A 14-Month Randomized Clinical Trial of Treatment Strategies for Attention-Deficit/Hyperactivity Disorder
Abstract
BACKGROUND: Previous studies have demonstrated the short-term efficacy of pharmacotherapy and behavior therapy for attention-deficit/hyperactivity disorder (ADHD), but no longer-term (i.e., >4 months) investigations have compared these 2 treatments or their combination. METHODS: A group of 579 children with ADHD Combined Type, aged 7 to 9.9 years, were assigned to 14 months of medication management (titration followed by monthly visits); intensive behavioral treatment (parent, school, and child components, with therapist involvement gradually reduced over time); the two combined; or standard community care (treatments by community providers). Outcomes were assessed in multiple domains before and during treatment and at treatment end point (with the combined treatment and medication management groups continuing medication at all assessment points). Data were analyzed through intent-to-treat random-effects regression procedures. RESULTS: All 4 groups showed sizable reductions in symptoms over time, with significant differences among them in degrees of change. For most ADHD symptoms, children in the combined treatment and medication management groups showed significantly greater improvement than those given intensive behavioral treatment and community care. Combined and medication management treatments did not differ significantly on any direct comparisons, but in several instances (oppositional/aggressive symptoms, internalizing symptoms, teacher-rated social skills, parent-child relations, and reading achievement) combined treatment proved superior to intensive behavioral treatment and/or community care while medication management did not. Study medication strategies were superior to community care treatments, despite the fact that two thirds of community-treated subjects received medication during the study period. CONCLUSIONS: For ADHD symptoms, our carefully crafted medication management was superior to behavioral treatment and to routine community care that included medication. Our combined treatment did not yield significantly greater benefits than medication management for core ADHD symptoms, but may have provided modest advantages for non-ADHD symptom and positive functioning outcomes.
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In the MTA study, the combination of behavioral therapy and stimulant medication was not significantly more effective than medication alone for ADHD's core symptoms after correcting for multiple tests in the primary analysis.
“In the MTA study, researchers found that although the combination of behavioral therapy and stimulant medication was not significantly more effective than treatment with medication alone for ADHD’s core symptoms, after correcting for multiple tests in the primary analysis,139”
From Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents (2019) · cites this paper as [139]
Behavioral therapy has positive effects when combined with medication for preadolescent children.
“Studies indicate that behavioral therapy has positive effects when it is combined with medication for preadolescent children.139”
From Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents (2019) · cites this paper as [139]
Clinical experience has long suggested that stimulants can have positive, favorable effects on emotional lability.
“Though debate persists over the neural mechanisms by which stimulants improve emotional lability, clinical experience has long suggested that stimulants can have positive, favorable effects on emotional lability.”
From Using Stimulants to Treat ADHD-Related Emotional Lability (2014) · cites this paper as [31]
Behavioral interventions are harder to maintain over long periods, cost more, and may be less effective than stimulants, especially for core ADHD symptoms.
“Behavioral interventions, in contrast, are often more difficult to sustain over long durations, are generally more costly, and, arguably, may be less effective than stimulant medications—particularly for the core symptoms of ADHD”
From Improving Outcomes for Youth with ADHD: A Conceptual Framework for Combined Neurocognitive and Skill-Based Treatment Approaches (2014) · cites this paper as MTA Cooperative Group, 1999
Pharmacological and psychosocial treatments for ADHD that have evidence support produce only short-term effects, usually do not transfer to untreated settings, seldom persist, and do not adequately improve functional impairment or executive functioning.
“Although evidence-based pharmacological and psychosocial treatments exist for ADHD, effects of these treatments are acute, do not typically generalize into non-treated settings, rarely sustain over time, and insufficiently affect key areas of functional impairment (i.e., family, social, and academic functioning) and executive functioning.”
From Improving Outcomes for Youth with ADHD: A Conceptual Framework for Combined Neurocognitive and Skill-Based Treatment Approaches (2014) · cites this paper as MTA Cooperative Group, 1999
Even though these treatments help behavioral symptoms, they do not normalize behavior for a substantial portion of youth with ADHD; in the MTA study, one-third to two-thirds did not show clinically significant improvement.
“these interventions do not normalize behavior for a significant number of youth with ADHD. As an example, Swanson and colleagues (2001) found that despite intensive, relatively long-term stimulant medication and behavioral treatment, one-third to two-thirds of youth with ADHD did not evince clinically significant improvements in the Multimodal Treatment of ADHD Study (MTA, 1999).”
From Improving Outcomes for Youth with ADHD: A Conceptual Framework for Combined Neurocognitive and Skill-Based Treatment Approaches (2014) · cites this paper as MTA, 1999
In the MTA, medication use mediated changes in ADHD symptom ratings from baseline to 14 months and from 14 to 24 months, supporting the initial 14-month randomized trial finding that carefully monitored t.i.d. stimulant medication, with or without behavioral therapy, produced better outcomes than community care or behavioral therapy alone.
“In the NIMH Collaborative Multisite Multimodal Treatment Study of Children With Attention-Deficit/Hyperactivity Disorder (MTA), medication use mediated the degree of baseline to 14-month, and 14-to 24-month changes in ADHD symptom ratings, buttressing the initial 14-month randomized clinical trial findings 4,5,15 that the use of a carefully monitored t.i.d.schedule of stimulant medication (with or”
From Medication Adherence in the MTA: Saliva Methylphenidate Samples Versus Parent Report and Mediating Effect of Concomitant Behavioral Treatment (2009) · cites this paper as [4]
In the MTA, 579 children with ADHD combined type aged 7-9.9 years were randomly assigned to medication management, behavior treatment, combined treatment, or community care.
“579 children with ADHD combined type (aged 7Y9.9 years) were randomly assigned to medication management consisting of titration with t.i.d.administration of 5 to 20 mg of immediate-release MPH followed by monthly visits (MedMgt); behavior treatment consisting of intensive parent, school, and child components, with therapist involvement gradually reduced over time (Beh); the two combined (Comb); or”
From Medication Adherence in the MTA: Saliva Methylphenidate Samples Versus Parent Report and Mediating Effect of Concomitant Behavioral Treatment (2009) · cites this paper as [4]
Random-effects regression was used for longitudinal analyses because it has advantages over traditional ANOVA for clinical trials data.
“Given the advantages of random-effects regression (RR) techniques over traditional analyses of variance for longitudinal clinical trials data, 4,11 we used RR for subsequent analyses”
From Medication Adherence in the MTA: Saliva Methylphenidate Samples Versus Parent Report and Mediating Effect of Concomitant Behavioral Treatment (2009) · cites this paper as [4]
In MTA, medication management and combination subjects began with a 28-day, double-blind, daily-switch titration of MPH hydrochloride using five randomly ordered repeats each of placebo, 5, 10, and 15 or 20 mg, with the higher dose determined by weight.
“subjects in the medication management and combination groups started with a 28-day, double-blind, daily-switch titