2: Studies comparing
diagnosis of ADHD in individuals through 17 years of pharmacologic agents approved by the
age. FDA for the treatment of ADHD that
have enrollment of fewer than 100
KQ 2: Any pharmacologic or nonpharmacologic patients with ADHD, or less than 6
treatment of ADHD, alone or in combination: months of follow-up
• Pharmacologic treatments considered are
brand name and generic formulations of the
following medicationsa:
o Psychostimulants
 Methylphenidate (MPH)
 Dexmethylphenidate (D-TMP)
 Dextroamphetamine (DEX)
 Lisdexamfetamine (LDX)
 Mixed amphetamine salts (MAS)
 Amphetamine
o Tricyclic antidepressants
 *Desipramine
 *Nortriptyline
o Selective norepinephrine reuptake inhibitors
 Atomoxetine (ATX)
o Alpha-2 agonists
 Clonidine
 Guanfacine extended release (GXR)
 *Guanfacine immediate release (GIR)
o Dopamine reuptake inhibitors
 *Modafinil
 *Armodafinil
o Norepinephrine-dopamine reuptake inhibitors
 *Bupropion
o Serotonin-norepinephrine reuptake inhibitors
 *Duloxetine
o Serotonin-norepinephrine-dopamine reuptake
inhibitors
 *Venlafaxine
o Monoamine oxidase type B inhibitors
 *Selegiline
o N-methyl-D-aspartate receptor antagonists
 *Amantadine
 *Memantine
• Nonpharmacologic therapies considered include
psychosocial interventions, behavioral
interventions, cognitive behavioral therapy, play
therapy, mindfulness-based therapies, school
interventions, cognitive training therapies,
biofeedback or neurofeedback, parent behavior
training, dietary supplements (e.g., omega-3 fatty
acids, vitamins, herbal supplements, probiotics),
homeopathy, acupuncture, elimination diets,
vision training, exercise, and chiropractic
treatment.

KQ 3: Follow-up visits in primary care with various


methods and within times (monthly to annually) for
repeat monitoring, independent of treatment.

11
PICOTS
Inclusion Criteria Exclusion Criteria
Element
Comparators KQ 1: Confirmation of diagnosis by a specialist (gold KQ 1: Comparison to diagnosis with a
standard), including psychologist or psychiatrist or other nonvalidated instrument
care provider using a well-validated and reliable
process of confirming the diagnosis of ADHD according
to the DSM-4 or DSM-5.

KQ 2: Specific treatments compared with other


treatments as described above or to no treatment.

KQ 3: Follow-up compared with differing durations of


follow-up or differing settings of follow-up.

12
Outcomes KQ 1:
• Accuracy of diagnostic strategy, as measured by:
o Diagnostic concordance of primary care
provider with specialist
o Inter-rater reliability
o Internal consistency
o Test-retest
o Sensitivity
o Specificity
o Positive predictive value
o Negative predictive value
o False positives
o False negatives
o Risk of missed condition that can appear as
ADHD (i.e., misdiagnosis)
• Labeling is any measure of stigma following
diagnosis comparing those with and without
ADHD.

KQ 2:
• Intermediate outcomes:
o Changes on standardized symptom scores or
progress toward patient-identified goals.
Standardized symptom scores include
narrow-band focused instruments (Vanderbilt
rating scales, ADHD Rating Scale) and
broad-band scales (Child Behavior Checklist
and Teacher Report Form, Behavior
Assessment System for Children, Conners’
Rating Scales-Revised, Conners’ 3 Parent,
Conners’ 3 Teacher)
o Acceptability of treatment
o Functional impairment (assessed using the
Clinical Global Impressions [CGI] scale or the
Impairment Rating Scale [IRS])
• Final outcomes include:
o Academic performance
 Academic Performance Rating Scale
 Academic Competency Evaluation Scale
(ACES)
 (Actual) School grades
 Grade Retention/Not being promoted
 Vanderbilt Teacher Form Academic
Performance Subscale
 Standardized achievement tests (WIAT,
WJ, WRAT)
o Workforce participation
o Quality of peer relationships
o Divorce/relationship status
o Motor vehicle collisions or other accidents
o Motor vehicle violations
o Risk-taking behaviors
o Incarceration or other interactions with the
legal system (juvenile detention, probation,
court-mandated interventions, need for
residential placement)
o Obesity
o Tobacco use
o Substance abuse
o Mood disorders
o Depression or anxiety

13
PICOTS
Inclusion Criteria Exclusion Criteria
Element
o Self-injurious nonsuicidal behavior
o Suicide (attempted or completed)
o Suicidal ideation
o Mortality
• Adverse effects of treatment, including:
o Changes in appetite
o Growth suppression
o Weight decrease
o Sleep disturbance
o Gastrointestinal symptoms
o Elevated blood pressure
o Increased heart rate
o Risk of sudden cardiac death
o Cardiac arrhythmias
o Conduction abnormalities
o Tics or other movement disorders
o Behavior changes
o Hallucination
o Aggression
o Suicide (attempted or completed)
o Suicidal ideation
o Overtreatment
o Diversion of pharmacotherapy
o Parental stress
o Personality change
o Time demands/opportunity cost
o Loss of spontaneity
o Chemical leukoderma
o Priapism

KQ 3:
• Changes in treatment or dose
• Adverse effects of treatment as described under
KQ 2
• Changes in intermediate outcomes (e.g.,
standardized symptom scores, progress toward
patient-identified goals, functional impairment) as
described under KQ 2
Timing KQ 1:
• For assessment of diagnostic accuracy: diagnostic
follow-up must be within 4 months of the initial
evaluation and must be completed before
treatment is initiated
• For labeling: any time after the ADHD diagnosis

KQs 2 and 3: Any


Settings KQ 1: Primary or specialty care settings None

KQs 2 and 3: Any

14
PICOTS
Inclusion Criteria Exclusion Criteria
Element
Study design • Original data Editorials, nonsystematic reviews,
• Randomized trials, prospective and retrospective letters, case series, case reports,
observational studies with comparator; for abstract-only, pre-post studies
diagnostic accuracy, cross-sectional studies are
acceptable if they include patients with diagnostic Because studies with fewer than 20
uncertainty and direct comparison of diagnosis in subjects are often pilot studies or
primary care to diagnosis by a specialist studies of lower quality, we excluded
them from our review. Given the large
• Randomized controlled trials with sample size:
evidence base for comparative
o ≥20 subjects for KQs 1 and 3
pharmacologic treatment studies in
o ≥50 subjects for KQ 2 (or 100 subjects for
KQ2 we increased this sample size
studies comparing two or more
limit to 50 subjects for KQ2 and to 100
pharmacologic treatments approved by
subjects for studies comparing two or
the FDA for the treatment of ADHD)
more pharmacologic treatments
• Observational studies with sample size:
approved by the FDA for the treatment
o ≥20 subjects for KQs 1 and 3 of ADHD. These sample size limits
o ≥50 subjects for KQ 2 (or 100 subjects for were seen as representing population
studies comparing two or more
study sizes that would be needed to
pharmacologic treatments approved by
substantially impact the assessment of
the FDA for the treatment of ADHD)
the existing evidence base.
Publications • English-language publications only Non-English language articlesc
• Published on or after January 1, 2009
• Relevant systematic reviews, meta-analyses, or
methods articles (used for background only)b
aPharmacologic treatments listed are FDA-approved for an indication of ADHD with the exception of those marked with an

asterisk, which are available within the United States and are FDA-approved but not specifically approved for ADHD.
bSystematic reviews and meta-analyses were excluded from direct abstraction; those representing key sources were hand-

searched as potential sources of additional citations to consider in the review.


cNon-English language articles were excluded due to: (1) the high volume of literature available in English language

publications, (2) the focus of our review on applicability to populations in the United States, and (3) the scope of our KQs.
Abbreviations: ADHD=attention deficit hyperactivity disorder; ATX=atomoxetine; DEX=dextroamphetamine; CGI=Clinical
Global Impressions scale; DSM=Diagnostic and Statistical Manual of Mental Disorders; D-TMP=dexmethylphenidate;
EEG=electroencephalograph; GIR=Guanfacine immediate release; GXR=guanfacine extended release; IRS=Impairment Rating
Scale; KQ=Key Question; LDX=lisdexamfetamine; MAS=mixed amphetamine salts; MPH=methylphenidate;
PICOTS=Populations, Interventions, Comparators, Outcomes, Timing, Settings; RCT=randomized controlled trial; WIAT=
Wechsler Individual Achievement Test; WJ=Woodcock-Johnson; WRAT=Wide Range Achievement Test

Study Selection
For citations retrieved from MEDLINE, Embase, PsycINFO, and CDSR, two reviewers used
the prespecified inclusion/exclusion criteria to review titles and abstracts for potential relevance
to the research questions. Articles included by either reviewer underwent full-text screening. At
the full-text screening stage, two independent reviewers were required to agree on a final
inclusion/exclusion decision. Disagreements were resolved by a third expert member of the team.
Articles meeting eligibility criteria were included for data abstraction. At random intervals
during screening, quality checks by senior team members were made to ensure that screening
and abstraction were consistent with inclusion/exclusion criteria and abstraction guidelines. All
results were tracked using the DistillerSR data synthesis software program (Evidence Partners
Inc., Manotick, ON, Canada).
Appendix C provides a list of all articles included for data abstraction. Appendix D provides
a list of articles excluded at the full-text screening stage, with reasons for exclusion.

15
Data Extraction
The research team created abstraction forms that were programmed into DistillerSR software
to collect the data required to evaluate the specified eligibility criteria for inclusion in this
review, as well as demographic and other data needed for determining outcomes (intermediate,
final, and adverse events outcomes). Particular attention was given to describing the details of
the treatment (e.g., pharmacotherapy dosing, methods of behavioral interventions), patient
characteristics (e.g., ADHD presentation, comorbidities, age), and study design (e.g., randomized
controlled trial [RCT] versus observational) that may be related to outcomes. Comparators were
described carefully because treatment standards may have changed during the period covered by
the review. The safety outcomes were framed to help identify adverse events, including those
from drug therapies and those resulting from misdiagnosis and labeling.
All data abstraction form templates were pilot-tested with a sample of included articles to
ensure that all relevant data elements (Appendix B) were captured and that there was consistency
and reproducibility between abstractors. Forms were revised as necessary before full abstraction
of all included articles. Final abstracted data will be uploaded to AHRQ’s Systematic Review
Data Repository.81
Based on clinical and methodological expertise, a pair of researchers abstracted data from
each of the eligible articles, with one researcher abstracting the data and the second over-reading
the article and the accompanying abstraction to check for accuracy and completeness.
Disagreements were resolved by consensus or by obtaining a third reviewer’s opinion if
consensus was not reached. To avoid duplication of patient cohorts, we linked related studies.

Quality Assessment of Individual Studies


We assessed the methodological quality, or risk of bias, for each individual study based on
the Cochrane Risk of Bias82 tool for randomized studies and the Newcastle-Ottawa Scale83 for
observational studies. We supplemented these tools with additional assessment questions, such
as use of appropriate analysis, based on recommendations in the AHRQ’s Methods Guide.20 We
rated each study as being of good, fair, or poor quality based on its adherence to well-accepted
standard methodologies. Table 2 defines these quality ratings, which are presented in the results
tables in the Results section as well as the strength of evidence (SOE) tables in the Discussion
section of the report.
Table 2. Definition of quality assessment ratings
Rating Definition
Good (low risk of bias) These studies had the least bias, and the results were considered valid. These
studies adhered to the commonly held concepts of high quality, including the
following: a clear description of the population, setting, approaches, and
comparison groups; appropriate measurement of outcomes; appropriate statistical
and analytical methods and reporting; no reporting errors; a low dropout rate; and
clear reporting of dropouts.
Fair These studies were susceptible to some bias, but not enough to invalidate the
results. They did not meet all the criteria required for a rating of good quality
because they had some deficiencies, but no flaw was likely to cause major bias.
The study may have been missing information, making it difficult to assess
limitations and potential problems.
Poor (high risk of bias) These studies had significant flaws that might have invalidated the results. They
had serious errors in design, analysis, or reporting; large amounts of missing
information; or discrepancies in reporting.

16
The grading was outcome-specific such that a given study that analyzed its primary outcome
well but did an incomplete analysis of a secondary outcome was assigned a different quality
grade for each of the two outcomes. Studies of different designs were graded within the context
of their respective design. Thus, RCTs were graded as good, fair, or poor, and observational
studies were separately graded as good, fair, or poor.

Data Synthesis
We began by summarizing key features of the included studies for each KQ. To the degree
that data were available, we abstracted information on study design; patient characteristics;
clinical settings; interventions; and intermediate, final, and adverse event outcomes. We ordered
our findings by treatment or diagnostic comparison and then within these comparisons by
outcome with long-term final outcomes emphasized. Existing systematic reviews were used to
identify potentially eligible studies. Individual studies from previous systematic reviews were not
directly synthesized with the included studies if they did not meet our inclusion criteria. We did
however compare the findings from our included studies with findings from key systematic
reviews.
We reviewed and highlighted studies using a hierarchy-of-evidence approach. The best
evidence available was the focus of our synthesis for each KQ. If high quality evidence was not
available, we described any lower quality evidence we were able to identify, but we underscored
the issues that made it lower quality and the uncertainties in our findings. We assessed and stated
whether the inclusion of lower quality studies would change any of our conclusions and
performed sensitivity analyses excluding this evidence where appropriate.
We then determined the feasibility of completing quantitative syntheses (i.e., meta-analyses).
Feasibility was dependent on the volume of relevant literature (we required 3 appropriate studies
to consider meta-analysis), conceptual homogeneity of the studies, and completeness of the
reporting of results. When a meta-analysis was appropriate, we used random-effects models to
synthesize the available evidence quantitatively. We tested for heterogeneity using graphical
displays and test statistics (Q and I2 statistics), while recognizing that the ability of statistical
methods to detect heterogeneity may be limited. We presented summary estimates, standard
errors, and confidence intervals. We anticipated that intervention effects may be heterogeneous.
We hypothesized that the methodological quality of individual studies, study type, the
characteristics of the comparator, and patients’ underlying clinical presentation were associated
with the intervention effects. When there were sufficient studies, we performed subgroup
analyses and/or meta-regression analyses to examine these hypotheses. We performed
quantitative and qualitative syntheses separately by study type and discussed their consistency
qualitatively. When only qualitative synthesis was possible, this was done through a narrative
description of the findings based on reasoned judgement rather than based on statistical
inference.

17
Strength of the Body of Evidence
We assessed the SOE using the approach described in AHRQ’s Methods Guide.20, 84 We
graded the SOE for each outcome assessed; thus, the SOE for two separate outcomes in a given
study may be graded differently. These grades are presented in the SOE tables in the Discussion
section of the report. The approach requires assessment of five domains: study limitations
(previously named risk of bias), consistency, directness, precision, and reporting bias, which
includes publication bias, outcome reporting, and analysis reporting bias (Table 3).84
Table 3. Required domains: Definitions and scores
Domain Definition and Elements Score and Application
Study Limitations Study limitations is the degree to which the included Score as one of three levels,
studies for a given outcome have a high likelihood of separately by type of study design:
adequate protection against bias (i.e., good internal
validity), assessed through two main elements: • Low level of study limitations
• Study design: Whether RCTs or other designs • Medium level of study
such as nonexperimental or observational limitations
studies. • High level of study limitations
• Study conduct. Aggregation of ratings of risk of
bias of the individual studies under consideration.
Directness Directness relates to (a) whether evidence links Score as one of two levels:
interventions directly to a health outcome of specific
importance for the review, and (b) for comparative • Direct
studies, whether the comparisons are based on head- • Indirect
to-head studies. The EPC should specify the
comparison and outcome for which the SOE grade If the domain score is indirect, EPCs
applies. should specify what type of
Evidence may be indirect in several situations such as: indirectness accounts for the rating.
• The outcome being graded is considered
intermediate (such as laboratory tests) in a
review that is focused on clinical health outcomes
(such as morbidity, mortality).
• Data do not come from head-to-head
comparisons but rather from two or more bodies
of evidence to compare interventions A and B—
e.g., studies of A vs. placebo and B vs. placebo,
or studies of A vs. C and B vs. C but not direct
comparisons of A vs. B.
• Data are available only for proxy respondents
(e.g., obtained from family members or nurses)
instead of directly from patients for situations in
which patients are capable of self-reporting and
self-report is more reliable.
Indirectness always implies that more than one body
of evidence is required to link interventions to the most
important health outcome.
Consistency Consistency is the degree to which included studies Score as one of three levels:
find either the same direction or similar magnitude of
effect. EPCs can assess this through two main • Consistent
elements: • Inconsistent
• Direction of effect: Effect sizes have the same • Unknown (e.g., single study)
sign (that is, are on the same side of no effect or
a minimally important difference [MID]) Single-study evidence bases
• Magnitude of effect: The range of effect sizes is (including mega-trials) cannot be
similar. EPCs may consider the overlap of CIs judged with respect to consistency.
when making this evaluation. In that instance, use “Consistency
The importance of direction vs. magnitude of effect will unknown (single study).”
depend on the Key Question and EPC judgments.

18

Domain Definition and Elements Score and Application


Precision Precision is the degree of certainty surrounding an Score as one of two levels:
effect estimate with respect to a given outcome, based
on the sufficiency of sample size and number of • Precise
events. • Imprecise
• A body of evidence will generally be imprecise if
the optimal information size (OIS) is not met. OIS A precise estimate is one that would
refers to the minimum number of patients (and allow users to reach a clinically
events when assessing dichotomous outcomes) useful conclusion (e.g., treatment A
needed for an evidence base to be considered is more effective than treatment B).
adequately powered.
• If EPCs performed a meta-analysis, then EPCs
may also consider whether the CI crossed a
threshold for an MID.
• If a meta-analysis is infeasible or inappropriate,
EPCs may consider the narrowness of the range
of CIs or the significance level of p values in the
individual studies in the evidence base.
Reporting Bias Reporting bias results from selectively publishing or Score as one of two levels:
reporting research findings based on the favorability of
direction or magnitude of effect. It includes: • Suspected
• Study publication bias; i.e., nonreporting of the • Undetected
full study.
• Selective outcome reporting bias; i.e., Reporting bias is suspected when:
nonreporting (or incomplete reporting) of planned • Testing for funnel plot
outcomes or reporting of unplanned outcomes. asymmetry demonstrates a
• Selective analysis reporting bias, i.e., reporting of substantial likelihood of bias,
one or more favorable analyses for a given And/or
outcome while not reporting other, less favorable • A qualitative assessment
analyses. suggests the likelihood of
Assessment of reporting bias for individual studies missing studies, analyses, or
depends on many factors–e.g. availability of study outcomes data that may alter
protocols, unpublished study documents, and patient- the conclusions from the
level data. Detecting such bias is likely with access to reported evidence.
all relevant documentation and data pertaining to a
journal publication, but such access is rarely available. Undetected reporting bias includes
all alternative scenarios.
Because methods to detect reporting bias in
observational studies are less certain, this guidance
does not require EPCs to assess it for such studies.
CI=confidence internal; EPC=Evidence-based Practice Center; MID=minimally important difference; OIS=optimal information
size; RCT=randomized controlled trial

Additional domains were used when appropriate (most relevant to observational studies) and
included coherence, dose-response association, impact of plausible residual confounders, and
strength of association (magnitude of effect). These domains were considered qualitatively, and a
summary rating of high, moderate, or low SOE was assigned for each outcome after discussion
by two reviewers. In some cases, high, moderate, or low ratings were impossible or imprudent to
make, for example, when no evidence is available or when evidence on the outcome was too
weak, sparse, or inconsistent to permit any conclusion to be drawn. In these situations, a grade of
“insufficient” was assigned. Table 4 defines the four-level grading scale.

19

Table 4. Definition of strength of evidence grades


Rating Definition
High We are very confident that the estimate of effect lies close to the true effect for this outcome.
The body of evidence has few or no deficiencies. We believe that the findings are stable, i.e.,
another study would not change the conclusions.
Moderate We are moderately confident that the estimate of effect lies close to the true effect for this
outcome. The body of evidence has some deficiencies. We believe that the findings are likely
to be stable, but some doubt remains.
Low We have limited confidence that the estimate of effect lies close to the true effect for this
outcome. The body of evidence has major or numerous deficiencies (or both). We believe that
additional evidence is needed before concluding either that the findings are stable or that the
estimate of effect is close to the true effect.
Insufficient We have no evidence, we are unable to estimate an effect, or we have no confidence in the
estimate of effect for this outcome. No evidence is available or the body of evidence has
unacceptable deficiencies, precluding reaching a conclusion.

Applicability
We assessed applicability across our KQs using the method described in AHRQ’s Methods
Guide.20, 85 In brief, this method uses the PICOTS format as a way to organize information
relevant to applicability. The most important issue with respect to applicability is whether the
outcomes are different across studies that recruit different populations (e.g., age groups, ADHD
presentations, exclusions for comorbidities) or use different methods to implement the
interventions of interest; that is, important characteristics are those that affect baseline (control
group) rates of events, intervention group rates of events, or both. We used a checklist to guide
assessment of the applicability to clinical practice, paying special attention to study eligibility
criteria, demographic features of the enrolled population in comparison with the target
population, characteristics of the intervention used in comparison with care models currently in
use, the possibility of diagnostic tool or treatment intervention learning curves, and clinical
relevance and timing of the outcome measures (Appendix B). We summarized issues of
applicability qualitatively.

Peer Review and Public Commentary


Experts in the fields of pediatrics and child development, child psychiatry and psychology,
pharmacology, and public health were invited to provide external peer review of the draft report.
AHRQ, an associate editor, and members of the Technical Expert Panel were also given the
opportunity to provide comments. In addition, the draft report was posted on the AHRQ EHC
Web site for public comment from October 17, 2016, to November 14, 2016. We have addressed
all reviewer comments, revising the text as appropriate, and have documented our responses in a
disposition of comments report that will be made available 3 months after the Agency posts the
final systematic review on the EHC Web site. A list of peer reviewers submitting comments on
the draft report is provided in the front matter of this report.

20
Results
In what follows, we begin by describing the results of our literature searches. We then
provide a brief overview description of the included studies. The remainder of the chapter is
organized by Key Question (KQ). Under each of the three KQs, we begin by listing the key
points of the findings, followed by a brief description of included studies, a detailed synthesis of
the evidence, and a final discussion of the results in sections on “Findings in Relation to What Is
Known” to provide context for the reader. Within KQ 2, the detailed syntheses are organized
first by treatment comparison and then by outcome. We conducted quantitative syntheses where
possible, as described in the Methods chapter. For a list of the abbreviations, please refer to the
end of the report.

Results of Literature Searches


Figure 2 depicts the flow of articles through the literature search and screening process.
Searches of PubMed®, Embase®, PsycINFO®, and the Cochrane Database of Systematic
Reviews yielded 10,742 unique citations. Manual searching of gray literature databases and
bibliographies of key articles or referral by investigators identified 21 additional citations, for a
total of 10,763 citations. After applying inclusion/exclusion criteria at the title-and-abstract level,
1,263 full-text articles were retrieved and screened. Of these, 1,160 were excluded at the full-text
screening stage, leaving 103 articles for data abstraction. These 103 articles described 90 unique
studies. The relationship of studies to the review questions is as follows: 21 studies relevant to
KQ 1, 69 studies relevant to KQ 2, 0 studies relevant to KQ 3.
Appendix C provides a detailed listing of included articles. Appendix D provides a complete
list of articles excluded at the full-text screening stage, with reasons for exclusion. Appendix E
provides a “study key” table listing the primary and companion publications for the 90 included
studies.

21
Figure 2. Literature flow diagram

15,161 citations identified by


literature search:
PubMed: 5,457
Duplicates removed: 4,419
EMBASE: 4,769
PsycINFO: 4,911
Cochrane: 24

Citations identified through


gray lit/manual searching or
referral by investigators: 22

10,764 citations identified

9,501 abstracts excluded

1,263 passed abstract


screening

1,160 articles excluded:


- Not a full publication OR full text not available: 55
- Not available in English: 21
- Not original data: 43
- Not a study design of interest OR does not meet sample size
requirements: 513
- No study population of interest: 172
- No intervention of interest: 80
- No comparator of interest: 162
- No outcomes of interest : 110
- Timing or setting not applicable: 4

103 articles
representing 90 studies passed
full-text screening and were
included for abstraction

Data abstracted for 90 studies:


KQ 1: 21 studies
KQ 2: 69 studies
KQ 3: 0 studies

KQ=Key Question

22
Description of Included Studies: Overview
Overall, we included 103 articles representing 90 studies: 21 studies were relevant to KQ 1,
69 studies to KQ 2, and 0 studies to KQ 3. Studies were conducted wholly or partly in
continental Europe or the United Kingdom (UK) (35 studies, 38%), the United States or Canada
(23 studies, 25%), the Middle East (13 studies, 14%), Asia (12 studies, 13%), Latin America (3
studies, 3%), Australia/New Zealand (NZ) (3 studies, 3%), both in the United States and
UK/Europe (2 studies, 2%), both in UK/Europe and Australia/NZ (1 study, 1%), and location not
reported (1 study, 1%). Further details on the studies included for each KQ are provided in the
relevant results sections below and in Appendixes F and G.
Note that our 90 included studies focused on individuals of varying age. To help the reader,
we have categorized the included articles as (1) those that targeted children 6 years of age and
under, (2) those that targeted children aged 7 through 17, and (3) those that included children of
all ages through 17 years. Table 5 lists all included studies by these categorizations, and then
throughout the results tables we indicate which age categories the specific studies addressed.
Table 5. Ages of individuals represented in included ADHD studies
Age Category of Included
KQ Studies
Participants
KQ 1 Ages 6 and under Bunte,201386
Thorell, 201087
Ages 7 through 17 Berger, 201088
Bloch, 201289
dosReis, 201090
Ferrin, 201291
Kim, 201592
Kim, 201593
Klenberg, 201094
Liechti, 201395
Markovska-Simoska, 201696
Martin-Martinez, 201297
Ogrim, 201298
Ohan, 201199
Park, 2016100
Soliva, 2010101
Zelnik, 2012102
All ages through 17 Carballo, 2014103
Castro-Cabrera, 2010104
Caudal, 2011105
Gonzalez, 2013106
KQ 2 Ages 6 and under Abikoff, 2015107

23
Age Category of Included
KQ Studies
Participants
Ages 7 through 17 2013108
Abikoff,
Anand, 2016109
Arcieri, 2012110
Arnold, 2011111
Bai, 2015112
Banaschewski, 2014113
Barragan, 2014114
Beck, 2010115
Bink, 2015116
Boyer, 2015117
Cetin, 2015118
Chacko, 2014119
Clemow, 2015120
Cortese, 2015121
Dovis, 2015122
Didoni, 2011123
Duric, 2012124
Dutta, 2012125
Egeland, 2013126
Ercan, 2014127
Evans, 2016128
Ferrin, 2016129
Findling, 2010130
Gelade, 2016131
Gevensleben, 2009132
Gustafsson, 2010133
Hahn-Markowitz, 2016134
Hammerness, 2012135
Hariri, 2012136
Hong, 2015137
Huang, 2015138
Johnson, 2009139
Katz, 2010140
Li, 2011141
Manor, 2012142
Milte, 2012143
Mohammadpour, 2016 144
Mohammadi, 2012145
Molina, 2009146
Moreno-Garcia, 2015147
Newcorn, 2016148
Oberai, 2013149
Ostberg, 2012150
Panei, 2010151
Pfiffner, 2014152
Power, 2012153
Raz, 2009154
Salehi, 2010155
Sallee, 2009156
Sayer, 2016157
Shakibaei, 2015158
Sibley, 2016159
Steiner, 2014160
Storebo, 2012161
Trzepacz, 2011162
van der Donk, 2015163
Vidal, 2015164
Widenhorn-Muller, 2014165
Zhang, 2010166

24
Age Category of Included
KQ Studies
Participants
All ages through 17 2009167
Chacko,
Ferrin, 2014168
Hiscock, 2015169
Mautone, 2012170
Myers, 2015171
Pelsser, 2011172
Tobaiqy, 2011173
van Dongen-Boomsma, 2014174
Webster-Stratton, 2011175
ADHD=attention deficit hyperactivity disorder; KQ=Key Question

25
We searched the ClinicalTrials.gov study registry as a mechanism for ascertaining
publication bias by identifying studies that have been completed but are as yet unpublished. We
acknowledge that this is not an exhaustive strategy, as several other registries also exist with
differing geographical focus and varying degrees of overlap in their trial listings; however, in the
opinion of the investigators, the widely used, U.S.-based ClinicalTrials.gov registry provided the
most relevant information to the populations and interventions of interest in this review. Our
search yielded 348 records of completed trials in the ClinicalTrials.gov registry. Manual review
identified 51 of the records from ClinicalTrials.gov as potentially relevant to this review. Of
those 51 records, we were not able to identify publications for 7 studies that had expected
completion dates 3 years or more prior to our search. Of the 43 studies for which we could
identify publications, all were considered potentially relevant to KQ 2. However, all publications
had been previously identified in our PubMed, Embase, PsycINFO, and the Cochrane Database
of Systematic Reviews searches. No novel publications were identified from our clinical trial
registry searches.
Comparisons assessed in the 7 studies that did not have publications were pharmacologic
versus pharmacologic (3 studies176-178), pharmacologic versus placebo (4 studies176, 179-181), and
nonpharmacologic versus placebo (1 study182). One study contained three different arms
evaluating both pharmacologic versus pharmacologic and pharmacologic versus placebo
comparisons. We did identify trial results posted online for one study comparing
lisdexamfetamine dimesylate versus methylphenidate hydrochloride versus placebo, and we also
identified a press release for another study comparing a d-amphetamine transdermal system
versus a placebo patch, but no corresponding peer-reviewed articles were found. These 7 studies
if completed would add 1,357 patients to our analysis. The included studies in KQ 2 represent
evidence from 14,737 patients and so although this is a substantial evidence base the inclusion of
an additional 1,357 patients would increase by approximately 9 percent. Given the range of
interventions studied and that 4 of them included placebo as a comparator of interest, we do not
believe that the 7 “missing” trials are likely to have had a meaningful impact on our review’s
results. Because of the relatively low proportion of unpublished studies identified through our
ClinicalTrials.gov registry analysis, we do not believe these findings indicate significant
publication bias in the evidence base that would impact our overall conclusions.

Key Question 1: ADHD Diagnosis


KQ 1 examined the comparative diagnostic accuracy of approaches that can be used in the
primary care practice setting or specialty clinic to initially diagnose attention deficit
hyperactivity disorder (ADHD). KQ 1a focuses on the comparative diagnostic accuracy of
approaches for diagnosing ADHD among individuals younger than 7 years of age. KQ 1b
examines the comparative diagnostic accuracy of electroencephalography (EEG), imaging, or
assessment of executive function that can be used to diagnose ADHD among individuals aged 7
through 17. KQ 1c focuses on how the comparative diagnostic accuracy of these approaches
varies by clinical setting or patient subgroup including age, sex, or other risk factors associated
with ADHD. KQ 1d examines the adverse effects associated with being labeled correctly or
incorrectly as having ADHD. This KQ was not addressed in the prior reports.
To help the reader, Table 6 summarizes the available tools for individuals across the age
spectrum and provides details on the domains assessed, the methods used for assessment, scoring
methods, and interpretation. Tools are listed within categories of interviews, rating scales, and
continuous performance tests.

26
Table 6. Description of available tools for ADHD assessment

Category Tool Domains Assessed Method Scoring Interpretation


Interviews
Standard clinical ADHD diagnosis Parent and/or child NA Diagnostic interview that
interview according to DSM-IV interview determines whether an individual
or DSM-5 criteria has ADHD.
K-SADS (Kiddie SADS) ADHD diagnosis Semi-structured Items rated on a 3- A diagnostic algorithm that
according to DSM-IV diagnostic interview with point scale for severity includes all DSM criteria for
or DSM-5 criteria parent and child (not present, ADHD. Results of the semi-
subthreshold, and structured interview indicate
threshold—which whether the individual has ADHD.
combines both
moderate and severe
presentations). Parent,
child, and summary
ratings are made.
DISC/DISC IV ADHD diagnosis Structured diagnostic Items rated as yes, no, A diagnostic algorithm that
(Diagnostic Interview according to DSM-IV interview with parent somewhat or includes the DSM criteria for
Schedule for Children) criteria and/or child sometimes ADHD. Results of the diagnostic
interview indicate whether the
individual has ADHD.
Rating
Scales

27
Category Tool Domains Assessed Method Scoring Interpretation
NICHQ (National • ADHD • Parent questionnaire Symptom Questions • A positive screen indicates the
Institute for Children’s Predominantly • Teacher questionnaire • Rated based on need for further evaluation
Health Quality) Inattentive frequency • The screening measure is
Vanderbilt Assessment • ADHD • 0–3 scale (never, positive if both of the following
Scale Predominantly occasionally, often, are met for a given domain:
Hyperactive/Impulsiv very often) - Specific number of Symptom
e • Number of Questions are rated 2 or 3
• ADHD Combined symptoms endorsed - At least one Performance
• Oppositional Defiant at a 2 (often) or 3 Question is rated 4 or 5
Disorder (very often) is
• Conduct Disorder summed for each
• Anxiety/Depression domain

Performance
Questions
• Rated based on
problem severity
• 0–5 scale (excellent,
above average,
average, somewhat
of a problem,
problematic)

28
Category Tool Domains Assessed Method Scoring Interpretation
Conners Rating Scales Note: Subscale • Parent questionnaire • Rated based on how • Raw scores for each scale are
• CPRS names vary slightly • Teacher questionnaire true the question is converted to T scores
• CTRS between versions of • Adolescent for the child (mean=50, SD=10) based on a
• CRS the Conners Rating questionnaire • 0–3 (not true at all, normative sample
• Conners 3 Scales, but include: just a little true, • Higher scores indicated
pretty much true, increased clinical concern
ADHD-related scales very much true). • Interpretation guidelines
• Inattention indicate that scores ≥ 60 are
• Hyperactivity/Impul above average
sivity
• Learning Problems
• Executive
Functioning
• DSM Symptoms
Scales
• ADHD Index
• Conners Global
Index

Behavioral/emotional
scales
• Defiance/Aggressio
n
• Peer Relations/
Social Problems
• Family Relations
• Oppositional
Defiant Disorder
• Conduct Disorder
• Cognitive Problems
• Anxious-Shy
• Perfectionism
• Psychosomatic

29
Category Tool Domains Assessed Method Scoring Interpretation
SNAP-IV (Swanson, • ADHD • Parent questionnaire • Rated based on • Scores can be interpreted in
Nolan and Pelham Predominantly • Teacher questionnaire frequency two different ways:
Revision) Inattentive • 0–3 scale (not at all, (1) Sum of items for each of
• ADHD just a little, quite a bit, the three subscales, with
Predominantly very much) high score indicating more
Hyperactive/Impul symptoms.
sive (2) Average rating per item
• ADHD Combined for each of the three
subscales. This rating is
compared to the
parent/teacher 5% cut off
and a higher score
indicates more symptoms.
DBDRS (Disruptive • ADHD • Parent questionnaire • Rated based on • Scales scores are computed
Behavior Disorder Predominantly • Teacher questionnaire frequency by summing the items in each
Rating Scale ) Inattentive • 4 point scale (not at domain.
• ADHD all, just a little, pretty • Scores were considered to be
Predominantly much, and very in the clinical range for ADHD
Hyperactive/Impuls much) if they are between the 95th to
ive 100th percentile.
• ADHD Combined
• Oppositional
Defiant Disorder
• Conduct Disorder
ADHD-RS (ADHD • ADHD • Parent questionnaire • Rated based on • Scores are calculated by
Rating Scale) Predominantly • Teacher questionnaire frequency summing the items in each
Inattentive • 0–3 (does not domain and the total items.
• ADHD experience the
Predominantly symptom at all …
Hyperactive/Impuls symptom very often)
ive
• ADHD Combined

30
Category Tool Domains Assessed Method Scoring Interpretation
SDQ (Strengths and • Emotional • Parent questionnaire • Rated based on how • Higher scores indicate more
Difficulties symptoms • Teacher questionnaire true the question is concerns in a given area.
Questionnaire) • Conduct problems for the child • Raw scores can be compared
• Hyperactivity/inatte • 0–2 (not true, to cut-points derived from a
ntion somewhat true, typical population.
• Peer relationship certainly true)
problems • Some items are
• Prosocial behavior reverse coded.
• Total difficulties
BRIEF (Behavior • Behavioral • Parent questionnaire • Rated based on • Raw scores are converted to T
Rating Inventory of Regulation Index • Teacher questionnaire frequency scores (mean=50; SD=10) and
Executive Function) (three scales) • 3-point scale (never, percentiles based on a
• Metacognition sometimes often) normative sample.
Index (five scales) • Higher scores indicate more
• Global Executive problems relative age-matched
Composite peers.

CHEXI (Childhood • Inhibition (inhibition • Parent questionnaire • Rated based on how • Subscale scores are
Executive Functioning and regulation • Teacher questionnaire true the question is calculated by computing the
Inventory) • Working Memory for the child mean score for items in each
(working memory • 0-5 point (definitely scale.
and planning) not true , not true, • Higher scores are indicative of
partially true, true, more severe symptoms.
definitely true)
ATTEX (Attention and • Distractibility • Teacher questionnaire • Rated based on • Subscale scores are
Executive Function • Impulsivity severity calculated by computing the
Rating Inventory) • Motor hyperactivity • 3-point scale (not a mean score for items in each
• Directing attention problem, sometimes scale.
• Sustaining a problem, often a • A Total Score is calculated by
attention problem) summing all of the scale
• Shifting attention scores.
• Initiative • Higher scores indicate greater
• Planning severity (i.e., the behavior is
• Execution of action more often a problems).
• Evaluation
• Total score
Continuous
Performance
Tests

31
Category Tool Domains Assessed Method Scoring Interpretation
Conners CPT • Attention • Computerized test • Responses to a • Raw and standardized scores are
(Continuous • Impulsivity target and nontarget calculated using an algorithm for
Performance Test) • Sustained each domain.
Attention • T scores and percentiles are
• Vigilance provided, with higher scores
indicating more problems in a
given area.
IVA CPT (Integrated • Auditory • Computerized test • Responses to the • Visual and Auditory domain
Visual and Auditory Response target (visual or scores are calculated for a total
Continuous Control auditory) and to the of 12 quotients.
Performance Test) • Visual Response nontarget (visual or • Omission and commission
Control auditory) scores are generated, with
• Auditory Attention more omission errors indicating
• Visual Attention greater distraction and more
• Auditory commission errors indicating
Sustained greater impulsivity.
Attention • Hyperactivity-impulsiveness and
• Visual sustained attention deficit scales are
Attention calculated from the omission
and commission errors, each
comprising 3 visual and 3
auditory quotients.
TOVA (Test of • Attention • Computerized test • Responses to the • Errors of omission (not
Variables of Attention) • Inhibitory control target (correct) and responding to the target) yield a
responses to the measure of inattention.
nontarget (incorrect) • Errors of commission
(responding to a nontarget)
yield a measure of impulsivity.

32
Category Tool Domains Assessed Method Scoring Interpretation
CANTAB (Cambridge • General memory • Computerized test • Scoring varies by • Interpretation varies depending
Neuro-psychological and learning, with domain and includes on the outcome measures (e.g.,
Test Automated subtests including: scores such as higher number of errors
Battery)a - Working percent correct, indicates more impairment;
memory number of errors, lower response latency
- Executive time to complete, indicates less impairment).
functioning response latency
- Visual
memory
- Attention
- Reaction time
- Decision
making
- Response
control
a CANTAB description from personal communication with Cambridge Cognition Ltd. (January 2017).

Abbreviations: ADHD=attention deficit hyperactivity disorder; CPRS=Conners Parent Rating Scale; CTRS=Conners Teacher Rating Scale; DSM=Diagnostic and Statistical
Manual of Mental Disorders

33
Description of Included Studies
For KQ 1, we identified 22 articles86-106, 183 representing 21 studies, 19 of which examined
the comparative diagnostic accuracy of approaches used to diagnose ADHD, and 2 of which
evaluated adverse effects of being labeled with ADHD. One study was described in more than
one publication; Appendix E provides a key to primary and companion articles. Primary and
companion papers are cited together in the text and tables that follow.
All 19 studies examining diagnostic accuracy were observational in design and represented a
total of 4,339 enrolled patients. The 2 studies examining the adverse effects of ADHD labeling
were observational in design and represented a total of 104 enrolled patients. Details of the study
characteristics of the included studies are in Appendix F. Appendix G provides an overview of
the included studies.

Key Points
• Among executive function tests, Attention and Executive Function Rating Inventory
(ATTEX) and Childhood Executive Function Inventory (CHEXI) performed better than
Cambridge Neuropsychological Testing Automated Battery (CANTAB) for individuals
aged 7–17 (strength of evidence [SOE]=low).
• This systematic evidence review identified limited studies with variable and inconsistent
findings for diagnostic accuracy for all other diagnostics tools evaluated, including
imagining and EEG-based tests (SOE=insufficient).
• Insufficient evidence was found regarding labeling or stigma of children with ADHD.

Detailed Synthesis—Diagnosis
Diagnostic Comparative Studies
Across the 19 diagnostic comparative studies, 14 different assessment tools were evaluated,
including electroencephalography (EEG), integrated visual and auditory computerized
performance test (IVA-CPT), continuous performance function tests (CPFT), event-related
potentials (ERP), magnetic resonance imaging (MRI) of caudate body volume, Test of Variables
of Attention (TOVA), CANTAB, ATTEX, CHEXI, electro interstitial scans (EIS), Disruptive
Behavior-Diagnostic Observation Schedule (DB-DOS), neurological subtle signs (NSS), Kiddie-
Disruptive Behavior Disorder Schedule (K-DBDS), and Strengths and Difficulties Questionnaire
(SDQ). The diagnostic accuracy of the tools was measured primarily by receiver operator
characteristics (ROC) for overall accuracy and area under the curve (AUC), from which
sensitivity, specificity, false positives, and false negatives could be derived as shown in Table H-
1, which summarizes findings from studies with subjects aged 6 years and younger, and Table H-
2, which summarizes findings from studies with older children and adolescents, in Appendix H.
The heterogeneity in methods and outcomes of these studies prevented quantitative meta-
analysis.
Among the imaging studies, EEG was variable in its accuracy, ranging from 46 percent to 87
percent in five studies.92, 93, 96, 98, 106 ERP evaluations yielded consistently higher accuracy scores
when conducted independently (91%, the highest imaging accuracy104) and in combination with
EEG (73%95). MRI scans of caudate body volume also had accuracy scores of 84%.101 IVA-CPT
had 75 percent to 82 percent based on outcomes assessed with omission errors and 68 percent to

34
85 percent based on outcomes assessed with omission errors.92, 93, 98 Other CPTs, such as the
TOVA, demonstrated limitations in their ability to correctly identify non-ADHD patients88, 89, 102
and subtypes such as inattentive and hyperactive/impulsive.100 Among the executive function
tests, ATTEX94 and CHEXI87 performed better with overall accuracy rates of 91 percent to 93
percent, respectively, than the CANTAB,89 which had low specificity (low SOE). Biometric
devices such as EIS and Actigraphy had high sensitivity (80% to 97%) and specificity (84% to
98%).97, 105 Additional approaches to diagnosing ADHD with promising clinical utility included
neurological examinations for subtle signs of abnormal functioning (overall accuracy 84%),
observational assessments of disruptive behaviors (92% AUC, 87% sensitivity, 79% specificity),
and interviews using the K-DBDS (98% AUC, 77% sensitivity, 98% specificity.86, 91, 183
Few studies examined whether there are differences in accuracy based on age,91 sex,94 and
ADHD presentation.86, 94, 100, 103, 183 Also, there were no studies that compared how approaches to
diagnosing ADHD differed by clinical settings. Collectively, a variety of approaches were tested
in primary care and specialty clinics. Approaches in primary care clinics (five studies) included
imaging, computerized function tests, executive function tests, and standardized questionnaires.
Similarly, studies conducted in specialty clinics (13 studies) investigated these same approaches
as well as biometric tools and observational assessments.

ADHD Labeling/Stigma Studies


Only two studies evaluated the adverse effects associated with being labeled correctly or
incorrectly as having ADHD.90, 99 These good-quality studies did not address the negative
experiences or outcomes of the children with ADHD but rather teachers’ reactions and parents’
concerns regarding ADHD labels for affected youth. Insufficient evidence was found regarding
labeling or stigma. This KQ was not addressed with the 2011 review.

Strength of Evidence—Diagnosis
Tables 7 and 8 summarize the SOE for the KQ 1 findings based on this report’s included
studies. The studies evaluated diverse tools and the heterogeneity in their findings and precision
led to insufficient SOE for most tools.

35
Table 7. Strength of evidence for major outcomes—diagnosis
No. Studies/
Design
Diagnostic Tool (N Patients)
Age Study Reporting
SOE Grade Categories Limitations Directness Consistency Precision Bias Findings
EEG and Imaging 5 Obs Medium Direct Inconsistent Imprecise None EEG demonstrated variability in five studies.95, 101, 104, 106 96
(259)
Insufficient 7–17, all
through 17
EEG, Imaging, 3 Obs Medium Direct Inconsistent Imprecise None EEG demonstrated variability in four studies..92, 93, 98
and CPT (355)
7–17
Insufficient
CPT 3 Obs Medium Direct Inconsistent Imprecise None CPT demonstrated variability in 3 observational studies.88,
100, 102
(402)
Insufficient 7–17
CPT and 1 Obs Medium Direct NA Imprecise None SOE was insufficient because of the sample size of the
executive function (34) single observational study available.89
7–17
Insufficient
Executive 2 Obs Medium Direct Consistent Precise None Among executive function tests, ATTEX and CHEXI
function (961) performed better than the CANTAB.87, 94
6 and under,
Low 7–17
Biometric Devices 2 Obs Medium Direct Inconsistent Imprecise None Biometric devices for EIS and actigraphy demonstrated
(175) variability in the 2 studies.97, 105
Insufficient 7–17, all
through 17
Observational 2 Obs Medium Direct Inconsistent Imprecise None SOE was insufficient because of variations across the 2
assessment (1,436) available observational studies.91, 183
6 and under,
Insufficient 7–17
Standardized 2 Obs Medium Direct Inconsistent Imprecise None SOE was insufficient because of variations across the 2
questionnaire (774) available observational studies.86, 103
6 and under,
Insufficient all through 17
Abbreviations: ATTEX=Attention and Executive Function Rating Inventory; CANTAB=Cambridge Neuropsychological Testing Automated Battery; CHEXI=Childhood
Executive Function Inventory; CPT=continuous performance test; EEG=electroencephalography; NA=not applicable; Obs=observational; SOE=strength of evidence

36
Table 8. Strength of evidence for major outcomes—labeling/stigma
No. Studies/
Design
Outcome (N Patients)
Age Study Reporting
SOE Grade Categories Limitations Directness Consistency Precision Bias Findings
Labeling/Stigma 2 Obs Low Indirect Consistent Imprecise None SOE was insufficient because the studies did not address
(104) the negative experiences or outcomes of the children with
Insufficient 7–17 ADHD but rather teachers’ reactions and parents’
concerns regarding ADHD labels for affected youth.90, 99
Abbreviations: ADHD=attention deficit hyperactivity disorder; Obs=Observational; SOE=strength of evidence

37
Key Question 2: ADHD Treatment
KQ 2 examined the comparative safety and effectiveness of pharmacologic and
nonpharmacologic treatments for improving outcomes associated with ADHD. KQ 2 also
evaluates how these outcomes vary by presentation (inattentive, hyperactive/impulsive, and
combined) or other comorbid conditions, and assesses the risk of diversion of pharmacologic
treatment. For the purposes of this review, supplements were classified as nonpharmacologic
treatments because they are not regulated by the FDA.

Description of Included Studies


For KQ 2, we identified 81 articles107-175, 184-195 representing 69 studies that examined the
comparative safety and effectiveness of pharmacologic and nonpharmacologic treatments for the
treatment of ADHD. Eleven studies were described in more than one publication; Appendix E
provides a key to primary and companion articles. Primary and companion papers are cited
together in the text and tables that follow.
Of the 69 included studies, 10 were observational, representing a total of 6,523 enrolled
patients.110, 115, 120, 121, 123, 127, 135, 151, 166, 173 The 59 remaining studies were randomized controlled
trials (RCTs), representing a total of 8,346 enrolled patients. Details of the study characteristics
of the included studies are in Appendix F. Appendix G provides an overview of the included
studies.
The next sections are organized by treatment comparisons as follows:
1. Pharmacologic versus placebo/usual care
2. Pharmacologic versus pharmacologic
3. Pharmacologic versus nonpharmacologic
4. Nonpharmacologic versus nonpharmacologic/placebo

Key Point for Pharmacologic Versus Placebo/Usual Care


• There was limited additional evidence concerning FDA-approved ADHD medications
compared with placebo or usual care across all outcomes in this updated systematic
evidence review (SOE=insufficient).

Detailed Synthesis—Pharmacologic Versus Placebo/Usual Care


For this comparison, we identified eight articles113, 130, 135, 146, 148, 162, 166, 192 representing seven
studies that compared an FDA-approved medication for ADHD with placebo or usual care. The
study with two publications was the National Institute of Mental Health (NIMH) Collaborative
Multisite Multimodal Treatment Study of Children with ADHD (MTA) in which one publication
reported academic performance, psychiatric outcomes, and antisocial behavior between
treatment arms at 8 years following the 14 months of active treatment,146 and the other reported
blood pressure and heart rate by initial treatment group assignments over 10 years.192 Three of
the six studies were conducted exclusively in the United States,130, 135, 146 two were conducted in
the United States and Europe,113, 148 one study was conducted in Asia,166 and one was conducted
in Europe, Australia, New Zealand, Israel, and South Africa.162
Two studies were rated poor quality113, 166 and the remaining rated fair quality. Both studies
rated as poor quality had incomplete reporting of methods and results along with a high dropout
rate. All but two135, 166 were multicenter studies, and all of the multicenter studies were classified

38
as RCTs; however, one study randomized subjects to treatment following an initial RCT
(withdrawal) to either continue lisdexamfetamine or placebo and assessed effects in the
“withdrawal period,”113 one study randomized treatment following an open-label study to either
extended release guanfacine or placebo and assessed effects in the “withdrawal period,”148 and
one study (two articles) reported results long after the RCT treatment periods.146, 192
Placebo was the comparator in all of the studies except the two observational studies135, 166
and the MTA study.146 For the findings from the MTA study discussed in this section, only the
comparison between the medication arm and community care arm are reported. There were only
two treatment arms in all of the RCTs with placebo comparators except for one study in which
there were three doses of lisdexamfetamine compared with placebo.130 In the MTA study, there
were also 4 treatment arms—medication management, behavioral management, combination of
medications and behavior management, and community care (usual care). Medication
management in MTA included 1-month double-blind titration with methylphenidate for best
dose, progressing to an open titration with other drugs, such as d-amphetamine, pemoline, or
imipramine if methylphenidate was unsatisfactory.
The two observational studies evaluated longer term outcomes. Methylphenidate (MPH) was
the pharmaceutical in both studies, with doses of 0.3 to 0.6 mg/kg per day166 and up to 1.5 mg/kg
per day.135 One study135 compared study participants in the treatment group with a naturalistic
sample as a control. The goal of that study was to determine if the 24-month use of MPH
affected the risk of alcohol and illicit drug outcomes. The other study166 also examined long-term
(2–4 years) use of MPH and the risk of height and weight gaps or growth deficits.

Changes in Standardized Symptom Scores


One fair-quality study presented results of ADHD symptom scores in children with active
pharmacologic treatment versus placebo.130 Three doses of lisdexamfetamine were compared
with placebo. Although no statistical comparisons were made, there was a much smaller
proportion of patients receiving placebo when compared with any dose of lisdexamfetamine that
had achieved symptomatic remission at 1 month, defined as an ADHD-RS-IV score ≤18 (23.6%
placebo, 62.3% lisdexamfetamine 30 mg/day, 67.6% lisdexamfetamine 50 mg/day, and 71.2%
lisdexamfetamine 70 mg/day).
A second fair-quality study presented results of ADHD symptom scores in children initially
stabilized on extended release guanfacine and then randomized to either continuation of the
extended release guanfacine or placebo during a 26-week “withdrawal period.”148 The difference
in the LS mean of the ADHD-RS-IV total score at the end of the “withdrawal period” for those
continuing extended release guanfacine was statistically significantly lower than those who
received placebo indicating that the effect of the treatment was better maintained with
continuation of extended release guanfacine as compared to placebo (-6.24; 95% confidence
interval [CI] -9.01 to -3.48; ES=0.51, p<0.001). These inconsistent and imprecise findings
resulted in insufficient SOE.

Functional Impairment
One fair-quality study presented results of the Clinical Global Impression-Severity scores in
children initially stabilized on extended release guanfacine and then randomized to either
continuation of the extended release guanfacine or placebo during a 26 week “withdrawal
period.”148 The proportion of children with low severity score (score 1 or 2) at the end of the
“withdrawal period” was statistically significantly lower in those who continued extended

39
release guanfacine versus placebo in the “withdrawal period” (50% vs. 32.5%, p =.0.001). The
SOE was insufficient given findings from this one study with imprecise findings and medium
risk of bias.

Alcohol Use
One fair-quality study focused on assessing youth self-reported alcohol use using the Drug
Use Screen Inventory in children aged 12 to 17 who were mostly male.135 The study groups for
this observational study conducted in the United States were clinical trial participants receiving
open label MPH, nonclinical trial youth receiving MPH or amphetamine per their primary care
provider, nonclinical trial youth not receiving any ADHD medications, and youth without
ADHD. A lower proportion of clinical trial participants reported alcohol use in the preceding
year (10%) than nonclinical trial youth receiving MPH or amphetamine (33%, p=0.008
compared with clinical trial participants) or nonclinical trial youth not receiving any ADHD
medications (35%, p=0.002 compared with clinical trial participants). However, it is not clear
whether the clinical trial participation or the more rigorous screening for the clinical trial created
a selection bias (insufficient SOE).

Sexual Development
One fair-quality study focused on sexual development in children initially aged 6 to 15 years
who were randomized to atomoxetine versus placebo.162 Among 394 patients who were mostly
male, no statistically significant differences were seen in median age of puberty (12.6 in
atomoxetine [ATX] group and 12.3 in placebo group, p=0.88) or frequency of onset of puberty
(26% in ATX group and 26.9% in placebo group p=0.88). However, the mean height change was
higher in the placebo group (3.2 inches in ATX group and 4.22 in placebo group, p=0.01). The
SOE was insufficient given imprecise evidence from this one study.

Peer Relationships
One poor-quality study reported results of the quality of peer relationships on the CHIP-CE
PRF subdomain for peer relationships at the end of a 6-week period in which one group had their
lisdexamfetamine continued and the other group was switched to placebo.113 The effect size was
0.434 (p<0.001) for the lisdexamfetamine group versus placebo, indicating better peer
relationships in the lisdexamfetamine group than placebo. The SOE was insufficient given
evidence from this one study with incomplete reporting of both methods and outcomes, along
with high dropout rates.

Risk Avoidance
One poor-quality study reported results of risk avoidance on the Child and Health Illness
Profile Child Edition, Parent Report Form (CHIP-CE PRF) subdomain risk avoidance at the end
of a 6-week period in which one group had their lisdexamfetamine continued and the other group
was switched to placebo.113 The effect size was 0.613 (p<0.01) for the lisdexamfetamine group
versus placebo, indicating greater risk avoidance in the lisdexamfetamine group than placebo.
Again limitations of the study, combined with imprecise findings led to an insufficient SOE.

Academic Performance
The four-arm MTA study reported results of academic performance at 8 years, finding no
statistically significant treatment effects identified for reading, math, or GPA at 8 years.146, 192

40
Insufficient evidence is available to know whether this is due to a lack of long-term treatment
benefit or reflects the need for more intensive care for the subjects after completion of the MTA
study.

Antisocial Behavior, Accidents, and Psychiatric Illness


The four-arm MTA study found no statistically significant treatment effects on incarceration,
aggression, or motor vehicle accidents at 8 years.146, 192 There was a statistically significant
treatment effect with anxiety at 8 years (14.9% medication management, 16.7% behavioral
management, 18.3% combination, and 19.7% placebo; p value for treatment effect=0.0217). The
SOE was insufficient as these findings were based on a stepped approach and it was unclear
which specific medications subjects received.

Adverse Effects
In one study, selected adverse effects of ATX versus placebo were reported.162 There was a
higher rate of increased appetite (7.1% vs 1.4%, p=0.006) and gastrointestinal symptoms (8.2%
vs. 2.7%, p=0.046) in patients receiving ATX versus placebo (insufficient SOE for both others).
Findings from this same study and the one poor-quality observational study166 indicate small
significant reductions in height and weight among the MPH groups and higher rates of alcohol or
drug use during the past year. Both studies compared ADHD participants with non-ADHD
participants. The SOE was insufficient given the findings were the large loss to followup and
potential risk of bias.

Findings in Relation to What Is Already Known—Pharmacologic


Versus Placebo/Usual Care
In the 2011 report,4 13 short-term studies compared MPH with placebo (one also compared
mixed amphetamine salts [MAS] with placebo) in children under 6 years of age; 9 longer term
studies compared pharmacologic agents (4 MPH, 2 ATX, 1 amphetamine or MAS, and 2 any
stimulant) with placebo. The studies in children under 6 years of age were relatively small and
thus most of the conclusions are based on a single larger RCT of good quality, the Preschool
ADHD Treatment Study (PATS),196 indicating that for children without comorbidities, MPH was
very effective (SOE=low).
In people 6 years of age and older, the 2011 report did not focus on comparative efficacy or
safety of pharmacologic drugs compared with placebo. Therefore, no definitive conclusions were
made in that report for any ADHD drug compared with placebo.
Our update evaluates one additional poor-quality study, observational in design, by Zhang et
166
al. that specifically looked at the long-term outcomes of height and weight from MPH use.
Findings from that study indicate small but significant reductions in height and weight among the
MPH groups compared with non-ADHD participants. Given the large rate of loss to follow up
within this study and inadequate reporting of methods and results the SOE was insufficient.
This updated systematic review—although focused on assessing the comparative efficacy
and safety of FDA approved ADHD medications versus placebo—was likewise unable to make
definitive conclusions given the small number of studies during the current time period and the
limited quality of those studies. There is insufficient overlap in study design and outcomes
between the findings in this updated systematic review and the 2011 report to qualitatively
improve the certainty regarding the benefits and harms of treatment beyond the individual
reviews’ findings.

41
Strength of Evidence—Pharmacologic Versus Placebo/Usual Care
Table 9 summarizes the SOE for comparisons between pharmacologic and placebo/usual
care treatments based on this report’s included studies. For most outcomes there was only one
either low- or fair-quality study exploring the outcome of interest with imprecise findings and so
the evidence was given an insufficient SOE grade.

42
Table 9. Strength of evidence for major outcomes—comparisons between pharmacologic and placebo/usual care treatments
No. Studies/
Outcome Design
(N Patients) Study Reporting
SOE Grade Age Category Limitations Directness Consistency Precision Bias Findings
Major outcomes
Changes in 2 RCTs (359) Medium Direct Inconsistent Imprecise Unclear SOE was insufficient because of inconsistent and
standardized 7–17 imprecise findings within 2 studies with medium risk of
symptom scores bias.130, 148

Insufficient
Functional 1 RCT (219) Medium Direct NA Imprecise Unclear SOE was insufficient because of only one study was
Impairment 7–17 included with medium risk of bias and imprecise
findings.148
Insufficient
Substance abuse 1 Obs (211) Medium Direct NA Imprecise None SOE was insufficient given medium risk of bias within one
7–17 observational study.135
Insufficient
Sexual 1 RCT (394) Medium Direct NA Imprecise None SOE was insufficient because only one study was
Development 7–17 included with medium risk of bias and imprecise
findings162
Insufficient
Quality of peer 1 RCT High Direct NA Imprecise Unclear SOE was insufficient given evidence from one low-quality
relationships (Unclear) study with imprecise findings.113
7–17
Insufficient
Risk-taking 1 RCT High Direct NA Imprecise Unclear SOE was insufficient given evidence from one low-quality
behaviors (Unclear) study with imprecise findings.113
7–17
Insufficient
Academic 1 RCT (436) Medium Direct NA Imprecise Unclear SOE was insufficient because medication management
performance 7–17 was based on a stepped approach and it was unclear
which specific medications subjects received.146, 192
Insufficient
Aggression 1 RCT (436) Medium Direct NA Imprecise Unclear SOE was insufficient because medication management
7–17 was based on a stepped approach and it was unclear
Insufficient which specific medications subjects received.146, 192
Incarceration 1 RCT (436) Medium Direct NA Imprecise Unclear SOE was insufficient because medication management
7–17 was based on a stepped approach and it was unclear
Insufficient which specific medications subjects received.146, 192.

43
No. Studies/
Outcome Design
(N Patients) Study Reporting
SOE Grade Age Category Limitations Directness Consistency Precision Bias Findings
Motor vehicle 1 RCT (436) Medium Direct NA Imprecise Unclear SOE was insufficient because medication management
collisions 7–17 was based on a stepped approach and it was unclear
which specific medications subjects received.146, 192
Insufficient
Depression or 1 RCT (436) Medium Direct NA Imprecise Unclear SOE was insufficient because medication management
anxiety 7–17 was based on a stepped approach and it was unclear
which specific medications subjects received.146, 192
Insufficient
Changes in 1 RCT (394) Medium Direct NA Imprecise None SOE was insufficient because only one study was
appetite 7–17 included with medium risk of bias and imprecise
findings162
Insufficient
Elevated blood 1 RCT (493) Medium Direct NA Imprecise Unclear SOE was insufficient because medication management
pressure 7–17 was based on a stepped approach and it was unclear
which specific medications subjects received.146, 192
Insufficient
Gastrointestinal 1 RCT (394) Medium Direct NA Imprecise None SOE was insufficient because of only one study was
symptoms 7–17 included with medium risk of bias and imprecise
findings.162
Insufficient
Growth 1 RCT, 1 Obs High Direct NA Imprecise None SOE was insufficient because of high risk of bias given
suppression (569) high loss to follow up combined with imprecise
7–17 findings.162, 166
Insufficient
Increased heart 1 RCT (507) Medium Direct NA Imprecise Unclear SOE was insufficient because medication management
rate 7–17 was based on a stepped approach and it was unclear
which specific medications subjects received.146, 192
Insufficient
Abbreviations: NA=not applicable; Obs=observational; RCT=randomized controlled trial; SOE=strength of evidence

44
Key Points for Pharmacologic Versus Pharmacologic
• Based on evidence from 3 observational studies identified in this systematic evidence
review, the proportion of patients reporting gastrointestinal (GI) effects was slightly
higher for ATX than MPH (SOE=low).
• Since the 2011 report which described the benefit of psychostimulant therapy for up to 24
months, little additional evidence has been generated for comparing safety and efficacy
of select FDA-approved medications for treatment of ADHD and SOE was insufficient
for all other outcomes.

Detailed Synthesis—Pharmacologic Versus Pharmacologic


For this comparison, we identified nine studies.110, 118, 120, 121, 123, 151, 156, 157, 173 Of these, seven
were multisite studies,110, 120, 121, 123, 151, 156, 173 and two were a single site.118, 157 Two studies were
RCTs.118, 157 Among the seven observational studies, four analyzed data from the Italian National
ADHD Registry—three from a whole region110, 121, 151 and one from selected sites in a specific
region.123 Government funding was reported for five studies,110, 123, 151, 157, 173 industry funding for
two studies,120, 156 and unknown funding for two studies.118, 121
Treatments compared in five of the studies were ATX versus MPH.110, 118, 121, 123, 151 One
study compared extended-release guanfacine monotherapy with extended release guanfacine plus
either amphetamine or MPH,156 one assessed ATX monotherapy compared with ATX combined
with any other ADHD medication,120, one was a survey collecting patient-reported adverse
events from any ADHD medication,173 and one study compared cardiovascular effects of
immediate release guanfacine, extended release dexmethylphenidate, or their combination.157
Of the nine studies, two reported results using one of the selected ADHD symptom scores,
the Conner Rating Scale-Parent118 and the ADHD Rating Scale.156 One study reported results
from one of the selected functional impairment tests, the Clinical Global Impression.120 Of the
nine studies, seven only reported adverse events of interest for this systematic review.110, 121, 123,
151, 156, 157, 173

Changes in Standardized Symptom Scores


Two studies reported results of ADHD symptom scores.118, 156 One study was an RCT
conducted in a single site in Turkey in which children between the ages of 7 and 16 were
randomly assigned to receive ATX (59 evaluable) or osmotic release oral system MPH (OROS-
MPH) (61 evaluable).118 The Conners Comprehensive Behavior Rating Scale-Teacher was used
to assess and compare changes on the hyperactive, inattentive, and behavior subscales from
baseline to 6 months and to compare the proportion of children achieving at least a 40-percent
reduction in the hyperactive, inattentive, and behavior subscales at 6 months. There were no
statistically significant differences between the children taking ATX and those taking OROS-
MPH in any of these measures. This study was rated as fair quality.
The second study was an observational study enrolling children from two prior RCTs
conducted in the United States evaluating extended-release guanfacine (one of which permitted
use of amphetamine or MPH with the extended-release guanfacine).156 In this observational
extension study, children aged 6 to 17 at initiation received one of four doses of extended-release
guanfacine monotherapy (n=206) or any dose of extended-release guanfacine in combination
with amphetamine or MPH as the combination group (n=53). The ADHD Rating Scale was used

45
to assess ADHD symptoms at various time points. The change in score within each treatment
arm (monotherapy or combination therapy) from baseline to last assessment (time varied up to
24 months) was determined, but treatment arms were not compared. There was a statistically
significant decrease in mean score in each arm; -20.1 (± 13.5) for monotherapy and -16.1 (± 11)
for combination therapy (both p < 0.001). This study was rated as poor quality given several
potential risks of bias including lack of allocation concealment and blinding. In addition
participants were subjects from prior studies who were titrated to tolerated dose of guanfacine
then assessed for changes in ADHD symptoms increasing potential bias.
The SOE was insufficient given the heterogeneity between the symptom scores,
inconsistency in findings, and the potential high risk of bias.

Functional Impairment Scores


Only one study presented results using a selected functional impairment tool.120 This study
was an industry-funded, observational study conducted in two U.S. sites. Chart-abstracted data
were used to compare least-square means of the Clinical Global Impression scale assessed at
least 50 days after the start of pharmacologic therapy in children aged 6 to 17 receiving ATX
monotherapy (n=37) compared with children receiving ATX combination therapy (combined
with any other ADHD medication) (n=34). The statistical model was adjusted using propensity
scores. No statistically significant difference in least-square mean Clinical Global Impressions
Score was found between the treatment groups (p=0.4072). This study was rated as poor quality
given its retrospective nature, lack of power, and issues with reporting of its methods and
outcomes (SOE=insufficient).

Adverse Events
Seven studies presented adverse events from ADHD pharmacologic therapies.110, 121, 123, 151,
156, 157, 173
One fair-quality study presented results from a single survey of the parents of 578
children aged 3 to 16 conducted in the UK to ascertain recalled adverse drug reactions to any
ADHD medication.173 Among 200 completed surveys, 80 percent were from children taking
MPH alone or in combination. Because the number of patients exposed to each drug or drug
combination was not reported, it is difficult to draw any conclusions from these results.
Four studies reporting adverse effects were observational studies comparing ATX with
MPH.110, 121, 123, 151 All of these used data from the Italian National ADHD Registry—three in
whole110, 121, 151 and one from selected sites in a specific region.123 Thus, it is not possible to
determine the total number of unique patients, as patients may have been included in more than
one study. Of these four studies, one poor-quality study focused on electrocardiogram (ECG),
blood pressure, and heart rate changes only.110 In this study, there was a higher risk of having at
least one altered ECG (right bundle branch block [RBBB], sinus bradycardia, sinus tachycardia,
increased QTc, and/or atrioventricular [AV] block) at 6 months (relative risk [RR] 1.29; 95% CI
0.52 to 3.21) and 12 months (RR 2.41; 95% CI 1.04 to 5.60) in patients receiving MPH versus
ATX, although the increased risk at 6 months was not statistically significant. Systolic blood
pressure, diastolic blood pressure, and heart rate were not compared by treatment arms but rather
by changes at 6, 12, and 24 months. The only statistically significant change in patients taking
MPH was an increase in heart rate at 6 months. The only statistically significant changes in
patients taking ATX were an increase in heart rate as measured at 6 and 12 months and an
increase in diastolic blood pressure as measured at 6 months. Given the short time frame for this

46
study and therefore lack of patients with events, there is concern that this study was not
representative.
The other three studies using the Italian National ADHD Registry and comparing ATX with
MPH reported on numerous adverse events (Table H-3 in Appendix H). Overall, gastrointestinal
side effects or decreased appetite were the most commonly reported problems. In one of these
studies after controlling for presence of comorbid psychiatric conditions, there was a statistically
higher incidence rate ratio for gastrointestinal side effects (4.56; 95% CI 2 to 10.43),
cardiovascular side effects (3.43; 95% CI 1.21 to 9.76), and neuropsychiatric side effects (2.54;
95% CI 1.34 to 4.74) for ATX versus MPH.121 In another, there was a statistically significant
greater risk of adverse reactions to ATX versus MPH (RR 3.57; 95% CI 1.92 to 6.64).151 These
studies were rated as fair to good quality.
A sixth study reporting adverse effects was a poor-quality RCT comparing extended-release
guanfacine monotherapy versus combination therapy with amphetamine or MPH.156 The rates of
selected adverse events are presented in Table H-4 in Appendix H. Among the adverse events
listed, somnolence and headache were the most common but were similar between the different
groups.
The last study reporting only side effects of interest was a single-center RCT of good quality
in which heart rate, systolic blood pressure, and diastolic blood pressure were reported over a 12
month open label follow-up period to a three armed RCT of immediate release guanfacine,
extended release dexmethylphenidate, or the combination.157 The number of patients who
continued in the follow-up period was not reported. There was no statistically significant
difference in heart rate over the 12 months between groups (p=0.09), but there were statistically
significant differences between groups in systolic and diastolic blood pressure (p=0.0005 and
p=0.01, respectively) with both systolic and diastolic blood pressure being higher for those who
received extended release dexmethylphenidate as compared to the other two treatment arms.
The SOE for a slight increase in gastrointestinal symptoms for patients on ATX compared
with MPH was low. For all other adverse effects the SOE was insufficient.

Findings in Relation to What Is Already Known—Pharmacologic


Versus Pharmacologic
The 2011 report4 included comparisons of pharmacologic agents (MPH, DEX, MAS, ATX,
and extended release guanfacine) in children under 6 years of age with ADHD or disruptive
behavior disorder as part of KQ 1 and in people 6 years of age and older (including adults) with
ADHD in KQ 2. In that systematic review, there were relatively few studies that directly
compared pharmacologic agents relative to the number of studies that compared medications to
placebo, nonpharmacologic assessment, and noncomparative studies. In children under 6 years of
age, no studies directly compared pharmacologic agents. Our review did not specifically focus
on this population of patients; however, children as young as 3 years of age were included in
studies reported on adverse events associated with pharmacologic agents in comparative
assessments.
In people aged 6 years and older, there were nine comparative studies of pharmacologic
agents in the 2011 report; however, that report was focused on ascertaining only longer-term
efficacy and safety. Because of the small number of comparative studies of pharmacologic
agents, no specific conclusions were made regarding the comparative efficacy or safety of the
included pharmacologic agents. The included studies spanned the following comparisons: one
study compared efficacy in people receiving MPH compared with pemoline;197 but pemoline is

47
not a pharmacologic agent of interest in this updated review as it has been removed from the US
market. One other study compared extended-release guanfacine monotherapy with extended
release guanfacine plus either amphetamine or MPH.156 That study is also included in this
updated review. Two studies assessed adverse events between ATX and unspecified
stimulants,198 and between MPH and DEX.199 The remaining four studies compared growth in
patients receiving MPH versus MAS,200 DEX versus MPH,201 amphetamine versus MPH,202 and
MPH versus DEX.203
This updated systematic review provides results from a larger number of studies comparing
FDA-approved pharmacologic agents, especially comparisons of ATX and MPH; however, the
SOE for efficacy or safety remains insufficient for most outcomes. There were no new
conclusions regarding the effectiveness of pharmacologic treatments as compared to one another
other than slightly higher gastrointestinal side effects for patients taking ATX as compared to
MPH (SOE low).

Strength of Evidence—Pharmacologic Versus Pharmacologic


Table 10 summarizes the SOE for comparisons of pharmacologic therapies based on this
report’s included studies. Small numbers of studies with variable quality demonstrating
inconsistent and imprecise findings caused insufficient SOE grades for all outcomes other than
GI symptoms.

48
Table 10. Strength of evidence for major outcomes—comparisons of pharmacologic treatments
No. Studies/
Outcome Design
(N Patients) Study Reporting
SOE Grade Age Category Limitations Directness Consistency Precision Bias Findings
Changes in 1 RCT and High Direct Inconsistent Imprecise Unclear SOE was insufficient across these 2 studies
standardized 1 Obs (379) because of heterogeneity in outcome measures,
symptom scores 7–17 inconsistency in findings, and high risk of bias. 118,
156

Insufficient
Acceptability of 1 Obs (130) Medium Direct NA Imprecise None SOE was insufficient because of the sample size
treatment- 7–17 and risk of bias related to the assessment of
Discontinuation adherence.123
Rate

Insufficient
Behavior changes 1 Obs (130) Medium Direct NA Imprecise None SOE was insufficient because of the study design
7–17 and limitations in the pre-post assessment of
Insufficient behavior changes.123

Cardiac 1 Obs (750) High Direct Consistent Imprecise None SOE was insufficient because of the risk of bias in
arrhythmias 7–17 the one observational study identified.110

Insufficient
Changes in 3 Obs (1,966) Medium Direct Inconsistent Imprecise None SOE was insufficient because of the risk of bias
appetite 7–17 and lack of consistency in the observational
studies.121, 123, 151
Insufficient
Conduction 1 Obs (1,424) Medium Direct NA Imprecise None SOE was insufficient because only one
abnormalities 7–17 observational study was available and there was a
risk that the outcome would not be identified.151
Insufficient
Elevated blood 2 Obs and 1 RCT High Direct Inconsistent Imprecise Unclear SOE was insufficient because of the risk of bias in
pressure (2,382) the 3 studies.110, 151 157
7–17
Insufficient
Gastrointestinal 3 Obs (1,966) Medium Direct Consistent Imprecise None The proportion of patients reporting
symptoms 7–17 gastrointestinal effects or disease was small in all
3 studies and slightly higher for ATX than MPH.121,
123, 151
Low

49
No. Studies/
Outcome Design
(N Patients) Study Reporting
SOE Grade Age Category Limitations Directness Consistency Precision Bias Findings
Increased heart 3 Obs and 1 RCT Low Direct Consistent Imprecise Unclear SOE was insufficient because of the risk of bias
rate (1137) and lack of consistent outcome assessment.110, 121,
123, 157
7–17
Insufficient
Sleep disturbance 1 Obs (130) Medium Direct NA Imprecise None SOE was insufficient because only one small
7–17 observational study was identified, and because of
Insufficient the risk of bias in the assessment of the outcome
measure.123
Suicide ideation 1 Obs (1424) Medium Direct Consistent Imprecise None SOE was insufficient because of study
1 Obs (NR) heterogeneity and risk that the outcome measure
Insufficient 7–17 was not detected.121, 151

Tics or other 2 Obs (1554) Medium Direct Consistent Imprecise None SOE was insufficient because of study
movement 7–17 heterogeneity and risk that the outcome measure
disorders was not detected.123, 151

Insufficient
Abbreviations: ATX-atomoxetine; ECG=electrocardiogram; MPH=methylphenidate; NA=not applicable; Obs=observational; RCT=randomized controlled trial; SOE=strength of
evidence; XR=extended release

50
Key Points for Pharmacologic Versus Nonpharmacologic
• MPH decreases appetite and causes more sleep disturbance than supplements including
gingko biloba, ningdong granule, or omega-3/6 fatty acids (SOE=low).
• Evidence identified in this systematic review was insufficient for all other outcomes.

Detailed Synthesis—Pharmacologic Versus Nonpharmacologic


For this KQ 2 comparison, we identified nine articles114, 124, 131, 141, 146, 147, 155, 189, 192
representing seven RCT studies published between 2009 and 2016 that met our inclusion criteria.
There was a total of 1,072 participants with a mean age ranging from 8.11 to 16.8, and the
majority were male (65% to 85.3%). Country sites varied, with the majority conducted in the UK
or Europe (n=3). More than half the studies (n=5) were government-sponsored research, most
were single site (n=5), and the majority of studies recruited participants from specialty clinics
(n=5). Study characteristics are in Table 11.
Of the 7 RCTs, MPH was the primary pharmaceutical intervention. Four trials were 3-arm
studies comparing MPH alone or in combination with a nonpharmacologic intervention. The
dosage of MPH was clinically adjusted according to tolerability and efficacy, ranging from 0.3
mg/kg per day to 1.5 mg/kg per day. Comparators in the trials included supplements (n=3;
gingko biloba, omega-3/6, and ningdong), neurofeedback (n=3), behavioral therapy (n=1), or a
combination of behavioral therapy, education, and physical activity (n=2). The duration of
studies ranged from 6 weeks to 8 years.

Outcome Measures
The selected outcome measures varied considerably across the 7 included studies (Table 11).
Change in the ADHD rating scale for parent (n=3) and teacher (n=2) was the most commonly
used outcome measure. Behavioral changes and academic performance were also commonly
measured outcomes.
Table 11. Characteristics of included studies

Characteristic Value
Study design, number of studies
RCTs 7
Combined number of patients; range of % males 1,072; 65.0% to 85.3%
Range of mean ages, years 8.11 to 16.8
Study years 2009-2016
Length of intervention / follow-up period 6 weeks to 8 years
Countries, number of studies
Asia 1
UK or Europe 3
Middle East 1
South America 1
USA 1
Funding source, number of studies
Government 5
Industry 1
Nongovernment, nonindustry 1
Study Sites, number of studies
Single site 5
Multisite 2

51
Characteristic Value
Setting, number of studies
Specialty clinic 5
Primary clinic 1
Academic setting 1
Interventions, number of studies
Supplements 3
Neurofeedback 3
Behavioral therapy 1
Physical exercise, education, behavioral modification 2
Pharmaceutical intervention and dosage, number of studies
Methylphenidate 7
0.3-1 mg/kg/day 6
1.5 mg/kg/day 1
Timing of last outcome assessment, number of studies
Short-term: ≤3 months 5
Long-term: 6+ months 2
Change in standardized scale outcomes, number of studies
ADHD Rating Scale–Parent 3
ADHD Rating Scale–Teacher 2
Barkley Rating Scale 1
Clinician Global Impression–Clinician 1
Clinician Global Impression–Parent 1
Visual and Auditory Continuous Performance 1
Other outcomes, number of studies
Behavior changes (sadness, aggression, irritability, anxiety, depression) 7
Academic performance 3
Incarceration 2
Motor vehicle collision 1
Sleep 1
Adverse effects of treatment, number of studies
Height and weight change 1
Gastrointestinal symptoms (nausea, dyspepsia, stomach pain) 2
Sleep disturbances (insomnia, hypersomnia, trouble falling asleep) 4
Changes in appetite (suppression, decreased, increased) 3
Abbreviations: ADHD=attention deficit hyperactivity disorder; RCT=randomized controlled trial

We identified three RCTs (2 good quality, 1 poor quality) comparing MPH with a
supplement of gingko biloba,155 ningdong granule,141 or omega-3/6 fatty acid.114 The poor-
quality study114 was unblinded and had high withdrawals (which differed between arms). Sample
sizes were small, consisting of 50 to 90 participants, with one 3-arm trial comparing the
combination of MPH plus omega-3/6. Changes in the ADHD Rating Scale were the primary
outcome for all three trials. Individual study findings suggest that gingko biloba was less
effective while ningdong granule and omega-3/6 had effects similar to MPH although the SOE
was insufficient given the small overall sample size, short-term outcomes (6-8 weeks for the two
good-quality RCTs), and lack of consistency and precision in the outcome measure.
Four RCTs (1 good quality, 2 fair quality, 1 poor quality) compared MPH with
neurofeedback or131, 147 behavioral therapy,146, 147, 192 and a 3-arm trial combined MPH with
neurofeedback.124, 189 Sample sizes were small in two of the trials (n=57 and 91) and large
(n=579) in the 8-year follow-up study.146, 147, 192 The primary outcome measures varied among
the trials. Study quality was reduced because of lack of blinding and variation in outcome
measurement.
Table H-5 in Appendix H summarizes these findings across the 7 studies.

52
Adverse Effects of Supplementation
Adverse effects were identified in four of the included studies.114, 131, 141, 155 Changes in
gastrointestinal symptoms (nausea, dyspepsia, stomach pain), sleep disturbances (insomnia,
hypersomnia, trouble falling asleep), and changes in appetite (suppression, decreased, increased)
were measured. A higher proportion of participants experienced adverse effects on sleep (low
SOE) or appetite (low SOE) when assigned to the MPH or combined group with MPH as
compared to the nonpharmacologic interventions in three studies.114, 141, 155 In the fourth study,
sleep quality was not affected by any of the received interventions.131 Table H-6 in Appendix H
summarizes the proportion of participants with adverse effects.

Findings in Relation to What Is Already Known—Pharmacologic


Versus Nonpharmacologic
Previous reviews have examined the relationship between pharmacologic and
nonpharmacologic treatments comparing omega-3/6 with placebo.204, 205 Previous reviews have
not included neurofeedback as an intervention of interest. Our summary findings directly
comparing MPH with the supplements of gingko biloba, ningdong granule, or omega-3/6 fatty
acids have not been reported in previous reviews. We found insufficient SOE that gingko biloba,
ningdong granule, or omega-3/6 supplements produced greater improvements in changes in
standardized symptom scores (ADHD Rating Scale) compared to MPH. Several limitations
existed among this literature including small sample sizes, and measuring only short-term
outcomes in the good-quality studies.
The 2011 report4 found that the evidence on long-term outcomes of MPH treatment was
sparse and inconclusive. One exception to this was the study by Molina et al.146, 192 (also
included in this updated review) that showed reduced ADHD symptoms in a mostly male sample
with ADHD combined type following 14 to 24 months of MPH treatment.
The 2011 report4 also reported on adverse effects of pharmacologic interventions. The
findings from that report were determined to be inconclusive due to information from
observational studies and uncontrolled extensions to clinical trials. However, that review did not
examine adverse effects of pharmacologic treatments when compared with supplements (i.e.,
gingko biloba, ningdong granule, and omega-3/6). Generally, a higher proportion of adverse
effects was reported with MPH or combination of supplements and MPH compared with
supplement (low SOE for both sleep disturbances and decreased appetite). Our SOE comparing
MPH with these supplements are limited due to small sample sizes, overall quality of the studies,
and assessment of short-term outcomes.

Strength of Evidence—Pharmacologic Versus Nonpharmacologic


Table 12 summarizes the SOE for pharmacologic versus nonpharmacologic treatments based
on this report’s included studies. Small numbers of studies with potential limitations and
inconsistent and imprecise findings caused insufficient SOE grades for all outcomes other than
sleep disturbance and changes in appetite.

53
Table 12. Strength of evidence for major outcomes—comparisons between pharmacologic and nonpharmacologic treatments
No. Studies/
Outcome Design
(N Patients) Study Reporting
SOE Grade Age Category Limitations Directness Consistency Precision Bias Findings
Changes in 5 RCTs (356) Medium Direct Inconsistent Imprecise Unclear SOE was insufficient because of the small overall sample
standardized 7–17 size and lack of consistency and precision in the outcome
symptom scores measure.114, 124, 141, 147, 155, 189

Insufficient
Behavior changes 3 RCTs (274) Medium Direct Inconsistent Imprecise None SOE was insufficient because of the small overall sample
7–17 size and lack of consistency and precision in the outcome
Insufficient measure.114, 131, 141
Aggression 1 RCT (436) Medium Direct NA Imprecise Unclear SOE was insufficient because of the risk of bias in the
7–17 single RCT identified.146, 192
Insufficient
Depression or 2 RCTs (486) Medium Direct Consistent Imprecise Unclear SOE was insufficient because of the small overall sample
anxiety 7–17 size and lack of consistency and precision in the outcome
measure.146, 155, 192
Insufficient
Academic 1 RCT (436) Medium Direct NA Imprecise Unclear SOE was insufficient because of the risk of bias in the
performance 7–17 single RCT identified.146, 192

Insufficient
Incarceration 1 RCT (436) Medium Direct NA Imprecise Unclear SOE was insufficient because of the small overall sample
7–17 size and lack of consistency and precision in the outcome
Insufficient measure.146, 192
Motor vehicle 1 RCT (436) Medium Direct NA Imprecise Unclear SOE was rated insufficient because of the small overall
collisions 7–17 sample size and lack of consistency and precision in the
outcome measure.146, 192
Insufficient
Changes in 3 RCT (212) Medium Direct Consistent Imprecise None All three studies found the MPH medication group to
appetite 7–17 have a significantly greater number of participants with
decreased appetite when compared to supplementation
Low by ningdong, omega-3/6 or gingko biloba.114, 141, 155
Elevated blood 1 RCT (493) Medium Direct NA Imprecise Unclear SOE was insufficient because of the small overall sample
pressure 7–17 size and lack of consistency and precision in the outcome
measure.146, 192
Insufficient
Gastrointestinal 2 RCTs (162) Medium Direct Inconsistent Imprecise None SOE was insufficient because of the small overall sample
symptoms 7–17 size and lack of consistency and precision in the outcome
measure.114, 141
Insufficient

54
Increased heart 1 RCT (507) Medium Direct NA Imprecise Unclear SOE was rated insufficient because of the small overall
rate 7–17 sample size and lack of consistency and precision in the
outcome measure.146, 192
Insufficient
Sleep disturbance 4 RCTs (324) Medium Direct Inconsistent Imprecise None There was a greater proportion of sleep disturbance
7–17 outcomes in the MPH medication group compared to
Low supplementation by ningdong granule, gingko biloba, or
neurofeedback.114, 141, 155 A fourth study found no
significant difference in sleep scores between
interventions131
Weight decrease 1 RCT (50) Medium Direct NA Imprecise None SOE was insufficient because of the sample size in the
7–17 single study and risk of bias measuring the outcome.155
Insufficient
Abbreviations: MPH=methylphenidate NA=not applicable; Obs=observational; RCT=randomized controlled trial; SOE=strength of evidence

55
Key Points for Nonpharmacologic Versus
Nonpharmacologic/Placebo
• There is insufficient evidence based on the studies identified in this systematic evidence
review to evaluate the effectiveness of neurofeedback in reducing ADHD symptoms.
• There is some evidence that cognitive training strategies such as the computer-based
Cogmed cognitive training program may reduce ADHD symptoms in the short term but
not the long term (SOE=low).
• Cognitive behavioral therapy resulted in improvement in ADHD symptoms (SOE=low).
• Child or parent training did not demonstrate differences in academic performance
(SOE=low).
• Child or parent training improves ADHD symptoms (SOE=moderate).
• Omega-3 fatty acid supplementation was no different than placebo on ADHD symptoms
(SOE=moderate).

Categories of Interventions for This Comparison


We organized the comparison of nonpharmacologic versus nonpharmacologic/placebo
treatments into the following seven intervention categories:
1. Neurofeedback
2. Cognitive training
3. Cognitive behavioral therapy (CBT), focusing on the development of specific skills for
patients to be aware of their symptoms of ADHD and developing strategies to minimize
the effects of these symptoms
4. Child or parent training or behavioral intervention
5. Dietary supplementation with omega-3/6 fatty acids
6. Herbal or dietary approaches
7. Other approaches
Other approaches included community programs and programs that addressed mentoring and
parent support, multisystemic intervention at school and with parents, in-home family training
intervention, a general parenting program, using melatonin as an adjunct treatment, acupuncture,
and a homeopathic intervention). Studies were included in these comparisons that had subjects in
all study arms that received other ADHD treatment, including psychostimulants.
As previously described, there is insufficient evidence to directly compare omega-3/6 fatty
acid supplementation to MPH or other psychostimulants. The effectiveness of omega-3/6 for the
treatment of ADHD symptoms was not included in the 2011 report. This current review
identified a single previous systematic review and meta-analysis (Bloch and Qawasmi204)
comparing omega-3 fatty acid supplementation with placebo and found a small but statistically
significant benefit on ADHD symptoms. The Bloch and Qawasmi systematic review included
ten trials of 699 children. Only two trials found a benefit and the overall effect size from the
meta-analysis was small (0.31). The meta-analysis conducted within this report found no benefit
for omega-3 fatty acid supplementation. In summary, omega-3/6 supplementation is unlikely to
have benefit.
Of the 7 intervention categories, only 2 had data from the previous systematic review thereby
allowing us to discuss our new findings in relation to what is already known: (1) child or parent

56
training or behavioral interventions and (2) other approaches. These findings are described in
their corresponding sections below.

Detailed Synthesis—Overview
For this KQ 2 comparison, we identified 61 articles107-109, 111, 112, 115-117, 119, 122, 125-129, 131-134, 136-140,
142-147, 149, 150, 152-154, 158-161, 163-165, 167-172, 174, 175, 184-188, 190-195
representing 50 studies that met our
inclusion criteria. All but two studies were RCTs.115, 127 Of the 47 RCTs, 28 were rated as good
quality,107-109, 112, 116, 119, 122, 125, 126, 129, 131-134, 139, 142, 143, 150, 152, 158, 160, 161, 164, 167-169, 172, 174 19 as fair
quality,111, 117, 128, 137, 138, 140, 144-147, 149, 153, 154, 159, 163, 165, 170, 171, 175 and 1 as poor quality.136 The two
observational studies were was rated as fair quality.115, 127 Of these, 20 were multisite studies, 29
were single-site studies, and one did not report the number of sites. Fifteen studies included
patients in the United States, 19 were conducted in Europe, and 16 included patients from the
Middle East, Asia, Australia, or New Zealand. Government funding supported 26 studies,
industry supported 3 studies, nongovernment and nonindustry funding supported 11 studies.
External funding was either not provided or not reported for 15 studies.
The 50 studies reported 54 comparisons of a nonpharmacologic therapy with either another
nonpharmacologic therapy or no therapy (e.g., a placebo intervention, usual care, or a waitlist
control). Of the 7 intervention categories, 5 evaluated neurofeedback; 10, cognitive training; 2,
CBT; 13, child or parent training or behavioral intervention; 8, dietary supplementation with
omega-3/6 fatty acids; 6, herbal or dietary approaches; and 9, other approaches. Details of these
comparisons are reported below, organized by intervention category.

Detailed Synthesis—Neurofeedback
Neurofeedback is a computer-aided type of nonpharmacologic treatment for ADHD that is
based on biofeedback principles. Treatment typically involves patients using a computer monitor
that shows brainwave activity through EEG. In the neurofeedback process, patients are trained to
adjust their attention and thereby their brainwave activity. Four good-quality116, 131, 132, 160, 186, 193,
194
and 1 fair-quality147 studies representing 353 patients evaluated neurofeedback. Findings are
summarized by outcome and described in Table H-7 in Appendix H. These studies had short
periods of intervention, with only one study116 describing findings to 6 months. Therefore, the
overall SOE was insufficient.

Acceptability of Treatment
Only one study examined parent-rated motivation of children to participate in treatment and
the effectiveness of treatment, finding no difference between neurofeedback and the attention
skills control condition.132, 193, 194 The SOE was insufficient given that the evidence was from
only one study which might have been underpowered.

Behavior Changes
Only one small but good-quality study assessed behavior changes associated with a 12-week
course of neurofeedback sessions. This study found no statistically significant differences in
postintervention mean scores for the Inattention and Hyperactivity/Impulsiveness subscales of
the Strengths and Weaknesses of ADHD and Normal Behavior (SWAN) questionnaire. The
single small study resulted in an insufficient SOE.131

57
Changes in Standardized Symptom Scores
One study found a statistically significant decrease in ADHD symptoms using a standard
scale comparing neurofeedback with an attention skills control condition.132, 193, 194 A second
study found no difference between neurofeedback and cognitive training, but did find significant
improvements in ADHD symptoms according to parent and teacher reporting for neurofeedback
compared with control.160, 186 A third study compared neurofeedback with standard
pharmacologic treatment and a behavioral treatment and found that the group treated with
neurofeedback showed greater improvement in a continuous performance test score when
compared with each of the other groups.147 Finally, a fourth study did not find any significant
changes between children receiving neurofeedback versus those receiving treatment as usual.116
The SOE was insufficient given the small sample sizes of all studies and the variation in
outcomes reported.

Sleep Disturbance
Only one study assessed sleep disturbance associated with a 12-week course of
neurofeedback sessions. This study found no significant difference in postintervention mean
scores in the Sleep Disturbance Scale for Children (SDSC) between neurofeedback and physical
activity. The single small study resulted in an insufficient SOE.131

Adverse Effects of Neurofeedback


No adverse effects from neurofeedback were reported.

Strength of Evidence—Neurofeedback
Table 13 summarizes the SOE for neurofeedback based on this report’s included studies.
Inconsistent findings and heterogeneous interventions caused the insufficient SOE grades.

58
Table 13. Strength of evidence for major outcomes—neurofeedback
No. Studies/
Outcome Design
(N Patients) Study Reporting
SOE Grade Age Category Limitations Directness Consistency Precision Bias Findings
Acceptability of 1 RCT (102) Low Direct NA Imprecise None SOE was insufficient because only one trial that might
treatment 7–17 have been underpowered was identified.132, 193, 194

Insufficient
Behavior change 1 RCT (103) Low Direct NA Imprecise None SOE was insufficient given findings from only one small
7–17 study.131
Insufficient

Changes in 4 RCTs (353) Low Direct Inconsistent Imprecise Unclear SOE was insufficient because of the small sample size in
standardized 7–17 the 4 trials and the variation in outcomes reported.116, 132,
147, 160, 186
symptom scores

Insufficient
Sleep disturbance 1 RCT (103) Low Direct NA Imprecise None SOE was insufficient given findings from only one small
7–17 study.131
Insufficient
Abbreviations: NA=not applicable; Obs=observational; RCT=randomized controlled trial; SOE=strength of evidence

59
Detailed Synthesis—Cognitive Training
Six good-quality119, 122, 126, 132, 160, 174, 186, 187 and 2 fair-quality115, 163 studies representing 768
patients evaluated cognitive training interventions. All but one study involved computer-based
cognitive training programs, and of those five used a specific brand of intervention (Cogmed).
Findings are summarized by outcome and described in Table H-8 in Appendix H. Meta-analysis
was not possible given heterogeneity in outcomes and time frame. The specific findings detailed
in the table are described below.

Academic Performance
A single, good-quality RCT found no significant treatment effects in improvement in Wide
Range Achievement Test 4 Progress Monitoring Version (WRAT) scores compared with a low-
level (placebo) working memory training program that was identical to active intervention with
respect to the types of training games utilized and the number of training trials per session, but
for which difficulty level was not adjusted according to each user’s performance parameters. 119
The SOE was insufficient given the small size of the single included study.

Acceptability of Treatment
A single study examined parent-rated motivation of children to participate in treatment and
the effectiveness of treatment, finding no difference between cognitive training and
neurofeedback.132, 193, 194The SOE was insufficient given the small size of the single included
study.

Behavior Changes
A good-quality RCT found no significant between-group differences in scores on the
Disruptive Behavior Disorder Rating Scale (DBDRS) compared with a partially-active-condition
where inhibition and cognitive-flexibility were trained and the working memory-training task
was presented in placebo-mode, or to a full placebo-condition.122 The SOE was insufficient
given the small size of the single included study.

Changes in Standardized Symptom Scores


Of studies examining the Cogmed cognitive training programs,115, 119, 126, 163, 174, 187 three of
these studies119, 126, 174, 187 found no significant changes on standard ADHD scales compared with
low-level working memory games or a waitlist control. Two studies found a significant
improvement on standardized scales.115, 163 Of those, one compared the Cogmed intervention
with a waitlist control, and at 4 months the treatment group had significantly better scores on
parent report on the ADHD Index, Conners Cognitive Problems/Inattention, Conners
Hyperactivity Parent, and BRIEF Metacognition Index.115 No teacher measures showed any
significant changes. In the other study, there was improvement at 2 and 6 months on the parent
rated BRIEF Metacognition Index, and at 2 months (but not 6 months) on the BRIEF parent-
rated behavioral index.163
Three other studies examined computer-based cognitive training programs.122, 132, 160, 186, 193,
194
One compared the Braingame program to a computer game that did not have any cognitive
training characteristics, finding no significant effect of this type of training.122 The other two
were studies comparing neurofeedback with computer-based cognitive training.132, 160, 186, 193, 194
There was no difference between cognitive training and control in one,160, 186 but neurofeedback

60
was found to be superior to both. The other directly compared the two interventions and found
neurofeedback superior to cognitive attention skills training on a standardized ADHD scale.132,
193, 194

Overall the evidence from these studies provided low SOE that cognitive training improved
standardized symptoms scores.

Adverse Effects of Cognitive Training


No adverse effects from cognitive training were reported in any of the included studies.

Findings in Relation to What Is Already Known—Cognitive


Training
The 2011 review did not evaluate cognitive training. Our current systematic review
demonstrates that cognitive training may improve symptoms scores (SOE=low).

Strength of Evidence—Cognitive Training


Table 14 summarizes the SOE for cognitive training based on this report’s included studies.
Small numbers of studies with imprecise findings caused insufficient SOE grades for all
outcomes other than changes in standardized symptom scores which had low SOE for a benefit
with cognitive training.

61
Table 14. Strength of evidence for major outcomes—cognitive training
No. Studies/
Outcome Design
(N Patients) Study Reporting
SOE Grade Age Category Limitations Directness Consistency Precision Bias Findings
Academic 1 RCT (85) Low Direct NA Imprecise None SOE was insufficient because only one small trial was
performance 7–17 identified.119

Insufficient

Acceptability of 1 RCT (102) Low Direct NA Imprecise None SOE was insufficient because only one small trial was
treatment 7–17 identified.132, 193, 194

Insufficient

Behavior changes 1 RCT (89) Low Direct NA Imprecise None SOE was insufficient because only one small trial was
7–17 identified.122
Insufficient
Changes in 9 RCTs (768) Medium Direct Inconsistent Imprecise None Cognitive training may improve symptom scores.115, 119, 122,
126, 132, 160, 163, 174, 186, 187, 193, 194
standardized 7–17, all
symptom scores through 17

Low
Abbreviations: NA=not applicable; Obs=observational; RCT=randomized controlled trial; SOE=strength of evidence

62
Detailed Synthesis—Cognitive Behavioral Therapy
One good-quality164 and 1 fair-quality117, 185 study representing 278 patients evaluated CBT.
Findings are summarized by outcome and described below and in Table H-9 in Appendix H.

Changes in Standardized Symptom Scores


Both studies found a statistically significant improvement in ADHD symptom scores for the
CBT program as opposed to the control condition after the initial treatment (low SOE). One fair-
quality study117, 185 followed patients through 12 months and found the CBT condition
maintained superiority in terms of ADHD scale scores. In addition, this study found that there
was a greater improvement in the CBCL conduct disorder/oppositional defiant disorder subscale
both immediately after treatment and at 12 months.

Depression or Anxiety
The fair-quality study117, 185 examined changes in the depression anxiety scale scores and
found that the CBT group had greater improvement in depression and anxiety scores as opposed
to the control group at 3 months and that the depression score improvements were maintained at
12 months. The SOE was insufficient given the evidence coming from only a single included
study with medium risk of bias.

Adverse Effects of CBT


No adverse effects from CBT were reported.

Strength of Evidence—Cognitive Behavioral Therapy


Table 15 summarizes the SOE for CBT based on this report’s included studies. Small
numbers of studies with imprecise findings caused insufficient SOE grades for all outcomes
other than changes in standardized symptom scores which had low SOE for a benefit from
cognitive behavioral therapy.

63
Table 15. Strength of evidence for major outcomes—cognitive behavioral therapy
No. Studies/
Outcome Design
(N Patients) Study Reporting
SOE Grade Age Category Limitations Directness Consistency Precision Bias Findings
Changes in 2 RCTs (278) Low Direct Consistent Imprecise Suspect There was statistically significant improvement in ADHD
standardized 7–17 (reasons symptoms associated with CBT relative to usual care or a
symptom scores for drop limited CBT intervention.117, 164, 185
out not
Low adequately
described)
Depression or 1 RCT (159) Medium Direct NA Imprecise Suspect SOE was insufficient because only one small trial was
anxiety 7–17 (reasons identified.117, 185
for drop
Insufficient out not
adequately
described)
Abbreviations: ADHD=attention deficit hyperactivity disorder; CBT=cognitive behavioral therapy; NA=not applicable; RCT=randomized controlled trial; SOE=strength of
evidence

64
Detailed Synthesis—Child or Parent Training or Behavioral
Interventions
Ten good-quality RCTs,108, 112, 129, 134, 150, 152, 161, 167-169 2 fair-quality RCTs,138, 159 and 1 fair-
quality observational study127 representing 1,583 patients evaluated child or parent training or
behavioral interventions. These included a range of different types of non-CBT behavioral
interventions including organizational skills, social skills, attention skills, positive parenting,
psychoeducational, sleep hygiene/behavioral, or parent or teacher behavioral training
interventions. Findings are summarized by outcome and described below and in Table H-10 in
Appendix H Note that the interventions were mixed in terms of their strategies: some were
interventions which helped parents learn how to cope with their own emotions, most strategies
focused on how parents could manage specific behaviors from their children with ADHD.

Academic Performance
Three RCTs of child-focused interventions evaluated academic performance outcomes.
These trials found no change compared with the control condition (low SOE). One of these trials
evaluated organizational skills training,108 one evaluated social skills training,161 and one
evaluated an adolescent-specific, skills-based therapy called Supporting Teens’ Autonomy Daily
(STAND).159

Acceptability of Treatment
The single RCT that assessed the outcome of acceptability of treatment found that parent
satisfaction with process was superior with the behavioral intervention compared to the control
group.167 The SOE was insufficient given the small size of the single included study.

Changes in Standardized Symptom Scores


Three RCTs examined psychoeducational programs for parents or families of children with
ADHD.112, 129, 168 All three found significant improvement on some standard measures of ADHD
symptoms with child or parent training (moderate SOE). One study that examined children 6 to
16 years of age compared psychoeducation with a general counseling control and found
significant improvement in overall ADHD scores for the intervention group compared with
control.112 Another study comparing psychoeducation with a control in children 5–18 years of
age found significantly better ADHD scores on a standard scale at 12 weeks for overall
symptoms and attention, and at 12 months there was significant difference only on
inattention/cognition standard scores.168 Another study compared a structured psychoeducation
program for family members of children with ADHD to usual care, with outcomes assessed at 6
weeks and 6 months.129 This study demonstrated significant improvements over time associated
with psychoeducation in the CPRS index, CPRS inattention and cognition, and CPRS
hyperactivity and impulsivity.
Other parenting interventions included a positive parenting program that did not find a strong
effect on ADHD symptoms, but did find a significant effect on overall impairment rating
compared to a behavioral parenting program and an even greater effect compared to a waitlist
control.167 There was a significant improvement in ADHD symptoms when comparing the
positive parenting program to the waitlist control. Another parenting intervention that evaluated
sleep hygiene and behavioral training for parents found improvements at 6 months in all parent-
reported ADHD scores, but no difference between controls on teacher reported scores.169, 184

65
Another parent study compared children on MPH who received MPH alone or medication plus
parent training; this study found no significant difference between groups.127
A combined behavioral training intervention for parents and teachers found no changes in
ADHD scores at 10 weeks as reported by parents or teachers, but at 3 months postintervention
did find improvement in parent reported ADHD scale scores, but not on teacher report.150
Another combined intervention study compared a combination of parent group and child group
interventions with parent intervention alone or community care in general.152 This study found
improvement on symptoms of the combined groups, compared to both comparison conditions at
3 months. At approximately 6 months the improvements in parent reported ADHD symptoms
were maintained. In terms of functional impairment there was no difference at 3 months between
groups, while at 6 months the parent-reported, but not teacher-rated, functional impairment was
improved in the intervention as compared to the parent group alone or the community
control. One study examined social skills for children with a parallel parent group and found
significant changes on the CBCL attention problem subscale as compared to a control condition
including treatment as usual.138 Another study evaluated an adolescent-specific, skills-based
therapy called STAND over the course of 6 months.159 This study found that the STAND
intervention was associated with statistically significant improvements in standardized scores
that assessed the severity of ADHD symptoms. Another study that evaluated the impact of 10
parent-child weekly cognitive-functional (Cog-Fun) intervention sessions found that the Cog-
Fun intervention was associated with significant improvements in the CPRS-R global index total
score when rated by parents but not when rated by teachers.134
In summary, of the 11 studies that included a parent intervention component, 9 showed
improvement in some standard measure of ADHD symptoms, often on parent report (Moderate
SOE). One of the two studies that did not show improvement on ADHD symptoms did show
improvement on functional impairment.

Depression or Anxiety
No differences in depression and anxiety were found in an RCT that evaluated sleep hygiene
counseling for parents combined with behavior therapy.169, 184 The SOE was insufficient given
the evidence of a single included study.

Functional Impairment
A good-quality RCT found that Child Life and Attention Skills Treatment was associated
with improved parent and teacher CGI scores relative to parent training alone or no
intervention.152 Another good-quality RCT167 found that the Strategies to Enhance Positive
Parenting (STEPP) program was more effective at reducing functional impairment than a waitlist
control, but not more effective than traditional behavioral parent training. Another study
compared a structured psychoeducation program for family members of children with ADHD to
usual care, with outcomes assessed at 6 weeks and 6 months.129 This study demonstrated
significant improvements over time associated with CGI global improvement, but not in the
CTRS index of CGI severity of illness. The SOE was insufficient given the evidence of a single
included study.

66
Sleep Disturbance
Sleep habits at 6 months were improved in a good-quality study which randomized patients
to an intervention that combined sleep hygiene counseling for parents and behavior therapy. SOE
was insufficient given imprecision of the findings and that there was only one study169, 184

Workforce Participation
A single RCT found that an intervention that combined sleep hygiene counseling for parents
and behavior therapy found that the intervention was associated with fewer days late for work
and fewer missed days of work for the parents (insufficient SOE)169, 184

Adverse Effects of Child or Parent Training or Behavioral


Interventions
No adverse effects of these behavioral treatments were examined.

Findings in Relation to What Is Already Known—Child or Parent


Training or Behavioral Interventions
The 2011 report4 identified 31 studies that evaluated parent behavior training for
preschoolers with disruptive behavior disorders. Of these, three RCTs included only preschoolers
who exhibited ADHD symptoms but who were not necessarily formally diagnosed with
ADHD.206-208 All three RCTs demonstrated significant improvement in the preschoolers’
behavior or symptoms relative to usual care only. In contrast, this updated review provides
results from 12 RCTs and 1 observational study that evaluated the effectiveness of either parent
or child behavior training on outcomes among children with a wider age range who had been
formally diagnosed with ADHD. Behavioral therapy appears effective for certain children with
ADHD, however there are still questions related to the comparative effectiveness with
pharmacotherapy alone or in combination with behavioral therapy. This reflects the complex
nature of ADHD and the specific factors related to the child including age.

Strength of Evidence—Child or Parent Training or Behavioral


Interventions
Table 16 summarizes the SOE for child or parent training or behavioral interventions based
on this report’s included studies. Small numbers of studies with imprecise findings caused
insufficient SOE grades for all outcomes other than academic performance (SOE=low) and
changes in standardized symptom scores (SOE=moderate) which did not demonstrate an effect
of child or parent training/behavioral interventions.

67
Table 16. Strength of evidence for major outcomes—child or parent training or behavioral interventions
No. Studies/
Design
Outcome (N Patients)
Age Study Reporting
SOE Grade Category Limitations Directness Consistency Precision Bias Findings
Academic 2 RCTs (356) Low Direct Consistent Imprecise None There were no differences in academic performance
performance 6 and under, associated with organizational skills or social skills
7–17 training relative to no intervention.108, 161
Low
Acceptability of 1 RCT (120) Low Direct NA Imprecise None SOE was insufficient because only one small trial was
treatment All through 17 identified.167

Insufficient
Changes in 8 RCTs, 1 Low Direct Consistent Imprecise None There was a significant improvement in ADHD symptoms
standardized Obs (966) associated with child or parent training or sleep
symptom scores 7–17, all hygiene.112, 127, 129, 138, 150, 152, 167-169, 184
through 17
Moderate
Depression or 1 RCT (244) Low Direct NA Imprecise None SOE was insufficient because only one small trial was
anxiety All through 17 identified.169, 184

Insufficient
Functional 1.RCT (199) Low Direct NA Imprecise None SOE was insufficient because only one small trial was
impairment 7–17 identified.152

Insufficient
Sleep disturbance 1 RCT (244) Low Direct NA Imprecise None SOE was insufficient because of findings from only one
All through 17 study which was imprecise169, 184
Insufficient
Workforce 1 RCT (244) Low Direct NA Imprecise None SOE was insufficient because of findings from only one
participation All through 17 study which was imprecise.169, 184

Insufficient
Abbreviations: NA=not applicable; Obs=observational; RCT=randomized controlled trial; SOE=strength of evidence

68
Detailed Synthesis—Omega-3/6 Fatty Acid Supplementation
We identified five good-quality,109, 133, 139, 142, 143 two fair-quality,154, 165 and one poor-quality
studies136 representing 1,130 patients evaluated essential fatty acid supplementation. Seven of
these trials compared essential fatty acid supplementation with placebo. Of these, the active
intervention was omega-3 alone in four trials,133, 136, 142, 165, 191 omega-6 alone in 1 trial,154 and a
combination of omega-3 and omega-6 in 2 trials.139, 195 Treatment duration ranged between 7-
weeks and 6-months. The enrolled children ranged 6–18 years of age and the range of included
male children was 59.4 percent to 77.3 percent across the trials. Inclusion of ADHD subtypes
varied with a mixed grouping of ADHD subtypes included in 3 of the trials, a specific
oppositional sub-type in one trial and three trials did not specify an ADHD sub-type of included
children. One of the 8 trials165 measured outcomes of ADHD symptoms with scales that were not
part of our inclusion criteria and were excluded from the meta-analysis. The remaining 7 trials
measured ADHD symptoms with the Conners Scale (full or abbreviated version) or the ADHD
Rating Scale. Findings are summarized below by outcome below and described in Table H-11 in
Appendix H. Overall, supplementation was not observed to be effective.

Behavior Changes
A good-quality RCT did not find a difference in the proportion of patients who were prone to
crying or who talked less after supplementation with omega-3 fatty acids, relative to placebo.191
The SOE was insufficient given that the imprecision in the findings and the small number of
participants who experienced the outcomes of interest.

Changes in Standardized Symptom Scores


We conducted meta-analyses of 4 eligible RCTs that reported parent ratings of ADHD total
symptoms and 3 eligible RCTs that reported teacher ratings of ADHD total symptoms. These
analyses demonstrated no significant differences between omega 3/6 and placebo for either
parent or teacher ratings (moderate SOE).

Parent Ratings of ADHD Total Symptoms


We summarized four RCTs, with random-effects meta-analysis, examining omega-3/6
supplementation versus placebo only with the outcome of parent-rated total ADHD
symptoms.133, 136, 139, 142, 191, 195 Effects were consistent and studies demonstrated moderate
heterogeneity; however, no statistical evidence was found that omega-3/6 was superior to
placebo with the outcome of parent rating of ADHD total symptoms (n=411, SMD -0.32, 95%
CI -0.80 to 0.15, I2=52.4%, Q=6.3, p=0.098) (Figure 3). The three trials that we excluded from
the meta-analysis found no significant differences between omega-3/6 versus placebo, versus
usual care, or between eicosapentaenoic acid and versus docosahexaenoiac acid for parent
ratings of ADHD total symptoms.

69
Figure 3. Meta-analysis for effects of omega-3/6 supplementation compared with placebo—parent
ratings

CI=confidence interval; SD=standard deviation; SMD=standardized mean difference

Teacher Ratings of ADHD Total Symptoms


We summarized three RCTs, with random effects meta-analysis, examining omega-3/6
versus placebo with the outcome of teacher rated total ADHD symptoms.133, 142, 154, 191 Effects
were fairly consistent and studies were homogeneous; however, we found no statistical evidence
that omega-3/6 was superior to placebo with the outcome of teacher rated total ADHD symptoms
(n=287, SMD -0.08, 95% CI -0.47 to 0.32, I2=0.0%; Q=1.2, p=0.56) (Figure 4). The two RCTs
excluded in this meta-analysis109, 165 also found no significant difference between omega-3 and
placebo or usual care for teacher ratings of ADHD total symptoms.
Figure 4. Meta-analysis for effects of omega-3/6 supplementation compared with placebo—teacher
ratings

CI=confidence interval; SD=standard deviation; SMD=standardized mean difference

Functional Impairment
A good-quality RCT found no difference in Clinical Global Impression scores associated
with omega-3 fatty acid supplementation compared with placebo.139, 195 The SOE was
insufficient given evidence from one small included study.

70
Adverse Effects of Omega-3 Fatty Acid Supplementation
A single good-quality RCT reported the incidence of adverse effects associated with omega-3
fatty acid supplementation compared with placebo.142, 191 This trial did not report statistically
significant between-group differences for any of the following adverse effects: chemical
leukoderma; elevated blood pressure; sleep disturbance; tics or other movement disorders;
gastrointestinal symptoms; growth suppression; increased heart rate; personality change; or
weight decrease. The SOE was insufficient however given the small number of patients in either
arm that experienced any of the outcomes of interest and the inconsistency between positive,
negative, and no effects that were observed for individual outcomes at varying time points.

Findings in Relation to What Is Already Known—Omega-3 Fatty


Acid Supplementation
The effectiveness of omega-3/6 for the treatment of ADHD symptoms was not included in
the 2011 report.4 However, a systematic review and meta-analysis comparing omega-3 fatty acid
supplementation with placebo was conducted in 2011 by Bloch and Qawasmi.204 Using only
PubMed, they searched from database inception to December 2010. Their findings, using fixed-
effects meta-analysis, indicated a small significant effect (SMD 0.31, 95% CI 0.16 to 0.47) on
ADHD symptoms with omega-3 use associated with improved symptoms. Due to an overlap in
search dates, our review includes 3 of the 10 studies that were also included in the Bloch and
Qawasmi review. Our inclusion and exclusion criteria differed from that review as we excluded
studies where the sample size was less than 50 participants.209 Given the differences in
measurement and perspective, our review also conducted a separate meta-analysis for teacher-
and parent-reported ADHD symptoms whereas the Bloch and Qawasmi review included only the
parent- or teacher-reported ADHD symptoms depending on the number of completed ADHD
subscales. Our meta-analysis (Figure 3) used random-effects models and corrected the standard
errors for a small sample meta-analysis using the Knapp-Hartung method, both techniques that
create a more conservative confidence interval.210 As such, due to differences in search dates,
inclusion/exclusion criteria and analytical approaches, differences in pooled estimates between
the two reviews would be expected. Note that given the wider confidence interval within our
analysis compared to the Bloch and Qawasmi meta-analysis, we did not find evidence of a
benefit.

Strength of Evidence—Omega-3 Supplementation


Table 17 summarizes the SOE for omega-3 supplementation based on this report’s included
studies. Small numbers of studies with imprecise findings caused insufficient SOE for all
outcomes other than changes in standardized symptom scores, for which we found moderate
SOE for no difference.

71
Table 17. Strength of evidence for major outcomes—omega-3 fatty acid supplementation
No. Studies/
Outcome Design
(N Patients) Study Reporting
SOE Grade Age Category Limitations Directness Consistency Precision Bias Findings
Behavior changes 1 RCTs (200) Low Direct NA Imprecise None SOE was insufficient because only one trial was identified
7–17 with imprecise findings and a small number of events of
Insufficient the outcomes of interest.142, 191
Changes in 7 RCTs (795) Low Direct Consistent Precise None Two meta-analyses of 4 and 3 good-quality studies
standardized 7–17 respectively found no significant differences between
symptom scores Omega-3/6 and placebo for parent ratings (n=411,
SMD -0.32, 95% CI -0.80 to 0.15, I2=52.4%, Q=6.3,
Moderate p=0.098) or teacher ratings of total ADHD symptoms
(n=287, SMD -0.08, 95% CI -0.47 to 0.32, I2=0.0%;
Q=1.2, p=0.56).133, 136, 139, 142, 143, 154, 190, 191, 195
Functional 1 RCT (75) Low Direct NA Imprecise None SOE was insufficient because only one small trial was
impairment 7–17 identified.139, 195

Insufficient
Chemical 1 RCT (200) Low Direct NA Imprecise None SOE was insufficient given the small number of patients
Leukoderma 7–17 in either arm that experienced any of the outcomes of
interest and the inconsistency between positive, negative,
Insufficient and no effects that were observed for individual adverse
effects at varying timepoints.142, 191
Elevated blood 1 RCT (200) Low Direct NA Imprecise None SOE was insufficient given the small number of patients
pressure 7–17 in either arm that experienced any of the outcomes of
interest and the inconsistency between positive, negative,
Insufficient and no effects that were observed for individual adverse
effects at varying timepoints.142, 191
Sleep disturbance 1 RCT (200) Low Direct NA Imprecise None SOE was insufficient given the small number of patients
7–17 in either arm that experienced any of the outcomes of
Insufficient interest and the inconsistency between positive, negative,
and no effects that were observed for individual adverse
effects at varying timepoints.142, 191
Tics or other 1 RCT (200) Low Direct NA Imprecise None SOE was insufficient given the small number of patients
movement 7–17 in either arm that experienced any of the outcomes of
disorders interest and the inconsistency between positive, negative,
and no effects that were observed for individual adverse
Insufficient effects at varying timepoints.142, 191

72
No. Studies/
Outcome Design
(N Patients) Study Reporting
SOE Grade Age Category Limitations Directness Consistency Precision Bias Findings
Gastrointestinal 1 RCT (200) Low Direct NA Imprecise None SOE was insufficient given the small number of patients
symptoms 7–17 in either arm that experienced any of the outcomes of
interest and the inconsistency between positive, negative,
Insufficient and no effects that were observed for individual adverse
effects at varying timepoints.142, 191
Growth 1 RCT (200) Low Direct NA Imprecise None SOE was insufficient given the small number of patients
suppression 7–17 in either arm that experienced any of the outcomes of
interest and the inconsistency between positive, negative,
Insufficient and no effects that were observed for individual adverse
effects at varying timepoints.142, 191
Increased heart 1 RCT (200) Low Direct NA Imprecise None SOE was insufficient given the small number of patients
rate 7–17 in either arm that experienced any of the outcomes of
interest and the inconsistency between positive, negative,
Insufficient and no effects that were observed for individual adverse
effects at varying timepoints.142, 191
Personality 1 RCT (200) Low Direct NA Imprecise None SOE was insufficient given the small number of patients
change 7–17 in either arm that experienced any of the outcomes of
interest and the inconsistency between positive, negative,
Insufficient and no effects that were observed for individual adverse
effects at varying timepoints.142, 191
Weight decrease 1 RCT (200) Low Direct NA Imprecise None SOE was insufficient given the small number of patients
7–17 in either arm that experienced any of the outcomes of
Insufficient interest and the inconsistency between positive, negative,
and no effects that were observed for individual adverse
effects at varying timepoints.142, 191
Abbreviations: NA=not applicable; Obs=observational; RCT=randomized controlled trial; SOE=strength of evidence

73
Detailed Synthesis—Herbal Interventions or Dietary Approaches
Three good-quality125, 158, 172 and 3 fair-quality111, 140, 144 studies representing 486 patients
evaluated herbal interventions or dietary approaches. Findings are summarized by outcome and
described in Table H-12 in Appendix H. A wide range of interventions were evaluated in these
studies, including an elimination diet, gingko biloba, Memomet syrup, zinc, and other patented
herbal preparations. Although some interventions appeared effective, findings are difficult to
interpret in studies that also allowed use of pharmacotherapy.

Behavior Changes
One good-quality RCT found that gingko biloba was associated with improved parent and
teacher ADHD-RS-Inattention scores but not ADHD-RS-Hyperactivity scores relative to
placebo.158 One fair-quality RCT found that an 8-week course of vitamin D supplementation
given with MPH was associated with improvement in Weekly Parent Ratings of Evening and
Morning Behavior (WPREMB) evening symptom scores and total score, but not WPREMB
morning scores compared to MPH and placebo.144 A third RCT (fair-quality) did not find
statistically significant differences between patients on placebo and those taking zinc
supplementation.111 The variability in interventions, outcomes assessed and the inconsistency in
the findings resulted in an insufficient SOE.

Changes in Appetite
Two fair-quality RCTs did not report statistical significance of the proportion of patients in
each study arm who reported changes in appetite associated with two doses of zinc
supplementation compared with placebo,111 or an herbal preparation compared with placebo.140
Given the variability in interventions, the small number of patients in each study experiencing
the outcome, and differential loss to followup resulted in insufficient SOE.

Changes in Standardized Symptom Scores


Four RCTs reported changes in symptom scores. One demonstrated improvement in ADHD-
RS scores associated with an elimination diet relative to a nonrestricted diet.172 The other three
RCTs found that neither Memomet syrup nor zinc supplementation nor vitamin D improved
ADHD symptoms compared with placebo (low SOE).111, 125, 144

Gastrointestinal Symptoms
Two RCTs did not report statistical significance of the proportion of patients in each study
arm who reported stomach aches or other gastrointestinal symptoms associated with two doses of
zinc supplementation111 or herbal preparation140 compared with placebo. The variability in
interventions, outcomes assessed and the loss to followup resulted in insufficient SOE.

Adverse Effects of Herbal Interventions or Dietary Approaches


An RCT that evaluated two doses of zinc supplementation compared with placebo111 did not
report statistical significance in the difference in proportion of patients in each study arm who
reported changes in appetite, stomach aches or other gastrointestinal symptoms, sleep
disturbance, harm to self or others, or stereotypical behaviors. Another RCT found no between-
group differences between an herbal preparation and placebo in gastrointestinal symptoms,
emotional lability, accidental injury, or sleep disturbance.140 The SOE was considered

74
insufficient because identified studies varied in the interventions and outcomes assessed and had
differential loss to follow up.

Strength of Evidence—Herbal Interventions or Dietary Approaches


Table 18 summarizes the SOE for herbal interventions or dietary approaches based on this
report’s included studies. Small numbers of studies with imprecise findings caused insufficient
SOe grades for all outcomes other than changes in standardized symptom scores.

75
Table 18. Strength of evidence for major outcomes—herbal interventions or dietary approaches
No. Studies/
Outcome Design
(N Patients) Study Reporting
SOE Grade Age Category Limitations Directness Consistency Precision Bias Findings
Behavior changes 3 RCTs (172) Low Direct Inconsistent Imprecise None The SOE was considered insufficient because identified
All through 17 studies varied in intervention and outcomes assessed
Insufficient and then demonstrated inconsistent findings.158 111, 144
Changes in 2 RCTs (172) Medium Direct Consistent Imprecise None The SOE was considered insufficient given the variability
appetite 7–17 in interventions, the small number of patients in each
study experiencing the outcome, and differential loss to
Insufficient followup..111, 140
Changes in 4 RCTs (292) Low Direct Inconsistent Imprecise None An elimination diet improved ADHD-RS scores relative to
standardized 7–17, all a non-restricted diet,172 but did not find a reduction in
symptom scores through 17 ADHD symptoms relative to placebo for either Memomet
syrup or zinc supplementation.111, 125, 144
Low
Gastrointestinal 2 RCTs (172) Medium Direct Inconsistent Imprecise None The SOE was considered insufficient because identified
symptoms 7–17 studies varied in the interventions and outcomes
assessed and had differential loss to follow up111, 140
Insufficient
Mood disorders 1 RCT (120) Medium Direct NA Imprecise None The SOE was considered insufficient because only one
7–17 study was identified which had imprecise findings and
differential loss to follow up..140
Insufficient
Motor vehicle 1 RCT (120) Medium Direct NA Imprecise None The SOE was considered insufficient because only one
collisions 7–17 small study was identified.140

Insufficient
Sleep disturbance 2 RCTs (172) Medium Direct Consistent Imprecise None The SOE was considered insufficient because identified
7–17 studies varied in the interventions and outcomes
Insufficient assessed and had differential loss to follow up111, 140}
Suicide ideation 1 RCT (52) Medium Direct NA Imprecise None The SOE was considered insufficient because only one
7–17 small study was identified.111
Insufficient
Tics or other 1 RCT (52) Medium Direct NA Imprecise None The SOE was considered insufficient because only one
movement 7–17 small study was identified.111
disorders

Insufficient
Abbreviations: NA=not applicable; Obs=observational; RCT=randomized controlled trial; SOE=strength of evidence

76
Detailed Synthesis—Other Approaches
One good-quality107 and 8 fair-quality studies128, 137, 145, 149, 153, 170, 171, 175 representing 1,286
enrolled patients evaluated other approaches. These studies looked at a range of programs
including community programs and programs that addressed mentoring and parent support,128
multisystemic intervention at school and with parents,153, 170 in-home family training
intervention,107 a general parenting program,175 using melatonin as an adjunct treatment,
acupuncture, and a homeopathic intervention. This diverse range of interventions share some
features with other interventions with several having parent components,107, 128, 153, 170, 175 but
each were different from typical parent focused interventions in that there were other major
components or they were generic parenting programs. Findings are summarized by outcome and
described in Table H-13 in Appendix H. Neither the Challenging Horizons Program – after
school version nor the Family School Success – Early Elementary Program improved academic
performance (SOE=low). The SOE was insufficient for all other outcomes for each of the
interventions considered.

Findings in Relation to What Is Already Known—Other


Approaches
The 2011 report4 identified 7 studies that examined multiple component psychosocial and/or
behavioral interventions for preschool children with disruptive behavior disorder. Of these, five
RCTs included only preschoolers who exhibited ADHD symptoms but who were not necessarily
formally diagnosed with ADHD.211-215 All five of these RCTs demonstrated significant
improvement in the preschoolers’ behavior or symptoms relative to their comparison groups,
most of which were usual care only. In contrast, this updated review provides results from two
RCTs that examined a multiple component intervention for children specifically diagnosed with
ADHD that included both school and parent components.153, 170 Findings of these two studies are
summarized by outcome and described in Table H-13 in Appendix H. Despite the support for
behavioral interventions from the 2011 report, this report found insufficient SOE to evaluate the
impact of these interventions on ADHD symptoms. In part, this is because we only included
studies where children received formal diagnosis of ADHD.

Strength of Evidence—Other Approaches


Table 19 summarizes the SOE for other approaches based on this report’s included studies.
Small numbers of studies with imprecise findings caused insufficient SOE grades for all
outcomes other than academic performance.

77
Table 19. Strength of evidence for major outcomes—other approaches
No. Studies/
Outcome Design
(N Patients) Study Reporting
SOE Grade Age Category Limitations Directness Consistency Precision Bias Findings
Academic 3 RCTs (586) Medium Direct Consistent Imprecise None Neither the Challenging Horizons Program (After School
performance 7–17, all version) nor the Family School Success (Early
through 17 Elementary) interventions were found to improve
Low academic performance in 3 fair-quality RCTs.128, 153, 170
Behavior changes 4 RCTs (508) Medium Direct Consistent Imprecise Suspect The SOE was considered insufficient because of
6 and under, 7– (given concerns about risk of reporting bias and lack of precision
Insufficient 17, all through dropout in study results. 107, 145, 149, 171 188
17 and lack of
clarity in
reporting
findings)
Changes in 1 RCT (60) Medium Direct NA Imprecise None The SOE was considered insufficient because only one
appetite 7–17 small study was identified.145, 188
Insufficient
Changes in 3 RCTs (252) Medium Direct Consistent Imprecise None The SOE was considered insufficient because of lack of
standardized 7–17, all precision across the 3 fair-quality studies with varying
symptom scores through 17 mean changes between different standardized scores.137,
145, 175, 188
Insufficient
Functional 1 RCT (326) Medium Direct NA Imprecise None The SOE was considered insufficient because only one
impairment 7–17 small study was identified.128
Insufficient
Gastrointestinal 1 RCT (60) Medium Direct NA Imprecise None The SOE was considered insufficient because only one
symptoms 7–17 small study was identified.145, 188
Insufficient
Sleep disturbance 1 RCTs (60) Medium Direct NA Imprecise None The SOE was considered insufficient because only one
7–17 small study was identified.145, 188
Insufficient
Tics or other 1 RCT (60) Medium Direct NA Imprecise None The SOE was considered insufficient because only one
movement 7–17 small study was identified.145, 188
disorders
Insufficient
Weight decrease 1 RCT (60) Medium Direct NA Imprecise None The SOE was considered insufficient because only one
7–17 small study was identified.145, 188
Insufficient
Abbreviations: NA=not applicable; Obs=observational; RCT=randomized controlled trial; SOE=strength of evidence

78
Key Question 3: ADHD Monitoring
KQ 3 examined the comparative safety and effectiveness of different monitoring strategies to
evaluate the effectiveness of treatment or changes in ADHD status (e.g., worsening or resolving
symptoms). We did not identify any studies that met criteria for inclusion for KQ 3.

79
Discussion
Key Findings and Strength of Evidence
In this Comparative Effectiveness Review (CER), we reviewed 21 studies involving 4,346
patients that evaluated attentional deficit hyperactivity disorder (ADHD) diagnostic strategies for
children and adolescents that could be used in the primary care setting and evaluated the impact
of being labeled as having ADHD (Key Question [KQ] 1) and 69 studies involving 14,737
patients to evaluate the comparative effectiveness of different pharmacologic and
nonpharmacologic therapies for ADHD (KQ 2). Because of variations in “usual care” often used
as the comparator, detailed descriptions of the comparator were made and considered in the
evaluation of the available evidence. We hoped to evaluate the comparative effectiveness of
different follow-up strategies for children and adolescents with ADHD (KQ 3). However, no
study was identified that met the criteria for inclusion.

KQ 1: ADHD Diagnosis
This review focused on evidence evaluating diagnosis in children under 7 years of age or for
older children (up to 17 years of age) using novel diagnostic techniques including imaging,
electroencephalography (EEG), or assessment of executive function. The strength of evidence
(SOE) was insufficient to evaluate the validity of diagnostic approaches for children under 7
years. The Attention and Executive Function Rating Inventory and Childhood Executive
Functioning Inventory performed better than the Cambridge Neuropsychological Test
Automated Battery for the diagnosis of ADHD in children and adolescents 7 through 17 years of
age (strength of evidence [SOE]=low).
Limited information was found regarding the harm of being labeled with ADHD. Only two
cross-sectional studies were evaluated, and they only assessed the perspective of parents and
teachers. Neither study directly assessed the experience of children or adolescents with ADHD.
Therefore, no conclusions could be drawn regarding the impact of ADHD diagnosis.

KQ 2: ADHD Treatment
ADHD treatment options include pharmacologic and nonpharmacologic therapies. The 2011
AHRQ report highlighted the benefit of psychostimulants for children 6 through 12 years of age
and the potential benefit of additional behavior therapy, especially for those with oppositional
defiant disorder. For younger children, the 2011 AHRQ report found parent behavioral
interventions to be effective
Atomoxetine and MPH were the most common drugs evaluated in the studies included in this
review (evaluated in 8 studies). The SOE was insufficient to determine which drug is more
effective or whether the side-effect profiles are different. There was also little evidence regarding
serious cardiovascular risk with use of these medications.
Of the nonpharmacologic therapies, the SOE since the last review was insufficient to
evaluate neurofeedback. Studies since the last review found that child or parent training appear
to improve standardized ADHD symptom scores (SOE=moderate) but had no difference in
academic performance (SOE=low). Cognitive training and cognitive behavioral therapy was
associated with improved standardized symptoms scores (SOE=low each).

80
The most well-studied nutritional therapy is dietary supplementation with omega-3/6 fatty
acids. However, based on our meta-analysis, there was no impact of omega-3/6 supplements on
parent or teacher rating scales of ADHD symptoms.
Table 20 summarizes the SOE findings for KQ 2 that were graded as low, moderate, or high.

81
Table 20. Summary strength of evidence for major outcomes for KQ 2
No. Studies/
Design
(N Patients)
Outcome Age Category Findings SOE Grade
Pharmacologic vs. Placebo Treatments: NA
Pharmacologic vs. Pharmacologic Treatments
Gastrointestinal 3 Obs (1,966) Atomoxetine has slightly higher GI effects or disease than MPH.121, 123, 151 Low
symptoms 7–17

Pharmacologic vs. Nonpharmacologic Treatments


Changes in appetite 3 RCTs (212) MPH decreased appetite compared to ningdong, omega-3/6 or gingko biloba.114, 141, 155 Low
7–17

Sleep disturbance 4 RCTs (324) MPH resulted in increased sleep disturbances compared to ningdong, gingko biloba, omega-3/6, Low
7–17 or neurofeedback.114, 141, 155

Nonpharmacologic vs. Nonpharmacologic or Other Treatments


Neurofeedback: NA
Cognitive Training
Changes in 9 RCTs (768) There is some evidence that cognitive training strategies such as the computer-based Cogmed Low
standardized 7–17, all through cognitive training program may reduce ADHD symptoms in the short term but not the long
symptom scores 17 term.115, 119, 122, 126, 132, 160, 163, 174

Cognitive Behavioral Therapy


Changes in 2 RCTs (278) CBT improved ADHD symptoms relative to usual care or a limited CBT intervention.117, 164 Low
standardized 7–17
symptoms scores

Child or Parent Training or Behavioral


Changes in 8 RCTs, 1 Obs ADHD symptoms were significantly improved with child or parent training, sleep hygiene, or Moderate
standardized (966) behavioral interventions.112, 127, 129, 138, 150, 152, 167-169, 184
symptom scores 7–17

Academic 2 RCTs (356) There were no differences in academic performance associated with organizational skills or social Low
performance 7–17 skills training relative to no intervention.108, 161

82
No. Studies/
Design
(N Patients)
Outcome Age Category Findings SOE Grade
Omega-3 Supplementation
Changes in 7 RCTs (795) Omega-3/6 did not improve parent ratings compared to placebo (SMD -0.32, 95% CI -0.80 to Moderate
standardized 7–17 0.15) or teacher ] (SMD -0.08, 95% CI -0.47 to 0.32).133, 136, 139, 142, 143, 154, 190, 191, 195
symptom scores

Herbal Interventions or Dietary Approaches


Changes in 3 RCTs (238) ADHD-RS scores improved with an elimination diet relative to a nonrestricted diet, while ADHD Low
standardized 7–17, all through symptoms were not reduced with either Memomet syrup or zinc supplementation relative to
symptom scores 17 placebo.111, 125, 172

Other Approaches
Academic 3 RCTs (586) Neither the Challenging Horizons Program-After School version nor the Family School Success- Low
performance 7–17, all through Early Elementary interventions improved academic performance.128, 153, 170
17
Abbreviations: ADHD=attention deficit hyperactivity disorder; CBT=cognitive behavioral therapy; GI=gastrointestinal; Obs=observational; RCT=randomized controlled trial;
RS=rating scale; SMD=standardized mean difference; SOE=strength of evidence

83
Findings in Relation to What Is Already Known
Table 21 summarizes the differences and similarities in scope across this current systematic
review compared with the 2011 review,4 along with our main findings.

84
Table 21. Differences in scope between the 2011 and current evidence reports
2011 Report Current Report
Key Questions This systematic review compared effectiveness and This systematic review updates and extends two previous
(KQs) adverse events of interventions for preschoolers at high systematic evidence reviews and focuses on the
risk for ADHD; compared long-term effectiveness and comparative effectiveness of methods to establish the
adverse events of interventions for ADHD among diagnosis of ADHD, updates the comparative effectiveness
persons of all ages; and described how identification and of pharmacologic and nonpharmacologic treatments, and
treatment for ADHD varied. evaluates different monitoring strategies in the primary care
setting for individuals from birth through 17 years of age.
Specifically, the KQs included:
Specifically, the KQs include:
1. Among children younger than 6 years of age with
ADHD or disruptive behavior disorders, what are the 1. For the diagnosis of ADHD:
effectiveness and adverse event outcomes following
a. What is the comparative diagnostic accuracy of
treatment?
approaches that can be used in the primary care
practice setting or by specialists to diagnose ADHD
2. Among people 6 years of age or older with ADHD,
among individuals younger than 7 years of age?
what are the effectiveness and adverse event
outcomes following 12 months or more of any b. What is the comparative diagnostic accuracy of EEG,
combination of followup or treatment, including, but imaging, or executive function approaches that can be
not limited to, 12 months or more of continuous used in the primary care practice setting or by
treatment? specialists to diagnose ADHD among individuals aged
7 through 17?
3. How do (a) underlying prevalence of ADHD and (b)
c. For both populations, how does the comparative
rates of diagnosis (clinical identification) and
diagnostic accuracy of these approaches vary by
treatment for ADHD vary by geography, time period,
clinical setting, including primary care or specialty
provider type, and sociodemographic characteristics?
clinic, or patient subgroup, including age, sex, or other
risk factors associated with ADHD?
d. What are the adverse effects associated with being
labeled correctly or incorrectly as having ADHD?

2. What are the comparative safety and effectiveness of


pharmacologic and/or nonpharmacologic treatments of
ADHD in improving outcomes associated with ADHD?
How do these outcomes vary by presentation
(inattentive, hyperactive/impulsive, and combined) or
other comorbid conditions? What is the risk of diversion
of pharmacologic treatment?

85
2011 Report Current Report

3. What are the comparative safety and effectiveness of


different monitoring strategies to evaluate the
effectiveness of treatment or changes in ADHD status
(e.g., worsening or resolving symptoms)?
Publication dates By KQ: 2009-2016
for included 1. Inception to 2010
studies 2. 1997-2010
3. 1980-2010
ADHD diagnosis Not addressed The Attention and Executive Function Rating Inventory and
Childhood Executive Functioning Inventory performed better
than the Cambridge Neuropsychological Test Automated
Battery for the diagnosis of ADHD between 7 and 17 years
of age (SOE=low). This systematic evidence review
identified limited studies with variable and inconsistent
findings for diagnostic accuracy for all other diagnostics
tools evaluated, including imagining and EEG-based tests
Treatment of Evidence favored treatment with parent behavior training. Not addressed
preschoolers with Only one good-quality study of the effectiveness of
disruptive behavior methylphenidate (MPH) was identified, which found
disorders, therapy to be effective.
including those at
risk of ADHD
Long-term • MPH is effective for ADHD treatment for 14 months • There are no new conclusions regarding the
effectiveness and and atomoxetine (ATX) for over 12 months. SOE was effectiveness of pharmacotherapy vs. placebo, of
safety of treatment low. comparing different pharmacologic treatments, or of
in people aged 6 comparing combined therapeutic approaches (i.e.,
and older • Combining medication and behavioral treatment can pharmacotherapy and nonpharmacotherapy).
improve outcome compared to medication alone for
some outcomes for those with ADHD combined type. • Gastrointestinal side effects are slightly higher for ATX
SOE was low and the population were not necessarily compared with MPH; however, the SOE was low.
formally diagnosed with ADHD.
• Compared with placebo, child or parent training can
improve ADHD symptoms. SOE was moderate. It did not
however improve academic performance (SOE low)
There are still questions related to the comparative
effectiveness with pharmacotherapy alone or in
combination with behavioral therapy.

86
2011 Report Current Report
• Compared with placebo, omega-3 fatty acid
supplementation had no difference on ADHD symptoms.
SOE was moderate.
• Cognitive behavioral therapy improved ADHD symptom
scores. SOE was low
Prevalence and There is significant variation in diagnosis and treatment, Not addressed
variations in with an overall increase in the use of pharmacotherapy.
diagnosis and
treatment
Monitoring Not addressed There were no studies found that compared monitoring
strategies strategies after the diagnosis of ADHD.
Abbreviations: ADHD=attention deficit hyperactivity disorder; ATX=atomoxetine; EEG=electroencephalography; KQ=Key Question; MPH=methylphenidate; SOE=strength of
evidence

87
Since publication of the American Academy of Pediatrics (AAP) clinical practice guideline,
there has been significant interest in the use of objective tests that could overcome the inherent
limitations in the use of behavioral rating scales. Our systematic review could not find sufficient
evidence to recommend that such tests now be incorporated into care, although the review was
limited to studies published in 2009 and later. The AAP guideline also recognized the potential
harm of labeling an individual with ADHD, but our review did not identify studies that would
allow an estimate of this potential harm.
The AAP clinical practice guideline, based on the 2011 review, recommends behavioral
therapy for children 4 through 5 years of age as the first line of therapy, with consideration of
methylphenidate (MPH) if such interventions fail. In contrast, the AAP preferably recommends
Food and Drug Administration (FDA)-approved medications and behavioral interventions for
older children and adolescents. A recent Cochrane review of randomized controlled trials for the
treatment of ADHD found that although MPH might improve ADHD symptoms, the level of
certainty was low because most trials were underpowered, of low quality, and had short duration
of follow-up.77 That review included studies of children and adolescents 18 years and younger
with ADHD according to DSM 3, 4, or 5 published by March 2015. Another systematic review
supported the use of MPH, atomoxetine, and extended-release guanfacine to improve ADHD
symptoms in adolescents.70 That review only included studies of subjects 12–18 years of age
published from 1999 through January 2016. As with the Cochrane review,77 limitations in study
quality were identified.
Our systematic review was not able to provide further evidence regarding the comparative
effectiveness of FDA-approved medications. Other than omega-3 supplements which had
moderate SOE for no difference in ADHD symptom scores, none of the other dietary
supplements for ADHD therapy has sufficient SOE. However, the behavioral interventions were
of did demonstrate effectiveness based on the studies included in this update. We found low SOE
for cognitive behavioral therapy and moderate SOE for child or parent training but no difference
in academic performance (SOE=low). Insufficient data were available to determine whether
there is a subgroup of children and adolescents with ADHD (e.g., based on age or other
characteristics) for whom these therapies might be more effective.
No existing systematic reviews or guidelines address the frequency that children or
adolescents receiving care for ADHD should receive follow-up in the primary care practice
setting or what approach should be used for monitoring after treatment is begun. Unfortunately,
our systematic review also found no information to inform this question.
Prior to the publication of the AAP clinical practice guideline, the American Academy of
Child and Adolescent Psychiatry released recommendations for establishing the diagnosis of
ADHD and treating the condition.216 These recommendations were consistent with the AAP
clinical practice guideline, including the need for a comprehensive evaluation to establish the
diagnosis and the need to personalize therapy, using behavioral interventions and/or stimulant
therapy. Since the publication of the AAP clinical practice guideline, the American Academy of
Neurology has released a guideline recommending against the use of EEG to confirm ADHD or
to support further testing within the context of usual clinical care.217 The 2011 review did not
address approaches to diagnosis. The current review did not find sufficient evidence to
recommend for or against the use of EEGs to confirm ADHD.

88
Applicability
The accuracy of diagnostic tests and the effects of interventions for ADHD as determined in
clinical studies do not always translate well to usual practice, where patient characteristics,
clinical training, and resources may differ from study conditions in key ways. In addition, the
availability of ADHD interventions studied in our review may differ from those easily available
to patients within the United States.
For our analysis of diagnostic tools, study participants were generally adequately described.
The main issue affecting applicability was the source of patients, who were selected from
specialty clinics. This might affect the reported test characteristics (e.g., sensitivity and
specificity). In general, given the scarcity of evidence we were not able to separately consider the
role of age, ADHD subtype, or prior therapy. Most studies of diagnostic tools are performed
outside of the primary care practice setting, further limiting applicability to children seen in the
primary care setting. The studies of labeling have low applicability because they did not address
specific patients or were surveys based on hypothetical children labeled with having ADHD.
The treatment studies we evaluated have moderate applicability due to significant
heterogeneity regarding the duration of therapy, the study population, and the follow-up period.
However, there was consistency in findings related to pharmacotherapy.
We were unable to find any studies that met the inclusion criteria regarding follow-up after
treatment initiation (KQ 3).
Table 22 shows potential issues with applicability for studies included for KQ 1. Table 23
shows similar information for studies included in KQ 2 and is broken down by type of
intervention.
Table 22. Potential issues with applicability of included studies for Key Question 1

Issue N=21 Studies


Population (P)
Narrow eligibility criteria and exclusion of those with comorbidities 2
More complex patients than typical of the community 2
Run-in period with high exclusion rate for non-adherence or side effects 0
DSM-4/5 diagnosis unclear 0
Intervention (I)
Diagnostic tools used differently than as recommended or commonly used in practice 0
Dosing not reflective of current practice 0
Co-interventions that are likely to modify the effectiveness of therapy 0
Highly selected intervention team or level of training/proficiency not widely available 1
Follow-up not reflective of current practice 0
Co-intervention that are likely to modify monitoring strategies 0
Comparator (C)
Diagnostic tools used differently than as recommended or commonly used in practice 0
Comparator unclear 0
Inadequate comparison therapy or use of a substandard alternative therapy 0
Outcomes (O)
Composite outcomes that mix outcomes of different significance 0
Short-term follow-up 0
Surrogate outcomes 0
Setting (S)
Level of care different from that in the community 9
DSM=Diagnostic and Statistical Manual of Mental Disorders

89
Table 23. Potential issues with applicability of included studies for Key Question 2
N=69 Studies
Pharm vs. Pharm vs. Pharm vs. Nonpharm vs. Nonpharm
Issue
Pharm Nonpharm Placebo Nonpharm vs. Placebo
N=9 N=7 N=7 N=15 N=37
Population (P)
Narrow eligibility criteria and
exclusion of those with 0 0 1 2 1
comorbidities
More complex patients than
0 0 0 0 0
typical of the community
Run-in period with high exclusion
rate for non-adherence or side 0 0 0 0 0
effects
DSM-4/5 diagnosis unclear 0 0 0 0 1
Intervention (I)
Diagnostic tools used differently
than as recommended or 0 0 0 0 0
commonly used in practice
Dosing not reflective of current
0 0 0 0 0
practice
Co-interventions that are likely to
modify the effectiveness of 1 1 2 0 4
therapy
Highly selected intervention team
or level of training/proficiency not 0 1 1 1 4
widely available
Follow-up not reflective of current
0 0 1 0 1
practice
Co-intervention that are likely to
0 0 0 0 0
modify monitoring strategies
Comparator (C)
Diagnostic tools used differently
than as recommended or 0 0 0 0 0
commonly used in practice
Comparator unclear 1 0 1 0 0
Inadequate comparison therapy or
use of a substandard alternative 1 0 0 1 3
therapy
Outcomes (O)
Composite outcomes that mix
0 0 0 0 0
outcomes of different significance
Short-term follow-up 0 2 1 4 10
Surrogate outcomes 0 0 0 0 0
Setting (S)
Level of care different from that in
0 1 2 2 4
the community
Abbreviations: DSM=Diagnostic and Statistical Manual of Mental Disorders; Pharm=pharmacologic;
Nonpharm=nonpharmacologic

Implications for Clinical and Policy Decisionmaking


The lack of strong evidence for objective tests for the diagnosis of ADHD suggests that
behavior rating scales should continue to be used as the primary strategy for diagnosing the
condition. Overall, pharmacotherapy has been more studied than other treatment approaches and
is generally considered the first approach to treatment for children and adolescents over 7 years
of age. Insufficient data were available to determine whether they should be the first line of
therapy for children under 7 years of age. Cognitive behavioral therapy (low SOE) or child or

90
parent training (moderate SOE) may reduce symptoms of ADHD but had no difference in
academic performance (low SOE). Insufficient data were available to evaluate the effect of
combining medication therapy with these approaches to care. There is a lack of supportive data
for other complementary therapies. Although regular follow-up is recommended for children and
adolescents with ADHD, no evidence was found about the comparative benefits and harms of
different approaches.

Limitations of the Systematic Review Process


Our findings have limitations related to the literature and our approach. Important limitations
of the literature include (1) population heterogeneity; (2) short follow-up periods; (3) small
sample sizes; (4) studies conducted outside of primary care; (5) variability in outcomes to assess
efficacy and tolerability; and (6) inconsistent reporting of comparative statistical analyses.
Our review methods also have limitations. This review was designed to extend two previous
systematic reviews.4, 19 However, these two previous reviews did not have the same focus on
issues related to the diagnosis and management of ADHD as this review. The time period of this
systematic review led to the exclusion of earlier larger studies. In addition, some of the earlier
reports regarding studies (e.g., the Multisite Multimodal Treatment Study of Children with
ADHD [MTA]) included in this review might have been excluded. Our study was limited to
English-language publications. Note that during the protocol development phase of our review
we made two scoping revisions in consultation with our Technical Expert Panel (TEP).
Specifically the review focused on:
• KQ 1: Diagnostic methods in children aged 6 or under or which compared novel
diagnostic methods (e.g., imaging or EEG)
• KQ 2: Studies comparing two or more pharmacologic treatments approved by the
FDA for the treatment of ADHD needed include 100 or more patients with ADHD
and have a followup period of 6 months or longer. Criteria were less stringent for
studies assessing nonpharmacologic treatments or pharmacologic treatments not
indicated by the FDA for the treatment of ADHD. Data for these interventions was
limited to studies including 50 or more patients with ADHD, with no specific
requirement for length of followup.
This change in scope was performed in consultation with the nominating partner and the TEP
in order to focus the systematic review on the areas of the greatest uncertainty and potential
impact.
Another limitation of this review is that medication doses were not abstracted. Abstracting
specific doses is challenging because many of the studies are based on dose escalation and there
is often insufficient information to be able to determine the dose per subject body weight.

Research Recommendations
ADHD is a common health problem that can be associated with significant impairment over
the life span. The current evidence base has several significant gaps regarding diagnosis,
treatment, and follow-up in the primary care setting. We did not identify any ongoing studies
through trial registries that would help resolve the gap. Here we describe opportunities for future
research organized by the three KQs.

91
KQ 1: ADHD Diagnosis Research Gaps
Significant gaps related to KQ 1 include the lack of studies conducted in primary care and the
lack of studies that prospectively evaluate the harm of labeling.
• Validity and reliability of behavior scales in direct comparison to new strategies for
diagnosis:
o Studies should include a typical population of children and adolescents in primary
care seeking initial diagnosis.
o The tools should be performed in the primary care setting.
o Confirmation should be based on DSM-5 criteria by an expert within a short period of
time to evaluate in the primary care setting. The expert should be blinded to the
results in primary care.
o Receiver operator characteristic (ROC) curves should be generated to evaluate the
validity of diagnosis using different cut-offs for the behavior scales and consider the
impact of combining behavior scales with other diagnostic strategies.
o Results should be stratified by age group and ADHD subtype.
o Reliability (test-retest reliability, inter-observer reliability, and intra-observer
reliability) should be evaluated.
• Harms of labeling: These can be assessed in a longitudinal cohort of patients diagnosed
with ADHD as part of an overall study to evaluate the effectiveness of interventions (see
KQ 2).

KQ 2: ADHD Treatment Research Gaps


Significant gaps related to KQ 2 include the lack of studies conducted in primary care and the
short duration of follow-up.
• Effectiveness of treatment:
o Secondary data analysis of electronic record data could be used to assess outcomes
from large cohorts of patients, but would be limited to the available data and lack of
randomization.
o Typical care would be better informed by a pragmatic randomized trial that includes
the typical spectrum of patients seen in primary care. Pragmatic trials can be
embedded with electronic medical records, making prospective studies more feasible.
o Three-arm studies, using pharmacologic, nonpharmacologic treatments (e.g.,
behavioral interventions), and a combination of approaches are needed. In a
pragmatic trial, therapy could be escalated or combined, based on the responsiveness
to treatment.
o Although behavioral interventions are recommended, more research is needed about
the comparative effectiveness of different approaches and how behavioral
interventions can be personalized within the context of care in which most children
and adolescents are treated.
o Studies should include a wide range of outcomes, including behavior rating scales,
school functioning, risk-taking behaviors, growth and development, comorbid
psychiatric disorders, and the typical adverse events monitored in drug trials.
o Studies should have a meaningful duration. Ideally, those enrolled in a pragmatic trial
would be followed for multiple years.

92
o Studies should include the full spectrum of children and adolescents seeking care in
the primary care setting.
o Follow-up monitoring should be evaluated, as described for KQ 3.

KQ 3: ADHD Monitoring Research Gaps


Monitoring individuals with ADHD is a central to assuring optimal treatment outcomes. It
allows for modification of the treatment plan based on assessment of adherence, changes in
symptoms, the presence of comorbidity, the effectiveness of therapy, and the presence of any
treatment-related harms. Factors that should be considered are time intervals, setting (e.g.,
primary care vs. specialty care), and the type of information to be evaluated. In addition, the role
of technology should be considered. For example, the use of technology (e.g., Web-based tools
or smartphone applications) could allow the collection of a wide array of data and decrease the
need for in-clinic evaluations. Telemedicine might enable health care providers to communicate
with the patient, family, and teachers.
• Monitoring treatment:
o Within a pragmatic trial, different strategies for monitoring could be embedded.
o Strategies should include the use of technology versus traditional in-person
evaluations.
o The frequency of monitoring should be a function of the ADHD symptoms and
the intervention.

Conclusions
Additional benefit of new strategies for diagnosing ADHD (e.g., imaging, EEG) is unclear.
Little is known about the harm of labeling. For ADHD treatment, the 2011 report found benefits
for psychostimulant therapy and behavioral therapy. This report using more stringent criteria for
inclusion (e.g., diagnostic confirmation of ADHD) found evidence for behavioral therapy
improving ADHD symptoms but no difference in academic performance and insufficient
evidence for other outcomes. In addition, we found that omega-3/6 fatty acid supplementation
does not appear to be effective in reducing ADHD symptoms. Overall, this review highlights the
need for more research regarding behavioral therapies. There are insufficient data available to
determine whether variations exist in effectiveness by age, sex, or presenting ADHD symptoms.
No data were identified to determine the optimal strategy for monitoring children and
adolescents with ADHD.

93
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of the revised new forest parenting programme Behavior Therapy. 2005;27(1):33-56. doi:
for preschoolers with attention deficit 10.1300/J019v27n01_03. PMID:
hyperactivity disorder. Eur Child Adolesc WOS:000230131600003.
Psychiatry. 2009 Oct;18(10):605-16. doi:
216. Pliszka S. Practice Parameter for the
10.1007/s00787-009-0020-0. PMID:
Assessment and Treatment of Children and
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Adolescents With Attention-
209. Belanger SA, Vanasse M, Spahis S, et al. Deficit/Hyperactivity Disorder. Journal of the
Omega-3 fatty acid treatment of children with American Academy of Child & Adolescent
attention-deficit hyperactivity disorder: A Psychiatry.46(7):894-921. doi:
randomized, double-blind, placebo-controlled 10.1097/chi.0b013e318054e724.
study. Paediatr Child Health. 2009
217. Gloss D, Varma JK, Pringsheim T, et al.
Feb;14(2):89-98. PMID: 19436468.
Practice advisory: The utility of EEG
210. Cornell JE, Mulrow CD, Localio R, et al. theta/beta power ratio in ADHD diagnosis:
Random-effects meta-analysis of inconsistent Report of the Guideline Development,
effects: a time for change. Ann Intern Med. Dissemination, and Implementation
2014 Feb 18;160(4):267-70. doi: Subcommittee of the American Academy of
10.7326/M13-2886. PMID: 24727843. Neurology. Neurology. 2016 Nov
29;87(22):2375-9. doi:
211. Williford AP, Shelton TL. Using mental health
10.1212/wnl.0000000000003265. PMID:
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18211278.
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108
Acronyms and Abbreviations
Acronym/Abbreviation Definition
AAP American Academy of Pediatrics
AACAP American Academy of Child and Adolescent Psychiatry
ACES Adverse Childhood Experiences Study
ADHD Attention deficit hyperactivity disorder
ADHD-C Attention deficit hyperactivity disorder-combined type
ADHD-HI Attention deficit hyperactivity disorder-hyperactive/impulsive type
ADHD-I Attention deficit hyperactivity disorder-inattentive type
ADHD-RS Attention Deficit Hyperactivity Disorder Rating Scale
ADHD RS-IV Attention Deficit Hyperactivity Disorder Rating Scale 4
AHRQ Agency for Healthcare Research and Quality
ATTEX Attention and Executive Function Rating Inventory
ATX Atomoxetine
AUC Area under the curve
AV Atrioventricular
BASC-2 Behavior Assessment System for Children, Second Edition
Behavior Assessment System for Children, Second Edition
BASC-2 BESS
Behavioral and Emotional Screening System
BPT Behavioral parent training
BRIEF Behavior Rating Inventory of Executive Function
CANTAB Cambridge Neuropsychological Test Automated Battery
CARE Coping With ADHD Through Relationships and Education
CBCL Child Behavior Checklist
CBRS Comprehensive Behavior Rating Scale
CBT Cognitive behavioral therapy
CBV Caudate body volume
CD Conduct disorder
CDI Children’s Depression Inventory
CDSR Cochrane Database of Systematic Reviews
CER Comparative effectiveness review
CGI Conners’ Global Index; Clinical Global Impression
CGI-S Clinical Global Impression Severity
CGI-SS Clinical Global Impression of Severity of Suicidality
CHEXI Childhood Executive Functioning Inventory
CHIP-CE-PRF Child and Health Illness Profile Child Edition, Parent Report Form
CHP-AS Challenging Horizons Program After School
CHP-M Challenging Horizons Program Mentoring
CI Confidence interval
CDI Children’s Depression Inventory
CLAS Child Life and Attention Skills

109
Acronym/Abbreviation Definition
Cog-Fun Cognitive Functional intervention
Cogmed Computerized memory training program
Conners 3 Conners 3rd Edition
Conners CPT Conners Continuous Performance Test
CPFT Continuous Performance Function Test
CPRS Conners Parent Rating Scale
CPT Continuous Performance Test
CRS Conners Rating Scale
CRS-P Conners Rating Scale Parent
CRS-T Conners Rating Scale Teacher
CTRS Conners Teacher Rating Scale
DASS Depression Anxiety Stress Scale
DB-DOS Disruptive Behavior Diagnostic Observation Schedule
DBDRS Disruptive Behavior Disorder Rating Scale
DBRS Disruptive Behavior Rating Scale
DBP Diastolic blood pressure
DEX Dextroamphetamine
DHA Docosahexaenoiacid
DICA-IV Diagnostic Interview for Children and Adolescents 4
DISC-IV Diagnostic Interview Schedule for Children Version IV
DSM-5 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition
Diagnostic and Statistical Manual of Mental Disorders, 4th Edition,
DSM-IV-TR
Text Revision
D-TMP Dexmethylphenidate
ECG Electrocardiograph
ED Emergency department
Electroencephalograph, electroencephalogram,
EEG
electroencephalography
EHC Effective Health Care
EIS Electro-interstitial scan
EMBASE Excerpta Medica Database
EPA Eicosapentaenoic acid
EPC Evidence-based Practice Center
ERP Event-related potentials
ES Effect size
FDA Food and Drug Administration
FSSEE Family-School Success–Early Elementary
GIR Guanfacine immediate release
GPA Grade point average
GXR Guanfacine extended release
HR Hazard ratio

110
Acronym/Abbreviation Definition
10th revision of the International Statistical Classification of
ICD-10
Diseases and Related Health Problems
ICTRP International Clinical Trials Registry Platform
IRS Impairment Rating Scale
IVA-2 (BrainTrain, Inc) Integrated Visual and Auditory 2
IVA-AE2 (BrainTrain,
Integrated Visual and Auditory Advanced Edition 2
Inc)
IVA-CPT Integrated Visual and Auditory Continuous Performance Test
IVA-QS (BrainTrain,
Integrated Visual and Auditory Quick Screening
Inc)
K-DBDS Kiddie Disruptive Behavior Disorder Schedule
K-DISC-IV Kiddie Computerized Diagnostic Interview Schedule for Children
KQ Key Question
Kiddie Schedule for Affective Disorders and Schizophrenia
K-SADS-PL
Present and Lifetime Version
LA Linoleic acid
LDX Lisdexamfetamine
MAS Mixed amphetamine salts
MASC Multidimensional Anxiety Scale for Children
MATH-CPT Mathematics Continuous Performance Test
MEDLINE National Library of Medicine bibliographic database
Mini International Neuropsychiatric Interview for Children and
Mini KID
Adolescents
MPH Methylphenidate
MRI Magnetic resonance imaging
MTA Multisite Multimodal Treatment Study of Children with ADHD
NA Not applicable
NDG Ningdong granule
NEBA Neuropsychiatric EEG-Based Assessment AID
NICHQ Vanderbilt
National Institute for Children’s Health Quality Vanderbilt
Assessment Scale–
Assessment Scale Parent
PARENT
NICHQ Vanderbilt
National Institute for Children’s Health Quality Vanderbilt
Assessment Scale–
Assessment Scale Teacher
TEACHER
NIMH National Institute of Mental Health
NS Not significant
NSS Neurological subtle signs
ODD/CD Oppositional defiant disorder/Conduct disorder
OROS-MPH Osmotic release oral system methylphenidate
PACS Parental account of children’s symptoms
PATS Preschool ADHD Treatment Study
P-DBDRS Parent Disruptive Behavior Disorder Rating Scale

111
Acronym/Abbreviation Definition
Populations, Interventions, Comparators, Outcomes, Timing,
PICOTS
Settings
Preferred Reporting Items for Systematic Reviews and Meta-
PRISMA
Analyses
PROSPERO Prospective Register of Systematic Reviews
PS Phosphatidylserine
RBBB Right bundle branch block
RR Relative risk
RCT Randomized controlled trial
ROC Receiver operator characteristic
SBP Systolic blood pressure
SD Standard deviation
SDQ Strengths and Difficulties Questionnaire
SDSC Sleep Disturbance Scale for Children
SE Standard error
SMD Standardized mean difference
SNAP-IV Swanson, Nolan and Pelham Revision
SOE Strength of evidence
STAND Supporting Teens’ Autonomy Daily
STEPP Strategies to Enhance Positive Parenting
SWAN Strengths and Weaknesses of ADHD and Normal Behavior
TBR Theta/beta ratio
TEP Technical expert panel
TOVA Test of Variables of Attention
WHO World Health Organization
WIAT Wechsler Individual Achievement Test
WJ Woodcock-Johnson test of achievement
WRAT Wide Range Achievement Test
WPREMB Weekly Parent Ratings of Evening and Morning Behavior
XR Extended release

112
Appendix A. Exact Search Strings

PubMed® Search Strategy (November 4, 2016)

Key Question 1
Set # Terms
#1 "Attention Deficit Disorder with Hyperactivity"[Mesh] OR "attention deficit hyperactivity disorder"[tiab]
OR "ADHD"[tiab] OR "attention deficit disorder"[tiab]
#2 "Pediatrics"[Mesh] OR "Adolescent"[Mesh] OR "Infant"[Mesh] OR "Child"[Mesh] OR child[tiab] OR
children[tiab] OR infant[tiab] OR infants[tiab] OR preschool[tiab] OR preschooler[tiab] OR pediatric[tiab]
OR teenager[tiab] OR teenagers[tiab] OR teenaged[tiab] OR teen[tiab] OR teens[tiab] OR
adolescent[tiab] OR adolescents[tiab] OR adolescence[tiab] OR youth[tiab]
#3 "Attention Deficit and Disruptive Behavior Disorders/diagnosis"[Majr] OR mass screening[mesh] OR
questionnaires[mesh] OR Interviews as Topic[Mesh] OR Psychometrics[Mesh] OR Psychiatric Status
Rating Scales[Mesh] OR diagnosis[mesh:noexp] OR "Diagnostic Techniques and Procedures"[Mesh]
OR "Diagnostic and Statistical Manual of Mental Disorders"[Mesh] OR "Referral and
Consultation"[Mesh] OR questionnaire[tiab] OR questionnaires[tiab] OR screening[tiab] OR screen[tiab]
OR scale[tiab] OR instrument[tiab] OR instruments[tiab] OR interview[tiab] OR interviews[tiab] OR
DSM*[tiab] OR diagnosis[tiab] OR diagnostic[tiab] OR diagnosed[tiab] OR (Vanderbilt[tiab] AND
scale[tiab]) OR conners[tiab] OR cprs[tiab] OR ctrs[tiab] OR cprs[tiab] OR crs[tiab] OR "snap-IV"[tiab]
OR "snap-4"[tiab] OR "basc-2"[tiab] OR "behavioral assessment system for children"[tiab] OR
dbdrs[tiab] OR "disruptive behavior disorder rating scale"[tiab] OR adhd-rs[tiab] OR "adhd rating
scale"[tiab] OR ksads[tiab] OR k-sads[tiab] OR kiddie-sads[tiab] OR DISC[tiab] OR "dominance
inducement submission and compliance"[tiab] OR "diagnostic interview schedule for children"[tiab] OR
"diagnostic inventory for screening children"[tiab] OR "mini-kid"[tiab] OR "Mini Interational
Neuropsychiatric interview"[tiab] OR "iva-2"[tiab] OR "iva-qs"[tiab] OR "iva-ae2"[tiab] OR tova[tiab] OR
"test of variables of attention"[tiab] OR "neuropsychiatric eeg-based assessment aid"[tiab] OR
neba[tiab]
#4 "Sensitivity and Specificity"[Mesh] OR "Diagnostic Errors"[Mesh] OR sensitivity[tiab] OR specificity[tiab]
OR accuracy[tiab] OR accurate[tiab] OR accurately[tiab] OR misdiagnos*[tiab] OR (randomized
controlled trial[pt] OR controlled clinical trial[pt] OR randomized[tiab] OR randomised[tiab] OR
randomization[tiab] OR randomisation[tiab] OR placebo[tiab] OR randomly[tiab] OR trial[tiab] OR
groups[tiab] OR Clinical trial[pt] OR “clinical trial”[tiab] OR “clinical trials”[tiab] OR "evaluation
studies"[pt] OR "evaluation studies as topic"[MeSH] OR "evaluation study"[tiab] OR evaluation
studies[tiab] OR "intervention studies"[MeSH] OR "intervention study"[tiab] OR "intervention
studies"[tiab] OR "case-control studies"[MeSH] OR "case-control"[tiab] OR "cohort studies"[MeSH] OR
cohort[tiab] OR "longitudinal studies"[MeSH] OR "longitudinal”[tiab] OR longitudinally[tiab] OR
"prospective"[tiab] OR prospectively[tiab] OR "retrospective studies"[MeSH] OR "retrospective"[tiab] OR
"Cross-Sectional Studies"[Mesh] OR cross-sectional[tiab] OR "comparative study"[pt] OR "comparative
study"[tiab] OR systematic[sb] OR "meta-analysis"[pt] OR "meta-analysis as topic"[MeSH] OR "meta-
analysis"[tiab] OR "meta-analyses"[tiab]) NOT (Editorial[ptyp] OR Letter[pt] OR Case Reports[pt] OR
Comment[pt]) NOT (animals[mh] NOT humans[mh]) AND English[la]
#5 #1 AND #2 AND #3 AND #4
Publication date from 2009/01/01

A-1
Key Question 2
Set # Terms
#1 "Attention Deficit Disorder with Hyperactivity"[Mesh] OR "attention deficit hyperactivity disorder"[tiab]
OR "ADHD"[tiab] OR "attention deficit disorder"[tiab]
#2 "Pediatrics"[Mesh] OR "Adolescent"[Mesh] OR "Infant"[Mesh] OR "Child"[Mesh] OR child[tiab] OR
children[tiab] OR infant[tiab] OR infants[tiab] OR preschool[tiab] OR preschooler[tiab] OR pediatric[tiab]
OR teenager[tiab] OR teenagers[tiab] OR teenaged[tiab] OR teen[tiab] OR teens[tiab] OR
adolescent[tiab] OR adolescents[tiab] OR adolescence[tiab] OR youth[tiab]
#3 #1 AND #2
#4 "Attention Deficit Disorder with Hyperactivity/drug therapy"[Majr] OR "Central Nervous System
Stimulants"[MeSH] OR "Methylphenidate"[MeSH] OR "Dexmethylphenidate"[MeSH] OR
"Dextroamphetamine"[MeSH] OR "Adderall"[Supplementary Concept] OR "lisdexamfetamine
dimesylate"[Supplementary Concept] OR "Amphetamine"[MeSH] OR "Guanfacine"[MeSH] OR
"Sympatholytics"[MeSH] OR "Clonidine"[MeSH] OR “Adrenergic Uptake Inhibitors"[MeSH] OR
"Adrenergic Uptake Inhibitors"[Pharmacological Action] OR "Receptors, Adrenergic, alpha-2"[MeSH]
OR "Adrenergic alpha-Agonists"[Mesh] OR "Adrenergic alpha-2 Receptor Agonists"[Mesh] OR
"atomoxetine"[Supplementary Concept] OR "Antidepressive Agents, Tricyclic"[MeSH] OR
"Desipramine"[MeSH] OR "Dopamine Uptake Inhibitors"[MeSH] OR "Sympathomimetics"[MeSH] OR
"modafinil"[Supplementary Concept] OR "Serotonin Uptake Inhibitors"[MeSH] OR "Serotonin Uptake
Inhibitors"[Pharmacological Action] OR "duloxetine" [Supplementary Concept] OR "Monoamine
Oxidase Inhibitors"[MeSH] OR "Monoamine Oxidase"[MeSH] OR "Selegiline"[MeSH] OR
"Bupropion"[MeSH] OR "armodafinil" [Supplementary Concept] OR "venlafaxine"[Supplementary
Concept] OR "Receptors, N-Methyl-D-Aspartate"[MeSH] OR "Memantine"[MeSH] OR
"Amantadine"[MeSH] OR "duloxetine"[Supplementary Concept] OR "Central Nervous System
Stimulants" [Pharmacological Action] OR "Adrenergic alpha-2 Receptor Agonists" [Pharmacological
Action] OR "Antidepressive Agents, Tricyclic" [Pharmacological Action] OR "Dopamine Uptake
Inhibitors" [Pharmacological Action] OR "Monoamine Oxidase Inhibitors" [Pharmacological Action] OR
"Central Nervous System Stimulants"[tiab] OR “psychostimulant”[tiab] OR “Methylphenidate”[tiab] OR
"Methylphenidate Hydrochloride"[tiab] OR “Aptensio”[tiab] OR “Concerta”[tiab] OR “Ritalin”[tiab] OR
“Ritalin LA”[tiab] OR “Medikinet”[tiab] OR “Equasym”[tiab] OR “Quillivant”[tiab] OR “Metadate”[tiab] OR
“Daytrana”[tiab] OR "Dexmethylphenidate"[tiab] OR “Dexmethylphenidate Hydrochloride”[tiab] OR
“Focalin”[tiab] OR “Dextroamphetamine”[tiab] OR “Dexedrine”[tiab] OR “Dextrostat”[tiab] OR
“ProCentra”[tiab] OR “Zenzedi”[tiab] OR “mixed amphetamine salts”[tiab] OR "Adderall" [tiab] OR
“lisdexamfetamine”[tiab] OR “lisdexamfetamine dimesylate”[tiab] OR “Vyvanse”[tiab] OR
"Venvanse"[tiab] OR "Elvanse"[tiab] OR "Tyvense"[tiab] OR "Dyanavel"[tiab] OR “Evekeo”[tiab] OR
"Guanfacine"[tiab] OR "Sympatholytics"[tiab] OR “Central alpha-2 Adrenergic Agonist”[tiab] OR
“Clonidine”[tiab] OR "Intuniv"[tiab] OR "Estulic"[tiab] OR “Tenex”[tiab] OR “Catapres”[tiab] OR
“Clophelin”[tiab] OR "Kapvay"[tiab] OR “Nexiclon”[tiab] OR "Duraclon"[tiab] OR “Norepinephrine
Reuptake Inhibitors”[tiab] OR “Selective Norepinephrine Reuptake Inhibitors”[tiab] OR “Adrenergic
Uptake Inhibitors"[tiab] OR "atomoxetine"[tiab] OR "Strattera"[tiab] OR "Tricyclic antidepressants"[tiab]
OR "Desipramine"[tiab] OR "Norpramin"[tiab] OR "Nortriptyline"[tiab] OR "Pamelor"[tiab] OR “Dopamine
Reuptake Inhibitors”[tiab] OR "modafinil"[tiab] OR “Provigil”[tiab] OR “Armodafinil”[tiab] OR
“Norepinephrine-dopamine Reuptake Inhibitors"[tiab] OR "Bupropion"[tiab] OR “Wellbutrin”[tiab] OR
“Forfivo”[tiab] OR “Cymbalta”[tiab] OR "venlafaxine"[tiab] OR “reboxetine”[tiab] OR “Monoamine
Oxidase Type B inhibitors”[tiab] OR "Selegiline"[tiab] OR “Eldepryl”[tiab] OR “Zelapar”[tiab] OR “NMDA
receptors”[tiab] OR “N-Methyl-D-aspartate receptor Antagonists”[tiab] OR "Amantadine"[tiab] OR
"Memantine"[tiab] OR “Pertofrane”[tiab] OR “Nuvigil”[tiab] OR “Cymbalta”[tiab] OR "duloxetine"[tiab] OR
"Effexor"[tiab] OR "Eldepryl"[tiab] OR "Emsam"[tiab] OR "Trevilor"[tiab] OR "Symmetrel"[tiab] OR
"Namenda"[tiab] OR "Zelapar"[tiab]

A-2
Set # Terms
#5 "Attention Deficit Disorder with Hyperactivity/diet therapy"[Majr] OR "Attention Deficit Disorder with
Hyperactivity/rehabilitation"[Majr] OR “Psychotherapy”[MeSH] OR "Behavior Therapy"[MeSH] OR
"Parent-Child Relations"[MeSH] OR "Play Therapy"[MeSH] OR "Cognitive Therapy"[MeSH] OR "Time
Management"[MeSH] OR "Computer-Assisted Instruction"[MeSH] OR "Diet Therapy"[MeSH] OR "Fatty
Acids, Omega-3/therapeutic use"[MeSH] OR "Vitamins/administration and dosage"[Mesh] OR
"Vitamins/therapeutic use"[MeSH] OR "Food Additives/adverse effects"[MeSH] OR
"Probiotics/therapeutic use"[MeSH] OR "Acupuncture Therapy"[MeSH] OR "Remedial
Teaching"[MeSH] OR "Early Intervention (Education)"[MeSH] OR "Complementary Therapies"[MeSH]
OR "Combined Modality Therapy"[MeSH] OR "psychosocial therapy"[tiab] OR "psychosocial
intervention"[tiab] OR "psychosocial interventions"[tiab] OR "psychosocial approach"[tiab] OR
"psychosocial approaches"[tiab] OR "psychosocial treatment"[tiab] OR "psychosocial support"[tiab] OR
"psychoeducation"[tiab] OR "nonpharmacologic therapy"[tiab] OR "nondrug therapy"[tiab] OR "non-drug
therapy"[tiab] OR "Play Therapy"[tiab] OR "cognitive behavioral therapy"[tiab] OR "cognitive behavior
therapy"[tiab] OR "cognitive behavioural therapy"[tiab] OR "cognitive behaviour therapy"[tiab] OR
Mindfulness[tiab] OR complementary[tiab] OR "alternative medicine"[tiab] OR "alternative therapy"[tiab]
OR "alternative therapies"[tiab] OR "Interpersonal skills training"[tiab] OR "Parent-Child Interaction
Therapy"[tiab] OR "parent training"[tiab] OR "parent engagement"[tiab] OR "parent management"[tiab]
OR "parenting skills"[tiab] OR "parenting intervention"[tiab] OR "parenting interventions"[tiab] OR
"Barkley's defiant child"[tiab] OR "Teacher-Child Interaction Training"[tiab] OR "Incredible Years"[tiab]
OR "New Forest Parenting"[tiab] OR "Triple P"[tiab] OR "Helping the Noncompliant Child"[tiab] OR
"child life and attention skills"[tiab] OR "clas"[tiab] OR PCIT[tiab] OR "parent child interaction
therapy"[tiab] OR "Summer Treatment Program"[tiab] OR "Daily Report Card"[tiab] OR "organization
skills"[tiab] OR "organizational skills"[tiab] OR "time management"[tiab] OR "homework
intervention"[tiab] OR braintrain[tiab] OR "memory training"[tiab] OR "Captain's log mindpower
builder"[tiab] OR "memory gyms"[tiab] OR "attention gym"[tiab] OR "smartdriver plus"[tiab] OR
"smartmind pro"[tiab] OR “RoboMemo”[tiab] OR "play attention"[tiab] OR metronome[tiab] OR
brainmaster[tiab] OR mindmed[tiab] OR "attention lab"[tiab] OR (activate[tiab] AND c8[tiab]) OR
"attention training"[tiab] OR “CogniPlus”[tiab] OR cogmed[tiab] OR "working memory training"[tiab] OR
biofeedback[tiab] OR neurofeedback[tiab] OR neuroagility[tiab] OR neuroptimal[tiab] OR
acupuncture[tiab] OR "vision training"[tiab] OR "visual training"[tiab] OR "vision therapy"[tiab] OR
"education intervention"[tiab] OR "cognitive remediation"[tiab] OR neurotherapy[tiab] OR "elimination
diet"[tiab] OR "diet therapy"[tiab] OR (("low carb" OR "low carbohydrate" OR "low carbohydrates"[tiab]
OR "gluten free") AND diet[tiab]) OR "feingold diet"[tiab] OR "red dye"[tiab] OR ((vitamin[tiab] OR
vitamins[tiab]) AND (supplement[tiab] OR supplements[tiab])) OR "herbal supplement"[tiab] OR "herbal
supplements"[tiab] OR probiotics[tiab] OR "omega 3"[tiab] OR "slow cortical potentials"[tiab] OR "few
foods diet"[tiab] OR "oligoantigenic diet"[tiab] OR "restriction diet"[tiab] OR "food intolerance"[tiab] OR
"food allergy"[tiab] OR "food allergies"[tiab] OR "food sensitivity"[tiab] OR "food sensitivities"[tiab] OR
“multimodal treatment”[tiab] OR homeopathy[tiab] OR homeopathic[tiab] OR chiropractic[tiab] OR
chiropractor[tiab]
#6 #4 OR #5
#7 #3 AND #6
#8 (randomized controlled trial[pt] OR controlled clinical trial[pt] OR randomized[tiab] OR randomised[tiab]
OR randomization[tiab] OR randomisation[tiab] OR placebo[tiab] OR randomly[tiab] OR trial[tiab] OR
groups[tiab] OR Clinical trial[pt] OR “clinical trial”[tiab] OR “clinical trials”[tiab] OR "evaluation
studies"[pt] OR "evaluation studies as topic"[MeSH] OR "evaluation study"[tiab] OR "evaluation
studies"[tiab] OR "intervention studies"[MeSH] OR "intervention study"[tiab] OR "intervention
studies"[tiab] OR "case-control studies"[MeSH] OR "case-control"[tiab] OR "cohort studies"[MeSH] OR
cohort[tiab] OR "longitudinal”[tiab] OR longitudinally[tiab] OR "prospective"[tiab] OR prospectively[tiab]
OR "retrospective"[tiab] OR "comparative study"[pt] OR "comparative study"[tiab] OR systematic[sb]
OR "meta-analysis"[pt] OR "meta-analysis as topic"[MeSH] OR "meta-analysis"[tiab] OR "meta-
analyses"[tiab]) NOT (Editorial[ptyp] OR Letter[pt] OR Case Reports[pt] OR Comment[pt]) NOT
(animals[mh] NOT humans[mh]) AND English[la]
#9 #7 AND #8
Publication date from 2009/01/01

A-3
Key Question 3
Set # Terms
#1 "Attention Deficit Disorder with Hyperactivity"[Mesh] OR "attention deficit hyperactivity disorder"[tiab]
OR "ADHD"[tiab] OR "attention deficit disorder"[tiab]
#2 "Pediatrics"[Mesh] OR "Adolescent"[Mesh] OR "Infant"[Mesh] OR "Child"[Mesh] OR child[tiab] OR
children[tiab] OR infant[tiab] OR infants[tiab] OR preschool[tiab] OR preschooler[tiab] OR pediatric[tiab]
OR teenager[tiab] OR teenagers[tiab] OR teenaged[tiab] OR teen[tiab] OR teens[tiab] OR
adolescent[tiab] OR adolescents[tiab] OR adolescence[tiab] OR youth[tiab]
#3 "Secondary Care"[Mesh] OR "Comprehensive Health Care"[Mesh] OR "primary care"[tiab] OR
monitor[tiab] OR monitored[tiab] OR monitoring[tiab] OR "follow up"[tiab] OR "followed up"[tiab] OR
visit[tiab] OR visits[tiab] OR session[tiab] OR sessions[tiab] OR appointment[tiab] OR
appointments[tiab]
#4 (randomized controlled trial[pt] OR controlled clinical trial[pt] OR randomized[tiab] OR randomised[tiab]
OR randomization[tiab] OR randomisation[tiab] OR placebo[tiab] OR randomly[tiab] OR trial[tiab] OR
groups[tiab] OR Clinical trial[pt] OR “clinical trial”[tiab] OR “clinical trials”[tiab] OR "evaluation
studies"[pt] OR "evaluation studies as topic"[MeSH] OR "evaluation study"[tiab] OR "evaluation
studies"[tiab] OR "intervention studies"[MeSH] OR "intervention study"[tiab] OR "intervention
studies"[tiab] OR "case-control studies"[MeSH] OR "case-control"[tiab] OR "cohort studies"[MeSH] OR
cohort[tiab] OR "longitudinal”[tiab] OR longitudinally[tiab] OR "prospective"[tiab] OR prospectively[tiab]
OR "retrospective"[tiab] OR "comparative study"[pt] OR "comparative study"[tiab] OR systematic[sb]
OR "meta-analysis"[pt] OR "meta-analysis as topic"[MeSH] OR "meta-analysis"[tiab] OR "meta-
analyses"[tiab]) NOT (Editorial[ptyp] OR Letter[pt] OR Case Reports[pt] OR Comment[pt]) NOT
(animals[mh] NOT humans[mh]) AND English[la]
#5 #1 AND #2 AND #3 AND #4
Publication date from 2009/01/01

A-4
Embase® Search Strategy (November 7, 2016)
Platform: Embase.com

Key Question 1
Set # Terms
#1 'attention deficit disorder'/exp OR "attention deficit hyperactivity disorder":ab,ti OR "ADHD":ab,ti OR
"attention deficit disorder":ab,ti
#2 'pediatrics'/exp OR 'adolescent'/exp OR 'infant'/exp OR 'child'/exp OR child:ab,ti OR children:ab,ti OR
infant:ab,ti OR infants:ab,ti OR preschool:ab,ti OR preschooler:ab,ti OR pediatric:ab,ti OR
teenager:ab,ti OR teenagers:ab,ti OR teenaged:ab,ti OR teen:ab,ti OR teens:ab,ti OR adolescent:ab,ti
OR adolescents:ab,ti OR adolescence:ab,ti OR youth:ab,ti
#3 'attention deficit disorder'/exp/mj/dm_di OR 'screening'/exp OR 'questionnaire'/exp OR 'interview'/exp
OR 'psychometry'/exp OR 'psychological rating scale'/exp OR 'diagnosis'/exp OR 'assessment of
humans'/exp OR 'checklist'/exp OR 'clinical assessment tool'/exp OR 'clinical observation'/exp OR
'Diagnostic and Statistical Manual of Mental Disorders'/exp OR 'patient referral'/exp OR
questionnaire:ab,ti OR questionnaires:ab,ti OR screening:ab,ti OR screen:ab,ti OR scale:ab,ti OR
instrument:ab,ti OR instruments:ab,ti OR interview:ab,ti OR interviews:ab,ti OR DSM*:ab,ti OR
diagnosis:ab,ti OR diagnostic:ab,ti OR diagnosed:ab,ti OR (Vanderbilt:ab,ti AND scale:ab,ti) OR
conners:ab,ti OR cprs:ab,ti OR ctrs:ab,ti OR cprs:ab,ti OR crs:ab,ti OR "snap-IV":ab,ti OR "snap-4":ab,ti
OR "basc-2":ab,ti OR "behavioral assessment system for children":ab,ti OR dbdrs:ab,ti OR "disruptive
behavior disorder rating scale":ab,ti OR adhd-rs:ab,ti OR "adhd rating scale":ab,ti OR ksads:ab,ti OR k-
sads:ab,ti OR kiddie-sads:ab,ti OR DISC:ab,ti OR "dominance inducement submission and
compliance":ab,ti OR "diagnostic interview schedule for children":ab,ti OR "diagnostic inventory for
screening children":ab,ti OR "mini-kid":ab,ti OR "Mini Interational Neuropsychiatric interview":ab,ti OR
"iva-2":ab,ti OR "iva-qs":ab,ti OR "iva-ae2":ab,ti OR tova:ab,ti OR "test of variables of attention":ab,ti
OR "neuropsychiatric eeg-based assessment aid":ab,ti OR neba:ab,ti
#4 ('sensitivity and specificity'/exp OR 'predictive value'/exp OR 'diagnostic error'/exp OR sensitivity:ab,ti
OR specificity:ab,ti OR accuracy:ab,ti OR accurate:ab,ti OR accurately:ab,ti OR misdiagnos*:ab,ti OR
'randomized controlled trial'/exp OR 'crossover procedure'/exp OR 'double blind procedure'/exp OR
'single blind procedure'/exp OR random*:ab,ti OR factorial*:ab,ti OR crossover*:ab,ti OR (cross NEAR/1
over*):ab,ti OR placebo*:ab,ti OR (doubl* NEAR/1 blind*):ab,ti OR (singl* NEAR/1 blind*):ab,ti OR
assign*:ab,ti OR allocat*:ab,ti OR volunteer*:ab,ti OR 'clinical study'/exp OR ‘clinical trial’:ti,ab OR
‘clinical trials’:ti,ab OR 'controlled study'/exp OR 'evaluation'/exp OR ‘evaluation study’:ab,ti OR
‘evaluation studies’:ab,ti OR ‘intervention study’:ab,ti OR ‘intervention studies’:ab,ti OR ‘case
control’:ab,ti OR 'cohort analysis'/exp OR cohort:ab,ti OR longitudinal*:ab,ti OR prospective:ab,ti OR
prospectively:ab,ti OR retrospective:ab,ti OR 'follow up'/exp OR ‘follow up’:ab,ti OR 'comparative
effectiveness'/exp OR 'comparative study'/exp OR ‘comparative study’:ab,ti OR ‘comparative
studies’:ab,ti OR 'evidence based medicine'/exp OR ‘systematic review’:ab,ti OR ‘meta-analysis’:ab,ti
OR ‘meta-analyses’:ab,ti) NOT ('case report'/exp OR 'case study'/exp OR 'editorial'/exp OR 'letter'/exp
OR 'note'/exp)
#5 #1 AND #2 AND #3 AND #4
#6 #5 AND [embase]/lim NOT [medline]/lim
#7 #6 AND [humans]/lim AND [2009-2015]/py

A-5
Key Question 2
Set # Terms
#1 'attention deficit disorder'/exp OR "attention deficit hyperactivity disorder":ab,ti OR "ADHD":ab,ti OR
"attention deficit disorder":ab,ti
#2 'pediatrics'/exp OR 'adolescent'/exp OR 'infant'/exp OR 'child'/exp OR child:ab,ti OR children:ab,ti OR
infant:ab,ti OR infants:ab,ti OR preschool:ab,ti OR preschooler:ab,ti OR pediatric:ab,ti OR
teenager:ab,ti OR teenagers:ab,ti OR teenaged:ab,ti OR teen:ab,ti OR teens:ab,ti OR adolescent:ab,ti
OR adolescents:ab,ti OR adolescence:ab,ti OR youth:ab,ti
#3 #1 AND #2
#4 'attention deficit disorder'/exp/mj/dm_dt OR 'central stimulant agent'/exp OR 'psychostimulant
agent'/exp OR 'guanfacine'/exp OR 'adrenergic receptor affecting agent'/exp OR 'atomoxetine'/exp OR
'antidepressant agent'/exp OR 'dopamine uptake inhibitor'/exp OR 'n methyl dextro aspartic acid
receptor'/exp OR 'memantine'/exp OR 'amantadine'/exp OR 'dopamine uptake inhibitor'/exp OR
'Central Nervous System Stimulants':ab,ti OR 'psychostimulant':ab,ti OR 'Methylphenidate':ab,ti OR
'Methylphenidate Hydrochloride':ab,ti OR 'Aptensio':ab,ti OR 'Concerta':ab,ti OR 'Ritalin':ab,ti OR
'Ritalin LA':ab,ti OR 'Medikinet':ab,ti OR 'Equasym':ab,ti OR 'Quillivant':ab,ti OR 'Metadate':ab,ti OR
'Daytrana':ab,ti OR 'Dexmethylphenidate':ab,ti OR 'Dexmethylphenidate Hydrochloride':ab,ti OR
'Focalin':ab,ti OR 'Dextroamphetamine':ab,ti OR 'Dexedrine':ab,ti OR 'Dextrostat':ab,ti OR
'ProCentra':ab,ti OR 'Zenzedi':ab,ti OR 'mixed amphetamine salts':ab,ti OR 'Adderall':ab,ti OR
'lisdexamfetamine':ab,ti OR 'lisdexamfetamine dimesylate':ab,ti OR 'Vyvanse':ab,ti OR 'Venvanse':ab,ti
OR 'Elvanse':ab,ti OR 'Tyvense':ab,ti OR 'Dyanavel':ab,ti OR 'Evekeo':ab,ti OR 'Guanfacine':ab,ti OR
'Sympatholytics':ab,ti OR 'Central alpha-2 Adrenergic Agonist':ab,ti OR 'Clonidine':ab,ti OR 'Intuniv':ab,ti
OR 'Estulic':ab,ti OR 'Tenex':ab,ti OR 'Catapres':ab,ti OR 'Clophelin':ab,ti OR 'Kapvay':ab,ti OR
'Nexiclon':ab,ti OR 'Duraclon':ab,ti OR 'Norepinephrine Reuptake Inhibitors':ab,ti OR 'Selective
Norepinephrine Reuptake Inhibitors':ab,ti OR 'Adrenergic Uptake Inhibitors':ab,ti OR 'atomoxetine':ab,ti
OR 'Strattera':ab,ti OR 'Tricyclic antidepressants':ab,ti OR 'Desipramine':ab,ti OR 'Norpramin':ab,ti OR
'Nortriptyline':ab,ti OR 'Pamelor':ab,ti OR 'Dopamine Reuptake Inhibitors':ab,ti OR 'modafinil':ab,ti OR
'Provigil':ab,ti OR 'Armodafinil':ab,ti OR 'Norepinephrine-dopamine Reuptake Inhibitors':ab,ti OR
'Bupropion':ab,ti OR 'Wellbutrin':ab,ti OR 'Forfivo':ab,ti OR 'Cymbalta':ab,ti OR 'venlafaxine':ab,ti OR
'reboxetine':ab,ti OR 'Monoamine Oxidase Type B inhibitors':ab,ti OR 'Selegiline':ab,ti OR
'Eldepryl':ab,ti OR 'Zelapar':ab,ti OR 'NMDA receptors':ab,ti OR 'N-Methyl-D-aspartate receptor
Antagonists':ab,ti OR 'Amantadine':ab,ti OR 'Memantine':ab,ti OR 'Pertofrane':ab,ti OR 'Nuvigil':ab,ti OR
'Cymbalta':ab,ti OR 'duloxetine':ab,ti OR 'Effexor':ab,ti OR 'Eldepryl':ab,ti OR 'Emsam':ab,ti OR
'Trevilor':ab,ti OR 'Symmetrel':ab,ti OR 'Namenda':ab,ti OR 'Zelapar':ab,ti

A-6
Set # Terms
#5 'attention deficit disorder'/exp/mj/dm_rh,dm_dm OR 'psychotherapy'/exp OR 'child psychiatry'/exp OR
'child parent relation'/exp OR 'time management'/exp OR 'feedback system'/exp OR 'teaching'/exp OR
'adaptive behavior'/exp OR 'diet therapy'/exp OR 'omega 3 fatty acid'/exp OR
'vitamin'/exp/dd_do,dd_dt,dd_ad OR 'food additive'/exp/dd_ae OR 'probiotic agent'/exp OR
'acupuncture'/exp OR 'early childhood intervention'/exp OR 'alternative medicine'/exp OR 'psychosocial
therapy':ab,ti OR 'psychosocial intervention':ab,ti OR 'psychosocial interventions':ab,ti OR 'psychosocial
approach':ab,ti OR 'psychosocial approaches':ab,ti OR 'psychosocial treatment':ab,ti OR 'psychosocial
support':ab,ti OR 'psychoeducation':ab,ti OR 'nonpharmacologic therapy':ab,ti OR 'nondrug
therapy':ab,ti OR 'non-drug therapy':ab,ti OR 'Play Therapy':ab,ti OR 'cognitive behavioral therapy':ab,ti
OR 'cognitive behavior therapy':ab,ti OR 'cognitive behavioural therapy':ab,ti OR 'cognitive behaviour
therapy':ab,ti OR Mindfulness:ab,ti OR complementary:ab,ti OR 'alternative medicine':ab,ti OR
'alternative therapy':ab,ti OR 'alternative therapies':ab,ti OR 'Interpersonal skills training':ab,ti OR
'Parent-Child Interaction Therapy':ab,ti OR 'parent training':ab,ti OR 'parent engagement':ab,ti OR
'parent management':ab,ti OR 'parenting skills':ab,ti OR 'parenting intervention':ab,ti OR 'parenting
interventions':ab,ti OR 'Barkleys defiant child':ab,ti OR 'Teacher-Child Interaction Training':ab,ti OR
'Incredible Years':ab,ti OR 'New Forest Parenting':ab,ti OR 'Triple P':ab,ti OR 'Helping the Noncompliant
Child':ab,ti OR 'child life and attention skills':ab,ti OR 'clas':ab,ti OR PCIT:ab,ti OR 'parent child
interaction therapy':ab,ti OR 'Summer Treatment Program':ab,ti OR 'Daily Report Card':ab,ti OR
'organization skills':ab,ti OR 'organizational skills':ab,ti OR 'time management':ab,ti OR 'homework
intervention':ab,ti OR braintrain:ab,ti OR 'memory training':ab,ti OR 'Captains log mindpower
builder':ab,ti OR 'memory gyms':ab,ti OR 'attention gym':ab,ti OR 'smartdriver plus':ab,ti OR 'smartmind
pro':ab,ti OR 'RoboMemo':ab,ti OR 'play attention':ab,ti OR metronome:ab,ti OR brainmaster:ab,ti OR
mindmed:ab,ti OR 'attention lab':ab,ti OR (activate:ab,ti AND c8:ab,ti) OR 'attention training':ab,ti OR
'CogniPlus':ab,ti OR cogmed:ab,ti OR 'working memory training':ab,ti OR biofeedback:ab,ti OR
neurofeedback:ab,ti OR neuroagility:ab,ti OR neuroptimal:ab,ti OR acupuncture:ab,ti OR 'vision
training':ab,ti OR 'visual training':ab,ti OR 'vision therapy':ab,ti OR 'education intervention':ab,ti OR
'cognitive remediation':ab,ti OR neurotherapy:ab,ti OR 'elimination diet':ab,ti OR 'diet therapy':ab,ti OR
(('low carb' OR 'low carbohydrate' OR 'low carbohydrates':ab,ti OR 'gluten free') AND diet:ab,ti) OR
'feingold diet':ab,ti OR 'red dye':ab,ti OR ((vitamin:ab,ti OR vitamins:ab,ti) AND (supplement:ab,ti OR
supplements:ab,ti)) OR 'herbal supplement':ab,ti OR 'herbal supplements':ab,ti OR probiotics:ab,ti OR
'omega 3':ab,ti OR 'slow cortical potentials':ab,ti OR 'few foods diet':ab,ti OR 'oligoantigenic diet':ab,ti
OR 'restriction diet':ab,ti OR 'food intolerance':ab,ti OR 'food allergy':ab,ti OR 'food allergies':ab,ti OR
'food sensitivity':ab,ti OR 'food sensitivities':ab,ti OR 'multimodal treatment':ab,ti OR homeopathy:ab,ti
OR homeopathic:ab,ti OR chiropractic:ab,ti OR chiropractor:ab,ti
#6 #4 OR #5
#7 #3 AND #6
#8 ('randomized controlled trial'/exp OR 'crossover procedure'/exp OR 'double blind procedure'/exp OR
'single blind procedure'/exp OR random*:ab,ti OR factorial*:ab,ti OR crossover*:ab,ti OR (cross NEAR/1
over*):ab,ti OR placebo*:ab,ti OR (doubl* NEAR/1 blind*):ab,ti OR (singl* NEAR/1 blind*):ab,ti OR
assign*:ab,ti OR allocat*:ab,ti OR volunteer*:ab,ti OR 'clinical study'/exp OR ‘clinical trial’:ti,ab OR
‘clinical trials’:ti,ab OR 'controlled study'/exp OR 'evaluation'/exp OR ‘evaluation study’:ab,ti OR
‘evaluation studies’:ab,ti OR ‘intervention study’:ab,ti OR ‘intervention studies’:ab,ti OR ‘case
control’:ab,ti OR 'cohort analysis'/exp OR cohort:ab,ti OR longitudinal*:ab,ti OR prospective:ab,ti OR
prospectively:ab,ti OR retrospective:ab,ti OR 'follow up'/exp OR ‘follow up’:ab,ti OR 'comparative
effectiveness'/exp OR 'comparative study'/exp OR ‘comparative study’:ab,ti OR ‘comparative
studies’:ab,ti OR 'evidence based medicine'/exp OR ‘systematic review’:ab,ti OR ‘meta-analysis’:ab,ti
OR ‘meta-analyses’:ab,ti) NOT ('case report'/exp OR 'case study'/exp OR 'editorial'/exp OR 'letter'/exp
OR 'note'/exp)
#9 #7 AND #8
#10 #9 AND [embase]/lim NOT [medline]/lim
#11 #10 AND [humans]/lim AND [2009-2015]/py

A-7
Key Question 3
Set # Terms
#1 'attention deficit disorder'/exp OR "attention deficit hyperactivity disorder":ab,ti OR "ADHD":ab,ti OR
"attention deficit disorder":ab,ti
#2 'pediatrics'/exp OR 'adolescent'/exp OR 'infant'/exp OR 'child'/exp OR child:ab,ti OR children:ab,ti OR
infant:ab,ti OR infants:ab,ti OR preschool:ab,ti OR preschooler:ab,ti OR pediatric:ab,ti OR
teenager:ab,ti OR teenagers:ab,ti OR teenaged:ab,ti OR teen:ab,ti OR teens:ab,ti OR adolescent:ab,ti
OR adolescents:ab,ti OR adolescence:ab,ti OR youth:ab,ti
#3 'evaluation and follow up'/exp OR 'primary health care'/exp OR 'secondary health care'/exp OR 'clinical
handover'/exp OR 'patient monitoring'/exp OR monitor:ab,ti OR monitored:ab,ti OR monitoring:ab,ti OR
"follow up":ab,ti OR "followed up":ab,ti OR visit:ab,ti OR visits:ab,ti OR session:ab,ti OR sessions:ab,ti
OR appointment:ab,ti OR appointments:ab,ti
#4 ('randomized controlled trial'/exp OR 'crossover procedure'/exp OR 'double blind procedure'/exp OR
'single blind procedure'/exp OR random*:ab,ti OR factorial*:ab,ti OR crossover*:ab,ti OR (cross NEAR/1
over*):ab,ti OR placebo*:ab,ti OR (doubl* NEAR/1 blind*):ab,ti OR (singl* NEAR/1 blind*):ab,ti OR
assign*:ab,ti OR allocat*:ab,ti OR volunteer*:ab,ti OR 'clinical study'/exp OR ‘clinical trial’:ti,ab OR
‘clinical trials’:ti,ab OR 'controlled study'/exp OR 'evaluation'/exp OR ‘evaluation study’:ab,ti OR
‘evaluation studies’:ab,ti OR ‘intervention study’:ab,ti OR ‘intervention studies’:ab,ti OR ‘case
control’:ab,ti OR 'cohort analysis'/exp OR cohort:ab,ti OR longitudinal*:ab,ti OR prospective:ab,ti OR
prospectively:ab,ti OR retrospective:ab,ti OR 'follow up'/exp OR ‘follow up’:ab,ti OR 'comparative
effectiveness'/exp OR 'comparative study'/exp OR ‘comparative study’:ab,ti OR ‘comparative
studies’:ab,ti OR 'evidence based medicine'/exp OR ‘systematic review’:ab,ti OR ‘meta-analysis’:ab,ti
OR ‘meta-analyses’:ab,ti) NOT ('case report'/exp OR 'case study'/exp OR 'editorial'/exp OR 'letter'/exp
OR 'note'/exp)
#5 #1 AND #2 AND #3 AND #4
#6 #5 AND [humans]/lim AND [2009-2015]/py
#7 #6 AND [embase]/lim NOT [medline]/lim

A-8
PsycInfo Search Strategy (November 7, 2016)

Key Question 1
Set # Terms
#1 DE "Attention Deficit Disorder with Hyperactivity" OR TI ( "attention deficit hyperactivity disorder" OR
ADHD OR "attention deficit disorder" ) OR AB ( "attention deficit hyperactivity disorder" OR ADHD OR
"attention deficit disorder"
#2 AG (childhood OR adolescence ) OR DE "Pediatrics" OR TI ( child OR children OR infant OR infants
OR preschool OR preschooler OR pediatric OR teenager OR teenagers OR teenaged OR teen OR
teens OR adolescent OR adolescents OR adolescence OR youth ) OR AB ( child OR children OR
infant OR infants OR preschool OR preschooler OR pediatric OR teenager OR teenagers OR teenaged
OR teen OR teens OR adolescent OR adolescents OR adolescence OR youth )
#3 DE "Screening" OR DE "Health Screening" OR DE "Questionnaires" OR DE "Screening Tests" OR
DE "Psychological Screening Inventory" OR DE "Psychiatric Evaluation" OR DE "Psychodiagnosis" OR
DE "Psychodiagnostic Interview" OR DE "Psychometrics" OR DE "Rating Scales" OR DE "Diagnosis"
OR DE "Diagnostic and Statistical Manual" OR DE "Professional Referral" OR DE "Diagnostic Interview
Schedule" OR DE "Behavioral Assessment" OR TI ( questionnaire OR questionnaires OR screening
OR screen OR scale OR instrument OR instruments OR interview OR interviews OR DSM* OR
diagnosis OR diagnostic OR diagnosed OR (Vanderbilt AND scale) OR conners OR cprs OR ctrs OR
cprs OR crs OR "snap-IV" OR "snap-4" OR "basc-2" OR "behavioral assessment system for children"
OR dbdrs OR "disruptive behavior disorder rating scale" OR adhd-rs OR "adhd rating scale" OR ksads
OR k-sads OR kiddie-sads OR DISC OR "dominance inducement submission and compliance" OR
"diagnostic interview schedule for children" OR "diagnostic inventory for screening children" OR "mini-
kid" OR "Mini Interational Neuropsychiatric interview" OR "iva-2" OR "iva-qs" OR "iva-ae2" OR tova OR
"test of variables of attention" OR "neuropsychiatric eeg-based assessment aid" OR neba ) OR AB (
questionnaire OR questionnaires OR screening OR screen OR scale OR instrument OR instruments
OR interview OR interviews OR DSM* OR diagnosis OR diagnostic OR diagnosed OR (Vanderbilt AND
scale) OR conners OR cprs OR ctrs OR cprs OR crs OR "snap-IV" OR "snap-4" OR "basc-2" OR
"behavioral assessment system for children" OR dbdrs OR "disruptive behavior disorder rating scale"
OR adhd-rs OR "adhd rating scale" OR ksads OR k-sads OR kiddie-sads OR DISC OR "dominance
inducement submission and compliance" OR "diagnostic interview schedule for children" OR
"diagnostic inventory for screening children" OR "mini-kid" OR "Mini Interational Neuropsychiatric
interview" OR "iva-2" OR "iva-qs" OR "iva-ae2" OR tova OR "test of variables of attention" OR
"neuropsychiatric eeg-based assessment aid" OR neba )
#4 (DE "Misdiagnosis" OR ZC "longitudinal study" OR ZC "empirical study" OR ZC "followup study" OR
ZC "longitudinal study" OR ZC "meta analysis" OR ZC "prospective study" OR ZC "retrospective study"
OR ZC "systematic review" OR ZC "treatment outcome/clinical trial"OR DE "Clinical Trials" OR DE
"Cohort Analysis" OR DE "Followup Studies" OR DE "Longitudinal Studies" OR DE "Prospective
Studies" OR DE "Meta Analysis" OR TI ( sensitivity OR specificity OR accuracy OR accurate OR
accurately OR misdiagnos* OR randomized OR randomised OR randomization OR randomisation OR
randomly OR trial OR groups OR trials OR "evaluation study" OR evaluation studies OR "intervention
study" OR "intervention studies" OR "case-control" OR cohort OR "cross-sectional" OR longitudinal OR
longitudinally OR prospective OR prospectively OR retrospective OR "comparative study" OR "meta-
analysis" OR "meta-analyses" ) OR AB ( sensitivity OR specificity OR accuracy OR accurate OR
accurately OR misdiagnos* OR randomized OR randomised OR randomization OR randomisation OR
randomly OR trial OR groups OR trials OR "evaluation study" OR evaluation studies OR "intervention
study" OR "intervention studies" OR "case-control" OR cohort OR "cross-sectional" OR longitudinal OR
longitudinally OR prospective OR prospectively OR retrospective OR "comparative study" OR "meta-
analysis" OR "meta-analyses" )) AND (ZZ "journal article")
#5 #1 AND #2 AND #3 AND #4
#6 #5, since 2009, English

A-9
Key Question 2
Set # Terms
#1 DE "Attention Deficit Disorder with Hyperactivity" OR TI ( "attention deficit hyperactivity disorder" OR
ADHD OR "attention deficit disorder" ) OR AB ( "attention deficit hyperactivity disorder" OR ADHD OR
"attention deficit disorder"
#2 AG (childhood OR adolescence ) OR DE "Pediatrics" OR TI ( child OR children OR infant OR infants
OR preschool OR preschooler OR pediatric OR teenager OR teenagers OR teenaged OR teen OR
teens OR adolescent OR adolescents OR adolescence OR youth ) OR AB ( child OR children OR
infant OR infants OR preschool OR preschooler OR pediatric OR teenager OR teenagers OR teenaged
OR teen OR teens OR adolescent OR adolescents OR adolescence OR youth )
#3 #1 AND #2
#4 DE "CNS Stimulating Drugs" OR DE "Methylphenidate" OR DE "Dextroamphetamine" OR DE
"Amphetamine" OR DE "Clonidine" OR DE "Serotonin Norepinephrine Reuptake Inhibitors" OR DE
"Atomoxetine" OR DE "Tricyclic Antidepressant Drugs" OR DE "Desipramine" OR DE "Nortriptyline" OR
DE "Bupropion" OR DE "Serotonin Norepinephrine Reuptake Inhibitors" OR DE "Venlafaxine" OR DE
"Monoamine Oxidase Inhibitors" OR DE "Amantadine" OR TI ( psychostimulants OR "CNS stimulating"
OR "Central Nervous System stimulants" OR methylphenidate OR Dexmethylphenidate OR
Dextroamphetamine OR lisdexamfetamine OR Amphetamine OR aptensio OR concerta OR Ritalin OR
methylin OR medikinet OR equasym OR quillivant OR metadate OR daytrana OR focalin OR
Dexedrine OR dextrostat OR procentra OR zenzedi OR Adderall OR vyvanse OR elvanse OR tyvense
OR dyanavel OR evekeo OR "alpha-2 agonists" OR guanfacine OR intuniv OR tenex OR estulic OR
afken OR clonidine OR catapres OR clophelin OR kapvay OR nexiclon OR duraclon OR "Serotonin
Norepinephrine Reuptake Inhibitors" OR Strattera OR atomoxetine OR "Tricyclic Antidepressants " OR
"Desipramine" OR "Nortriptyline" OR norpramin OR pertofrane OR pamelor OR "dopamine reuptake
inhibitors" OR modanifil OR Provigil OR alertec OR modavigil OR modiodal OR modalert OR
armodafinil OR nuvigil OR "norepinephrine-dopamine reuptake inhibitors" OR bupropion OR Wellbutrin
OR zyban OR forfivo OR "Serotonin Norepinephrine Reuptake Inhibitors" OR duloxetine OR Cymbalta
OR "serotonin norepinephrine dopamine reuptake inhibitors" OR "Venlafaxine" OR Effexor OR trevilor
OR (Monoamine Oxidase AND Inhibitors) OR selegiline OR eldepryl OR emsam OR selgene OR
zelapar OR "n methyl d aspartate receptor agonists" OR "Amantadine" OR symmetrel OR memantine
OR Namenda) ) OR AB ( psychostimulants OR "CNS stimulating" OR "Central Nervous System
stimulants" OR methylphenidate OR Dexmethylphenidate OR Dextroamphetamine OR
lisdexamfetamine OR Amphetamine OR aptensio OR concerta OR Ritalin OR methylin OR medikinet
OR equasym OR quillivant OR metadate OR daytrana OR focalin OR Dexedrine OR dextrostat OR
procentra OR zenzedi OR Adderall OR vyvanse OR elvanse OR tyvense OR dyanavel OR evekeo OR
"alpha-2 agonists" OR guanfacine OR intuniv OR tenex OR estulic OR afken OR clonidine OR catapres
OR clophelin OR kapvay OR nexiclon OR duraclon OR "Serotonin Norepinephrine Reuptake Inhibitors"
OR Strattera OR atomoxetine OR "Tricyclic Antidepressants " OR "Desipramine" OR "Nortriptyline" OR
norpramin OR pertofrane OR pamelor OR "dopamine reuptake inhibitors" OR modanifil OR Provigil OR
alertec OR modavigil OR modiodal OR modalert OR armodafinil OR nuvigil OR "norepinephrine-
dopamine reuptake inhibitors" OR bupropion OR Wellbutrin OR zyban OR forfivo OR "Serotonin
Norepinephrine Reuptake Inhibitors" OR duloxetine OR Cymbalta OR "serotonin norepinephrine
dopamine reuptake inhibitors" OR "Venlafaxine" OR Effexor OR trevilor OR (Monoamine Oxidase AND
Inhibitors) OR selegiline OR eldepryl OR emsam OR selgene OR zelapar OR "n methyl d aspartate
receptor agonists" OR "Amantadine" OR symmetrel OR memantine OR Namenda) )

A-10
Set # Terms
#5 DE "Psychotherapy" OR DE "Adolescent Psychotherapy" OR DE "Multisystemic Therapy" OR DE
"Behavior Therapy" OR DE "Dialectical Behavior Therapy" OR DE "Brief Psychotherapy" OR DE "Child
Psychotherapy" OR DE "Play Therapy" OR DE "Client Centered Therapy" OR DE "Cognitive Behavior
Therapy" OR DE "Group Psychotherapy" OR DE "Therapeutic Community" OR DE "Integrative
Psychotherapy" OR DE "Psychotherapeutic Counseling" OR DE "Family Therapy" OR DE "Supportive
Psychotherapy" OR DE "Cognitive Therapy" OR DE "Parent Training" OR DE "Parent Child Relations"
OR DE "Time Management" OR DE "Mindfulness" OR DE "School Based Intervention" OR DE
"Memory Training" OR DE "Biofeedback Training" OR DE "Biofeedback" OR DE "Computer Assisted
Instruction" OR DE "Intelligent Tutoring Systems" OR DE "Diets" OR DE "Dietary Supplements" OR DE
"Food Additives" OR DE "Fatty Acids" OR DE "Acupuncture" OR DE "Remedial Education" OR DE
"Early Intervention" OR DE "Alternative Medicine" OR TI ( "psychosocial therapy" OR "psychosocial
intervention" OR "psychosocial interventions" OR "psychosocial approach" OR "psychosocial
approaches" OR "psychosocial treatment" OR "psychosocial support" OR "psychoeducation" OR
"nonpharmacologic therapy" OR "nondrug therapy" OR "non-drug therapy" OR "Play Therapy" OR
"cognitive behavioral therapy" OR "cognitive behavior therapy" OR "cognitive behavioural therapy" OR
"cognitive behaviour therapy" OR Mindfulness OR complementary OR "alternative medicine" OR
"alternative therapy" OR "alternative therapies" OR "Interpersonal skills training" OR "Parent-Child
Interaction Therapy" OR "parent training" OR "parent engagement" OR "parent management" OR
"parenting skills" OR "parenting intervention" OR "parenting interventions" OR "Barkley's defiant child"
OR "Teacher-Child Interaction Training" OR "Incredible Years" OR "New Forest Parenting" OR "Triple
P" OR "Helping the Noncompliant Child" OR "child life and attention skills" OR "clas" OR PCIT OR
"parent child interaction therapy" OR "Summer Treatment Program" OR "Daily Report Card" OR
"organization skills" OR "organizational skills" OR "time management" OR "homework intervention" OR
braintrain OR "memory training" OR "Captain's log mindpower builder" OR "memory gyms" OR
"attention gym" OR "smartdriver plus" OR "smartmind pro" OR “RoboMemo” OR "play attention" OR
metronome OR brainmaster OR mindmed OR "attention lab" OR (activate AND c8) OR "attention
training" OR “CogniPlus” OR cogmed OR "working memory training" OR biofeedback OR
neurofeedback OR neuroagility OR neuroptimal OR acupuncture OR "vision training" OR "visual
training" OR "vision therapy" OR "education intervention" OR "cognitive remediation" OR neurotherapy
OR "elimination diet" OR "diet therapy" OR (("low carb" OR "low carbohydrate" OR "low carbohydrates"
OR "gluten free") AND diet) OR "feingold diet" OR "red dye" OR ((vitamin OR vitamins) AND
(supplement OR supplements)) OR "herbal supplement" OR "herbal supplements" OR probiotics OR
"omega 3" OR "slow cortical potentials" OR "few foods diet" OR "oligoantigenic diet" OR "restriction
diet" OR "food intolerance" OR "food allergy" OR "food allergies" OR "food sensitivity" OR "food
sensitivities" OR “multimodal treatment” OR homeopathy OR homeopathic OR chiropractic OR
chiropractor ) OR AB ( "psychosocial therapy" OR "psychosocial intervention" OR "psychosocial
interventions" OR "psychosocial approach" OR "psychosocial approaches" OR "psychosocial
treatment" OR "psychosocial support" OR "psychoeducation" OR "nonpharmacologic therapy" OR
"nondrug therapy" OR "non-drug therapy" OR "Play Therapy" OR "cognitive behavioral therapy" OR
"cognitive behavior therapy" OR "cognitive behavioural therapy" OR "cognitive behaviour therapy" OR
Mindfulness OR complementary OR "alternative medicine" OR "alternative therapy" OR "alternative
therapies" OR "Interpersonal skills training" OR "Parent-Child Interaction Therapy" OR "parent training"
OR "parent engagement" OR "parent management" OR "parenting skills" OR "parenting intervention"
OR "parenting interventions" OR "Barkley's defiant child" OR "Teacher-Child Interaction Training" OR
"Incredible Years" OR "New Forest Parenting" OR "Triple P" OR "Helping the Noncompliant Child" OR
"child life and attention skills" OR "clas" OR PCIT OR "parent child interaction therapy" OR "Summer
Treatment Program" OR "Daily Report Card" OR "organization skills" OR "organizational skills" OR
"time management" OR "homework intervention" OR braintrain OR "memory training" OR "Captain's
log mindpower builder" OR "memory gyms" OR "attention gym" OR "smartdriver plus" OR "smartmind
pro" OR “RoboMemo” OR "play attention" OR metronome OR brainmaster OR mindmed OR "attention
lab" OR (activate AND c8) OR "attention training" OR “CogniPlus” OR cogmed OR "working memory
training" OR biofeedback OR neurofeedback OR neuroagility OR neuroptimal OR acupuncture OR
"vision training" OR "visual training" OR "vision therapy" OR "education intervention" OR "cognitive
remediation" OR neurotherapy OR "elimination diet" OR "diet therapy" OR (("low carb" OR "low
carbohydrate" OR "low carbohydrates" OR "gluten free") AND diet) OR "feingold diet" OR "red dye" OR
((vitamin OR vitamins) AND (supplement OR supplements)) OR "herbal supplement" OR "herbal
supplements" OR probiotics OR "omega 3" OR "slow cortical potentials" OR "few foods diet" OR
"oligoantigenic diet" OR "restriction diet" OR "food intolerance" OR "food allergy" OR "food allergies"
OR "food sensitivity" OR "food sensitivities" OR “multimodal treatment” OR homeopathy OR
homeopathic OR chiropractic OR chiropractor )
6 #4 OR #5

A-11
Set # Terms
7 #3 AND #6
8 ZC "longitudinal study" OR ZC "empirical study" OR ZC "followup study" OR ZC "longitudinal study"
OR ZC "meta analysis" OR ZC "prospective study" OR ZC "retrospective study" OR ZC "systematic
review" OR ZC "treatment outcome/clinical trial"OR DE "Clinical Trials" OR DE "Cohort Analysis" OR
DE "Followup Studies" OR DE "Longitudinal Studies" OR DE "Prospective Studies" OR DE "Meta
Analysis" OR TI (randomized OR randomised OR randomization OR randomisation OR randomly OR
trial OR groups OR trials OR "evaluation study" OR evaluation studies OR "intervention study" OR
"intervention studies" OR "case-control" OR cohort OR longitudinal OR longitudinally OR prospective
OR prospectively OR retrospective OR "comparative study" OR "meta-analysis" OR "meta-analyses" )
OR AB (randomized OR randomised OR randomization OR randomisation OR randomly OR trial OR
groups OR trials OR "evaluation study" OR evaluation studies OR "intervention study" OR "intervention
studies" OR "case-control" OR cohort OR longitudinal OR longitudinally OR prospective OR
prospectively OR retrospective OR "comparative study" OR "meta-analysis" OR "meta-analyses" ) AND
(ZZ "journal article")
9 #7 AND #8
10 #9, since 2009

Key Question 3
Set # Terms
#1 DE "Attention Deficit Disorder with Hyperactivity" OR TI ( "attention deficit hyperactivity disorder" OR
ADHD OR "attention deficit disorder" ) OR AB ( "attention deficit hyperactivity disorder" OR ADHD OR
"attention deficit disorder"
#2 AG (childhood OR adolescence ) OR DE "Pediatrics" OR TI ( child OR children OR infant OR infants
OR preschool OR preschooler OR pediatric OR teenager OR teenagers OR teenaged OR teen OR
teens OR adolescent OR adolescents OR adolescence OR youth ) OR AB ( child OR children OR
infant OR infants OR preschool OR preschooler OR pediatric OR teenager OR teenagers OR teenaged
OR teen OR teens OR adolescent OR adolescents OR adolescence OR youth )
#3 (((((DE "Continuum of Care") OR (DE "Outpatient Treatment")) OR (DE "Primary Health Care")) OR
(DE "Monitoring")) OR (DE "Community Psychiatry")) OR TI ( "primary care" OR monitor OR monitored
OR monitoring OR "follow up" OR "followed up" OR visit OR visits OR session OR sessions OR
appointment OR appointments ) OR AB ( "primary care" OR monitor OR monitored OR monitoring OR
"follow up" OR "followed up" OR visit OR visits OR session OR sessions OR appointment OR
appointments )
#4 ZC "longitudinal study" OR ZC "empirical study" OR ZC "followup study" OR ZC "longitudinal study"
OR ZC "meta analysis" OR ZC "prospective study" OR ZC "retrospective study" OR ZC "systematic
review" OR ZC "treatment outcome/clinical trial"OR DE "Clinical Trials" OR DE "Cohort Analysis" OR
DE "Followup Studies" OR DE "Longitudinal Studies" OR DE "Prospective Studies" OR DE "Meta
Analysis" OR TI (randomized OR randomised OR randomization OR randomisation OR randomly OR
trial OR groups OR trials OR "evaluation study" OR evaluation studies OR "intervention study" OR
"intervention studies" OR "case-control" OR cohort OR longitudinal OR longitudinally OR prospective
OR prospectively OR retrospective OR "comparative study" OR "meta-analysis" OR "meta-analyses" )
OR AB (randomized OR randomised OR randomization OR randomisation OR randomly OR trial OR
groups OR trials OR "evaluation study" OR evaluation studies OR "intervention study" OR "intervention
studies" OR "case-control" OR cohort OR longitudinal OR longitudinally OR prospective OR
prospectively OR retrospective OR "comparative study" OR "meta-analysis" OR "meta-analyses" ) AND
(ZZ "journal article")
#5 #1 AND #2 AND #3 AND #4
#6 #5, since 2009 and English

A-12
Cochrane Search Strategy (November 7, 2016)
Platform: Wiley
Database searched: Cochrane Database of Systematic Reviews

Key Question 1
Set # Terms
#1 [mh "Attention Deficit Disorder with Hyperactivity"]
#2 "attention deficit hyperactivity disorder":ab,ti OR "ADHD":ab,ti OR "attention deficit disorder":ab,ti
#3 #1 OR #2
#4 [mh Pediatrics] OR [mh Adolescent] OR [mh Infant] OR [mh Child]
#5 child:ab,ti OR children:ab,ti OR infant:ab,ti OR infants:ab,ti OR preschool:ab,ti OR preschooler:ab,ti OR
pediatric:ab,ti OR teenager:ab,ti OR teenagers:ab,ti OR teenaged:ab,ti OR teen:ab,ti OR teens:ab,ti OR
adolescent:ab,ti OR adolescents:ab,ti OR adolescence:ab,ti OR youth:ab,ti
#6 #4 OR #5
#7 [mh "Attention Deficit Disorder with Hyperactivity"/DI] OR [mh "mass screening"] OR [mh
questionnaires] OR [mh "Interviews as Topic"] OR [mh Psychometrics] OR [mh "Psychiatric Status
Rating Scales"] OR [mh ^diagnosis] OR [mh "Diagnostic Techniques and Procedures"] OR [mh
"Diagnostic and Statistical Manual of Mental Disorders"] OR [mh "Referral and Consultation"]
#8 questionnaire:ab,ti OR questionnaires:ab,ti OR screening:ab,ti OR screen:ab,ti OR scale:ab,ti OR
instrument:ab,ti OR instruments:ab,ti OR interview:ab,ti OR interviews:ab,ti OR DSM*:ab,ti OR
diagnosis:ab,ti OR diagnostic:ab,ti OR diagnosed:ab,ti OR (Vanderbilt:ab,ti AND scale:ab,ti) OR
conners:ab,ti OR cprs:ab,ti OR ctrs:ab,ti OR cprs:ab,ti OR crs:ab,ti OR "snap-IV":ab,ti OR "snap-4":ab,ti
OR "basc-2":ab,ti OR "behavioral assessment system for children":ab,ti OR dbdrs:ab,ti OR "disruptive
behavior disorder rating scale":ab,ti OR adhd-rs:ab,ti OR "adhd rating scale":ab,ti OR ksads:ab,ti OR k-
sads:ab,ti OR kiddie-sads:ab,ti OR DISC:ab,ti OR "dominance inducement submission and
compliance":ab,ti OR "diagnostic interview schedule for children":ab,ti OR "diagnostic inventory for
screening children":ab,ti OR "mini-kid":ab,ti OR "Mini Interational Neuropsychiatric interview":ab,ti OR
"iva-2":ab,ti OR "iva-qs":ab,ti OR "iva-ae2":ab,ti OR tova:ab,ti OR "test of variables of attention":ab,ti
OR "neuropsychiatric eeg-based assessment aid":ab,ti OR neba:ab,ti
#9 #7 OR #8
#10 #3 AND #6 AND #9
#11 #10, since 2009, in CDSR only

A-13
Key Question 2
Set # Terms
#1 [mh "Attention Deficit Disorder with Hyperactivity"]
#2 "attention deficit hyperactivity disorder":ab,ti OR "ADHD":ab,ti OR "attention deficit disorder":ab,ti
#3 #1 OR #2
#4 [mh Pediatrics] OR [mh Adolescent] OR [mh Infant] OR [mh Child]
#5 child:ab,ti OR children:ab,ti OR infant:ab,ti OR infants:ab,ti OR preschool:ab,ti OR preschooler:ab,ti OR
pediatric:ab,ti OR teenager:ab,ti OR teenagers:ab,ti OR teenaged:ab,ti OR teen:ab,ti OR teens:ab,ti OR
adolescent:ab,ti OR adolescents:ab,ti OR adolescence:ab,ti OR youth:ab,ti
#6 #4 OR #5
#7 [mh "Attention Deficit Disorder with Hyperactivity"/DT] OR [mh "Central Nervous System Stimulants"]
OR [mh Methylphenidate] OR [mh Dexmethylphenidate] OR [mh Dextroamphetamine] OR [mh
Amphetamine] OR [mh Guanfacine] OR [mh Sympatholytics] OR [mh Clonidine] OR [mh “Adrenergic
Uptake Inhibitors"] OR [mh "alpha-2 Adrenergic Receptors"] OR [mh "Adrenergic alpha-Agonists"] OR
[mh "Adrenergic alpha-2 Receptor Agonists"] OR [mh "Tricyclic Antidepressive Agents"] OR [mh
Desipramine] OR [mh "Dopamine Uptake Inhibitors"] OR [mh Sympathomimetics] OR [mh "Serotonin
Uptake Inhibitors"] OR [mh "Monoamine Oxidase Inhibitors"] OR [mh "Monoamine Oxidase"] OR [mh
Selegiline] OR [mh Bupropion] OR [mh "N-Methyl-D-Aspartate Receptors"] OR [mh Memantine] OR
[mh Amantadine]
#8 "Central Nervous System Stimulants":ab,ti OR “psychostimulant”:ab,ti OR “Methylphenidate”:ab,ti OR
"Methylphenidate Hydrochloride":ab,ti OR “Aptensio”:ab,ti OR “Concerta”:ab,ti OR “Ritalin”:ab,ti OR
“Ritalin LA”:ab,ti OR “Medikinet”:ab,ti OR “Equasym”:ab,ti OR “Quillivant”:ab,ti OR “Metadate”:ab,ti OR
“Daytrana”:ab,ti OR "Dexmethylphenidate":ab,ti OR “Dexmethylphenidate Hydrochloride”:ab,ti OR
“Focalin”:ab,ti OR “Dextroamphetamine”:ab,ti OR “Dexedrine”:ab,ti OR “Dextrostat”:ab,ti OR
“ProCentra”:ab,ti OR “Zenzedi”:ab,ti OR “mixed amphetamine salts”:ab,ti OR "Adderall" :ab,ti OR
“lisdexamfetamine”:ab,ti OR “lisdexamfetamine dimesylate”:ab,ti OR “Vyvanse”:ab,ti OR
"Venvanse":ab,ti OR "Elvanse":ab,ti OR "Tyvense":ab,ti OR "Dyanavel":ab,ti OR “Evekeo”:ab,ti OR
"Guanfacine":ab,ti OR "Sympatholytics":ab,ti OR “Central alpha-2 Adrenergic Agonist”:ab,ti OR
“Clonidine”:ab,ti OR "Intuniv":ab,ti OR "Estulic":ab,ti OR “Tenex”:ab,ti OR “Catapres”:ab,ti OR
“Clophelin”:ab,ti OR "Kapvay":ab,ti OR “Nexiclon”:ab,ti OR "Duraclon":ab,ti OR “Norepinephrine
Reuptake Inhibitors”:ab,ti OR “Selective Norepinephrine Reuptake Inhibitors”:ab,ti OR “Adrenergic
Uptake Inhibitors":ab,ti OR "atomoxetine":ab,ti OR "Strattera":ab,ti OR "Tricyclic antidepressants":ab,ti
OR "Desipramine":ab,ti OR "Norpramin":ab,ti OR "Nortriptyline":ab,ti OR "Pamelor":ab,ti OR “Dopamine
Reuptake Inhibitors”:ab,ti OR "modafinil":ab,ti OR “Provigil”:ab,ti OR “Armodafinil”:ab,ti OR
“Norepinephrine-dopamine Reuptake Inhibitors":ab,ti OR "Bupropion":ab,ti OR “Wellbutrin”:ab,ti OR
“Forfivo”:ab,ti OR “Cymbalta”:ab,ti OR "venlafaxine":ab,ti OR “reboxetine”:ab,ti OR “Monoamine
Oxidase Type B inhibitors”:ab,ti OR "Selegiline":ab,ti OR “Eldepryl”:ab,ti OR “Zelapar”:ab,ti OR “NMDA
receptors”:ab,ti OR “N-Methyl-D-aspartate receptor Antagonists”:ab,ti OR "Amantadine":ab,ti OR
"Memantine":ab,ti OR “Pertofrane”:ab,ti OR “Nuvigil”:ab,ti OR “Cymbalta”:ab,ti OR "duloxetine":ab,ti OR
"Effexor":ab,ti OR "Eldepryl":ab,ti OR "Emsam":ab,ti OR "Trevilor":ab,ti OR "Symmetrel":ab,ti OR
"Namenda":ab,ti OR "Zelapar":ab,ti
#9 #7 OR #8
#10 [mh "Attention Deficit Disorder with Hyperactivity"/DH] OR [mh "Attention Deficit Disorder with
Hyperactivity"/RH] OR [mh Psychotherapy] OR [mh "Behavior Therapy"] OR [mh "Parent-Child
Relations"] OR [mh "Play Therapy"] OR [mh "Cognitive Therapy"] OR [mh "Time Management"] OR
[mh "Computer-Assisted Instruction"] OR [mh "Diet Therapy"] OR [mh "Omega-3 Fatty Acids"/TU] OR
[mh Vitamins/AD] OR [mh Vitamins/TU] OR [mh "Food Additives"/AE] OR [mh Probiotics/TU] OR [mh
"Acupuncture Therapy"] OR [mh "Remedial Teaching"] OR [mh "Early Intervention (Education)"] OR
[mh "Complementary Therapies"] OR [mh "Combined Modality Therapy"]

A-14
Set # Terms
#11 "psychosocial therapy":ab,ti OR "psychosocial intervention":ab,ti OR "psychosocial interventions":ab,ti
OR "psychosocial approach":ab,ti OR "psychosocial approaches":ab,ti OR "psychosocial
treatment":ab,ti OR "psychosocial support":ab,ti OR "psychoeducation":ab,ti OR "nonpharmacologic
therapy":ab,ti OR "nondrug therapy":ab,ti OR "non-drug therapy":ab,ti OR "Play Therapy":ab,ti OR
"cognitive behavioral therapy":ab,ti OR "cognitive behavior therapy":ab,ti OR "cognitive behavioural
therapy":ab,ti OR "cognitive behaviour therapy":ab,ti OR Mindfulness:ab,ti OR complementary:ab,ti OR
"alternative medicine":ab,ti OR "alternative therapy":ab,ti OR "alternative therapies":ab,ti OR
"Interpersonal skills training":ab,ti OR "Parent-Child Interaction Therapy":ab,ti OR "parent training":ab,ti
OR "parent engagement":ab,ti OR "parent management":ab,ti OR "parenting skills":ab,ti OR "parenting
intervention":ab,ti OR "parenting interventions":ab,ti OR "Barkley's defiant child":ab,ti OR "Teacher-
Child Interaction Training":ab,ti OR "Incredible Years":ab,ti OR "New Forest Parenting":ab,ti OR "Triple
P":ab,ti OR "Helping the Noncompliant Child":ab,ti OR "child life and attention skills":ab,ti OR
"clas":ab,ti OR PCIT:ab,ti OR "parent child interaction therapy":ab,ti OR "Summer Treatment
Program":ab,ti OR "Daily Report Card":ab,ti OR "organization skills":ab,ti OR "organizational skills":ab,ti
OR "time management":ab,ti OR "homework intervention":ab,ti OR braintrain:ab,ti OR "memory
training":ab,ti OR "Captain's log mindpower builder":ab,ti OR "memory gyms":ab,ti OR "attention
gym":ab,ti OR "smartdriver plus":ab,ti OR "smartmind pro":ab,ti OR “RoboMemo”:ab,ti OR "play
attention":ab,ti OR metronome:ab,ti OR brainmaster:ab,ti OR mindmed:ab,ti OR "attention lab":ab,ti OR
(activate:ab,ti AND c8:ab,ti) OR "attention training":ab,ti OR “CogniPlus”:ab,ti OR cogmed:ab,ti OR
"working memory training":ab,ti OR biofeedback:ab,ti OR neurofeedback:ab,ti OR neuroagility:ab,ti OR
neuroptimal:ab,ti OR acupuncture:ab,ti OR "vision training":ab,ti OR "visual training":ab,ti OR "vision
therapy":ab,ti OR "education intervention":ab,ti OR "cognitive remediation":ab,ti OR neurotherapy:ab,ti
OR "elimination diet":ab,ti OR "diet therapy":ab,ti OR (("low carb" OR "low carbohydrate" OR "low
carbohydrates":ab,ti OR "gluten free") AND diet:ab,ti) OR "feingold diet":ab,ti OR "red dye":ab,ti OR
((vitamin:ab,ti OR vitamins:ab,ti) AND (supplement:ab,ti OR supplements:ab,ti)) OR "herbal
supplement":ab,ti OR "herbal supplements":ab,ti OR probiotics:ab,ti OR "omega 3":ab,ti OR "slow
cortical potentials":ab,ti OR "few foods diet":ab,ti OR "oligoantigenic diet":ab,ti OR "restriction diet":ab,ti
OR "food intolerance":ab,ti OR "food allergy":ab,ti OR "food allergies":ab,ti OR "food sensitivity":ab,ti
OR "food sensitivities":ab,ti OR “multimodal treatment”:ab,ti OR homeopathy:ab,ti OR
homeopathic:ab,ti OR chiropractic:ab,ti OR chiropractor:ab,ti
#12 #10 OR #11
#13 #12 OR #9
#14 #3 AND #6 AND #13
#15 #14, since 2009, limited to CDSR

Key Question 3
Set # Terms
#1 [mh "Attention Deficit Disorder with Hyperactivity"]
#2 "attention deficit hyperactivity disorder":ab,ti OR "ADHD":ab,ti OR "attention deficit disorder":ab,ti
#3 #1 OR #2
#4 [mh Pediatrics] OR [mh Adolescent] OR [mh Infant] OR [mh Child]
#5 child:ab,ti OR children:ab,ti OR infant:ab,ti OR infants:ab,ti OR preschool:ab,ti OR preschooler:ab,ti OR
pediatric:ab,ti OR teenager:ab,ti OR teenagers:ab,ti OR teenaged:ab,ti OR teen:ab,ti OR teens:ab,ti
OR adolescent:ab,ti OR adolescents:ab,ti OR adolescence:ab,ti OR youth:ab,ti
#6 #4 OR #5
#7 [mh "Secondary Care"] OR [mh "Comprehensive Health Care"]
#8 "primary care":ab,ti OR monitor:ab,ti OR monitored:ab,ti OR monitoring:ab,ti OR "follow up":ab,ti OR
"followed up":ab,ti OR visit:ab,ti OR visits:ab,ti OR session:ab,ti OR sessions:ab,ti OR appointment:ab,ti
OR appointments:ab,ti
#9 #7 OR #8
#10 #3 AND #6 AND #9
#11 #10, since 2009, limit to CDSR

A-15
Gray Literature Searches

ClinicalTrials.gov (November 28, 2016)


Category Description
Conditions ADHD OR attention deficit
Recruitment Completed studies
Study Results All studies
Study type Interventional studies
Age group Child
Phase Phase 2, Phase 3, Phase 4

Total number of results for screening: 377

WHO: International Clinical Trials Registry Platform Search Portal


(November 28, 2016)
Category Description
Conditions ADHD OR attention deficit
Recruiting status All

Total number of results exported: 945 records/828 trials

Results were imported into an excel file and refined as follows:


1. Removed records with a registration date of December 31, 2004 or earlier; records with
an enrollment start date of December 31, 2004 or earlier; records of recruiting studies;
records with a population age above 17 years; studies that were explicitly designated as
Phase 0 or 1—497 records.
2. Removal of records originating from ClinicalTrials.gov (the ClinicalTrials.gov database
was searched separately)—302 records removed, 195 remaining.

Total number of results for screening: 195

National Guidelines Clearinghouse (November 28, 2016)


Platform: www.guideline.gov

Category Description
Keywords ADHD OR "attention deficit disorder" OR "attention deficit hyperactivity disorder"
Age of Target Adolescent (13 to 18 years), Child (2 to 12 years), Infant (1 to 23 months), Infant, Newborn (to 1
Population month)
Publication 2009, 2010, 2011, 2012, 2013, 2014, 2015
Year

Total number of results: 37

A-16
Appendix B. Data Abstraction Elements

Study Characteristics
• Study Identifiers
o Study Name or Acronym
o NCT number or other trial registry identifier
o Last name of first author
• Additional Articles Used in This Abstraction
• Study Sites
o Single center, Multicenter, Unclear/Not reported
o Number of sites
• Geographic Location (Select all that apply)
o US, Canada, UK/Europe, Latin America, Middle East (including Israel), Asia,
Africa, Australia/NZ, Unclear/Not reported
• Study Design
o RCT
o Observational
• Funding Source (Select all that apply)
o Government, Industry, Non-government/non-industry, Unclear/Not reported
• Setting (Select all that apply)
o Primary Care; Specialty Care; Community Resource; School; Other; Unclear/Not
reported
• Study Enrollment/Study Completion
o N enrolled/included
o N completed
• Key Question Applicability (Select all that apply)
o KQ1, KQ2, KQ3
• Comments

Baseline Characteristics – Record the following elements for Total Population, Total ADHD
Population, Arm 1, Arm 2, Arm 3, and Arm 4 (as applicable)
o Number of Patients (N and %)
o Gender (N and %)
 Male
 Female
o Age in years
 Mean
 Median
 Standard Deviation
 Min. age
 Max. age
 25% IQR
 75% IQR
 Categorical
 Other, specify

B-1
o Race/Ethnicity (N and %)
 Hispanic or Latino
 Black/African American
 American Indian or Alaska Native
 Asian
 Native Hawaiian or Pacific Islander
 White
 Multiracial
 Other (specify)
o ADHD Subtype (N and %)
 Inattentive
 Hyperactive
 Combined
• Were there significant differences noted between groups in any baseline characteristic?
(Yes/No)
o If yes, please explain the differences
• Comments

Intervention Characteristics
• What intervention comparison is being tested in this study? Mark all that apply.
o Pharmacological vs. pharmacological,
o Pharmacological vs. non-pharmacological
o Pharmacological vs. placebo/usual care
 Placebo, Pharmacological Usual Care, Non-pharmacological Usual Care
o Non-pharmacological vs. non-pharmacological
o Non-pharmacological vs. placebo/usual care
 Placebo, Pharmacological Usual Care, Non-pharmacological Usual Care
• Intervention Descriptors
o Describe the intervention received by each patient group (For each Arm).
• Indicate components of the intervention (For each Arm)
o Pharmacological
o Nonpharmacological
o Placebo or usual/standard care
• Indicate all intervention characteristics that are varied in this study
o Pharmacological Details
 Psychostimulants
• Methylphenidate, Dexmethylphenidate, Dextroamphetamine,
Lisdexamphetamine, Mixed amphetamine salts, Amphetamine
 Tricyclic antidepressants
• Desipramine, Nortriptyline
 Selective norepinephrine reuptake inhibitors
• Atomoxetine
 Alpha-2 agonists
• Clonidine, Guanfacine extended release
 Dopamine reuptake inhibitors
• Modafinil

B-2
• Armodafinil
 Norepinephrine-dopamine reuptake inhibitors
• Bupropion
 Serotonin-norepinephrine reuptake inhibitors
• Duloxetine
 Serotonin-norepinephrine-dopamine reuptake inhibitors
• Venlafaxine
 Monoamine oxidase type B inhibitors
• Selegiline
 N-methyl-D-aspartate receptor antagonists
• Amantadine, Memantine
o Nonpharmacological Details
 Psychosocial interventions
 Behavioral interventions
 Cognitive behavioral therapy
 Play therapy
 Mindfulness-based therapies
 School interventions
 Cognitive training therapies
 Biofeedback or neurofeedback
 Parent behavior training
 Dietary supplements
 Homeopathy
 Acupuncture
 Elimination diets
 Vision training
 Exercise
 Chiropractic treatment
o Placebo/Control details
 Placebo
 Usual care control/optimal medical therapy
 Other (specify)
o Indicate the intervention target
 ADHD patients
 Parents
 Teachers
 Other (Specify)
o Indicate the Intervention Setting
 Primary Care
 Specialty Care
 Home
 School
 Other (specify)
• Duration of Follow-up reported for Total overall study f/u, Arm 1 f/u, Arm 2 f/u, Arm 3
f/u, Arm 4 f/u (Reported or Not reported)
 Mean follow-up in months or years (include units)

B-3
 Mean Variability
• SD, SE, IQR, NR
 Median Follow-up in months or years (include units)
 Median variability
• SD, SE, IQR, NR
• Comments

KQ 1 Diagnostic Tools
• Gold Standard
o Is confirmation of diagnosis by a specialist including psychologist or psychiatrist
or other care provider using a well-validated and reliable process of confirming
the diagnosis of ADHD according to the DSM-IV or DSM-V the gold standard?
 Yes (Describe the gold standard)
 No (Article may be eligible for exclusion. Please check with the team)
o Who performed the diagnosis?
 Specialist, other care, provider, researcher, unclear/NR, other (specify)
• Select the outcome(s) reported on this form:
o Diagnostic Accuracy, Misdiagnosis/risk of missed condition, labeling/stigma
• Select the Age Group
o Under 7 with any diagnostic tool, 7-17 with a novel diagnostic tool,
labeling/stigma
• Subgroup Analyses
o Is this outcome form for a subgroup of interest? (Y or N)
 If Y, indicate the factor being considered
• Age
• Sex
• ADHD presentation
• Comorbidity (e.g. anxiety, depression)
• Risk factors
• Race/ethnicity
• Socioeconomic status
• Insurance status
• Geographic location
• Clinical setting
• Any additional description/clarification of subgroup reported on
this form
• Diagnostic Accuracy
o Timing of the outcome data
o Test results reported for Instrument 1, Instrument 2, Instrument 3 (Select
instrument used)
 True positive (# patients)
 True negative (# patients)
 False positive (# patients)
 False negative (# patients)
 Sensitivity

B-4
• %, Std dev, Upper confidence interval bound, lower confidence
interval bound
 Specificity
• %, Std dev, Upper confidence interval bound, lower confidence
interval bound
 Positive predictive value
• %, Std dev, Upper confidence interval bound, lower confidence
interval bound
 Negative predictive value
• %, Std dev, Upper confidence interval bound, lower confidence
interval bound
 Positive likelihood ratio
 Negative likelihood ratio
o Reliability
 Test-retest
 Kappa statistics
 Inter-rater
 Intra-rater
 Intraclass correlation
 Diagnostic concordance of primary care provider with specialist
 Internal consistency
• Misdiagnosis/Risk of Missed Condition Measure
o Timing of the outcome reported
o Describe outcome
• Labeling/Stigma
o Timing of the outcome data reported
o Describe outcome
• Comments

KQ 2 Outcomes
• Specific RefID
• Where was this data in the article found? (pg #, table #, etc)
• Select the outcome reported on this form:
o Academic performance
o Acceptability of treatment
o Aggression
o Behavior changes
o Cardiac arrhythmias
o Changes in appetite
o Changes in standardized symptom scores or progress toward patient-identified
goals
o Chemical leukoderma
o Conduction abnormalities
o Depression or anxiety
o Diversion of pharmacotherapy
o Divorce/relationship status

B-5
o Elevated blood pressure
o Functional impairment
o Gastrointestinal symptoms
o Growth suppression
o Hallucination
o Incarceration or other interactions with the legal system
o Increased heart rate
o Loss of spontaneity
o Mood disorders
o Mortality
o Motor vehicle collisions or other accidents
o Motor vehicle violations
o Obesity
o Overtreatment
o Parental stress
o Personality change
o Priapism
o Quality of peer relationships
o Risk of sudden cardiac death
o Risk-taking behaviors
o Self-injurious non-suicidal behavior
o Sleep disturbance
o Substance abuse
o Suicide (attempted or completed)
o Suicide ideation
o Tics or other movement disorders
o Time demands/opportunity cost
o Tobacco use
o Weight decrease
o Workforce participation
• Any additional description / clarification of the outcome reported on this form
• Is this outcome form for a subgroup of interest? (Yes/No)
o What subpopulation is this outcome reported for on this form?
 Age
 Sex
 ADHD presentation
 Comorbidity
 Risk factors
 Race/ethnicity
 Socioeconomic status
 Insurance status
 Geographic location
 Clinical setting
o Any additional description / clarification of subgroup reported on this form
• Total N Analyzed for this outcome
• Timepoint reported on this form

B-6
o Short-term
o Long-term
• Specify actual timing of the outcome (in months)
• For each arm:
o N Analyzed (enter UNK if unknown)
o Unadjusted Result
 Number of patients with outcome
 % of patients with outcome
 Events/denominator
 Odds ratio
 Hazard ratio
 Relative risk
 Mean
 Median
 Mean within group change
 Mean between group change
 Other (specify)
o Unadjusted Result Variability
 95% CI
 IQR
 Standard Error (SE)
 Standard Deviation (SD)
 Other % CI (specify)
 Other (specify)
o Unadjusted Result, p-value between groups
o Unadjusted Result, indicate reference group (for comparison between groups)
o Adjusted Result
 Number of patients with outcome
 % of patients with outcome
 Events/denominator
 Odds ratio
 Hazard ratio
 Relative risk
 Mean
 Median
 Mean within group change
 Mean between group change
 Other (specify)
o Adjusted Result Variability
 95% CI
 IQR
 Standard Error (SE)
 Standard Deviation (SD)
 Other % CI (specify)
 Other (specify)
o Adjusted Result, p-value between groups

B-7
o Adjusted Result, indicate reference group (for comparison between groups)
o If adjusted data is recorded, indicate the adjustments applied
• Comments

Quality
• Study Type (select one): RCT, Observational
• If RCT, select Yes/No/Unclear for each of the following questions:
o Sequence Generation
 Was the allocation sequence generated adequately (e.g., random number
table, computer-generated randomization)?
o Allocation concealment
 Was the allocation of treatment adequately concealed (e.g., pharmacy-
controlled randomization or use of sequentially numbered sealed
envelopes)?
o Blinding of participants, personnel and outcome assessors
 Was knowledge of the allocated intervention adequately prevented during
the study?
o Incomplete outcome data
 Were incomplete outcome data adequately addressed?
o Selective outcome reporting
 Are reports of the study free of suggestion of selective outcome reporting?
o Other sources of bias
 Was the study apparently free of other problems that could put it at a high
risk of bias?
o Comments
• If Observational, Study design (select one)
 Case-control, Cohort
• If Case-Control:
o Selection
 Is the case definition adequate?
• Yes, with independent validation
• Yes, eg record linkage or based on self reports?
• No description
• comments
 Representativeness of the cases
• Consecutive or obviously representative series of cases
• Potential for selection biases or not stated
• comments
 Selection of controls
• Community controls
• Hospital controls
• No description
• Comments
 Definition of controls
• No history of disease (endpoint)

B-8
• No description of source
• Comments
o Comparability
 Comparability of cases and controls on the basis of the design or analysis
• Study controls for severity of ADHD
• Study controls for any additional factor
• Comments
o Exposure
 Ascertainment of exposure
• Secure record
• Structured interview where blind to case/control status
• Interview not blinded to case/control status
• Written self report or medical record only
• No description
• comments
 Same method of ascertainment for cases and controls (Y, N, comments)
 Non-response rate
• Same rate for both groups
• Non respondent described
• Rate different and no designation
• Comments
• If Cohort:
o Selection
 Representativeness of the exposed cohort Yes, with independent
validation
• Truly representative of the average ADHD patient in the
community
• Somewhat representative of the average ADHD patient in the
community
• Selected group of users (eg nurses, volunteers)
• No description of the derivation of the cohort
• Comments
 Selection of the non-exposed cohort
• Drawn from the same community as the exposed cohort
• Drawn from a different source
• No description of the derivation of the non-exposed cohort
• Comments
 Ascertainment of exposure
• Secure record (e.g., surgical records)
• Structured interview
• Written self-report
• No description
• Comments
 Demonstration that outcome of interest was not present at start of study
(Y, N, Comments)
B-9
o Comparability
 Comparability of cohorts on the basis of the design or analysis
• Study controls for severity of ADHD
• Study controls for any additional factor
• Comments
o Outcome
 Assessment of Outcome
• Independent blind assortment
• Record linkage
• Self report
• No description
• comments
 Was follow-up long enough for outcome to occur (Y, N, comments)
 Adequacy of follow up of cohorts
• Complete follow up - all subjects accounted for
• Subjects lost to follow up unlikely to introduce bias - small number
lost - >80% follow up, or description provided of those lost
• Follow up rate
• No statement
• Comments
• Overall Study Rating (Good/Fair/Poor)
o Good (low risk of bias). These studies have the least bias, and the results are
considered valid. These studies adhere to the commonly held concepts of high
quality, including the following: a clear description of the population, setting,
approaches, and comparison groups; appropriate measurement of outcomes;
appropriate statistical and analytical methods and reporting; no reporting errors; a
low dropout rate; and clear reporting of dropouts.
o Fair. These studies are susceptible to some bias, but not enough to invalidate the
results. They do not meet all the criteria required for a rating of good quality
because they have some deficiencies, but no flaw is likely to cause major bias.
The study may be missing information, making it difficult to assess limitations
and potential problems.
o Poor (high risk of bias). These studies have significant flaws that may have
invalidated the results. They have serious errors in design, analysis, or reporting;
large amounts of missing information; or discrepancies in reporting.
o If the study is rated as “Fair” or “Poor,” provide rationale.
• Outcome-specific quality rating
o Do you think that any of the outcomes abstracted for this study should be assigned
a quality rating DIFFERENT from the overall study rating? (No/Yes)
 If you think any of the abstracted outcomes should have a quality rating
different from the overall study, please provide the outcome(s), rating(s)
and rationale(s).

Applicability – Use the PICOS format to identify specific issues, if any, that may limit the
applicability of the study.

B-10
• Population (P)
o Narrow eligibility criteria and exclusion of those with comorbidities
o More complex patients than typical of the community
o Run-in period with high exclusion rate for non-adherence or side effects
o DSM-4/5 diagnosis unclear
• Intervention (I)
o as recommended or commonly used in practice
o Dosing not reflective of current practice
o Co-intervention that are likely to modify the effectiveness of therapy
o Highly selected intervention team or level of training/proficiency not widely
available
o Follow-up not reflective of current practice
o Co-intervention that are likely to modify monitoring strategies
• Comparator (C)
o Diagnostic tools used differently than as recommended or commonly used in
practice
o Comparator unclear
o Inadequate comparison therapy or use of a substandard alternative therapy
• Outcomes (O)
o Composite outcomes that mix outcomes of different significance
o Short-term follow-up
o Surrogate outcomes
• Setting (S)
o Level of care different from that in the community
• Do you have other concerns regarding applicability of this study? (Y, N, describe
concerns)
• Comment

B-11
Appendix C. List of Included Studies
Abikoff H, Gallagher R, Wells KC, et al. Remediating
organizational functioning in children with ADHD: Bloch Y, Fixman M, Maoz H, et al. Can computerized
immediate and long-term effects from a randomized cognitive tests assist in the clinical diagnosis of attention-
controlled trial. J Consult Clin Psychol 2013;81(1):113-28. deficit hyperactivity disorder?. J Neuropsychiatry Clin
PMID: 22889336. Neurosci 2012;24(1):111-4. PMID: 22450621.

Abikoff HB, Thompson M, Laver-Bradbury C, et al. Parent Boyer BE, Geurts HM, Prins PJ, et al. Two novel CBTs for
training for preschool ADHD: a randomized controlled trial adolescents with ADHD: the value of planning skills. Eur
of specialized and generic programs. J Child Psychol Child Adolesc Psychiatry 2015;24(9):1075-90. PMID:
Psychiatry 2015;56(6):618-31. PMID: 25318650. 25549767.

Anand P and Sachdeva A. Effect of Poly Unsaturated Fatty Bunte TL, Schoemaker K, Hessen DJ, et al. Clinical
Acids Administration on Children with Attention Deficit usefulness of the Kiddie-Disruptive Behavior Disorder
Hyperactivity Disorder: A Randomized Controlled Trial. J Schedule in the diagnosis of DBD and ADHD in preschool
Clin Diagn Res 2016;10(9):Oc01-oc05. PMID: 27790483. children. J Abnorm Child Psychol 2013;41(5):681-90.
PMID: 23474833.
Arcieri R, Germinario EA, Bonati M, et al. Cardiovascular
measures in children and adolescents with attention- Carballo JJ, Rodriguez-Blanco L, Garcia-Nieto R, et al.
deficit/hyperactivity disorder who are new users of Screening for the ADHD Phenotype Using the Strengths
methylphenidate and atomoxetine. J Child Adolesc and Difficulties Questionnaire in a Clinical Sample of
Psychopharmacol 2012;22(6):423-431. PMID: 23362511. Newly Referred Children and Adolescents. J Atten Disord
2014. PMID: 25515677.
Arnold LE, Disilvestro RA, Bozzolo D, et al. Zinc for
attention-deficit/hyperactivity disorder: placebo-controlled Castro-Cabrera P, Gomez-Garcia J, Restrepo F, et al.
double-blind pilot trial alone and combined with Evaluation of feature extraction techniques on event-related
amphetamine. J Child Adolesc Psychopharmacol potentials for detection of attention-deficit/hyperactivity
2011;21(1):1-19. PMID: 21309695. disorder. Conf Proc IEEE Eng Med Biol Soc
2010;2010:851-4. PMID: 21096317.
Bai GN, Wang YF, Yang L, et al. Effectiveness of a
focused, brief psychoeducation program for parents of Caudal F. New marker using bioimpedance technology in
ADHD children: Improvement of medication adherence screening for attention deficit/hyperactivity disorder
and symptoms. Neuropsychiatric Disease and Treatment (ADHD) in children as an adjunct to conventional
2015;11:2721-2735. diagnostic methods. Psychol Res Behav Manag
2011;4:113-7. PMID: 22114541.
Banaschewski T, Johnson M, Lecendreux M, et al. Health-
related quality of life and functional outcomes from a Çetin FH, Taş Torun Y and Işik Taner Y. Atomoxetine
randomized-withdrawal study of long-term versus OROS methylphenidate in attention deficit
lisdexamfetamine dimesylate treatment in children and hyperactivity disorder: A six-month follow up study for
adolescents with attention-deficit/hyperactivity disorder. efficacy and adverse effects. Turkiye Klinikleri Journal of
CNS Drugs 2014;28(12):1191-203. PMID: 25139785. Medical Sciences 2015;35(2):88-96.

Barragan E, Breuer D and Dopfner M. Efficacy and Safety Chacko A, Bedard AC, Marks DJ, et al. A randomized
of Omega-3/6 Fatty Acids, Methylphenidate, and a clinical trial of Cogmed Working Memory Training in
Combined Treatment in Children With ADHD. J Atten school-age children with ADHD: a replication in a diverse
Disord 2014. PMID: 24464327. sample using a control condition. J Child Psychol
Psychiatry 2014;55(3):247-55. PMID: 24117656.
Beck SJ, Hanson CA, Puffenberger SS, et al. A controlled
trial of working memory training for children and Chacko A, Wymbs BT, Wymbs FA, et al. Enhancing
adolescents with ADHD. J Clin Child Adolesc Psychol traditional behavioral parent training for single mothers of
2010;39(6):825-36. PMID: 21058129. children with ADHD. J Clin Child Adolesc Psychol
2009;38(2):206-18. PMID: 19283599.
Berger I and Goldzweig G. Objective measures of
attention-deficit/hyperactivity disorder: a pilot study. Isr Clemow DB, Mason OW, Sarkis EH, et al. Atomoxetine
Med Assoc J 2010;12(9):531-5. PMID: 21287795. monotherapy compared with combination therapy for the
treatment of ADHD: a retrospective chart review study.
Bink M, van Nieuwenhuizen C, Popma A, et al. Behavioral Expert Rev Neurother 2015;:1-14. PMID: 26488905.
effects of neurofeedback in adolescents with ADHD: a
randomized controlled trial. Eur Child Adolesc Psychiatry Cortese S, Panei P, Arcieri R, et al. Safety of
2015;24(9):1035-48. PMID: 25477074. Methylphenidate and Atomoxetine in Children with
Attention-Deficit/Hyperactivity Disorder (ADHD): Data
from the Italian National ADHD Registry. CNS Drugs
2015;29(10):865-77. PMID: 26293742.

C-1
Didoni A, Sequi M, Panei P, et al. One-year prospective Findling RL, Adeyi B, Chen G, et al. Clinical response and
follow-up of pharmacological treatment in children with symptomatic remission in children treated with
attention-deficit/hyperactivity disorder. Eur J Clin lisdexamfetamine dimesylate for attention-
Pharmacol 2011;67(10):1061-7. PMID: 21538145. deficit/hyperactivity disorder. CNS Spectrums
2010;15(9):559-568.
dosReis S, Barksdale CL, Sherman A, et al. Stigmatizing
experiences of parents of children with a new diagnosis of Gelade K, Janssen TW, Bink M, et al. Behavioral Effects of
ADHD. Psychiatric Services 2010;61(8):811-816. PMID: Neurofeedback Compared to Stimulants and Physical
2010-16657-009. Activity in Attention-Deficit/Hyperactivity Disorder: A
Randomized Controlled Trial. J Clin Psychiatry
Dovis S, Van der Oord S, Wiers RW, et al. Improving 2016;77(10):e1270-e1277. PMID: 27631143.
executive functioning in children with ADHD: training
multiple executive functions within the context of a Gevensleben H, Holl B, Albrecht B, et al. Is neurofeedback
computer game. a randomized double-blind placebo an efficacious treatment for ADHD? A randomised
controlled trial. PLoS One 2015;10(4):e0121651. PMID: controlled clinical trial. J Child Psychol Psychiatry
25844638. 2009;50(7):780-9. PMID: 19207632.
Duric NS, Assmus J, Gundersen D, et al. Neurofeedback Gonzalez JJ, Mendez LD, Manas S, et al. Performance
for the treatment of children and adolescents with ADHD: a analysis of univariate and multivariate EEG measurements
randomized and controlled clinical trial using parental in the diagnosis of ADHD. Clin Neurophysiol
reports. BMC Psychiatry 2012;12:107. PMID: 22877086. 2013;124(6):1139-50. PMID: 23332776.
Dutta B, Barua TK, Ray J, et al. A study of evaluation of Gustafsson PA, Birberg-Thornberg U, Duchen K, et al.
safety and efficacy of memomet, a multi herbal formulation EPA supplementation improves teacher-rated behaviour
(memomet) in the treatment of behavioural disorder in and oppositional symptoms in children with ADHD. Acta
children. International Journal of Research in Paediatr 2010;99(10):1540-9. PMID: 20491709.
Pharmaceutical Sciences 2012;3(2):282-286.
Hahn-Markowitz J, Berger I, Manor I, et al. Efficacy of
Egeland J, Aarlien AK and Saunes BK. Few effects of far Cognitive-Functional (Cog-Fun) Occupational Therapy
transfer of working memory training in ADHD: a Intervention Among Children With ADHD: An RCT. J
randomized controlled trial. PLoS One 2013;8(10):e75660. Atten Disord 2016. PMID: 27637735.
PMID: 24124503.
Hammerness P, Petty C, Faraone SV, et al. Do Stimulants
Ercan ES, Ardic UA, Kutlu A, et al. No beneficial effects Reduce the Risk for Alcohol and Substance Use in Youth
of adding parent training to methylphenidate treatment for With ADHD? A Secondary Analysis of a Prospective, 24-
ADHD + ODD/CD children: a 1-year prospective follow- Month Open-Label Study of Osmotic-Release
up study. J Atten Disord 2014;18(2):145-57. PMID: Methylphenidate. J Atten Disord 2012. PMID: 23264367.
22522574.
Hariri M, Djazayery A, Djalali M, et al. Effect of n-3
Evans SW, Langberg JM, Schultz BK, et al. Evaluation of a supplementation on hyperactivity, oxidative stress and
School-Based Treatment Program for Young Adolescents inflammatory mediators in children with attention-deficit-
With ADHD. Journal of Consulting and Clinical hyperactivity disorder. Malays J Nutr 2012;18(3):329-35.
Psychology 2015. PMID: 24568073.
Ferrin M and Vance A. Examination of neurological subtle Hiscock H, Sciberras E, Mensah F, et al. Impact of a
signs in ADHD as a clinical tool for the diagnosis and their behavioural sleep intervention on symptoms and sleep in
relationship to spatial working memory. J Child Psychol children with attention deficit hyperactivity disorder, and
Psychiatry 2012;53(4):390-400. PMID: 22141455. parental mental health: randomised controlled trial. Bmj
2015;350:h68. PMID: 25646809.
Ferrin M, Moreno-Granados JM, Salcedo-Marin MD, et al.
Evaluation of a psychoeducation programme for parents of Hong SS and Cho SH. Treating attention deficit
children and adolescents with ADHD: immediate and long- hyperactivity disorder with acupuncture: A randomized
term effects using a blind randomized controlled trial. Eur controlled trial. European Journal of Integrative Medicine
Child Adolesc Psychiatry 2014;23(8):637-47. PMID: 2015.
24292412.
Huang YH, Chung CY, Ou HY, et al. Treatment effects of
Ferrin M, Perez-Ayala V, El-Abd S, et al. A Randomized combining social skill training and parent training in
Controlled Trial Evaluating the Efficacy of a Taiwanese children with attention deficit hyperactivity
Psychoeducation Program for Families of Children and disorder. Journal of the Formosan Medical Association
Adolescents With ADHD in the United Kingdom: Results 2015;114(3):260-267.
After a 6-Month Follow-Up. J Atten Disord 2016. PMID:
26838557. Johnson M, Ostlund S, Fransson G, et al. Omega-3/omega-
6 fatty acids for attention deficit hyperactivity disorder: a
randomized placebo-controlled trial in children and
adolescents. J Atten Disord 2009;12(5):394-401. PMID:
18448859.

C-2
Katz M, Levine AA, Kol-Degani H, et al. A compound Mohammadpour N, Jazayeri S, Tehrani-Doost M, et al.
herbal preparation (CHP) in the treatment of children with Effect of vitamin D supplementation as adjunctive therapy
ADHD: a randomized controlled trial. J Atten Disord to methylphenidate on ADHD symptoms: A randomized,
2010;14(3):281-91. PMID: 20228219. double blind, placebo-controlled trial. Nutr Neurosci
2016:1-8. PMID: 27924679.
Kim J, Lee Y, Han D, et al. The utility of quantitative
electroencephalography and Integrated Visual and Auditory Mohammadi MR, Mostafavi SA, Keshavarz SA, et al.
Continuous Performance Test as auxiliary tools for the Melatonin effects in methylphenidate treated children with
Attention Deficit Hyperactivity Disorder diagnosis. Clin attention deficit hyperactivity disorder: a randomized
Neurophysiol 2015;126(3):532-40. PMID: 25088931. double blind clinical trial. Iran J Psychiatry 2012;7(2):87-
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Kim JW, Lee J, Kim BN, et al. Theta-phase gamma-
amplitude coupling as a neurophysiological marker of Molina BS, Hinshaw SP, Swanson JM, et al. The MTA at 8
attention deficit/hyperactivity disorder in children. years: prospective follow-up of children treated for
Neurosci Lett 2015;603:25-30. PMID: 26170246. combined-type ADHD in a multisite study. J Am Acad
Child Adolesc Psychiatry 2009;48(5):484-500. PMID:
Klenberg L, Jamsa S, Hayrinen T, et al. The Attention and 19318991.
Executive Function Rating Inventory (ATTEX):
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PMID: 20338019. therapy in hyperactivity: Multilevel analysis of treatment
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Li JJ, Li ZW, Wang SZ, et al. Ningdong granule: a
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complementary and alternative therapy in the treatment of PMID: 2015-48012-005.
attention deficit/hyperactivity disorder.
Psychopharmacology (Berl) 2011;216(4):501-9. PMID: Myers K, Vander Stoep A, Zhou C, et al. Effectiveness of a
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Liechti MD, Valko L, Muller UC, et al. Diagnostic value of randomized controlled trial. J Am Acad Child Adolesc
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Topogr 2013;26(1):135-51. PMID: 23053601. Newcorn JH, Harpin V, Huss M, et al. Extended-release
guanfacine hydrochloride in 6-17-year olds with ADHD: a
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Lopez S, et al. Nonlinear analysis of actigraphic signals for
the assessment of the attention-deficit/hyperactivity Ohan JL, Visser TAW, Strain MC, et al. Teachers' and
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503. PMID: 21296237. 19381995.
Pfiffner LJ, Hinshaw SP, Owens E, et al. A two-site Tobaiqy M, Stewart D, Helms PJ, et al. Parental reporting
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Psychol 2014;82(6):1115-27. PMID: 24865871. attending specialist paediatric clinics in the UK. Drug Saf
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randomized clinical trial. J Consult Clin Psychol atomoxetine on Tanner stage sexual development in
2012;80(4):611-23. PMID: 22506793. children and adolescents with attention deficit/hyperactivity
disorder: 18-month results from a double-blind, placebo-
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2009;19(2):167-77. PMID: 19364294. et al. Cognitive training for children with ADHD: a
randomized controlled trial of cogmed working memory
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adolescents: a double blind, randomized controlled trial.
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2010;34(1):76-80. PMID: 19815048. al. Working memory training in young children with
ADHD: a randomized placebo-controlled trial. J Child
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Child Adolesc Psychopharmacol 2009;19(3):215-26. adolescents with attention-deficit/hyperactivity disorder: a
PMID: 19519256. randomized controlled trial. J Am Acad Child Adolesc
Psychiatry 2015;54(4):275-82. PMID: 25791144.
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Disorder. J Child Adolesc Psychopharmacol 2016. PMID: with ADHD. J Clin Child Adolesc Psychol 2011;40(2):191-
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in children and adolescents. A randomized, placebo- polyunsaturated fatty acids on behavior and cognition in
controlled, trial. Complement Ther Clin Pract children with attention deficit/hyperactivity disorder
2015;21(2):61-7. PMID: 25925875. (ADHD): a randomized placebo-controlled intervention
trial. Prostaglandins Leukot Essent Fatty Acids 2014;91(1-
Sibley MH, Graziano PA, Kuriyan AB, et al. Parent-teen 2):49-60. PMID: 24958525.
behavior therapy + motivational interviewing for
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2016;84(8):699-712. PMID: 27077693. variables of attention reliable for the diagnosis of attention-
deficit hyperactivity disorder (ADHD)?. J Child Neurol
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analysis of caudate abnormalities in pediatric ADHD:
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2010;182(3):238-43. PMID: 20488672. treatment of methylphenidate on height and weight of
school age children with ADHD. Neuropediatrics
Steiner NJ, Frenette EC, Rene KM, et al. Neurofeedback 2010;41(2):55-9. PMID: 20799150.
and cognitive attention training for children with attention-
deficit hyperactivity disorder in schools. J Dev Behav
Pediatr 2014;35(1):18-27. PMID: 24399101.
Storebo OJ, Gluud C, Winkel P, et al. Social-skills and
parental training plus standard treatment versus standard
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SOSTRA trial. PLoS One 2012;7(6):e37280. PMID:
22745657.

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Appendix D. List of Excluded Studies

All studies listed below were reviewed in their full-text version and excluded for the reasons
cited. Reasons for exclusion signify only the usefulness of the articles for this study and are not
intended as criticisms of the articles.

Not a Full Publication or Full Text Not Available


Ang A, Hillhouse M, Jenkins J, et al. Methylphenidate for methamphetamine use disorders in
participants with and without ADHD. Drug and Alcohol Dependence 2015;156:e7.

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Timing or Setting Not Applicable


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D-97
Appendix E. Key to Included Primary and Companion
Articles
*The companion article marked with an asterisk did not individually meet criteria for inclusion
but was considered for supplemental information (e.g., methods data pertinent to an included
study).

Table E-1. Key to included primary and companion articles

Study Designation Primary Abstracted Article Companion Articles


CATTS (Children’s ADHD Myers, 20151 None
Telemental Health Treatment
Study)
INCA (Impact of Nutrition on Pelsser, 20112 None
Children with ADHD)
MTA (Multimodal Treatment Molina, 20093 Vitiello, 20124
Study) *MTA Cooperative Group, 19995
SOSTRA (SOcial Skills TRaining Storebo, 20126 None
Attachment)
None Abikoff, 20157 None
None Abikoff, 20138 None
None Anand, 20169 None
None Arcieri, 201210 None
None Arnold, 201111 None
None Bai, 201512 None
None Banaschewski, 201413 None
None Barragan, 201414 None
None Beck, 201015 None
None Berger, 201016 None
None Bink, 201517 None
None Bloch, 201218 None
None Boyer, 201519 Boyer, 201520
None Bunte, 201321 Bunte, 201322
None Carballo, 201423 None
None Castro-Cabrera, 201024 None
None Caudal, 201125 None
None Cetin, 201526 None
None Chacko, 201427 None
None Chacko, 200928 None
None Clemow, 201529 None
None Cortese, 201530 None
None Didoni, 201131 None
None dosReis, 201032 None
None Dovis, 201533 None
None Duric, 201234 Duric, 201435
None Dutta, 201236 None
None Egeland, 201337 Hovik, 201338
None Ercan, 201439 None
None Evans, 201640 None
None Ferrin, 201641 None
None Ferrin, 201442 None
None Ferrin, 201243 None
None Findling, 201044 None

E-1
Study Designation Primary Abstracted Article Companion Articles
None Gelade,201645 None
None Gevensleben, 200946 Wangler, 201147
Gevensleben, 201048
None Gonzalez, 201349 None
None Gustafsson, 201050 None
None Hahn-Markowitz, 201651 None
None Hammerness, 201252 None
None Hariri, 201253 None
None Hiscock, 201554 Papadopoulos, 201555
None Hong, 201556 None
None Huang, 201557 None
None Johnson, 200958 Johnson, 201259
None Katz, 201060 None
None Kim, 201561 None
None Kim, 201562 None
None Klenberg, 201063 None
None Li, 201164 None
None Liechti, 201365 None
None Manor, 201266 Manor, 201367
None Markovska-Simoska, 201668 None
None Martin-Martinez, 201269 None
None Mautone, 201270 None
None Milte, 201271 Milte, 201572
None Mohammadi, 201273 Mostafavi, 201274
None Mohammadpour, 201675 None
None Moreno-Garcia, 201576 None
None Newcorn, 201677 None
None Oberai, 201378 None
None Ogrim, 201279 None
None Ohan, 201180 None
None Ostberg, 201281 None
None Pane, 201082 None
None Park, 201683 None
None Pfiffner, 201484 None
None Power, 201285 None
None Raz, 200986 None
None Salehi, 201087 None
None Sallee, 200988 None
None Sayer, 201689 None
None Shakibaei, 201590 None
None Sibley, 201691 None
None Soliva, 201092 None
None Steiner, 201493 Steiner, 201494
None Thorell, 201095 None
None Tobaiqy, 201196 None
None Trzepacz, 201197 None
None van der Donk, 201598 None
None van Dongen-Boomsma, 201499 None
None Vidal, 2015100 None
None Webster-Stratton, 2011101 None
None Widenhorn-Muller, 2014102 None
None Zelnik, 2012103 None
None Zhang, 2010104 None

E-2
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ADHD. Neuropediatrics. 2010
Aug;41(2):55-9. doi: 10.1055/s-0030-
1261893. PMID: 20799150.

E-10
Appendix F. Characteristics of Included Studies
Appendix Table F-1. Characteristics of included studies for KQ 1
Study Design
Mean Age Outcomes
Geographic Quality
Study (Years unless Gold Standard Diagnostic Tools (Subgroups
Location
specified) analyzed)
N Completed
Berger, 20101 Observational ADHD: 9.86 (SD A neurologic examination, the Continuous Performance Overall accuracy Fair
Middle East 1.89) completion of DSM-based Functions Tests Sensitivity
58 Non-ADHD: questionnaires by parents and TOVA False negative
10.50 (SD 1.81) teachers, and neuropsychologic Conners CPT
evaluation confirmed the diagnosis. TOVA + Conner’s CPT
Bloch, 20122 Observational Total pop.: 11.5, Consensus achieved on a structured CANTAB Sensitivity Fair
Middle East Min. age: 7 interview by a psychologist using TOVA (Test of Variable of Specificity
34 Max. age: 17 DSM-IV based assessment and a Attention) False positive
clinical interview by child and False negative
adolescent psychiatrist .
Bunte, 20133 Observational ADHD: 54.7 Clinical interview with psychiatrist and Disruptive Behavior Diagnostic Sensitivity Fair
UK/Europe months (SD: 8.8) psychologist who agreed on Observation Schedule (DB- Specificity
251 Non-ADHD: 53.1 diagnosis using K-DBDS semi- DOS) AUC
months (SD: 8.4) structured DSM-4 interview. Kiddie-Disruptive Behavior
Disorder Schedule (K-DBDS)
(Comorbidity)
Carballo, Observational Min. age: 3 Positive ADHD diagnosis based SDQ Sensitivity Poor
20144 UK/Europe Max. age: 17 exclusively on the ADHD RS-IV Specificity
523 which assesses DSM-IV-TR ADHD
symptoms. (ADHD
presentation)
Castro- Observational Min. age: 4 Medical diagnostic was determined Event-Related Potentials Overall accuracy Fair
Cabrera, Latin America Max. age: 15 by neurophysiological evaluation (ERPs) Sensitivity
20105 46 based on clinical criteria of DSM IV. Specificity
AUC
Caudal, 20116 Observational ADHD: 8.00 Children diagnosed with ADHD Electro-interstitial scans (EIS) Sensitivity Fair
UK/Europe Non-ADHD: 8.70 according to the DSM-IV and further Specificity
112 examinations.
dosReis, Observational Total: 8.8 (SD Unclear/NR Unclear/NR Labeling/Stigma Good
20107 USA 2.30)
48

F-1
Study Design
Mean Age Outcomes
Geographic Quality
Study (Years unless Gold Standard Diagnostic Tools (Subgroups
Location
specified) analyzed)
N Completed
Ferrin, 20128 Observational ADHD: 131.44 ADHD status was categorically Neurological subtle signs Overall accuracy Fair
Australia/NZ months (SD defined by the semistructured clinical (NSS) AUC
1,185 38.93 months) interview of their parent’s K–SADS–
Non-ADHD: PL, and dimensionally by the (Age)
133.16 months Conners Global Index (CGI). The K-
(SD 27.95 SADS-PL is a semi-structured
months) diagnostic interview designed to
assess current and past episodes of
psychopathology in children and
adolescents according to DSM-IV
criteria.
Gonzalez, Observational Min. age: 4 Physical examination, clinical EEG IM generalized Overall accuracy Fair
20139 UK/Europe Max. age: 15 interview and a structured checklist EEG IM beta band Sensitivity
43 covering DSM-IV and ICD-10 criteria. Specificity
Kim, 201510 Observational ADHD: 10.16 ADHD Diagnosis was based on a EEG-TGC Overall accuracy Fair
Asia (SD 1.90) Korean version of the Diagnostic EEG Delta Wave Sensitivity
157 Non-ADHD: 9.62 Interview Schedule for Children EEG Theta/beta ratio Specificity
(SD 1.72) Version IV (DISC-IV) and the IVA CPT commission error
diagnoses were confirmed by multiple IVA CPT omission error
child and adolescent psychiatrists.
The DISC-IV uses diagnostic criteria
as specified in DSM-IV.
Kim, 201511 Observational ADHD: 9.25 (SD ADHD Diagnosis was based on a EEG Theta Wave Overall accuracy Fair
Asia 1.63) Korean version of the Diagnostic EEG Delta Wave Sensitivity
97 Non-ADHD: 9.56 Interview Schedule for Children EEG Theta/beta ratio Specificity
(SD 1.98) Version IV (DISC-IV) and the IVA CPT commission error
diagnoses were confirmed by multiple IVA CPT omission error
child and adolescent psychiatrists.
The DISC-IV uses diagnostic criteria
as specified in DSM-IV.
Klenberg, Observational ADHD: 10.10 Diagnoses were based on structured Attention and Executive Overall accuracy Good
201012 UK/Europe (SD 2.40) interviews of parents and children Function Rating Inventory Sensitivity
916 Non-ADHD: and a parent rating scale (ADHD RS- (ATTEX) Specificity
10.70 (SD 2.50) IV: Home Version) and teacher AUC
reports from school.

F-2
Study Design
Mean Age Outcomes
Geographic Quality
Study (Years unless Gold Standard Diagnostic Tools (Subgroups
Location
specified) analyzed)
N Completed
Liechti, Observational ADHD: 11.1 (SD Children with ADHD combined EEG + Event Related Overall accuracy Fair
201313 UK/Europe 2.10) subtype (DSM-IV), aged 8–16 years, Potentials (ERPs) Sensitivity
62 Non-ADHD: 11.2 were diagnosed using the semi- Specificity
(SD 2.10) structured clinical diagnostic
interview PACS (parental
account of children’s symptoms); plus
Conners teacher rating scale—
revised
Markovska- Observational ADHD: 9 (SD Team of neuropsychologist, EEG TBR Cz Diagnostic Fair
Simoska, Latin America 2.44) pediatrician and clinical psychologist. EEG absolute theta Cz accuracy
2016 14 120 Also used Conners rating scale. EEG absolute beta Cz
EEG relative theta Cz
EEG relative beta Cz
Martin- Observational Total pop.: 6 Case group was diagnosed as having Actigraphy - PCA1 [Px00(15 Overall accuracy Poor
Martinez, UK/Europe the combined kind of ADHD min, D) + Pz22(1 min, FR) + Sensitivity
201215 63 according to the DSM-IV criteria Py01(15 min, AA)] Specificity
AUC
Ogrim, 201216 Observational Total pop.: 11 All diagnoses were according to DSM EEG Theta Overall accuracy Fair
UK/Europe (SD 3.00) IV-TR and accepted clinical EEG Theta/beta ratio
101 guidelines. A senior Visual CPT omission error
neuropsychologist (GO) was
responsible for diagnostic
conclusions after discussions in the
team, which included a pediatrician
and a clinical psychologist.
Ohan, 201117 Observational Not Reported Not Applicable Not Applicable Labeling/Stigma Good
Canada
56
Park, 2016 18 Observational ADHD: 7.6 (SD DSM-4 criteria and Korean version of Advanced Test of Attention, Diagnostic Fair
Asia 1.5) the K-SADS-PL-K Any Item with SD >1 Accuracy
114 Advanced Test of Attention,
Any Item with SD >1.5
Advanced Test of Attention,
Any Item with SD >12

F-3
Study Design
Mean Age Outcomes
Geographic Quality
Study (Years unless Gold Standard Diagnostic Tools (Subgroups
Location
specified) analyzed)
N Completed
Soliva, 201019 Observational ADHD: 10.90 ADHD subjects were diagnosed by a MRI of Caudate Body Volume Overall accuracy Fair
UK/Europe (SD 2.83) team consisting of a psychologist and Sensitivity
78 Non-ADHD: a psychiatrist. Scoring was based on Specificity
11.46 (SD 2.86) parent and teacher rating scales, as
well as a semi-structured clinical
(Sex and ADHD
interview, which systematically
presentation)
reviewed DSM-IV-TR criteria for
ADHD, oppositional-defiant disorder,
conduct disorder, and depressive and
anxiety disorders (DICA-IV).
Thorell, Observational Unclear/NR Children met the symptom criteria, Childhood Executive Function Overall accuracy Fair
201020 UK/Europe the age of onset criterion (i.e., < 7 Inventory (CHEXI)- Parent Sensitivity
45 years) the pervasiveness criterion rating inhibition subscale Specificity
(symptoms present in two settings),
and the duration criterion (> 6
months) for ADHD according to
DSM-IV. Subjects saw a child
psychologist and if deemed "at risk"
they were given scales to confirm
diagnosis.
Zelnik, 201221 Observational Total pop.: 10 Clinical diagnostic work-up included a TOVA (Test of Variable of Sensitivity Fair
Middle East (SD 2.70) family interview about the behavioral Attention) Specificity
230 and neurodevelopmental history of False positive
the child, neurological evaluation and False negative
observation at the physician’s office,
utilization of the DSM-IV diagnostic
criteria, and employment of the
Conners Rating Scales.
Abbreviations: ADHD=attention deficit hyperactivity disorder; AUC=area under the curve; DISC-IV=Diagnostic Interview Schedule for Children Version IV;
DSM= Diagnostic and Statistical Manual of Mental Disorders; EEG=electroencephalograph; K-DBDS= Kiddie Disruptive Behavior Disorder Schedule;
MRI=magnetic resonance imaging; NR=not reported; SD=standard deviation; TBR=theta/beta ratio

F-4
Appendix Table F-2. Characteristics of included studies for KQ 2
Study
Design Percent Mean Age Outcomes
Quality
Study Geographic ADHD (Years unless Interventions (Subgroups
Location Subtypea specified) analyzed)
N Completed
Abikoff, 201322 RCT Inattentive: Arm 1: 9.06 Organizational Skills Training (teaching children new Academic Good
USA 49.4% (SD: 0.91) organizational tools and routines) performance
151 Combined: Arm 2: 9.01 vs.
38.9% (SD: 0.79) Performance based intervention precluding skill
Arm 3: 9.15 without organizational skills training
(SD: 0.76) vs.
Waitlist control
Abikoff, 201523 RCT Inattentive: Total: 3.57 New Forest Parenting Package (home-based Behavior changes Good
USA 15.3% (SD: 0.5) intervention)
164 Hyperactive: vs.
33.7% Helping the noncompliant child (clinic-based parenting
Combined: intervention)
50.9% vs.
Waitlist control
Anand, 201624 RCT Unclear/NR Unclear/NR Dietary supplements Changes in Good
Asia vs. standardized
50 Atomoxetine symptom scores
Arcieri, 201225 Observational Inattentive: Arm 1: 10.41 Registry with patients on methylphenidate Cardiac arrhythmias; Poor
UK/Europe 6% (SD: 2.62) vs. Elevated blood
751 Hyperactive: Arm 2: 10.82 Registry with patients on strattera pressure
4% (SD: 2.81) vs.
Combined: Arm 3: 10.56 In registry taking both methylphenidate and strattera
90% (SD: 2.55)

Arnold, 201126 RCT Inattentive: Arm 1: 10.24 Zinc 15mg once daily Changes in Fair
USA 29.1%, 15%, (SD: 2.69) vs. standardized
52 50% Arm 2: 9.61 Zinc 15mg twice daily symptom scores;
Combined: (SD: 3.36) vs. Behavior changes;
70.8%, 85% Arm 3: 8.89 Placebo Changes in appetite;
(SD: 2.31) Suicide ideation;
Sleep disturbance;
Tics or other
movement
disorders;
Gastrointestinal
symptoms

F-5

Study
Design Percent Mean Age Outcomes
Quality
Study Geographic ADHD (Years unless Interventions (Subgroups
Location Subtypea specified) analyzed)
N Completed
Bai, 201527 RCT Unclear/NR Arm 1: 9.3 Planned behavior psychoeducation program for Changes in Good
Asia (SD: 2.8) parents standardized
89 Arm 2: 9.6 vs. symptom scores;
(SD: 2.9) General clinical counseling for parents, without Acceptability of
psychoeducation treatment
Banaschewski, RCT Unclear/NR Total: 11.1 Randomized to Lisdexamfetamine dimesylate (LDX) Quality of peer Poor
201428 USA, (SD: 2.59) after 52 weeks of being on the drug (vs. withdrawal on relationships;
UK/Europe placebo--see below) Risk-taking
73 vs. behaviors
Randomized to placebo after 52 weeks of being on
LDX.
Barragan, 201429 RCT Unclear/NR Total: 8.27 Methylphenidate (maximum 1 mg/kg/day) Changes in appetite; Poor
Latin America (SD: 1.74) vs. Behavior changes;
69 Methylphenidate (maximum 1 mg/kg/day and omega Sleep disturbance;
3/6 fatty acid supplementation (6 capsules/day) Gastrointestinal
vs. symptoms;
Omega 3/6 fatty acid supplementation (6 Changes in
capsules/day) standardized
symptom scores
Beck, 201030 Observational Inattentive: Total: 11.75 Computer-based working memory intervention Changes in Fair
USA 71% vs. standardized
51 Hyperactive: Waitlist control symptom scores
0%
Combined:
29%
Bink, 201531 RCT Unclear/NR Arm 1: 16.1 Neurofeedback (NF) plus treatment as usual. Changes in Good
UK/Europe (SD: 3.3) NF training over about 25 wks, with 2-3 training standardized
71 Arm 2: 16.2 sessions/wk. Participants offered 40 training sessions symptom scores
(SD: 3.4) of 30 minutes. Mean # of sessions was 37 (minimum
19). Theta/sensorimotor rhythm training was applied.
vs.
Treatment as usual
Boyer, 201532 RCT Inattentive: Arm 1: 14.4 CBT with an aim to improve planning skills Depression or Fair
UK/Europe 74.7%, 65.8% (SD: 1.2) vs. anxiety;
136 Hyperactive: Arm 2: 14.4 Solution-focused CBT without an aim to improve Changes in
7.2%, 2.6% (SD: 1.3) planning skills standardized
Combined: symptom scores
18.1%, 31.6%

F-6

Study
Design Percent Mean Age Outcomes
Quality
Study Geographic ADHD (Years unless Interventions (Subgroups
Location Subtypea specified) analyzed)
N Completed
Çetin, 201533 RCT Inattentive: Arm 1: 9.55 Atomoxetine (ATX) Changes in Fair
Middle East 12.5% (SD: 2.71) vs. standardized
120 Combined: Arm 2: 9.95 Osmotic release oral system methylphenidate (OROS­ symptom scores
87.5% (SD: 2.02) MPH)

Chacko, 201434 RCT Inattentive: Arm 1: 8.4 Cogmed working memory training with difficulty titrated Changes in Good
USA 34%, 41% (SD: 1.4) to a user’s ability standardized
73 Combined: Arm 2: 8.4 vs. symptom scores;
66%, 59% (SD: 1.3) “Placebo” cogmed working memory training with Academic
difficulty not titrated to a user’s ability performance
Chacko, 200935 RCT Unclear/NR Arm 1: 7.36 Strategies to Enhance Positive Parenting (STEPP) Changes in Good
USA (SD: 1.86) program (a manualized, behavioral parent training standardized
118; 115 Arm 2: 8.17 program for single mothers) with concurrent group symptom scores;
follow-up (SD: 2.42) social skills program for children Acceptability of
Arm 3: 8.02 vs. treatment
(SD: 2.15) Behavioral parent training program with concurrent
group social skills program for children
vs.
Waitlist control
Clemow, 201536 Observational Inattentive: Arm 1: 24.0 First prescribed atomoxetine (ATX) and not switched Changes in Poor
USA 48.1%, 51.9% (SD: 15.3) or the monotherapy portion of time spent by those standardized
71 Combined: Arm 2: 26.2 prescribed ATX with another ADHD drug and then was symptom scores
26%, 38.9% (SD: 15.2) switched to ATX only.
vs.
First prescribed ATX with another drug and did not
switch or the combination portion of time spent by
those who were first prescribed ATX and then had
another ADHD prescribed.
Cortese, 201537 Observational Inattentive: Arm 1: 10.55 Methylphenidate immediate release, at a dosage of Cardiac arrhythmias Good
UK/Europe 11.5%, 11.9% (SD: 2.75) 0.3-0.6 mg/kg/dose/day, in 2-3 doses/day
2411 Hyperactive: Arm 2: 10.87 vs.
2.4%, 5.2% (SD: 2.84) Atomoxetine, starting with 0.5mg/kg daily for at least 7
Combined: days, then increasing up to 1.2mg/kg/day
85.9%, 82.7%

F-7

Study
Design Percent Mean Age Outcomes
Quality
Study Geographic ADHD (Years unless Interventions (Subgroups
Location Subtypea specified) analyzed)
N Completed
Didoni, 201138 Observational Inattentive: Arm 1: 10.7 Methylphenidate Acceptability of Fair
UK/Europe 11.7%, 14.5% (SD: 2.7) vs. treatment;
229 Hyperactive: Arm 2: 11 Strattera Changes in appetite;
8.8%, 6.2% (SD: 2.7) Behavior changes;
Combined: Sleep disturbance;
79.4%, 70.1% Increased heart rate;
Gastrointestinal
symptoms;
Tics or other
movement disorders
Dovis, 201539 RCT Combined: Arm 1: 10.6 "Braingame Brian" (computerized, home-based Behavior changes Good
UK/Europe 0%, 100%, (SD: 1.4) executive functioning training)
89 100% Arm 2: 10.3 vs.
(SD: 1.3) Braingame Brian in training mode and the working
Arm 3: 10.5 memory task in placebo mode
(SD: 1.3) vs.
All tasks in training mode (overall easier)
Duric, 201240 RCT Inattentive: Arm 1: 10.9 MPH (dose not reported) Changes in Poor
UK/Europe 5.4% (SD: 2.4) vs. standardized
91 Hyperactive: Arm 2: 11.2 MPH + Neurofeedback symptom scores
15.4% (SD: 2.8) vs.
Combined: Arm 3: 11.4 Neurofeedback
79.1% (SD: 3.1)
Dutta, 201241 RCT Unclear/NR Arm 1: 8 Memomet syrup (Bacopa monniera 125 mg, Changes in Good
Asia (SD: 1.12) Convulvulus pleuricaulis 100 mg, Centella asiatica 100 standardized
86 Arm 2: 9.1 mg) symptom scores
(SD: 1.1) vs.
Placebo
Egeland, 201342 RCT Unclear/NR Arm 1: 10.5 Cogmed robomemo program Changes in Good
UK/Europe (SD: 0.7) vs. standardized
67 Arm 2: 10.3 Waitlist control symptom scores
(SD: 0.8)

Ercan, 201443 Observational Combined: Arm 1: 9.23 MPH+11 months of parent training Changes in Fair
UK/Europe 100% (SD: 2) vs. standardized
45 Arm 2: 8.7 MPH (Usual care) symptom scores
(SD: 1.7)

F-8

Study
Design Percent Mean Age Outcomes
Quality
Study Geographic ADHD (Years unless Interventions (Subgroups
Location Subtypea specified) analyzed)
N Completed
Evans, 201644 RCT Combined: Arm 1: 12.1 Challenging Horizons Program-After School (CHP-AS) Functional Fair
USA 49.1%, 50%, (SD: 0.9) program (organization, social functioning, and impairment;
312 47.1% Arm 2: 12.1 academic study skills training) Academic
(SD: 0.9) vs. performance
Arm 3: 12.2 Challenging Horizons Program Mentoring Version
(SD: 1.0) (students paired with a mentor who delivered a subset
of the CHP-AS interventions during school)
vs.
Usual care
Ferrin, 201445 RCT Combined: Arm 1: 11.25 Psychoeducational program Changes in Good
UK/Europe 72.1%, 81.1% (SD: 2.96) vs. standardized
76 Arm 2: 9.94 Parent support group symptom scores
(SD: 3.04)

Ferring, 201646 RCT Combined: Arm 1: 10.86 Psychosocial interventions Changes in Good
UK/Europe 60.0%, (SD 3.04) vs. standardized
62 79.41% Arm 2: 10.56 Usual care symptom scores
(SD 3.20)

Findling, 201047 RCT Combined: Min. age: 8.7 Lisdexamfetamine dimesylate (LDX) 30mg/day Changes in Fair
USA 96% Max. age: 9.4 vs. standardized
230 Lisdexamfetamine dimesylate (LDX) 50mg/day symptom scores
vs.
Lisdexamfetamine dimesylate (LDX) 70mg/day
vs.
Placebo
Gelade, 201648 RCT Unclear/NR Unclear/NR Biofeedback or neurofeedback Sleep disturbance; Good
UK/Europe vs. Behavior changes
103 Methylphenidate
vs.
Exercise
Gevensleben, RCT Inattentive: Arm 1: 9.10 Neurofeedback Changes in Good
200949 UK/Europe 33.8%, 22.8% (SD: 1.3) vs. standardized
94 Combined: Arm 2: 9.4 Attention skills training symptom scores;
66.1%, 77.1% (SD: 1.2) Acceptability of
treatment

F-9

Study
Design Percent Mean Age Outcomes
Quality
Study Geographic ADHD (Years unless Interventions (Subgroups
Location Subtypea specified) analyzed)
N Completed
Gustafsson, RCT Unclear/NR Min. age: 7 Omega-3 fatty acid supplementation Changes in Good
201050 UK/Europe Max. age: 12 (eicosapentaenoic acid 500 mg daily) standardized
82 vs. symptom scores
Placebo
Hahn-Markowitz, RCT Inattentive: Arm 1: 8.4 (SD Cognitive training therapies Changes in Good
201651 Middle East 43%, 55% 0.9) vs. standardized
99 Hyperactive: Arm 2: 8.6 (SD Waitlist symptom scores
4%, 6% 0.8)
Combined:
54%, 40%
Hammerness, Observational Unclear/NR Arm 1: 15.5 Clinical Trial Participant on MPH Substance abuse Fair
201252 USA (SD: 1.7) vs.
115 Arm 2: 14.9 Non-clinical trial participants on medication
(SD: 3.4 vs.
Arm 3: 15.7 Non-clinical trial participants not on medication
(SD: 2.7) vs.
Arm 4: 14.8 Non ADHD Group
(SD: 2.9)

Hariri, 201253 RCT Unclear/NR Arm 1: 7.9 Omega-3 fatty acid supplementation (900 mg daily) Changes in Poor
Middle East (SD: 1.53) vs. standardized
103 Arm 2: 7.9 Placebo symptom scores
(SD: 1.45)

Hiscock, 201554 RCT Unclear/NR Arm 1: 10.3 Sleep hygiene Changes in Good
Australia/NZ (SD: 1.8) vs. standardized
196 Arm 2: 9.9 Usual care symptom scores;
(SD: 2.1) Depression or
Arm 3: 10.3 anxiety;
(SD: 1.7) Workforce
Arm 4: 9.8 participation;
(SD: 2.0) Sleep disturbance

(Comorbidity)
Hong, 201555 RCT Unclear/NR Arm 1: 10.87 Acupuncture Changes in Fair
Asia (SD 2.86) vs. standardized
48 Arm 2: 11.11 Usual care symptom scores
(SD 2.79)

F-10

Study
Design Percent Mean Age Outcomes
Quality
Study Geographic ADHD (Years unless Interventions (Subgroups
Location Subtypea specified) analyzed)
N Completed
Huang, 201556 RCT Inattentive: Arm 1: 8.2 Behavioral based social skill training for patients and Changes in Fair
Asia 13.3%, 25% (SD: 0.9) parallel parent group sessions standardized
97 Combined: Arm 2: 8.5 vs. symptom scores
86.7%, 75% (SD: 0.9) Group therapy for motivation and treatment per their
usual care

Johnson, 200957 RCT Inattentive: Arm 1: 11.8 Omega-3/6 fatty acid supplementation (792 mg daily) Changes in Good
UK/Europe 24%, 29% (SD: 2.14) vs. standardized
59 Hyperactive: Arm 2: 12.2 Placebo symptom scores;
0%, 0% (SD: 2.19) Functional
Combined: impairment
25%, 21%
Katz, 201058 RCT Unclear/NR Arm 1: 9.72 Patented herbal preparation Motor vehicle Fair
Middle East (SD: 1.58) vs. collisions;
92 Arm 2: 9.20 Placebo Changes in appetite;
(SD: 1.82) Gastrointestinal
symptoms;
Sleep disturbance;
Mood disorders
Li, 201159 RCT Unclear/NR Arm 1: 9.3 Methylphenidate 1 mg/kg/day Chemical Good
Asia (SD: 1.8) vs. leukoderma;
69 Arm 2: 9.2 Ningdong granule (a traditional Chinese medicine Changes in
(SD: 2.2) preparation) standardized
symptom scores;
Gastrointestinal
symptoms;
Sleep disturbance;
Behavior changes;
Changes in appetite

F-11

Study
Design Percent Mean Age Outcomes
Quality
Study Geographic ADHD (Years unless Interventions (Subgroups
Location Subtypea specified) analyzed)
N Completed
Manor , 201260 RCT Inattentive: Arm 1: 9.2 PS-Omega 3 Chemical Good
Middle East 31%, 34% (SD: 2.0) vs. leukoderma;
162 Hyperactive: Arm 2: 9.2 Placebo Changes in
3%, 0% (SD: 1.8) standardized
Combined: symptom scores;
66%, 65.9% Elevated blood
pressure;
Increased heart rate;
Weight decrease;
Growth suppression;
Sleep disturbance;
Behavior changes;
Changes in appetite;
Gastrointestinal
symptoms;
Tics or other
movement
disorders;
Personality change
Mautone, 201261 RCT Inattentive: Unclear NR Family-School Success—Early, Elementary (school­ Academic Fair
USA 10.3%, 15.6% based intervention) performance
53 Hyperactive: vs.
27.6%, 28.1% Parent support and education program
Combined:
62.1%, 56.3%
Milte, 201262 RCT Unclear/NR Arm 1: 8.77 Fish oil rich in the omega-3 fatty acid, Changes in Good
Australia/NZ (SD: 1.76) eicosapentaenoic acid standardized
70 Arm 2: 8.89 vs. symptom scores
(SD: 1.6) Fish oil rich in the omega-3 fatty acid,
Arm 3: 9.14 docosahexaenoiacid
(SD: 2.03) vs.
Safflower oil

F-12

Study
Design Percent Mean Age Outcomes
Quality
Study Geographic ADHD (Years unless Interventions (Subgroups
Location Subtypea specified) analyzed)
N Completed
Mohammadi, RCT Combined: Arm 1 Median: MPH + melatonin Changes in Fair
201263 Middle East 100% 9.57 (SD: vs. standardized
50 1.65) MPH+placebo symptom scores;
Arm 2 Median: Sleep disturbance;
8.83 (SD: Changes in appetite;
1.82) Weight decrease;
Gastrointestinal
symptoms;
Behavior changes;
Tics or other
movement disorders
Mohammadpour, RCT Unclear/NR Arm 1: 7.70 Dietary supplements Changes in Fair
201664 Middle East (SD 1.77) vs. standardized
54 Arm 2: 8.03 Placebo symptom scores,
(SD 1.44) Behavior changes

Molina, 200965 RCT Unclear/NR Total: 16.8 Medication Management Aggression; Fair
USA (SD: 1.0) vs. Incarceration;
346 at 10­ Behavioral training(parent group, parent individual, Depression or
year follow- classroom (student), and teacher sessions) anxiety;
up; 436 at 8­ vs. Academic
year follow- Combination: Medication management and Behavioral performance;
up training Motor vehicle
vs. collisions;
Usual care Elevated blood
pressure;
Increased heart rate
Moreno-García, RCT Inattentive: Arm 1: 9.21 Neurofeedback Changes in Fair
201566 UK/Europe 42.1 %, (SD: 1.9) vs. standardized
57 42.1%, 57.9% Arm 2: 9.21 Standard Pharmacological Treatment symptom scores
Hyperactive: (SD: 2.2) vs.
21.05%, Arm 3: 8.11 Behavioral Treatment
15.78%, (SD: 1.3)
15.78%
Combined:
36.84%,
42.10%,
26.31%

F-13

Study
Design Percent Mean Age Outcomes
Quality
Study Geographic ADHD (Years unless Interventions (Subgroups
Location Subtypea specified) analyzed)
N Completed
Myers, 201567 RCT Inattentive: Arm 1: 9.2 6 telehealth sessions using both synchronous and Behavior changes Fair
USA 82.8%, 82.1% (SD: 2) asynchronous technologies
NR Hyperactive: Arm 2: 9.3 vs.
66.6%, 58% (SD: 2) Single consultation with a tele-psychiatrist
Combined:
60.3%, 51.8%
Newcorn, 201668 RCT Inattentive: Arm 1: 10.7 Psychosocial interactions Changes in Fair
USA, 12.7%, 11.4% (SD 2.64) vs. standardized
Canada, Hyperactive: Arm 2: 11.0 Usual care symptom scores
UK/Europe 2.5%, 5.1% (SD 2.69)
129 Combined:
84.7%, 83.5%
Oberai, 201369 RCT Unclear/NR Arm 1: 8.6 Homeopathy Behavior changes Fair
Asia (SD: 2.2) vs.
54 Arm 2: 9.9 Placebo
(SD: 2.8)

Ostberg, 201270 RCT Unclear/NR Arm 1: 11.1 Barkley Parent + Teacher behavioral intervention Changes in Good
UK/Europe (SD: 2.1) vs. standardized
61 Arm 2: 10.8 Waitlist control symptom scores
(SD: 1.8)

Pane, 201071 Observational Inattentive: Median: 10.8 Atomoxetine Suicide ideation; Fair
UK/Europe 11.7% Min. age: 6 vs. Conduction
1424 Hyperactive: Max. age: 18 Methylphenidate abnormalities;
5% Tics or other
Combined: movement
83.3% disorders;
Changes in appetite;
Gastrointestinal
symptoms;
Elevated blood
pressure

F-14

Study
Design Percent Mean Age Outcomes
Quality
Study Geographic ADHD (Years unless Interventions (Subgroups
Location Subtypea specified) analyzed)
N Completed
Pelsser, 201172 RCT Inattentive: Arm 1: 6.8 Restricted elimination diet Changes in Good
UK/Europe 6%, 6% (SD: 1.3) vs. standardized
100 analyzed Hyperactive: Arm 2: 7.0 No elimination diet symptom scores
in first phase 12%, 6% (SD: 1.3)
Combined: (ADHD
82%, 88% Presentation)
Pfiffner, 201473 RCT Inattentive: Arm 1: 8.8 Child Life and Attention Skills Treatment for children Changes in Good
USA 100% (SD: 1.2) and parents standardized
195 Arm 2: 8.7 vs. symptom scores;
(SD: 1.2) Child Life and Attention Skills Treatment—parents Functional
Arm 3: 8.4 group component only impairment
(SD: 1.1) vs.
Usual care
Power, 201274 RCT Inattentive: Unclear NR Family-School Success—Early, Elementary (school­ Changes in Fair
USA 55%, 48.5% based intervention) standardized
181 Combined: vs. symptom scores;
45%, 51.5% Parent support and education program Academic
performance
Raz, 200975 RCT Inattentive: Arm 1: 10.46 Omega-3 fatty acid supplementation Changes in Fair
Middle East 94%, 94% (SD: 1.42) vs. standardized
63 Hyperactive: Arm 2: 10.51 Placebo symptom scores
44%, 47% (SD: 1.47)

Salehi, 201076 RCT Unclear/NR Arm 1: 9.12 Ginkgo biloba Changes in Good
Middle East (SD: 1.61) vs. standardized
46 Arm 2: 9.61 MPH (up to 30 mg/day) symptom scores;
(SD: 2.26) Changes in appetite;
Depression or
anxiety;
Sleep disturbance;
Weight decrease

F-15

Study
Design Percent Mean Age Outcomes
Quality
Study Geographic ADHD (Years unless Interventions (Subgroups
Location Subtypea specified) analyzed)
N Completed
Sallee, 200977 RCT Inattentive: Total: 10.7 Guanfacine XR 1 mg/day with or without amphetamine Changes in Poor
Unclear/NR 23.9% (SD: 2.6) or MPH standardized
60 Hyperactive: vs. symptom scores
3.1% Guanfacine XR 2 mg/day with or without amphetamine
Combined: or MPH
73% vs.
Guanfacine XR 3 mg/day with or without amphetamine
or MPH
vs.
Guanfacine XR 4 mg/day with or without amphetamine
or MPH
Sayer, 201678 RCT Unclear/NR Total: 10.2 Guanfacine immediate release Increased heart rate Good
USA (SD 2.1) Vs.
NR Dexmethylphenidate
Vs.
Dexmethylphenidate, guanfacine immediate release
Shakibaei, 201579 RCT Unclear/NR Arm 1: 7.83 Methylphenidate and Ginkgo Biloba Behavior changes Good
Middle East (SD: 1.12) vs.
60 Arm 2: 8.41 Methylphenidate and placebo
(SD: 1.40)
Sibley, 201680 RCT Unclear/NR Arm 1: 12.65 Behavioral interventions, mindfulness-based Changes in Fair
USA (SD: 0.85) therapies, and parent behavior training standardized
109 vs. symptom scores;
Arm 2: 12.85 Usual care Academic
(SD 0.87) performance
Steiner, 201481 RCT Unclear/NR Arm 1: 8.4 Neurofeedback Changes in Good
USA (SD: 1.1) vs. standardized
98 Arm 2: 8.9 Cognitive Training symptom scores
(SD: 1.0) vs.
Arm 3: 8.4 Waitlist control
(SD: 1.1)
Storebo, 201282 RCT Inattentive: Arm 1: 10.6 Social Skills Group Academic Good
UK/Europe 35.7%, 22.2% (SD: 1.29) vs. performance
55 Hyperactive: Arm 2: 10.2 Usual care
0%, 7.4% (SD: 1.34)
Combined:
31.4%, 59.2%

F-16

Study
Design Percent Mean Age Outcomes
Quality
Study Geographic ADHD (Years unless Interventions (Subgroups
Location Subtypea specified) analyzed)
N Completed
Tobaiqy, 201183 Observational Unclear/NR Max. age: 16 No arms. Questionnaire administered to elicit Changes in Fair
UK/Europe retrospective data to assess self-reported AEs for standardized
200 many different drugs used for ADHD. symptom scores
Trzepacz, 201184 RCT Inattentive: Arm 1 Median: 12 month follow up on atomoxetine after 3 month initial Growth suppression; Fair
UK/Europe, 23.1%, 19.4% 10.6 (SD: 2.3) trial Changes in appetite;
Australia/NZ Hyperactive: Arm 2 Median: vs. Gastrointestinal
394 4.6%, 5.3% 10.2 (SD: 2.2) 12 month follow up on placebo after 3 month initial trial symptoms
Combined:
7.1%, 75.2%
van der Donk, RCT Inattentive: Arm 1: 9.8 Cogmed Working Memory Training Changes in Fair
201585 UK/Europe 30%, 20% (SD: 1.3) vs. standardized
100 Combined: Arm 2: 10.0 Paying Attention in Class (experimental, combined symptom scores
58%, 70% (SD: 1.3) working memory and compensatory training)
van Dongen- RCT Inattentive: Arm 1: 6.5 Cogmed training program Changes in Good
Boomsma, UK/Europe 7.7%, 9.5% (SD: 0.6) vs. standardized
201486 47 Hyperactive: Arm 2: 6.6 Cogmed training program without adjustment to symptom scores
11.5%, 33.3% (SD: 0.7) patient skill level (control group)
Combined:
80.8%, 57.1%
Vidal, 201587 RCT Inattentive: Arm 1: 17.47 CBT Behavior changes Good
UK/Europe 35.6%, 0% (SD: 1.88) vs.
89 Hyperactive: Arm 2: 16.9 Usual care
1.7%, 41.6% (SD: 1.75)
Combined:
62.7%, 58.3%
Webster-Stratton, RCT Unclear/NR Arm 1: 64.1 Increadible Years Program (a parent training Changes in Fair
201188 USA months intervention) standardized
94 (SD: 11.3) vs. symptom scores
Arm 2: 64.4 Waitlist control
months
(SD: 10.6)

Widenhorn- RCT Inattentive: Arm 1: 8.90 Omega-3 fatty acid supplementation (720 mg daily) Changes in Fair
Muller, 201489 UK/Europe 54.7% (SD: 1.48) plus 15 mg vitamin E standardized
95 Hyperactive: Arm 2: 8.92 vs. symptom scores
2.1% (SD: 1.24) Placebo
Combined:
43.2%

F-17

Study
Design Percent Mean Age Outcomes
Quality
Study Geographic ADHD (Years unless Interventions (Subgroups
Location Subtypea specified) analyzed)
N Completed
Zhang, 201090 Observational Inattentive: Arm 1: 7.42 Methylphenidate, 10-20 mg/d, 0.27-0.64 mg/kg for Growth suppression Poor
Asia 16.4%, 24.1% Min. age: 6.0 about 40 wks/yr (they also took a drug holiday).
175 Hyperactive: Max. age: 9.8 vs.
8.9%, 27.6% Arm 2: 8.35 Control
Combined: Min. age: 6.0
74.7%, 48.3% Max. age: 12.5
a
Multiple values are listed for percent female and age in instances where baseline data is reported by study arm rather than for the total population.
Abbreviations: ADHD=attention deficit hyperactivity disorder; AE=adverse events; ATX=atomoxetine; CBT=cognitive behavioral therapy;
MPH=methylphenidate; NF=neurofeedback; NR=not reported; RCT=randomized controlled trial; SD=standard deviation; XR=extended release

F-18

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F-25
Appendix G. Overview of Included Studies

Table G-1. Overview of included studies in KQ 1


Study descriptions Number of studies
Overview of all studies
Single center 201-20
Multiple centers 121
Primary care setting 53,7,11,15,18
Specialty practice 121,2,4,8-10,12,14-16,18,19
Community setting 33,15,21
School setting 56,11,19-21
Unclear or unknown location 35,13,17
Asia 31,7,16
Australia/NZ 12
Canada 120
Latin America 26,17
Middle East 38-10
United States 118
UK/Europe 103-5,11-15,19,21
Government funding 41-3,18
Non-government/non-industry funding 46,16,17,19
Combination of funding sources:
Government/non-government 24,5
Government/industry 121
Unclear/NR 107-15,20
Good quality 318-20
Fair quality 161-3,6-17,21
Poor quality 24,5
Studies examining diagnostic accuracy
Gold standard based on DSM-IV diagnostic criteria:
ADHD-Rating Scale 24,19
Conners Teacher Rating Scale 29,21
K-DBDS 111
K-SADS-PL 22,16
Disc-IV 21,7
DICA-IV 114
Structured checklist 13
Specific ratings scales not reported (included 85,6,8,10,12,13,15,17
mixture of parent/teacher scales, clinical
evaluations, and various DSM-IV criteria checklists)
Diagnosis confirmed by specialist 131,3,6-12,14,16,17,19
Diagnosis confirmed by other care provider 112
Unclear validation of diagnosis 72-5,13,15,21
Subgroups
Age 12
Sex 114
ADHD subtype 24,14
Comorbidity 111

G-1

Table G-2. Overview of included studies in KQ 2


Study descriptions Number of studies
Overview of all studies
Single center 3622-57
Multiple centers 3158-88
NR or unclear 289,90
Primary care setting 923-25,30,52,57,63,69,81
Specialty practice 4122,26-28,32-35,37-42,44,46-51,53,56,58-60,62,64,66,72,73,75-78,80,82,83,86-88
Community setting 143
School setting 445,65,68,85
Other location 554,61,67,79,86
Specialty practice/school setting 164
Specialty practice/other location 155
Unclear 929,31,36,70,71,74,84,89,90
Asia 822-26,54,57,58
Australia/NZ 259,60
Latin America 127
Middle East 1028-34,61,87,88
United States 1935-43,55,62-69,85
UK/Europe 2544-53,56,71-82,89,90
UK/Europe and United States 270,86
UK/Europe and Australia/NZ 183
Unclear 184
Government funding 3030,37,38,40,42,45-48,50-52,55,56,58-60,63-68,72-74,78,81,85,89
Industry 927,31,35,62,69,70,83,84,86
Non-government/non-industry funding 824,28,33,53,54,87,88,90
Combination of funding sources:
Industry/government/non-government 123
Non-government/industry 180
Government/non-government 243,79
Unclear/NR 1822,25,26,29,32,34,36,39,41,44,49,57,61,71,75-77,82
Good quality 3223,25,28,31,33,37,38,43,47-49,51,53,55-60,64-66,71,75,76,78-82,87,90
Fair quality 3024,26,30,32,34-36,39-42,44-46,52,54,61,63,67-69,72-74,77,83,85,86,88
Poor quality 722,27,29,62,70,84,89

G-2

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G-9
Appendix H. Data Tables
Table H-1. Diagnostic accuracy of included studies with subjects ages 6 and under
a
Quality (Study) Overall
N Subjects Gold Standard AUC Sensitivity Specificity PPV NPV
Accuracy
Diagnostic Tool(s)
Observational assessment
studies
Fair quality (Bunte, 20131,2) Clinical interview with
178 subjects psychiatrist and
(120 ADHD, 58 non-ADHD) psychologist who agreed
1. Disruptive Behavior – on diagnosis using K- 92% 87% 79%
Diagnostic Observation DBDS semi-structured
Schedule DSM-4 interview
Executive function studies
Fair quality (Thorell, 20103) Children met the symptom
52 subjects criteria, the age of onset
(22 ADHD, 30 non-ADHD) criterion (i.e., <7 years) the
1. Childhood Executive pervasiveness criterion 93.3% 93.3% 93.3%
Function Inventory– (symptoms present in two
Parent rating inhibition settings), and the duration
subscale criterion (>6 months) for
ADHD according to DSM-
IV. Subjects saw a child
psychologist and if deemed
"at risk" they were given
scales to confirm
diagnosis.
Standardized questionnaire
studies
Fair quality (Bunte, 20131,2) Clinical interview with
Subgroup = ADHD subtypes psychiatrist and
168 subjects psychologist who agreed
(110 ADHD HI, 58 non- on diagnosis using K-
ADHD) DBDS semi-structured
1. Kiddie-Disruptive DSM-4 interview 98% (ADHD-HI) 77% (ADHD-HI) 98% (ADHD-HI)
Behavior Disorder
Schedule (K-DBDS) –
specific coding method
a See Methods section “Quality Assessment of Individual Studies” for definitions of quality assessment ratings.

H-1
Abbreviations: ADHD=attention deficit hyperactivity disorder; ADHD-C=ADHD combined type; ADHD-HI=ADHD hyperactive/impulsive type; ADHD-I=ADHD inattentive
type; AUC=area under the curve; CPT=continuous performance test; EEG=electroencephalogram; IVA=integrated visual and auditory; MRI=magnetic resonance imaging; NPV=
negative predictive value; PPV= positive predictive value; TOVA=test of variables of attention

Table H-2. Diagnostic accuracy of included studies with subjects ages 7-17
a
Quality (Study) Overall
N Subjects Gold Standard AUC Sensitivity Specificity PPV NPV
Accuracy
Diagnostic Tool(s)
Biometric devices
Poor quality (Martin- Case group was
Martinez, 20124) diagnosed as having the
63 subjects combined kind of ADHD
(31 ADHD, 32 non-ADHD) according to the DSM-IV 90.48% 94.96% 96.77% 84.38%
1. Actigraphy-PCA1 criteria
[Px00(15 min, D) + Pz22
(1 min, FR) + Py01 (15
min, AA)]
EEG and imaging studies
Fair quality (Markovska- Team of
Simoska, 20165) neuropsychologist,
60 subjects pediatrician and clinical
(30 ADHD, 30 non-ADHD) psychologist. Also used 58.6% 92.2%
1. EEG Theta-Beta Ratio Conners rating scale 100% 71.1%
2. EEG absolute theta 86.2% 34.4%
3. EEG absolute beta 68.6% 60.0%
4. EEG relative theta 0% 100%
5. EEG relative beta
Fair quality (Gonzalez, Physical examination,
20136) clinical interview and a
43 subjects structured checklist
(22 ADHD, 21 non-ADHD) covering DSM-IV and ICD- 86.7% 81.80% 90.50%
1. EEG IM generalized 10 criteria 74.4% 63.60% 90.50%
2. EEG IM beta band

H-2
a
Quality (Study) Overall
N Subjects Gold Standard AUC Sensitivity Specificity PPV NPV
Accuracy
Diagnostic Tool(s)
Fair quality (Liechti, 20137) Children with ADHD
62 subjects combined subtype (DSM-
(32 ADHD, 30 non-ADHD) IV), aged 8–16 years, were
1. EEG + event-related diagnosed using the semi- 72.6% 71.9% 73.3%
potentials–including all structured clinical
stepwise variables diagnostic interview PACS
(parental
account of children’s
symptoms; plus Conners
teacher rating scale—
revised
Fair quality (Castro-Cabrera, Medical diagnostic was
20108) determined by
46 subjects neurophysiological
(23 ADHD, 23 non-ADHD) evaluation based on 91.3% 94% 96% 87%
1. Event-related clinical criteria of DSM IV
potentials–best
combination of features
Fair quality (Soliva, 20109) ADHD subjects were
Subgroup = ADHD subtypes diagnosed by a team
78 subjects consisting of a
(39 ADHD, 39 non-ADHD) psychologist and a
1. MRI of caudate body psychiatrist. Scoring was 84% 60.0% 95.0%
volume based on parent and
teacher rating scales, as
well as a semi-structured
clinical interview, which
systematically reviewed
DSM-IV-TR criteria for
ADHD, oppositional-
defiant disorder, conduct
disorder, and depressive
and anxiety disorders
(DICA-IV).
EEG, imaging, and CPT
studies

H-3
a
Quality (Study) Overall
N Subjects Gold Standard AUC Sensitivity Specificity PPV NPV
Accuracy
Diagnostic Tool(s)
Fair quality (Kim, 201510) ADHD Diagnosis was
97 subjects based on a Korean version
(53 ADHD, 44 non-ADHD) of the Diagnostic Interview
1. EEG theta-phase Schedule for Children 71.1% 60% 23%
gamma-amplitude Version IV (DISC-IV) and
coupling the diagnoses were 63.3% 56% 27%
2. EEG delta wave confirmed by multiple child 58.7% 49% 30%
3. EEG theta/beta ratio and adolescent 75.3% 66% 18%
4. IVA CPT commission psychiatrists. The DISC-IV 68.1% 58% 27%
error uses diagnostic criteria as
5. IVA CPT omission error specified in DSM-IV.
Fair quality (Kim, 201511) ADHD Diagnosis was
157 subjects based on a Korean version
(85 ADHD, 72 non-ADHD) of the Diagnostic Interview
1. EEG delta wave Schedule for Children 60.8% 60.1% 43.0%
2. EEG theta wave Version IV (DISC-IV) and 56.4% 48.2% 40.5%
3. EEG theta/beta ratio the diagnoses were 45.7% 47.1% 49.4%
4. IVA CPT commission confirmed by multiple child 82.1% 68.1% 9.54%
error and adolescent 78.6% 64.7% 13.7%
5. IVA CPT omission error psychiatrists. The DISC-IV
uses diagnostic criteria as
specified in DSM-IV.
Fair quality (Ogrim, 201212) All diagnoses were
101 subjects according to DSM IV-TR
(62 ADHD, 39 non-ADHD) and accepted clinical
1. EEG theta guidelines. A senior 63%
2. EEG theta/beta ratio neuropsychologist (GO) 58%
3. Visual CPT omission was responsible for 85%
error diagnostic conclusions
after discussions in the
team, which included a
pediatrician and a clinical
psychologist.
CPT studies
Fair quality (Park, 201613) DSM-4 criteria and Korean
Subgroups = ADHD subtype version of the K-SADS-PL-
114 subjects K
(79 ADHD, 35 non-ADHD)
1. Advanced Test of 72.8% 84.8% 45.7% 77.9% 57.1%
Attention

H-4
a
Quality (Study) Overall
N Subjects Gold Standard AUC Sensitivity Specificity PPV NPV
Accuracy
Diagnostic Tool(s)
Fair quality (Zelnik, 201214) Clinical diagnostic work-up
230 subjects included a family interview
(179 ADHD, 51 non-ADHD) about the behavioral and
1. TOVA (Test of Variables neurodevelopmental 91.1% 21.6% 80.3% 40.7%
of Attention) history of the child,
neurological evaluation
and observation at the
physician’s office,
utilization of the DSM-IV
diagnostic criteria, and
employment of the
Conners Rating Scales
Fair quality (Berger, 201015) A neurologic examination,
58 subjects the completion of DSM-
(45 ADHD, 13 non-ADHD) based questionnaires by
1. Continuous performance parents and teachers, and 94.8% 100%
functions tests (CPT) neuropsychologic
2. TOVA evaluation confirmed the – 75%
3. Conners CPT diagnosis – 52%
4. TOVA + Conners CPT – 64%
CPT and executive
function studies
Fair quality (Bloch, 201216) Consensus achieved on a
34 subjects structured interview by a
(27 ADHD, 7 non-ADHD) psychologist using DSM-IV
1. Cambridge based assessment and a 57%-71% 7%-22% 94% 37%
Neuropsychological clinical interview by child
Testing Automated and adolescent 63% 85%
Battery psychiatrist
2. TOVA
Executive function studies
Good quality (Klenberg, Diagnoses were based on
201017) structured interviews of
Subgroups = sex & ADHD parents and children and a
subtype parent rating scale (ADHD
916 subjects RS-IV: Home Version) and 91% (boys) 87% 85% (boys) 84% (boys)
(215 ADHD, 701 non-ADHD) teacher reports from 93% (girls) subtype 83% (girls) 85% (girls)
1. Attention and Executive school 81% (subtype) 76% (subtype)
Function Rating
Inventory

H-5
a
Quality (Study) Overall
N Subjects Gold Standard AUC Sensitivity Specificity PPV NPV
Accuracy
Diagnostic Tool(s)
Biometric devices
Fair quality (Caudal, 201118) Children diagnosed with
112 subjects ADHD according to the
(52 ADHD, 60 non-ADHD) DSM-IV and further
1. Electro-interstitial scans examinations 80% 98%
Observational assessment
studies
Fair quality (Ferrin, 201219) ADHD status was
Subgroup = age categorically defined by
1185 subjects the semistructured clinical
(1055 ADHD, 130 non- interview of their parent’s
ADHD) K–SADS–PL, and 84% 90.3%
1. Neurological subtle dimensionally by the (<13 year)
signs Conners’ Global Index 77.9%
(CGI). The K-SADS-PL is (≥13 year)
a semi-structured
diagnostic interview
designed to assess current
and past episodes of
psychopathology in
children and adolescents
according to DSM-IV
criteria.
Poor quality (Carballo, Positive ADHD diagnosis
201420) based exclusively on the
Subgroup = ADHD subtypes ADHD RS-IV which 38.3% (ADHD) 66.7% (ADHD)
523 subjects assesses DSM-IV-TR 84% (ADHD-C) 60.0% (ADHD-
(283 ADHD, 240 non-ADHD) ADHD symptoms 25% (ADHD-I) C)
1. Strengths and 77.8% (ADHD- 75.0% (ADHD-I)
Difficulties HI) 66.7% (ADHD-
Questionnaire HI)
a See Methods section “Quality Assessment of Individual Studies” for definitions of quality assessment ratings.

Abbreviations: ADHD=attention deficit hyperactivity disorder; ADHD-C=ADHD combined type; ADHD-HI=ADHD hyperactive/impulsive type; ADHD-I=ADHD inattentive
type; AUC=area under the curve; CPT=continuous performance test; EEG=electroencephalogram; IVA=integrated visual and auditory; MRI=magnetic resonance imaging; NPV=
negative predictive value; PPV= positive predictive value; TOVA=test of variables of attention

H-6
Table H-3. Adverse events reported in Italian National ADHD Registry
Reported Adverse Event of Interest Atomoxetine (%) Methylphenidate (%)
Cortese, 201521 N=753 N=1350
GI effects 1.3 0.4
Eating disorders 1.5 0.7
Suicidal Ideation 0.7 0
Sleep disorders 0.4 .07
Mood disorders 0.5 0.07
Tachycardia 0.5 0.1
Didoni, 201122 N=96 N=34
Decreased appetite 16 15
Irritability 9 0
Tachycardia 8 0
Unstable mood 7 0
Insomnia 3 3
Tics 2 3
Abdominal pain 3 0
Dyspepsia 3 0
Epigastralgia 8 0
Pane, 201023 N=781 N=643
Suicidal ideation 0.4 0
ECG abnormality 1 0.9
Tics 0 0.2
Decreased appetite 0.3 0.3
GI disease 0.9 0
Increased blood pressure 0.1 0.2
Abbreviations: ECG=electrocardiogram; GI=gastrointestinal

Table H-4. Rates of adverse events


Monotherapy Combination Therapy
Selected Adverse Event
N=206 N=53
Somnolence 38% –
Headache 25% 23%
Fatigue 15% –
Upper abdominal pain 12% 15%
Syncope 2% 0%

H-7
Table H-5. Findings on pharmacologic versus nonpharmacologic interventions for ADHD
Study Type of ADHD
(Companion) Diagnosis
Follow-
N Criteria
Intervention Comparison up Findings–Intervention Findings–Comparison
Qualitya Age range in
Times
Design years
Age Categoryb % Male
Academic performance
Molina, 200924 Combined Type Medication Behavioral training 8 years WIAT reading WIAT reading
(Vitiello, 201225) DSM-IV management (parent group, parent Mean = 96.1 (SD = 14.2) Mean = 96.2 (SD = 13.2)
579 7.0-9.9 years individual, classroom p=.8541 WIAT math = 96 (SD = 17)
Fair 80% Male (student), and teacher WIAT math = 91.5 (SD = 14.8) GPA = 2.83 (SD = .56)
RCT sessions) p=.5156
GPA = 2.79 (SD = .57)
b Combination: p=.3354
Medication WIAT reading
management and Mean = 94.7 (SD = 14.5)
Behavioral training WIAT math = 94.7 (SD = 17.4)
GPA = 2.7 (SD = 0.56)
Usual care
WIAT reading
Mean = 95.6 (SD = 13.4)
WIAT math = 95.7 (SD = 15.9)
GPA = 2.71 (SD = 0.59)
Aggression
Molina, 200924 Combined Type Medication Behavioral training 8 years Aggression conduct parent measure Aggression conduct parent measure
(Vitiello, 201225) DSM-IV management (parent group, parent rated 1 (never) to 4 (often) rated 1 (never) to 4 (often)
579 7.0-9.9 years individual, classroom Mean = 1.17 (SD = .22 ) Mean = 1.13 (SD = .17)
Fair 80% Male (student), and teacher p=.4511
RCT sessions)

b Combination: Aggression conduct parent measure


Medication rated 1 (never) to 4 (often)
management and Mean = 1.15 (SD = .24)
Behavioral training

Aggression conduct parent measure


Usual care rated 1 (never) to 4 (often)
Mean = 1.15 (SD = .23)

H-8
Study Type of ADHD
(Companion) Diagnosis
Follow-
N Criteria
Intervention Comparison up Findings–Intervention Findings–Comparison
Qualitya Age range in
Times
Design years
Age Categoryb % Male
Behavior changes
Gelade, 201626 Combined Type Neurofeedback MPH 12 weeks SWAN-Inattention (parent) SWAN-Inattention (parent)
112 DSM-IV-TR training Mean = -0.32 (95% CI: -0.53, -0.10) Mean = -0.78 (95%CI: -1.03 to -0.53)
Good 9.63 years SWAN-Hyperactivity/Impulsiveness SWAN-Hyperactivity/Impulsiveness
RCT (SD1.76) (parent) (parent)
76% Male Mean = -0.29 (95% CI: -0.50, -0.07) Mean = -0.52 (95% CI: -0.74 to -0.30)
b
SWAN-Inattention (teacher) SWAN-Inattention (teacher)
Mean = -0.10 (95% CI: -0.31, -0.11) Mean = -0.95 (95% CI: -1.23 to -0.68)
SWAN-Hyperactivity/Impulsiveness SWAN-Hyperactivity/Impulsiveness
(teacher) (teacher)
Mean = -0.03 (95% CI: -0.28, 0.23) Mean = -0.70 (95% CI: -1.05 to -0.34)
Barragan, Any subtype MPH (maximum 1 Omega-3/6 fatty acid 1 year Irritability by the end of the study Irritability by the end of the study period
201427 DSM-IV-TR mg/kg/day) supplementation (6 period (clinical assessment) (clinical assessment)
90 6-12 years capsules/day) % patients with outcome = 23.33 % patients with outcome = 0
Poor 67.0% Male
RCT MPH (maximum 1 Irritability by the end of the study period
mg/kg/day and % patients with outcome = 0
b omega-3/6 fatty acid
supplementation (6
capsules/day)
Li, 201128 NR MPH 1 mg/kg/day Ningdong granule (a 8 weeks Anxiety Anxiety
72 DSM-IV traditional Chinese # patients with outcome = 5 # patients with outcome = 1
Good 6-13 years medicine preparation)
RCT 65.3% Male

b
Changes in appetite
Barragan, Any subtype MPH (maximum 1 Omega-3/6 fatty acid 1 year Appetite suppression by the end of Appetite suppression by the end of the
201427 DSM-IV-TR mg/kg/day) supplementation (6 the study period study period
90 6-12 years capsules/day) % patients with outcome = 70 % patients with outcome = 33.3
Poor 67.0% Male
RCT MPH (maximum 1 Appetite suppression by the end of the
mg/kg/day and study period
b omega-3/6 fatty acid % patients with outcome = 6.7
supplementation (6
capsules/day)
Li, 201128 NR MPH 1 mg/kg/day Ningdong granule (a 8 weeks Decreased appetite Decreased appetite
72 DSM-IV traditional Chinese # patients with outcome = 13 # patients with outcome = 1
Good 6-13 years medicine preparation) Increased appetite Increased appetite
RCT 65.3% Male # patients with outcome = 4 # patients with outcome = 5

H-9
Study Type of ADHD
(Companion) Diagnosis
Follow-
N Criteria
Intervention Comparison up Findings–Intervention Findings–Comparison
Qualitya Age range in
Times
Design years
Age Categoryb % Male
Salehi, 201029 Combined Type MPH (up to 30 Ginkgo biloba 6 weeks Decreased appetite Decreased appetite
50 DSM-IV-TR mg/day) # patients with outcome = 5 # patients with outcome = 19
Good 6-14 years
RCT 78% Male

b
Changes in standardized symptom scores
Barragan, Any subtype MPH (maximum 1 Omega-3/6 fatty acid 1 year ADHD-RS total score – 6 month ADHD-RS total score – 6 month
201427 DSM-IV-TR mg/kg/day) supplementation (6 Mean = 25.43 (SD = 4.84) Mean = 28.17 (SD = 7.92)
90 6-12 years capsules/day) ADHD-RS inattention – 6 months ADHD-RS inattention – 6 months
Poor 67.0% Male Mean = 11.73 (SD = 1.78) Mean = 12.33 (SD = 2.83)
RCT ADHD- RS hyperactivity – 6 months ADHD-RS hyperactivity – 6 months
Mean = 13.7 (SD = 3.71) Mean = 15.83 (SD = 5.78)
b ADHD- RS – total – 12 month ADHD-RS – total – 12 month
Mean = 25.83 (SD = 4.67) Mean = 27.77 (SD = 7.84)
ADHD-RS inattention – 12 month ADHD-RS inattention – 12 month
Mean = 12.03 (SD = 1.71) Mean = 12.17 (SD = 2.7)
ADHD-RS hyperactive – 12 month ADHD-RS hyperactive – 12 month
Mean = 13.8 (SD = 3.68) Mean = 15.6 (SD = 5.68)

MPH (maximum 1 ADHD-RS total score – 6 month


mg/kg/day and Mean = 25.5 (SD = 5.01)
omega-3/6 fatty acid ADHD-RS inattention – 6 months
supplementation (6 Mean = 11.7 (SD = 2.17)
capsules/day) ADHD-RS hyperactivity – 6 months
Mean = 13.8 (SD = 3.28)
ADHD-RS – total – 12 month
Mean = 24.33 (SD = 5.09)
ADHD-RS inattention – 12 month
Mean = 11.3 (SD = 1.95)
ADHD-RS hyperactive – 12 month
Mean = 13.03 (SD = 3.44)
Duric 201230 Attention and MPH (dose not Neurofeedback 10 weeks Total: Barkley Rating Scale for Total: Barkley Rating Scale for parent’s
(Duric, 201431) Hyperactive reported) parent’s Mean w/in group change = 8.6
91 ICD-10 MPH + Mean w/in group change = 7.9 95% CI = 5.0-12.2
Poor Diagnosis Neurofeedback 95% CI = 4.5-11.4
RCT Criteria p=0.31
6-18 years
b 80% Male

H-10
Study Type of ADHD
(Companion) Diagnosis
Follow-
N Criteria
Intervention Comparison up Findings–Intervention Findings–Comparison
Qualitya Age range in
Times
Design years
Age Categoryb % Male
Li, 201128 NR MPH 1 mg/kg/day Ningdong granule (a 8 weeks ADHD-RS Parent ADHD-RS Parent
72 DSM-IV traditional Chinese Mean w/in group change = 13.3 (SD Mean w/in group change = 14.1 (SD =
Good 6-13 years medicine preparation) = 3.2) 2.9)
RCT 65.3% Male

b
Salehi, 201029 Combined Type MPH (up to 30 Ginkgo biloba 6 weeks Parent ADHD Rating Scale-IV Parent ADHD Rating Scale-IV
50 DSM-IV-TR mg/day) Mean = 26 ( 13,38) Mean = 16 ( 5, 27)
Good 6-14 years p<0.01
RCT 78% Male Teacher ADHD Rating Scale-IV Teacher ADHD Rating Scale-IV
Mean = 25 (15,35) Mean = 11 (4, 20)
b p<0.001
Moreno-Garcia, Combined, Standard Neurofeedback 20 weeks Integrated Visual and Auditory Integrated Visual and Auditory
201532 Inattentive and Pharmacological Continuous Performance Test Continuous Performance Test
57 Hyperactive/Im Treatment (IVA/CPT) – Full Scale Attention (IVA/CPT) – Full Scale Attention
Fair pulsive Mean = 2.1 (SD = 16.88) Mean = -28.57 (SD = 11.67)
RCT DSM-V p=.002
7-14 years Behavioral treatment p=0.013 Integrated Visual and Auditory
b 77.2% Male Continuous Performance Test
(IVA/CPT) – Full Scale Attention
Mean = -3.88 (SD = 16.24)
Chemical leukoderma
Li, 201128 NR MPH 1 mg/kg/day Ningdong granule (a 8 weeks ADHD-RS Teacher ADHD-RS Teacher
72 DSM-IV traditional Chinese Mean w/in group change = Mean w/in group change =
Good 6-13 years medicine preparation) 12.3 (SD = 3.1) 13.9 (SD = 2.3)
RCT 65.3% Male

b
Depression or anxiety
Salehi, 201029 Combined Type MPH (up to 30 Ginkgo biloba 6 weeks Sadness Sadness
50 DSM-IV-TR mg/day) # patients with outcome = 2 # patients with outcome = 7
Good 6-14 years Anxiety Anxiety
RCT 78% Male # patients with outcome = 7 # patients with outcome = 9

H-11
Study Type of ADHD
(Companion) Diagnosis
Follow-
N Criteria
Intervention Comparison up Findings–Intervention Findings–Comparison
Qualitya Age range in
Times
Design years
Age Categoryb % Male
Molina, 200924 Combined Type Medication Behavioral training 8 years Depression (CDI) Depression (CDI)
(Vitiello, 201225) DSM-IV management (parent group, parent Mean = 5.78 (SD = 7.84) Mean = 7.84 (SD = 7.24)
579 7.0-9.9 years individual, classroom Anxiety (MASC) Anxiety (MASC)
Fair 80% Male (student), and teacher Mean = 77.7 (SD = 14.9) Mean = 82.8 (SD = 16.7)
RCT sessions)

b Combination: Depression (CDI)


Medication Mean = 8 (SD = 7.66)
management and Anxiety (MASC)
Behavioral training Mean = 84.1 (SD = 18.3)

Depression (CDI)
Usual care Mean = 7.19 (SD = 7.73)
Anxiety (MASC)
Mean = 85.8 (SD = 19.7)
Elevated blood pressure
Molina, 200924 Combined Type Medication Behavioral training 8 years SBP at 14 months SBP at 14 months
(Vitiello, 201225) DSM-IV management (parent group, parent Mean = 102.4 (SD = 9.7) Mean = 103.2 (SD = 10.3)
579 7.0-9.9 years individual, classroom DBP at 14 months DBP at 14 months
Fair 80% Male (student), and teacher Mean = 67.6 (SD = 9.6) Mean = 68.9 (SD = 9.1)
RCT sessions)

b Combination: SBP at 14 months


Medication Mean = 102.6 (SD = 10.2)
management and DBP at 14 months
Behavioral training Mean = 66.5 (SD = 10.4)

Usual care SBP at 14 months


Mean = 104.1 (SD = 10.6)
DBP at 14 months
Mean = 67.8 (SD = 8.8)

H-12
Study Type of ADHD
(Companion) Diagnosis
Follow-
N Criteria
Intervention Comparison up Findings–Intervention Findings–Comparison
Qualitya Age range in
Times
Design years
Age Categoryb % Male
Functional impairment
Barragan, Any subtype MPH (maximum 1 Omega-3/6 fatty acid 1 year CGI-severity – parents- 6 months CGI-severity – parents- 6 months
201427 DSM-IV-TR mg/kg/day) supplementation (6 Mean = 4 (SD = 0.98) Mean = 3.97 (SD = 1.33)
90 6-12 years capsules/day) CGI-clinician – 6 months CGI-clinician – 6 months
Poor 67.0% Male Mean = 4 (SD = 1.08) Mean = 4.1 (SD = 1.32)
RCT CGI-parent – 12 month CGI-parent – 12 month
Mean = 4.1 (SD = 1.06) Mean = 3.7 (SD = 1.51)
b CGI-clinician – 12 month CGI-clinician – 12 month
Mean = 4.1 (SD = 1.06) Mean = 3.7 (SD = 1.51)

MPH (maximum 1 CGI-severity – parents- 6 months


mg/kg/day and Mean = 3.23 (SD = 0.866)
omega-3/6 fatty acid CGI-clinician – 6 months
supplementation (6 Mean = 3.23 (SD = 0.86)
capsules/day) CGI-parent – 12 month
Mean = 3.63 (SD = 0.85)
CGI-clinician – 12 month
Mean = 3.63 (SD = 0.85)
Gastrointestinal symptoms
Barragan, Any subtype MPH (maximum 1 Omega-3/6 fatty acid 1 year Dyspepsia by the end of the study Dyspepsia by the end of the study
201427 DSM-IV-TR mg/kg/day) supplementation (6 period period
90 6-12 years capsules/day) % patients with outcome = 0 % patients with outcome = 0
Poor 67.0% Male
RCT MPH (maximum 1 Dyspepsia by the end of the study
mg/kg/day and period
b omega-3/6 fatty acid % patients with outcome = 40
supplementation (6
capsules/day)
Li, 201128 NR MPH 1 mg/kg/day Ningdong granule (a 8 weeks Nausea Nausea
72 DSM-IV traditional Chinese # patients with outcome = 16 # patients with outcome = 2
Good 6-13 years medicine preparation) Stomach pain Stomach pain
RCT 65.3% Male # patients with outcome = 12 # patients with outcome = 2

b
Incarceration

H-13
Study Type of ADHD
(Companion) Diagnosis
Follow-
N Criteria
Intervention Comparison up Findings–Intervention Findings–Comparison
Qualitya Age range in
Times
Design years
Age Categoryb % Male
Molina, 200924 Combined Type Medication Behavioral training 8 years Arrested once Arrested once
(Vitiello, 201225) DSM-IV management (parent group, parent % patients with outcome = 22.4 % patients with outcome = 17.4
579 7.0-9.9 years individual, classroom p=.735 Arrested 2 or more times
Fair 80% Male (student), and teacher Arrested 2 or more times % patients with outcome = 7.8
RCT sessions) % patients with outcome = 10.3
p=.735
b Combination: Arrested once
Medication % patients with outcome = 18.9
management and Arrested 2 or more times
Behavioral training % patients with outcome = 5.7

Usual care Arrested once


% patients with outcome = 22.9
Arrested 2 or more times
% patients with outcome = 7.8
Increased heart rate
Molina, 200924 Combined Type Medication Behavioral training 14 Heart rate at 14 months Heart rate at 14 months
(Vitiello, 201225) DSM-IV management (parent group, parent months Mean = 84.2 (SD = 12.4) Mean = 79.1 (SD = 12)
579 7.0-9.9 years individual, classroom Incidence of Tachycardia at 14 Incidence of Tachycardia at 14 months
Fair 80% Male (student), and teacher months % patients with outcome = .8
RCT sessions) % patients with outcome = .8

b Combination: Heart rate at 14 months


Medication Mean = 84.6 (SD = 12.2)
management and Incidence of Tachycardia at 14 months
Behavioral training % patients with outcome = 2.2

Heart rate at 14 months


Usual care Mean = 78.9 (SD = 12.9)
Incidence of Tachycardia at 14 months
% patients with outcome = 2.5

H-14
Study Type of ADHD
(Companion) Diagnosis
Follow-
N Criteria
Intervention Comparison up Findings–Intervention Findings–Comparison
Qualitya Age range in
Times
Design years
Age Categoryb % Male
Motor vehicle collisions
Molina, 200924 Combined Type Medication Behavioral training 8 years Accidents, citations, ticket Accidents, citations, ticket
(Vitiello, 201225) DSM-IV management (parent group, parent % patients with outcome = 28.6 % patients with outcome = 19.7
579 7.0-9.9 years individual, classroom
Fair 80% Male (student), and teacher
RCT sessions)

b Combination: Accidents, citations, ticket


Medication % patients with outcome = 19
management and
Behavioral training

Usual care Accidents, citations, ticket


% patients with outcome = 21.5
Sleep disturbance
Barragan, Any subtype MPH (maximum 1 Omega-3/6 fatty acid 1 year Insomnia by the end of the study Insomnia by the end of the study period
201427 DSM-IV-TR mg/kg/day) supplementation (6 period % patients with outcome = 0
90 6-12 years capsules/day) % patients with outcome = 20
Poor 67.0% Male
RCT MPH (maximum 1 Insomnia by the end of the study period
mg/kg/day and % patients with outcome = 0
b omega-3/6 fatty acid
supplementation (6
capsules/day)
Gelade, 201626 Combined Type Neurofeedback MPH 12 weeks SDSC SDSC
112 DSM-IV-TR training Mean = -2.16 (95% CI: -4.82, 0.51) Mean = -0.54 (95% CI: -2.90, 1.81)
Good 9.63 years
RCT (SD1.76)
76% Male
b
Li, 201128 NR MPH 1 mg/kg/day Ningdong granule (a 8 weeks Trouble falling asleep Trouble falling asleep
72 DSM-IV traditional Chinese # patients with outcome = 9 # patients with outcome = 1
Good 6-13 years medicine preparation) Hypersomnia Hypersomnia
RCT 65.3% Male # patients with outcome = 0 # patients with outcome = 6

b
Salehi, 201029 Combined Type MPH (up to 30 Ginkgo biloba 6 weeks Insomnia Insomnia
50 DSM-IV-TR mg/day) # patients with outcome = 3 # patients with outcome = 12
Good 6-14 years
RCT 78% Male

H-15
Study Type of ADHD
(Companion) Diagnosis
Follow-
N Criteria
Intervention Comparison up Findings–Intervention Findings–Comparison
Qualitya Age range in
Times
Design years
Age Categoryb % Male
Weight decrease
Salehi, 201029 Combined Type MPH (up to 30 Ginkgo biloba 6 weeks Weight loss Weight loss
50 DSM-IV-TR mg/day) # patients with outcome = 3 # patients with outcome = 8
Good 6-14 years
RCT 78% Male

b
a See Methods section “Quality Assessment of Individual Studies” for definitions of quality assessment ratings.
b Age categories: a = children aged ≤6 years, b = children aged 7-17, c = children of all ages ≤17.

Abbreviations: CDI=Children’s Depression Inventory; DSM=Diagnostic and Statistical Manual of Mental Disorders; MASC=Multidimensional Anxiety Scale for Children;
MPH=methylphenidate; WIAT=Wechsler Individual Achievement Test

Table H-6. Summary of adverse effects

Adverse Effect Findings


Physical
Weight loss29 12.0% (n=3) receiving gingko biloba and 32.0% (n=8) receiving MPH
Gastrointestinal
5.6% (n=2) receiving NDG and 44.4% (n=16) receiving MPH
Nausea27,28
20%(n=6) receiving MPH alone
Dyspepsia27 40% (n=9) receiving omega-3/6 alone after 1 month of treatment
5.6% (n=2) receiving NDG and 33.3% (n=12) receiving MPH
Stomach pain28,29
12.0% (n=3) receiving gingko biloba and 20.0% (n=5) receiving MPH
Sleep
20% (n=6) receiving MPH alone
Insomnia27,29
12.0% (n=3) receiving gingko biloba and 48.0% (n=12) receiving MPH
Hypersomnia28 16.7% (n=5) receiving NDG and 0 receiving MPH
Trouble falling asleep28 2.8% (n=1) receiving NDG and 13.9% (n=5) receiving MPH
Appetite
Suppression27 70% (n=21) receiving MPH alone, 6.7% (n=2) receiving omega-3/6 alone, and 33.3% (n=10) receiving combined
2.8% (n=1) receiving NDG and 36.1% (n=13) receiving MPH
Decreased28,29
20.0% (n=5) receiving gingko biloba and 76.0% (n=19) receiving MPH
Increased28 13.9% (n=5) receiving NDG and 11.1% (n=4) receiving MPH
Abbreviations: MPH=methylphenidate, NDG=ningdong granule

H-16
Table H-7. Findings on neurofeedback interventions for ADHD
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Acceptability of treatment
Gevensleben, Neuro- Attention skills 2 months Effectiveness of treatment Effectiveness of treatment
200933 feedback training
(Gevensleben, training Mean = 3.19 (SD = .82) Mean = 3.13 (SD = .90) p=.77
201034
Wangler, Parent rated motivation of their children to Parent rated motivation of their children to
201135) participate in treatment participate in treatment
102 p = .71
Good Mean = .64 (SD = .77) Mean = .56 (SD = 1.13)
RCT

b
Behavior changes
Gelade, 201626 Neuro- Physical 12 weeks SWAN-Inattention (parent) SWAN-Inattention (parent) NS
103 feedback activity Mean = -0.32 (95% CI: -0.53, -0.10 Mean = -0.17 (95%CI: -0.37, 0.02)
Good training
RCT SWAN-Hyperactivity/Impulsiveness SWAN-Hyperactivity/Impulsiveness (parent) NS
(parent) Mean = -0.21 (95% CI: -0.41, -0.01)
b Mean = -0.29 (95% CI: -0.50, -0.07)
SWAN-Inattention (teacher) NS
SWAN-Inattention (teacher) Mean = -0.05 (95% CI: -0.23, -0.12)
Mean = -0.10 (95% CI: -0.31, -0.11)
SWAN-Hyperactivity/Impulsiveness (teacher) NS
SWAN-Hyperactivity/Impulsiveness Mean = -0.02 (95% CI: -0.18, 0.13)
(teacher)
Mean = -0.03 (95% CI: -0.28, 0.23)

H-17
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Changes in standardized symptom scores
Bink, 201536 Neuro- Treatment as 0 months ADHD-RS Inattention ADHD-RS Inattention NS
90 feedback plus usual baseline Mean=4.4 (SD=2.49) Mean=5.27 (SD=2.16)
Good treatment as
RCT usual ADHD-RS Hyperactivity/inattention ADHD-RS Hyperactivity/inattention
Mean=3.44 (SD=2.12) Mean=3.27 (SD=2.01)
b
Youth Self Report Total score Youth Self Report Total score
Mean=48.5 (SD=22.01) Mean=52.58 (SD=18.89)

CBCL Total score CBCL Total score


Mean=60.81 (SD=28.57) Mean=63.77 (SD=27)

6 months ADHD-RS Inattention ADHD-RS Inattention


Mean=2.84 (SD=2.59) Mean=3.62 (SD=2.45)

ADHD-RS Hyperactivity/inattention ADHD-RS Hyperactivity/inattention


Mean=2.36 (SD=2.16) Mean=2.38 (SD=2.14)

Youth Self Report Total score Youth Self Report Total score
Mean= 40.43 (SD=18.24) Mean= 46.12 (SD=20.17)

CBCL Total score CBCL Total score


Mean= 53.35 (SD= 27.55) Mean=52.81 (SD=30.28)
Gevensleben, Neuro- Attention skills 2 months German ADHD rating scale German ADHD rating scale
200933 feedback training
(Gevensleben, training Mean within group change = -.39 (SD = Mean within group change = -.1 (SD = .44) p<.005
201034 .37)
Wangler,
201135)
102
Good
RCT

H-18
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Moreno-Garcia, Neuro- Standard NR Integrated Visual and Auditory Integrated Visual and Auditory Continuous
201532 feedback Pharmacologic Continuous Performance Test – Full Performance Test – Full Scale Attention
57 al Treatment Scale Attention
Fair Mean = 28.57 (SD = 11.67) p =.002
RCT Mean = 2.1 (SD = 16.88)
Changes in standardized symptom scores
b
Behavioral Integrated Visual and Auditory Continuous
Treatment Performance Test – Full Scale Attention

Mean = 3.88 (SD = 16.24) p =.013


Steiner, 201437 Neuro- Cognitive Conner 3 Parent Inattention Conner 3 Parent Inattention
(Steiner, feedback training Within-group effect size = -0.8 Within-group effect size = -0.46
201438)
104 Conners 3 Parent Executive Functioning Conners 3 Parent Executive Functioning
Good Within-group effect size = -0.49 Within-group effect size -0.12
RCT
Conners 3 Parent Global Index Conners 3 Parent Global Index
b Within-group effect size = -0.37 Within-group effect size = -0.09

Conners 3 Teacher Inattention Conners 3 Teacher Inattention p<.05


Within-group effect size = -0.25 Within-group effect size = -0.24

Control Conner 3 Parent Inattention


Within-group effect size = -0.15
p<.001
Conners 3 Parent Executive Functioning
Within-group effect size = -0.09
p<.001
Conners 3 Parent Global Index
Within-group effect size = -0.05
p<.001
Conners 3 Teacher Inattention
Within-group effect size =0
Sleep disturbance
Gelade, 201626 Neuro- Physical 12 weeks SDSC SDSC NS
103 feedback activity Mean = -2.16 (95% CI: -4.82, 0.51) Mean = -1.03 (95% CI: -2.86, 0.80)
Good training
RCT

b
a See Methods section “Quality Assessment of Individual Studies” for definitions of quality assessment ratings.
b Age categories: a = children aged ≤6 years, b = children aged 7-17, c = children of all ages ≤17.

Abbreviations: ADHD=attention deficit hyperactivity disorder; CBCL=Child Behavior Checklist; RS=rating scale; SD=standard deviation

H-19
Table H-8. Findings on cognitive training interventions for ADHD
Study
(Companion)
N Follow-up Between group
Intervention Comparison Findings–Intervention Findings–Comparison
Qualitya Times P value
Design
Age Categoryb
Academic performance
Chacko, 201439 Cogmed “Placebo” 3 weeks post WRAT-4 – word reading Treatment effect
85 working Cogmed = -2.72 (SE =
Good memory working 5.5) p = -.5
RCT training with memory
difficulty titrated training with
b to a user’s difficulty not WRAT-4 Sentence completion Treatment effect
ability titrated to a = 5.6 (SE = 4.7)
user’s ability p = .23

WRAT-4 Math computation Treatment effect


= 5.22 (SE =
5.21) p = .31

WRAT-4 Spelling Treatment effect


= 1.28 (SE =
6.17) p = .83
Acceptability of treatment
Gevensleben,2 Neurofeedback Attention 2 months Effectiveness of treatment Effectiveness of treatment
00933 training skills training Mean = 3.19 (SD = .82) Mean = 3.13 (SD = .90) P= .77
(Gevensleben,
201034 Parent-rated motivation of their children Parent-rated motivation of their children to
Wangler, to participate in treatment participate in treatment
201135) Mean = .64 (SD = .77) Mean = .56 (SD = 1.13) P= .71
102
Good
RCT

H-20
Study
(Companion)
N Follow-up Between group
Intervention Comparison Findings–Intervention Findings–Comparison
Qualitya Times P value
Design
Age Categoryb
Behavior changes
Dovis, 201540 Braingame Braingame 3 months Parent DBDRS Inattention Parent DBDRS Inattention NS
89 Brian Brian in Mean=12.9 (SD=4.1) Mean = 14.6 (SD = 5.3)
Good (computerized, training mode
RCT home-based and the P-DBDRS Hyperactivity/Impulsivity P-DBDRS Hyperactivity/Impulsivity NS
executive working Mean = 12.6 (SD = 6.4) Mean = 13 (SD = 5.1)
b functioning memory task
training) in placebo Teacher DBDRS Inattention Teacher DBDRS Inattention NS
mode Mean = 12.2 (SD = 5.8) Mean = 13.3 (SD = 6.6)

Teacher DBDRS Teacher DBDRS Hyperactivity/Impulsivity NS


Hyperactivity/Impulsivity Mean = 11.5 (SD = 7)
Mean = 9.3 (SD = 4.9)
Parent DBDRS Inattention NS
Mean = 14.1 (SD = 4.7)
All tasks in
training mode P-DBDRS Hyperactivity/Impulsivity NS
(overall Mean = 12.5 (SD = 5.7)
easier)
Teacher DBDRS Inattention NS
Mean = 11.3 (SD = 5.1)

Teacher DBDRS Hyperactivity/Impulsivity NS


Mean = 6 (SD = 9.1)
Changes in standardized symptom scores
Chacko, 201439 Cogmed “Placebo” 3 weeks post Parent Disruptive Behavior Disorder Treatment effect
85 working Cogmed Rating Scale – Inattention symptoms = 1.98 (SE =
Good memory working 1.17) p = .2
RCT training with memory
difficulty titrated training with Parent Disruptive Behavior Disorder Treatment effect
b to a user’s difficulty not Rating Scale – Hyperactive symptoms = 1.88 (SE =
ability titrated to a 1.15) p = .2
user’s ability
Teacher Disruptive Behavior Disorder Treatment effect
Rating Scale – Inattention symptoms = 1.84 (SE =
1.49) p = .22

Teacher Disruptive Behavior Disorder Treatment effect


Rating Scale – Hyperactive = 1.94 (SE =
1.54) p = .21

H-21
Study
(Companion)
N Follow-up Between group
Intervention Comparison Findings–Intervention Findings–Comparison
Qualitya Times P value
Design
Age Categoryb
Egeland, Cogmed Waitlist 8 months ADHD-RS Total Score Teacher ADHD-RS Total Score Teacher NS
201341 RoboMemo control Mean=20.1 (SD=9.8) Mean=22.6 (SD=12.3)
(Hovik, 201342) program
75 ADHD-RS Parent ADHD-RS Parent NS
Good Mean=27 (SD=11.5) Mean=28.1 (SD=11)
RCT

b
Gevensleben, Neurofeedback Attention 1 month German ADHD rating scale (FBB-HKS) German ADHD rating scale (FBB-HKS)
200933 Training skills training P<.005
(Gevensleben, Mean w/in group change = -.39 (SD = Mean w/in group change = -.1 (SD = .44)
201034 .37)
Wangler,
201135)
102
Good
RCT

b
Steiner, 201437 Neurofeedback Cognitive 5 months Conner 3 Parent Inattention Conner 3 Parent Inattention
(Steiner, training Within-group effect size = -0.8 Within-group effect size = -0.46 p<.05
201438)
104 Conners 3 Parent Executive Functioning Conners 3 Parent Executive Functioning NS
Good Within-group effect size = -0.49 Within-group effect size -0.12
RCT
Conners 3 Parent Global Index Conners 3 Parent Global Index p<.05
b Within-group effect size = -0.37 Within-group effect size = -0.09

Conners 3 Teacher Inattention Conners 3 Teacher Inattention p<.05


Within-group effect size = -0.25 Within-group effect size = 0.24

Waitlist Conner 3 Parent Inattention p<.001


control Within-group effect size = -0.15

Conners 3 Parent Executive Functioning p<.001


Within-group effect size = -0.09

Conners 3 Parent Global Index p<.001


Within-group effect size = -0.05

Conners 3 Teacher Inattention NS


Within-group effect size =0

H-22
Study
(Companion)
N Follow-up Between group
Intervention Comparison Findings–Intervention Findings–Comparison
Qualitya Times P value
Design
Age Categoryb
van Dongen- Cogmed Cogmed 5 weeks ADHD-RS Total Investigator Score ADHD-RS Total Investigator Score NS
Boomsma, training training Mean=32.4 (SE=5.7) Mean=30.3 (SE=7.4)
201443 program program
51 without ADHD-RS Teacher ADHD-RS Teacher NS
Good adjustment for Mean=27.5 (SE=10.1) Mean=25.5 (SE=7.7)
RCT patient skill
level (control
c group)

H-23
Study
(Companion)
N Follow-up Between group
Intervention Comparison Findings–Intervention Findings–Comparison
Qualitya Times P value
Design
Age Categoryb
Beck, 201044 Computer- Waitlist Baseline/ ADHD Index Parent Mean = 71.7 (SD = ADHD Index Parent Mean = 69.92 (SD = p=.01
52 based working control 4-month 8.82) / Mean = 62.78 (SD = 9.35) 7.86) / Mean = 67.33 (SD = 7.33)
Fair memory follow-up
Observational intervention Conners Cognitive Problems/Inattention Conners Cognitive Problems/Inattention p<.01
Parent Mean = 67.96 (SD = 9.55) / Parent Mean = 65.38 (SD = 9.22) /
b Mean = 59.89 (SD = 9.15) Mean = 64.75 (SD = 10.22)

Conners Hyperactivity Parent Conners Hyperactivity Parent p=.04


Mean = 68.37 (SD = 15.98) / Mean = 65.7 (SD = 16.5) /
Mean = 59.59 (SD = 14.89) Mean = 62.75 (SD = 13.73)

Conners Oppositional Parent Conners Oppositional Parent p=.10


Mean = 60 (SD = 13.34)/ Mean = 59.79 (SD = 12.17) /
Mean = 53.96 (SD = 9.67) Mean = 57.5 (SD = 10.59)

Conners ADHD Index Teacher Conners ADHD Index Teacher p=.43


# patients with outcome = 60.78 (SD = # patients with outcome = 58.4 (SD =
14.96) / # patients with outcome = 56.38 11.4) /
(SD = 13.28) # patients with outcome = 56.52 (SD =
10.25)

Conners Cognitive Problems/Inattention Conners Cognitive Problems/Inattention p=.23


Teacher Mean = 60.89 (SD = 10.58) / Teacher Mean = 56.24 (SD = 11.05) /
Mean = 57.5(SD = 7.91) Mean = 55.56 (SD = 10.26)

Conners Hyperactivity Teacher Conners Hyperactivity Teacher p=.25


Mean = 59.59 (SD = 15.17) / Mean = 55.36 (SD = 13.2) /
Mean = 56.31 (SD = 13.47) Mean = 55.64 (SD = 11.14)

Conners Oppositional Teacher Conners Oppositional Teacher p=.59


Mean = 56.52 (SD = 8.93) / Mean = 52.92 (SD = 8.93) /
Mean = 52.35 (SD = 10.12) Mean = 50.58 (SD = 8.71)

BRIEF Metacognition Index Parent BRIEF Metacognition Index Parent p=.01


Mean = 72.96 (SD = 8.06)/ Mean = 71.38 (SD = 7.73) /
Mean = 64.19 (SD = 9.24) Mean = 69.61 (SD = 7.19)

BRIEF Metacognition Index Teacher BRIEF Metacognition Index Teacher p=.22


Mean = 67.96 (SD = 18.67) / Mean = 60.2 (SD = 13.04) /
Mean = 64.85 (SD = 16.35) Mean = 60.79 (SD = 12.76)

H-24
Study
(Companion)
N Follow-up Between group
Intervention Comparison Findings–Intervention Findings–Comparison
Qualitya Times P value
Design
Age Categoryb
Van der Donk, Cogmed Paying 6 weeks CBCL Attention Problems Scale CBCL Attention Problems Scale NR
201545 Working Attention in
105 Memory Class
Fair Training (experimental, CBCL Externalizing Problems Scale CBCL Externalizing Problems Scale NR
RCT combined
working 6 months
b memory and
compensatory
training)
Functional impairment
van Dongen- Cogmed Cogmed 5 weeks CGI-I CGI-I P=0.514
Boomsma, training training # patients w/ outcome = 25 # patients w/ outcome = 21
43
2014 program program
51 without
Good adjustment for
RCT patient skill
level (control
c group)
a See Methods section “Quality Assessment of Individual Studies” for definitions of quality assessment ratings.
b Age categories: a = children aged ≤6 years, b = children aged 7-17, c = children of all ages ≤17.

Abbreviations: ADHD=attention deficit hyperactivity disorder; BRIEF=Behavior Rating Inventory of Executive Function; CBCL= Child Behavior Checklist; DBDRS=Disruptive
Behavior Disorder Rating Scale; SNAP=Swanson, Nolan and Pelham Revision

Table H-9. Findings on cognitive behavioral therapy interventions for ADHD


Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Changes in standardized symptom scores
Vidal, 201546 CBT Usual care 12 weeks ADHD-RS Adolescent Inattention ADHD-RS Adolescent Inattention ES=8.57
119 Mean 10.14 (0.51) Mean 14.47 (0.5) (p<.001)
Good
RCT ADHD-RS Adolescent Impulsivity ADHD-RS Adolescent Impulsivity ES=4.9
Mean 8.29 (0.7) Mean 11.72 (0.7) (p<.001)
b
ADHD-RS Parents Inattention ADHD-RS Parents Inattention ES=9.62
11.31 (0.58) Mean 16.99 (0.6) (p<.001)

ADHD RS Parents Impulsivity ADHD RS Parents Impulsivity ES=4.95


Mean 7.72 (0.77) Mean 11.56 (0.78) (p<.001)

H-25
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Boyer, 201547 CBT with an Solution- 3 months ADHD symptom scale – combined inattentive ADHD symptom scale – combined inattentive
(Boyer, 201548) aim to improve focused CBT and Hyperactivity/Impulsivity and Hyperactivity/Impulsivity
159 planning skills without an aim Mean = 18.66 (9.64) Mean = 19.99 (9.69)
Fair to improve
RCT planning skills Disruptive Behavior Disorders – summarized Disruptive Behavior Disorders – summarized
ODD/CD subscales ODD/CD subscales
b Mean = 5.84 (5.49) Mean = 5.99 (5.78)

12 months ADHD symptom scale – combined inattentive ADHD symptom scale – combined inattentive p < .001
and Hyperactivity/Impulsivity and Hyperactivity/Impulsivity
Mean = 18.41 (9.76) Mean = 20.02 (8.21)

Disruptive Behavior Disorders – summarized Disruptive Behavior Disorders – summarized p < .001
ODD/CD subscales ODD/CD subscales
Mean = 4.74 (4.30) Mean = 4.55 (3.80)
Depression or anxiety
Boyer, 201547 CBT with an Solution- 3 months Child Depression Inventory Child Depression Inventory
(Boyer, 201548) aim to improve focused CBT Mean = 8.92 (6.82) Mean = 9.21 (5.57)
159 planning skills without an aim
Fair to improve Screen for Child Anxiety Related Emotional Screen for Child Anxiety Related Emotional
RCT planning skills Disorders Disorders
Mean = 20.49 (16.17) Mean = 19.54 (18.17)
b

12 months Child Depression Inventory Child Depression Inventory p < .001


Mean = 7.68 (5.10) Mean = 8.48 (4.65)

Screen for Child Anxiety Related Emotional Screen for Child Anxiety Related Emotional p < .001
Disorders Disorders
Mean = 18.86 (14.39) Mean = 18.53 (16.17)
Functional impairment
Vidal, 201546 CBT Usual care 12 weeks CGI-S Self Report CGI-S Self Report ES=3.75
119 Mean 2.9 )0.12) Mean 3.35 (0.12) (p<.001)
Good
RCT CGI-S Clinician CGI-S Clinician ES=7.71
2.86 (0.07) 3.4 (0.07) (p<.001)
b
a See Methods section “Quality Assessment of Individual Studies” for definitions of quality assessment ratings.
b Age categories: a = children aged ≤6 years, b = children aged 7-17, c = children of all ages ≤17.

Abbreviation: CBT=cognitive behavioral therapy; CGI-S=Clinical Global Impression-Severity; ODD/CD=Oppositional defiant disorder/conduct disorder

H-26
Table H-10. Findings on child or parent training or behavioral interventions for ADHD
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Academic performance
Abikoff, 201349 Organizational Performance 12 weeks Academic Performance Rating Scale Academic Performance Rating Scale NS
180 skills -based Mean=pre: 53.45; post: 62.16 Mean=pre: 54.45; post: 63.96 (SD=pre: 11.12;
Good intervention (SD=pre: 10.34; post: 10.52) post: 11.90)
RCT precluding
skill Academic Proficiency Scale Academic Proficiency Scale
b Mean=pre: 16.39; post: 18.55 (SD=pre: 4.27; Mean=pre: 17.08; post: 18.35 (SD=pre: 3.54;
post: 4.26) post: 3.89)

Waitlist Academic Performance Rating Scale NS


Mean=pre: 54.06 ; post: 54.53 (SD=pre: 8.58;
post: 9.74)

Academic Proficiency Scale


Mean=pre: 16.05 ; post: 16.63 (SD= pre: 3.22;
post: 3.30)
Storebo, 201250 Social skills Medication 3 months Conners CBRS Academic Score Mean=20.13 Conners CBRS Academic Score Mean=17.88 NS
56 group + management (SD=15.15) (SD=10.11)
Good medication (usual care)
RCT management 6 months Conners CBRS Academic Score Mean=21.04 Conners CBRS Academic Score Mean=21.52
(SD= 11.98); Between group MD: -0.48 (95% (SD 12.56)
b CI=-7.254 to 6.293)
Acceptability of treatment
Chacko, 200951 STEPP BPT program 2.07 Parent Treatment Attitude Inventory- Parent Treatment Attitude Inventory- Satisfaction
120 months Satisfaction with Process with Process
Good Mean = 16.36 (SD = 2.03) Mean = 14.12 (SD = 2.09) P<0.01
RCT Waitlist

c
Changes in standardized symptom scores
Bai, 201552 A psycho- General 3 months ADHD-RS-IV ADHD-RS-IV P=.008
89 education clinical Mean=33.7 (SD=5.4) Mean=45.1 (SD=7.9)
Good program counseling (Baseline mean=49.9, SD 11.5) (Baseline mean=48.1, SD 8.1)
RCT based on the
theory of
b planned
behavior

H-27
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Chacko, 200951 STEPP BPT program 2.07 Disruptive Behavior Disorder scale-Inattentive Disruptive Behavior Disorder scale-Inattentive NR
120 months Mean = 1.78 (SD = .63) Mean = 1.67 (SD = .74)
Good
RCT Disruptive Behavior Disorder- Disruptive Behavior Disorder- NR
Hyperactive/Impulsive: Hyperactive/Impulsive:
c Mean = 1.69 (SD = .57) Mean = 1.59 (SD = .70)

Treatment Attitude Inventory- Satisfaction with Treatment Attitude Inventory- Satisfaction with NR
Outcome Outcome
Mean = 24.18 (SD = 3.02) Mean = 20.20 (SD = 2.35)

Waitlist Disruptive Behavior Disorder scale-Inattentive NR


Mean = 1.72 (SD = .65)

Disruptive Behavior Disorder-


Hyperactive/Impulsive: NR
Mean = 1.72 (SD = .56)
Ferrin, 201453 Psycho- Control 12 weeks CPRS inattention -12 weeks CPRS inattention -12 weeks P=0.001
81 educational Mean = 7.95 (SD = 3.84) p = .001 Mean = 11 (SD = 3.28)
Good program
RCT CPRS hyperactivity/impulsivity -12 weeks CPRS hyperactivity/impulsivity -12 weeks NS
Mean = 6.74 (SD = 4.84) Mean = 8.45 (SD = 4)
c
12 months Conners parent rating scale – index Conners parent rating scale – index NS
Mean = 18.6 (SD = 8.66) Mean = 21.16 (SD = 7.08)

Conners parent rating scale – opposition Conners parent rating scale – opposition NS
subscale subscale
Mean = 5.2 (SD = 4.06) Mean = 5.63 (SD = 3.86)
P=0.0032
Conners parent rating scale- Conners parent rating scale- inattention/cognition
inattention/cognition Mean = 10.41 (SD = 3.62)
Mean = 8.26 (SD = 4.3) p = .032 NS
Conners parent rating scale –
Conners parent rating scale – hyperactivity/impulsivity
hyperactivity/impulsivity Mean = 8.47 (SD = 3.82)
Mean = 7.4 (SD = 4.84) P=0.001
CPRS index -12 weeks
CPRS index -12 weeks Mean = 22.44 (SD = 6.13)
Mean = 16.8 (SD = 7.18) p = .001 NS
CPRS opposition -12 weeks
CPRS opposition -12 weeks Mean = 6.18 (SD = 3.87)
Mean = 4.95 (SD = 3.79)

H-28
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Hiscock, 201554 Sleep hygiene Children in ADHD rating scale IV-total symptoms (parent ADHD rating scale IV-total symptoms (parent P=0.004
(Papadopoulos, practices and the control 6 Months report) report)
201555) standardized group Mean = 28.4 (SD = 10.8) Mean = 33.8 (SD = 9.5)
244 behavioral received
Good strategies usual clinical ADHD Rating Scale IV – Parent Report ADHD Rating Scale IV – Parent Report P=0.001
RCT care (Inattentive) (Inattentive)
Mean = 15.1 (SD = 6.0) Mean = 18.2 (SD = 4.8)
c
ADHD Rating Scale IV – Parent Report ADHD Rating Scale IV – Parent Report
(Hyperactivity/Impulsivity) (Hyperactivity/Impulsivity) P=0.04
Mean = 13.3 (SD = 6.0) Mean = 15.6 (SD = 5.8)

ADHD rating scale IV Total Score (Teacher ADHD rating scale IV Total Score (Teacher
Report) Report) P=0.31
Mean = 20.6 (SD = 11.6) Mean = 25.1 (SD = 12.6)

ADHD Rating Scale IV: Teacher Report ADHD Rating Scale IV: Teacher Report
(Inattentive) (Inattentive) P=0.59
Mean = 14.1 (SD = 6.9) Mean = 12.3 (SD = 6.9)

ADHD Rating Scale IV: Teachers Report ADHD Rating Scale IV: Teachers Report P=0.19
(Hyperactivity/Impulsivity) (Hyperactivity/Impulsivity)
Mean = 8.4 (SD = 6.2) Mean = 10.9 (SD = 7.1)

Ostberg, 201256 Barkley based Waitlist 10 weeks ADHD-C Parent ADHD-C Parent NS
92 Parent + Mean = 9.1 (SD = 4.5) Mean = 9.8 (SD = 6)
Good Teacher
RCT behavioral ADHD-C Teacher ADHD-C Teacher NS
intervention Mean = 7.7 (SD = 6.3) Mean = 9.4 (SD = 6.3)
b
3 months ADHD-C Parent ADHD-C Parent
Mean = 7.7 (SD = 4.7) Mean = 10.1 (SD = 5.3) P<.05

ADHD-C Teacher ADHD-C Teacher


Mean = 7.7 (SD = 5.7) Mean = 9.4 (SD = 5.4) NS

H-29
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Pfiffner, 201457 Child Life and Parent group 10-13 Parent Child Symptom Inventory Parent Child Symptom Inventory P=.001
199 Attention component weeks Mean=2.2 (SE=0.3) Mean=3.2 (SE=0.3)
Good Skills only
RCT Treatment Child Symptom Inventory Child Symptom Inventory P<0.001
Mean=2.99 (SE=0.3) Mean=4.2 (SE=0.3)
b NR
Parent Child Symptom Inventory
Mean=4.1 (SE=0.4)
NR
Child Symptom Inventory
Mean=5 (SE=0.4)
Evaluation NR
and Parent Child Symptom Inventory
community Mean=3.2 (SE=0.3)
care NR
Child Symptom Inventory
Mean=4.2 (SE=0.4)
Parent Child Symptom Inventory
Parent group Mean=4.1 (SE=0.4) P<0.001
component 5-7 Parent Child symptom inventory
only months Mean=2.2 (SE=0.3) Child Symptom Inventory
Mean=4.2 (SE=0.4)
Child symptom inventory P=0.396
Mean=3.7 (SE=0.4)
Parent Child Symptom Inventory
Mean=4.1 (SE=0.4)
Evaluation NR
and Child Symptom Inventory
community Mean=4.2 (SE=0.4)
care
Ercan, 201458 MPH+11 MPH (Usual 12 months CPRS CPRS NS
120 months of care) Mean w/in group change = 7.91 (SD = 6.9) Mean w/in group change = 10.07 (SD = 5.74)
Fair parent training
Observational CTRS–teacher CTRS–teacher
Mean = 29.69 (SD = 15.03) Mean = 35.27 (SD = 13.47)
b

H-30
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Huang, 201559 Behavioral- Group 6 months Change in Child Behavioral Checklist Change in Child Behavioral Checklist Withdrawn P=0.84
97 based social therapy for Withdrawn Subscale Subscale
Fair skill training motivation Mean= -.84 (SD=2.3) Mean= -.28 (SD=1.6)
RCT for patients and
and parallel treatment per Change in CBCL Somatic Complaints Change in CBCL Somatic Complaints Subscale P=0.14
b parent group usual care, Subscale Mean within group change= -1.42 (SD=3.7)
sessions such as Mean within group change= -.14 (SD=2.7)
medication CBCL Change Anxious/Depressed Subscale
and CBCL Change Anxious/Depressed Subscale Mean within group change= -.89 (SD=3.7) P=0.79
counseling at Mean within group change= -2.19 (SD=4)
the CBCL Change Social Problems Subscale
outpatient CBCL Change Social Problems Subscale Mean within group change= -.92 (SD=2.2) P=0.57
department Mean within group change= -1.4 (SD=2.3)
CBCL Change Thought Problems Subscale
CBCL Change Thought Problems Subscale Mean within group change= -1.06 (SD=2.1) P=0.60
Mean within group change= -1.02 (SD=2.8)
CBCL Change Attention Problems Subscale
CBCL Change Attention Problems Subscale Mean within group change= -1.772 (SD=3.2) P=0.04
Mean within group change= -1.26 (SD=2.8)
CBCL Change Delinquent Behavior Subscale
CBCL Change Delinquent Behavior Subscale Mean within group change= -.6 (SD=1.9) P=0.91
Mean within group change= -.76 (SD=2.2)
CBCL Change Aggressive Behavior Subscale
CBCL Change Aggressive Behavior Subscale Mean within group change= -2.37 (SD=5.9) P=0.94
Mean within group change= -4 (SD=7.1)
Depression or anxiety
Hiscock, 201554 Sleep hygiene Children in 6 Months Depression or anxiety-Depression Anxiety Depression or anxiety-Depression Anxiety Stress P=0.55
(Papadopoulos, practices and the control Stress Scale Scale
201555) standardized group Mean = 31.3 (SD = 23.6) Mean = 33.9 (SD = 28.5)
244 behavioral received
Good strategies usual clinical Depression or anxiety-Parent mental health
RCT care with the Depression Anxiety Stress Scale –
Total score
c
Functional impairment
Chacko, 200951 STEPP BPT program 2.07 Impairment Rating Scale (IRS)-Overall Impairment Rating Scale (IRS)-Overall P<.01
120 months Mean = 3.31 (SD 1.41) Mean = 4.11 (SD 1.67)
Good
RCT Impairment Rating Scale (IRS)- Overall NR
Waitlist Mean = 4.65 (SD 1.30)
c

H-31
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Pfiffner, 201457 Child Life and Parent group 10-13 Parent CGI Parent CGI P=0.0
199 Attention component weeks Mean=6 (SE=0.7) Mean=5.8 (SE=0.9)
Good Skills only
RCT Treatment Teacher CGI Severity Teacher CGI Severity P=0.0
Mean=5.8 (SE=0.8) Mean=5.2 (SE=1)
b
Parent CGI NR
Evaluation Mean=5 (SE=1)
and
community Teacher CGI Severity NR
care Mean=5 (SE=1.1)

5-7 Parent CGI Parent CGI P=0.001


months Mean=6 (SE=1) Mean=5.8 (SE=1)

Parent group Teacher CGI-Severity Teacher CGI-Severity P=0.775


component Mean=3.4 (SE=0.2) Mean=3.5 (SE=0.2)
only
Parent CGI NR
Mean=5.3 (SE=0.23)

Teacher CGI Severity NR


Evaluation Mean=3.6 (SE=0.2)
and
community
care

Sleep disturbance
Hiscock, 201554 Sleep hygiene Children in 6 Months Sleep disturbance-Child Sleep Habits Sleep disturbance-Child Sleep Habits P<0.001
(Papadopoulos, practices and the control Questionnaire (CSHQ) Total Score Questionnaire (CSHQ) Total Score, Mean = 55.9
201555) standardized group Mean 53.2 (7.5) (8.8)
244 behavioral received
Good strategies usual clinical
RCT care
c

H-32
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Workforce participation
Hiscock, 201554 Sleep hygiene Children in 3 months Workforce participation-Days late for work P=0.02
(Papadopoulos, practices and the control
201555) standardized group Workforce participation-Missed days of work P=0.03
244 behavioral received (both
Good strategies usual clinical non-
RCT care parametri
c tests)
c
a See Methods section “Quality Assessment of Individual Studies” for definitions of quality assessment ratings.
b Age categories: a = children aged ≤6 years, b = children aged 7-17, c = children of all ages ≤17.

Abbreviations: ADHD=attention deficit hyperactivity disorder; BPT=Behavioral Parent training; CBCL=Child Behavior Checklist; CBRS=Comprehensive Behavior Rating Scale;
CGI=Clinician Global Impressions; DASS=Depression Anxiety Stress Scale; NR=not reported; STEPP=Strategies to Enhance Positive Parenting; RCT=randomized controlled
trial

H-33
Table H-11. Findings on omega-3 fatty acid supplementation for ADHD
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Behavior changes
Manor, 201260 Phospha- Placebo 15 weeks Euphoric Euphoric NR
(Manor, 201361) tidylserine % patients with outcome = 38.9 % patients with outcome = 34.6
200 enriched with
Good omega-3 fatty Anxiety Anxiety NR
RCT acids % patients with outcome = 45 % patients with outcome = 63.5

b Irritable Irritable NR
% patients with outcome = 79.1 % patients with outcome = 84.6

Prone Cry Prone Cry NR


% patients with outcome = 62.7 % patients with outcome = 57.7

Talk Less Talk Less NR


% patients with outcome = 31.8 % patients with outcome = 32.7

Sad/Unhappy Sad/Unhappy NR
% patients with outcome = 40 % patients with outcome = 34

Irritability Irritability NR
% patients with outcome = 15.31 % patients with outcome = 11.63
Changes in standardized symptom scores
Anand, 201662 Polyunsaturat Atomoxetine 4 months Conners Parent Rating Scale-Revised: Short Conners Parent Rating Scale-Revised: Short NS
50 ed fatty acids (0.5 mg/kg/d) Form Form
Good (300 mg/d) Mean = 36.6 (SD = 2.21) Mean = 37.4 (SD = 2.18)
RCT plus
atomoxetine
c (0.5 mg/kg/d)
Gustafsson, Omega-3 fatty Placebo 15 weeks Total Conners Parent Rating Scale score Total Conners Parent Rating Scale score NS
201063 acid Mean = 43.8 (SD = 18.6) Mean = 39.4 (SD = 18.4)
109 supplemen-
Good tation (eico-
RCT sapentaenoic Total Conners Rating Scale score Total Conners Rating Scale score NS
acid 500mg Mean = 43.1 (SD = 18.8) Mean = 40.7 (SD = 17.9)
b daily)

H-34
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Johnson, Omega-3/6 Placebo 3 months ADHD Rating Scale ADHD Rating Scale NS
200964 fatty acid (double-blind Mean change = -3.78 (7.14) Mean change = -1.65 (4.54)
(Johnson, supplemen- phase)
201265) tation (792mg 6 months NS
75 daily) (open-label ADHD Rating Scale ADHD Rating Scale
Good extension: Mean change = -7.82 (8.07) Mean change = -5.81 (7.16)
RCT continuous
and naïve
b groups)
Manor, 201260 Phospha- Placebo 15 weeks CRS-P PS-Omega-3 continuous (30 weeks) CRS-P Placebo (weeks 1-15) NS
(Manor, 201361) tidylserine (treatment and ADHD Index Mean = 64.05 (10.21) ADHD Index Mean = 65.67 (12.79)
200 enriched with placebo
Good omega-3 fatty groups, CRS-T PS-Omega-3 continuous (30 weeks) CRS-T Placebo (weeks 1-15) NS
RCT acids N=162) ADHD Index Mean= 62.35 (10.64) ADHD Index Mean = 64.44 (10.07)

b 30 weeks
(open-label CRS-P PS-Omega-3 continuous (30 weeks) CRS-P PS-Omega-3 (weeks 15-30) NS
extension: ADHD Index Mean Change = -0.95 (7.91) ADHD Index Mean Change = -2.86 (8.51)
continuous
and naïve CRS-T PS-Omega-3 continuous (30 weeks) CRS-T PS-Omega-3 (weeks 15-30) NS
groups, ADHD Index Mean Change = 0 (8.62) ADHD Index Mean Change = -1.72 (6.19)
N=147)
Milte, 201266 Fish oil rich in Fish oil rich 4 months Conners Parent Rating Scale ADHD total Conners Parent Rating Scale ADHD total NR
(Milte, 201567) the omega-3 in the Mean between-group change (vs. placebo) = Mean between-group change (vs. placebo) =
90 fatty acid, omega-3 1.56 (1.77) 1.64 (1.9)
Good eico- fatty acid,
RCT sapentaenoic docosahexae
acid (EPA) noiacid EPA vs.
b (DHA) placebo
p=0.38

Placebo: DHA vs.


Linoleic acid placebo
(LA) p=0.39
Raz, 200968 Omega-3 fatty Placebo 1.75 months Conners-ADHD (Teacher) Conners-ADHD (Teacher) NS
78 acid Mean = 3.64 (1.48) Mean = 3.66 (1.12)
Fair supplemen-
RCT tation Conners Mood (Teacher) Conners Mood (Teacher) NS
Mean = 2.76 (1.28) Mean = 2.74 (1.30)
b
Conners Mood (Parent) Conners Mood (Parent) NS
Mean = 3.44 (1.42) Mean = 4.03 (1.25)

H-35
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Widenhorn- Omega-3 fatty Placebo 4 CBCL total problems CBCL total problems P=0.98
Muller, 201469 acid Mean = 62.36 (SE = 1.47) Mean = 60.15 (SE = 1.38)
110 supplementati
Fair on (720 mg Teacher Report Form--total problems Teacher Report Form--total problems P=0.62
RCT daily) plus 15 Mean = 55.8 (SE = 1.09) Mean = 56.82 (SE = 1.16)
mg vitamin E
b
Hariri, 201270 Omega-3 fatty Placebo 8 weeks Conners Abbreviated Conners Abbreviated P=0.251
120 acid Mean = 21.03 (3.98) Mean = 24.02 (4.22)
Poor supplemen-
RCT tation (900 mg
daily)
b
Elevated blood pressure
Manor, 201260 Phospha- Placebo 15 weeks Systolic Systolic P=0.955
(Manor, 201361) tidylserine Mean = 103.6 (SD = 14.82) Mean = 100.25 (SD = 12.95)
200 enriched with
Good omega-3 fatty Diastolic Diastolic P=0.342
RCT acids Mean = 64.66 (SD = 11.39) Mean = 63.89 (SD = 10.28)

b
Functional impairment
Johnson, Omega-3/6 Placebo 3 months Clinical Global Impression score Clinical Global Impression score NS
200964 fatty acid (double-blind Mean change = -0.58 (0.87) Mean change = -0.13 (0.50)
(Johnson, supplementati phase)
201265) on (792 mg
75 daily) 6 months Clinical Global Impression score Clinical Global Impression score NS
Good (open-label Mean change = -1.24 (1.07) Mean change = -0.93 (0.92)
RCT extension:
continuous
b and naïve
groups)
Sleep disturbance
Manor, 201260 Phospha- Placebo 15 weeks Insomnia Insomnia NR
(Manor, 201361) tidylserine % patients with outcome = 38.2 % patients with outcome = 53.9
200 enriched with
Good omega-3 fatty Severe insomnia Severe insomnia NR
RCT acids % patients with outcome = 2.04 % patients with outcome = 6.98

b Nightmares Nightmares NR
% patients with outcome = 29.1 % patients with outcome = 34.6

H-36
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Tics or other movement disorders
Manor, 201260 Phospha- Placebo 15 weeks Tics Tics NR
(Manor, 201361) tidylserine % patients with outcome = 22.7 % patients with outcome = 32.7
200 enriched with
Good omega-3 fatty
RCT acids

b
Gastrointestinal symptoms
Manor, 201260 Phospha- Placebo 15 weeks Stomachaches Stomachaches NR
(Manor, 201361) tidylserine % patients with outcome = 39.5 % patients with outcome = 46.2
200 enriched with NR
Good omega-3 fatty Decreased appetite Decreased appetite
RCT acids % patients with outcome = 32.7 % patients with outcome = 32.7
NR
b Severely decreased appetite Severely decreased appetite
% patients with outcome = 4.08 % patients with outcome = 4.65
Growth suppression
Manor, 201260 Phospha- Placebo 15 weeks Height in cm Height in cm P=0.196
(Manor, 201361) tidylserine Mean = 135.25 (SD = 13.35) Mean = 136.77 (SD = 12.26)
200 enriched with
Good omega-3 fatty
RCT acids

b
Increased heart rate
Manor, 201260 Phospha- Placebo 15 weeks Increased Heart Rate Increased Heart Rate p=0.825
(Manor, 201361) tidylserine Mean = 79.72 (SD = 12.03) Mean = 81.18 (SD = 13.24)
200 enriched with
Good omega-3 fatty
RCT acids

b
Personality change
Manor, 201260 Phospha- Placebo 15 weeks Uninterested Uninterested NR
(Manor, 201361) tidylserine % patients with outcome = 32.7 % patients with outcome = 38
200 enriched with
Good omega-3 fatty
RCT acids

H-37
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Weight decrease
Manor, 201260 Phospha- Placebo 15 weeks Weight (kg) Weight (kg) P=0.980
(Manor, 201361) tidylserine Mean = 33.39 (SD = 10.61) Mean = 33.06 (SD = 8.42)
200 enriched with
Good omega-3 fatty
RCT acids

b
a See Methods section “Quality Assessment of Individual Studies” for definitions of quality assessment ratings.
b Age categories: a = children aged ≤6 years, b = children aged 7-17, c = children of all ages ≤17.

Abbreviations: ADHD=attention deficit hyperactivity disorder; CRS-P=Conners Rating Scale-Parent; CRS-T=Conners Rating Scale-Teacher; NR=not reported; SE=standard
error; SD=standard deviation; RCT=randomized controlled trial

Table H-12. Findings on herbal interventions or dietary approaches for ADHD


Study
N Between
Follow-up
Qualitya Intervention Comparison Findings–Intervention Findings–Comparison group P
Times
Design value
Age Categoryb
Behavior changes
Shakibaei, Methylphenid Methylphenid 6 weeks Parent ADHD Rating Scale IV Inattention Parent ADHD Rating Scale IV Inattention P<.001
201571 ate and ate and Mean = 13.58 (SD = 3.68) Mean = 14.34 (SD = 4.03)
66 Ginkgo placebo
Good Biloba Parent ADHD Rating Scale IV Hyperactivity- Parent ADHD Rating Scale IV Hyperactivity- P=0.417
RCT Impulsivity Impulsivity
Mean = 11.54 (SD = 4.42) Mean = 11.37 (SD = 4.11)
b
Teacher ADHD Rating Scale IV Inattention Teacher ADHD Rating Scale IV Inattention P=0.004
Mean = 13.74 (SD = 4.04) Mean = 13.75 (SD = 3.85)

Teacher ADHD Rating Scale IV Hyperactivity- Teacher ADHD Rating Scale IV Hyperactivity-
Impulsivity Impulsivity P=0.203
Mean = 10.93 (SD = 4.06) Mean = 11.2 (SD = 4.43)

Children’s Global Assessment Scale (CGAS) CGSA P=0.901


Mean w/in group change = 8.92 (SD = 7.37) Mean w/in group change = 8.51 (SD = 5.33)

H-38
Study
N Between
Follow-up
Qualitya Intervention Comparison Findings–Intervention Findings–Comparison group P
Times
Design value
Age Categoryb
Arnold, 201172 Zinc 15 mg Zinc 15mg 8 weeks Affective blunting Affective blunting NR
52 once daily twice daily # patients with outcome = 1 # patients with outcome = 0
Fair
RCT >8 weeks Affective blunting Affective blunting NR
(> 8 weeks # patients with outcome = 4 # patients with outcome = 0
b with
amphetamin 8 weeks Anxiety Anxiety NR
e in all # patients with outcome = 6 # patients with outcome = 2
groups)
>8 weeks Anxiety Anxiety NR
# patients with outcome = 9 # patients with outcome = 3

8 weeks Depression Depression NR


# patients with outcome = 7 # patients with outcome = 2

>8 weeks Depression Depression NR


# patients with outcome = 11 # patients with outcome = 4

8 weeks Irritability Irritability NR


# patients with outcome = 9 # patients with outcome = 5

>8 weeks Irritability Irritability NR


# patients with outcome = 9 # patients with outcome = 6

Placebo 8 weeks Affective blunting NR


# patients with outcome = 1

>8 weeks Affective blunting NR


# patients with outcome = 6

8 weeks Anxiety NR
# patients with outcome = 6

>8 weeks Anxiety NR


# patients with outcome = 5

8 weeks Depression NR
# patients with outcome = 5

>8 weeks Depression NR


# patients with outcome = 9

8 weeks Irritability NR
# patients with outcome = 10

>8 weeks Irritability NR


# patients with outcome = 14

H-39
Study
N Between
Follow-up
Qualitya Intervention Comparison Findings–Intervention Findings–Comparison group P
Times
Design value
Age Categoryb
Mohammadpour, 2000 IU Placebo 2 days WPREMB morning symptoms WPREMB morning symptoms NS
201673 Vitamin D Vitamin D Mean = 2.76 (SD 2.2) Mean = 3.65 (SD 3.1)
54 plus MPH plus MPH
Fair WPREMB evening symptoms WPREMB evening symptoms Significant
RCT Mean = 8.32 (SD 3.9) Mean = 11.68 (SD 5.4)

c WPREMB total score WPREMB total score Significant


Mean = 11.08 (SD 5.5) Mean = 15.34 (SD 7.7)
Changes in appetite
Arnold, 201172 Zinc 15 mg Zinc 15mg 8 weeks Changes in appetite Changes in appetite NR
52 once daily twice daily # patients with outcome = 3 # patients with outcome = 4
Fair
RCT >8 weeks Changes in appetite Changes in appetite NR
(> 8 weeks # patients with outcome = 15 # patients with outcome = 8
b with
amphetamin Placebo 8 weeks Changes in appetite NR
e in all # patients with outcome = 4
groups)
>8 weeks Changes in appetite NR
# patients with outcome = 17

Katz, 201074 Patented Placebo 0.5 months Decreased appetite Decreased appetite NR
120 herbal # patients with outcome = 1 # patients with outcome = 2
Fair preparation
RCT

b
Changes in standardized symptom scores
Dutta, 201275 Memomet Placebo 4 months Conners 10-point rating scale (hyperactivity) Conners 10-point rating scale (hyperactivity) Reported
86 syrup Mean Percent Change Mean Percent Change as
Good (Bacopa 48% 29% significant
RCT monniera in text
125 mg,
b Convulvulus
pleuricaulis
100 mg,
Centella
asiatica 100
mg)

H-40
Study
N Between
Follow-up
Qualitya Intervention Comparison Findings–Intervention Findings–Comparison group P
Times
Design value
Age Categoryb
Pelsser, 201176 Restricted No 5 weeks ADHD rating scale--Parental total score ADHD rating scale--Parental total score p<.0001
100 elimination elimination after Mean 24.2 95% CI=19.5, 29.0 Mean 1.3 95% CI = 0.2, 2.5
Good diet diet intervention Mean between group change = 23.7
RCT started 95% CI = 18.6, 28.8
ADHD rating scale, teacher total score ADHD rating scale, teacher total score p<.0001
c
Mean 14.3 95% CI=11.6, 17.1 Mean -0.4 95% CI=-1.7, 1.0
Mean between group change = 15.3
95% CI = 12.0, 18.6
ADHD rating scale, Parent inattention score ADHD rating scale, Parent inattention score p<.0001
Mean 11.3 95% CI=8.9, 13.8 Mean 0.2 95% CI=-0.4, 0.8
Mean between group change = 11.8
95% CI = 9.1, 14.4
ADHD rating scale, parent hyperactivity and ADHD rating scale, parent hyperactivity and p<.0001
impulsivity score impulsivity score
Mean 12.9 95% CI 10.5, 15.3 Mean 0.3 95% CI=-0.6, 1.1
Mean between group change = 11.9
95% CI = 9.3, 14.5
ADHD rating scale, Teacher hyperactivity and ADHD rating scale, Teacher hyperactivity and p<.0001
impulsivity score impulsivity score
Mean 7.8 95% CI= 6.2, 9.5 Mean -0.6 95% CI=-1.4, 0.2
Mean between group change = 8.5
95% CI = 6.8, 10.3
Abbreviated Conners' scale-Parent Abbreviated Conners' scale-Parent p<.0001
Mean 12.0 95% CI=9.4, 14.6 Mean 0.1 95% CI=-0.7, 0.8
Mean between group change = 11.8
95% CI = 9.2, 14.5
Abbreviated Conners' scale-Teacher Abbreviated Conners' scale-Teacher p<.0001
Mean 6.6 95% CI= 4.9, 8.4 Mean -0.8 95% CI=-1.4, -0.3
Mean between group change = 7.5
95% CI = 5.9, 6.2
ADHD Rating Scale "Behaviour scores" ADHD Rating Scale "Behaviour scores"
Total score Total score
Mean = 9.6 (SD = 6.9) Mean = 46.9 (SD = 5.5)
ADHD Rating Scale "Behaviour scores" ADHD Rating Scale "Behaviour scores"
Inattention Inattention
Mean = 4.1 (SD = 3.9) Mean= 23.4 (SD = 26.3)
ADHD Rating Scale Hyperactivity and ADHD Rating Scale Hyperactivity and p<.0001
Impulsivity Impulsivity
Mean = 5.3 (SD = 3.9) Mean = 24.1 (SD = 4.2)
Abbreviated Conners Scale Abbreviated Conners Scale
Mean = 5.9 (SD = 3.7) Mean = 24 (SD = 3.7)

H-41
Study
N Between
Follow-up
Qualitya Intervention Comparison Findings–Intervention Findings–Comparison group P
Times
Design value
Age Categoryb
Arnold, 201172 Zinc 15 mg Zinc 15mg 8 weeks SNAP parent DSM-IV ADHD symptoms SNAP parent DSM-IV ADHD symptoms NR
52 once daily twice daily Mean = 1.92 (SD = 0.54) Mean = 1.47 (SD = 0.65)
Fair
CRS-parent CRS-parent NR
RCT (> 8 weeks
Mean = 1.93 (SD = 0.49) Mean = 1.62 (SD = 0.73)
with
b amphetamin CRS-Teacher * zinc vs. placebo CRS-Teacher * zinc vs. placebo NR
e in all Mean = 1.90 (0.67) Mean = 1.71 (SD = 0.79)
groups)
Placebo SNAP parent DSM-IV ADHD symptoms NR
Mean = 1.9 (SD = 0.63)
CRS-parent NR
Mean = 1.84 (0.56)
SNAP parent DSM-IV ADHD symptoms SNAP parent DSM-IV ADHD symptoms NR
Zinc 15mg 10 weeks Mean = 1.61 (SD = 0.52) Mean = 1.26 (0.62)
twice daily
CRS-parent CRS-parent NR
Mean = 1.52 (SD = 0.52) Mean = 1.21 (SD = 0.75)
CRS-Teacher * zinc vs. placebo CRS-Teacher * zinc vs. placebo NR
Mean = 1.23 (SD = 0.58) Mean = 1.40 (0.81)
SNAP parent DSM-IV ADHD symptoms NR
Placebo
Mean = 1.47 (0.51)
CRS-parent NR
Mean = 1.24 (0.5)
SNAP parent DSM-IV ADHD symptoms SNAP parent DSM-IV ADHD symptoms NR
Zinc 15mg 13 weeks Mean = 1.19 (0.56) Mean = 0.67 (0.38)
twice daily
CRS-parent CRS-parent NR
Mean = 1.08 (SD = 0.45) Mean = 0.81 (SD = 0.58)
CRS-Teacher * zinc vs. placebo CRS-Teacher * zinc vs. placebo NR
Mean = 0.9 (SD = 0.65) Mean = 0.63 (0.58)
Placebo SNAP parent DSM-IV ADHD symptoms NR
Mean = 1.01 (SD = 0.38)
CRS-parent NR
Mean = 0.91 (0.43)
SNAP parent DSM-IV ADHD symptoms SNAP parent DSM-IV ADHD symptoms NR
Zinc 15mg 21 weeks Mean = .99 (SD = 0.52) Mean = 0.67 (SD = 0.56)
twice daily
CRS-parent CRS-parent
Mean = .83 (SD = 0.47) Mean = 0.8 (SD = 0.59)
CRS-Teacher * zinc vs. placebo CRS-Teacher * zinc vs. placebo
Mean = 1.17 (SD = 0.53) Mean = 0.94 (0.69)
Placebo
SNAP parent DSM-IV ADHD symptoms
Mean = 0.82 (0.44)
H-42 CRS-parent
Mean = 0.72 (0.52)
Study
N Between
Follow-up
Qualitya Intervention Comparison Findings–Intervention Findings–Comparison group P
Times
Design value
Age Categoryb
Mohammadpour, 2000 IU Placebo 2 days CPRS Oppositional CPRS Oppositional NR
201673 Vitamin D Vitamin D Mean = 55.28 (SD 11.6) Mean = 59.76 (SD 12.1)
54 plus MPH plus MPH
Fair CPRS Cognitive CPRS Cognitive NR
RCT Mean = 56 (SD 11.8) Mean = 57.21 (SD 10.5)

c CPRS Hyperactive CPRS Hyperactive NR


Mean = 56.92 (SD 11.8) Mean = 59.79 (SD 12.4)

CPRS ADHD index CPRS ADHD index NR


Mean = 55.84 (SD 10.2) Mean = 56.79 (SD 9.6)

ADHD-RS, Inattentive ADHD-RS, Inattentive NR


Mean = 49.80 (SD 31.7) Mean = 61.37 (SD 29.5)

ADHD-RS, Hyperactive/Impulsive ADHD-RS, Hyperactive/Impulsive NR


Mean = 69.40 (SD 22.4) Mean = 77.44 (SD 19.5)

ADHD-RS, Total score ADHD-RS, Total score NR


Mean = 60.44 (SD 22.1) Mean = 71.75 (SD 23.6)
Gastrointestinal symptoms
Arnold, 201172 Zinc 15 mg Zinc 15mg 8 weeks Stomachaches + other GI Stomachaches + other GI NR
52 once daily twice daily # patients with outcome = 11 # patients with outcome = 4
Fair
RCT >8 weeks Stomachaches + other GI Stomachaches + other GI NR
# patients with outcome = 11 # patients with outcome = 3
b
Placebo 8 weeks Stomachaches + other GI NR
# patients with outcome = 18

>8 weeks Stomachaches + other GI NR


# patients with outcome = 14
Katz, 201074 Patented Placebo 0.5 months GI discomfort GI discomfort NR
120 herbal # patients with outcome = 2 # patients with outcome = 3
Fair preparation
RCT

b
Mood disorders
Katz, 201074 Patented Placebo 0.5 months Emotional lability Emotional lability NR
120 herbal # patients with outcome = 2 # patients with outcome = 4
Fair preparation
RCT

H-43
Study
N Between
Follow-up
Qualitya Intervention Comparison Findings–Intervention Findings–Comparison group P
Times
Design value
Age Categoryb
Motor vehicle collisions
Katz, 201074 Patented Placebo 0.5 months Accidental injury Accidental injury NR
120 herbal # patients with outcome = 1 # patients with outcome = 2
Fair preparation
RCT

b
Sleep disturbance
Arnold, 201172 Zinc 15 mg Zinc 15mg 8 weeks Sleep Sleep NR
52 once daily twice daily # patients with outcome = 0 # patients with outcome = 1
Fair
RCT >8 weeks Sleep Sleep NR
# patients with outcome = 8 # patients with outcome = 6
b
Placebo 8 weeks Sleep NR
# patients with outcome = 4

>8 weeks Sleep NR


# patients with outcome = 16
Katz, 201074 Patented Placebo 0.5 months Sleep disturbance Sleep disturbance NR
120 herbal # patients with outcome = 1 # patients with outcome = 4
Fair preparation
RCT

b
Suicide ideation
Arnold, 201172 Zinc 15 mg Zinc 15mg 8 weeks Harm to self or others Harm to self or others NR
52 once daily twice daily # patients with outcome = 1 # patients with outcome = 0
Fair
RCT >8 weeks Harm to self or others Harm to self or others NR
# patients with outcome = 1 # patients with outcome = 0
b
Placebo 8 weeks Harm to self or others NR
# patients with outcome = 0

>8 weeks Harm to self or others NR


# patients with outcome = 0

H-44
Study
N Between
Follow-up
Qualitya Intervention Comparison Findings–Intervention Findings–Comparison group P
Times
Design value
Age Categoryb
Tics or other movement disorders
Arnold, 201172 Zinc 15 mg Zinc 15mg 8 weeks Stereotypical behaviors Stereotypical behaviors NR
52 once daily twice daily # patients with outcome = 3 # patients with outcome = 1
Fair
RCT >8 weeks Stereotypical behaviors Stereotypical behaviors NR
# patients with outcome = 7 # patients with outcome = 2
b
Placebo 8 weeks Stereotypical behaviors NR
# patients with outcome = 5

>8 weeks Stereotypical behaviors NR


# patients with outcome = 9

aSee Methods section “Quality Assessment of Individual Studies” for definitions of quality assessment ratings.
bAge categories: a = children aged ≤6 years, b = children aged 7-17, c = children of all ages ≤17.
Abbreviations: ADHD=attention deficit hyperactivity disorder; CRS=Conners Rating Scale; SNAP=Swanson, Nolan and Pelham Revision; WPREMB=Weekly Parent Ratings of
Evening and Morning Behavior

Table H-13. Findings on other approaches for ADHD


Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Academic performance
Evans, 201677 Challenging Challenging 12 months GPA GPA P= 0.146
326 Horizons Horizons Mean = 2.3 Mean = 2.1
Fair Program–after Program–
RCT school version mentoring
version
b
Community GPA
Care Mean = 2.1

H-45
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Mautone, 201278 Family-School Coping with 12 weeks Academic Competence Evaluation Scales Academic Competence Evaluation Scales NR
61 Success-Early ADHD score score
Fair Elementary through Mean = 3.38 (SD = 0.57) Mean = 3.11 (SD = 0.5)
RCT Relationship
s and 2 months ACES score ACES score NR
c Education post-12 weeks Mean = 3.39 (SD = 0.48) Mean = 3.25 (SD = 0.66)

Power, 201279 Family School Coping With 3 months Academic Performance Rating Scale Academic Performance Rating Scale NS
199 Success ADHD Mean = 3.32 (SD = 0.65) Mean = 3.2 (SD = 0.68)
Fair Therapy Through
RCT Relationship 6 months Mean = 3.51 (SD = 0.64) Mean = 3.36 (SD = 0.76) NS
s and
b Education
Behavior changes

H-46
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Abikoff, 201580 New Forest Helping the 6.8 months Behavior changes-Conners Parent Rating Behavior changes-Conners Parent Rating NS
164 Parenting noncompliant Scale Revised Scale-Revised - Total Scale Revised Scale-Revised - Total
Good Package child Mean = 68.01 (SD = 11.69) Mean = 63.44 (SD = 10.13)
RCT
Behavior changes-Conners Parent Rating NS
Behavior changes-Conners Parent Rating
Scale Revised Scale-Revised - Inattention
a Scale Revised Scale-Revised - Inattention
Mean = 61.74 (SD 10.04)
Mean = 65.60 (SD 13.53)
Behavior changes-Conners Parent Rating NS
Behavior changes-Conners Parent Rating Scale Revised Scale-Revised -
Scale Revised Scale-Revised - Hyperactivity Hyperactivity
Mean = 68.08 (SD 10.69) Mean = 63.39 (SD 10.24)
Behavior changes-Conners Teachers NS
Behavior changes-Conners Teachers Rating
Rating Scale Revised Scale-Revised -
Scale Revised Scale-Revised - Total
Total
Mean = 64.27 (SD = 12.27)
Mean = 62.06 (SD = 11.39)
Behavior changes-Conners Teacher Rating Behavior changes-Conners Teacher Rating NS
Scale Revised Scale-Revised - Inattention Scale Revised Scale-Revised - Inattention
Mean = 61.39 (SD = 13.58) Mean = 60.48 (SD = 11.79)
Behavior changes-Conners Teacher Rating NS
Behavior changes-Conners Teacher Rating
Scale Revised Scale-Revised -
Scale Revised Scale-Revised - Hyperactivity
Hyperactivity
Mean = 64.25 (SD = 11.64)
Mean = 62.01 (SD = 12.06)
Behavior changes-Conners Parent Rating P=.001
Scale Revised Scale-Revised - Total
Control Mean = 76.44 (SD = 9.84)
Behavior changes-Conners Parent Rating P=.001
Scale Revised Scale-Revised - Inattention
Mean = 75.31 (SD 10.38)
Behavior changes-Conners Parent Rating P=.001
Scale Revised Scale-Revised -
Hyperactivity
Mean = 74.45 (SD 10.67)
Behavior changes-Conners Teachers NS
Rating Scale Revised Scale-Revised -
Total
Mean = 70.65 (SD = 11.22)
Behavior changes-Conners Parent Rating NS
Scale Revised Scale-Revised - Inattention
Mean = 68.22 (SD = 11.81)
Behavior changes-Conners Parent Rating NS
Scale Revised Scale-Revised -
Hyperactivity
H-47 Mean = 70.26 (SD = 11.98)
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Mohammadi, MPH + MPH + 8 weeks Irritability Irritability
201281 melatonin placebo # patients with outcome = 16 # patients with outcome = 10 NR
(Mostafavi,
201282) Sadness Sadness
60 # patients with outcome = 10 # patients with outcome = 2 NR
Fair
RCT

b
Myers, 201583 Telemedicine Usual Care + 25 weeks Behavior changes-Vanderbilt caregiver,
223 Consult meeting criteria for inattention P<.001
Fair
RCT Behavior changes-Vanderbilt caregiver,
meeting criteria for hyperactivity P=.02
c
Behavior changes-Vanderbilt caregiver,
meeting criteria for Combined P=.005

Behavior changes-Vanderbilt teacher, meeting


criteria for inattention NS

Behavior changes-Vanderbilt teacher, meeting


criteria for hyperactivity P=.02

Behavior changes-Vanderbilt teacher, meeting


criteria for combined P=.045

H-48
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Oberai, 201384 Homeopathy Placebo 6 weeks CPRS-R Oppositional CPRS-R Oppositional NR
61 Mean = 56.4 (SD = 7) Mean = 63.2 (SD = 8.3)
Fair
RCT CPRS-R Cognition Problems CPRS-R Cognition Problems NR
Mean = 56.6 (SD = 7.4) Mean = 67.4 (SD = 5.4)
b
CPRS-R Hyperactivity CPRS-R Hyperactivity NR
Mean = 63.7 (SD = 9.8) Mean = 78.3 (SD = 7.9)

CPRS-R ADHD Index CPRS-R ADHD Index NR


Mean = 58.2 (SD = 7.3) Mean = 68.3 (SD = 4.6)

12 weeks CPRS-R Oppositional CPRS-R Oppositional P=.0001


Mean =49.5 (9.5) Mean = 66.2 (7.6)

CPRS-R Cognition Problems CPRS-R Cognition Problems P=.0001


Mean = 50.7 (7.7) Mean = 66.6 (6.2)

CPRS-R Hyperactivity CPRS-R Hyperactivity P=.0001


Mean = 55.6 (11.9) Mean = 78.2 (6.9)

CPRS-R ADHD Index CPRS-R ADHD Index P=.0001


Mean = 51.8 (9.1) Mean = 68.4 (5)

Conners Parent Rating Scale – Revised P = 0.005


Effect size = 0.22
Changes in appetite
Mohammadi, MPH + MPH + 8 weeks Appetite score Appetite score P=0.755
201281 melatonin placebo Mean = 13.26 Mean = 12.33
(Mostafavi82)
60 Loss of appetite Loss of appetite
Fair # patients with outcome = 14 # patients with outcome = 11
RCT

H-49
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Changes in standardized symptom scores
Hong, 201585 Acupuncture Waitlist 1.5 months ADHD-RS (Korean version) total score ADHD-RS (Korean version) total score 0.561
48 control Mean = -4.91 (SD 10.50) Mean = -4.00 (SD 11.00)
Fair
RCT ADHD-RS Inattention ADHD-RS Inattention 0.250
Mean w/in group change = -2.67 (SD 4.90) Mean w/in group change = -1.68 (SD 4.61)
b
ADHD-RS Hyperactivity/Impulsivity ADHD-RS Hyperactivity/Impulsivity 0.956
Mean w/in group change = -2.26 (SD 5.50) Mean w/in group change = -2.84 (SD 4.00)

Conners-RS Conners-RS 0.385


Mean w/in group change = -2.51 (SD 4.95) Mean w/in group change = -1.78 (SD 4.14)

CBCL total score CBCL total score 0.393


Mean w/in group change = -7.79 (SD 16.69) Mean w/in group change = -3.00 (SD
25.00)
CBCL-ADHD subscale 0.247
Mean w/in group change = -1.38 (SD 3.54) CBCL-ADHD subscale
Mean w/in group change = -0.64 (SD 4.36)
CBCL-external subscale 0.632
Mean w/in group change = -1.85 (SD 7.19) CBCL-external subscale
Mean w/in group change = -1.00 (SD
10.00)
Mohammadi, MPH + MPH + 8 weeks ADHD RS attention score ADHD RS attention score P= 0.974
201281 melatonin placebo Mean = 11.11 Mean = 11.29
(Mostafavi,
201282) ADHD-RS Hyperactivity score ADHD-RS Hyperactivity score P= 0.720
60 Mean = 11.62 Mean = 10.96
Fair
RCT

b
Webster- Incredible Waitlist 5 months CBCL-mother Attention problems CBCL-mother Attention problems NS
Stratton, 201186 Years Mean = 65.8 (SD = 7) Mean = 68.8 (SD = 9.6)
99 Program
Fair CBCL Father – Attention problems CBCL Father – Attention problems NS
RCT Mean = 64.8 (SD = 8.6) Mean = 65.8 (SD = 10)

H-50
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Functional impairment
Evans, 201677 Challenging Challenging 6 months Impairment Rating Scale- Parent report; Impairment Rating Scale- Parent report; NR
326 Horizons Horizons post-treatment relation to children relation to children
Fair Program–after Program– Mean = 1.76 (SD = 1.89) Mean = 1.67 (SD = 1.78)
RCT school version mentoring
version
b

Community Impairment Rating Scale- Teacher report; Impairment Rating Scale- Teacher report; NS
Care Relation with peers Relation with peers
Mean = 1.93 (SD = 1.91) Mean = 1.97 (SD = 1.83)

Impairment Rating Scale- Parent report; NS


relation to children
Mean = 1.8 (SD = 1.69)

Impairment Rating Scale- Teacher report;


Relation with peers
Mean = 1.72 (SD = 1.94)
Hong, 201585 Acupuncture Waitlist 1.5 months CGI-S CGI-S 0.012
48 control Mean w/in group change = -0.83 (SD 1.00) Mean w/in group change = 0.00 (SD 1.00)
Fair
RCT

b
Oberai, 201384 Homeopathy Placebo 6 weeks CGI-SS CGI-SS NR
61 Mean = 2.9 (SD = 0.7) Mean = 3.8 (SD = 0.6)
Fair
RCT 12 weeks Clinical Global Impression Severity Scale Clinical Global Impression Severity Scale P=.0001
Mean = 2.5 (0.7) Mean = 4 (0.6)
b
Gastrointestinal symptoms
Mohammadi, MPH + MPH + 8 weeks Stomachache Stomachache
201281 melatonin placebo # patients with outcome = 9 # patients with outcome = 5 NR
(Mostafavi,
201282) Nausea and vomiting Nausea and vomiting
60 # patients with outcome = 3 # patients with outcome = 3 NR
Fair
RCT

H-51
Study
(Companion)
Between
N Follow-up
Intervention Comparison Findings–Intervention Findings–Comparison group P
Qualitya Times
value
Design
Age Categoryb
Sleep disturbance
Mohammadi, MPH + MPH + 8 weeks Mean sleep latency (min) Mean sleep latency (min) P=0.267
201281 melatonin placebo Mean = 17.96 Mean = 26.37
(Mostafavi,
201282) Total sleep (hour) Total sleep (hour) P= 0.197
60 Mean = 8.51 Mean = 8.27
Fair
RCT SDSC sleep score SDSC sleep score P= 0.528
Mean = 41.3 Mean = 45.5
b
Insomnia Insomnia NR
# patients with outcome = 8 # patients with outcome = 8

Sleepiness Sleepiness NR
# patients with outcome = 4 # patients with outcome = 4
Tics or other movement disorders
Mohammadi, MPH + MPH + 8 weeks Dyskinesias Dyskinesias
201281 melatonin placebo # patients with outcome = 0 # patients with outcome = 2 NR
(Mostafavi,
201282) Tics Tics
60 # patients with outcome = 1 # patients with outcome = 1 NR
Fair
RCT

b
Weight decrease
Mohammadi, MPH + MPH + 8 weeks Weight loss Weight loss
201281 melatonin placebo # patients with outcome = 9 # patients with outcome = 9 NR
(Mostafavi,
201282)
60
Fair
RCT

b
a See Methods section “Quality Assessment of Individual Studies” for definitions of quality assessment ratings.
b Age categories: a = children aged ≤6 years, b = children aged 7-17, c = children of all ages ≤17.

Abbreviations: ADHD=attention deficit hyperactivity disorder; CBCL=Child Behavior Checklist; CGI-SS= Clinical Global Impression of Severity of Suicidality; CPRS=Conners
Parent Rating Scale; GPA=grade point average; SDSC=Sleep Disturbance Scale for Children

H-52
References to Appendix H
1. Bunte TL, Laschen S, Schoemaker K, et al. 7. Liechti MD, Valko L, Muller UC, et al.
Clinical usefulness of observational Diagnostic value of resting
assessment in the diagnosis of DBD and electroencephalogram in attention-
ADHD in preschoolers. J Clin Child deficit/hyperactivity disorder across the
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10.1080/15374416.2013.773516. PMID: 51. doi: 10.1007/s10548-012-0258-6.
23477379. PMID: 23053601.
2. Bunte TL, Schoemaker K, Hessen DJ, et al. 8. Castro-Cabrera P, Gomez-Garcia J, Restrepo
Clinical usefulness of the Kiddie-Disruptive F, et al. Evaluation of feature extraction
Behavior Disorder Schedule in the diagnosis techniques on event-related potentials for
of DBD and ADHD in preschool children. J detection of attention-deficit/hyperactivity
Abnorm Child Psychol. 2013 Jul;41(5):681- disorder. Conf Proc IEEE Eng Med Biol
90. doi: 10.1007/s10802-013-9732-1. Soc. 2010;2010:851-4. doi:
PMID: 23474833. 10.1109/iembs.2010.5626862. PMID:
21096317.
3. Thorell LB, Eninger L, Brocki KC, et al.
Childhood executive function inventory 9. Soliva JC, Fauquet J, Bielsa A, et al.
(CHEXI): a promising measure for Quantitative MR analysis of caudate
identifying young children with ADHD? J abnormalities in pediatric ADHD: proposal
Clin Exp Neuropsychol. 2010 Jan;32(1):38- for a diagnostic test. Psychiatry Res. 2010
43. doi: 10.1080/13803390902806527. Jun 30;182(3):238-43. doi:
PMID: 19381995. 10.1016/j.pscychresns.2010.01.013. PMID:
20488672.
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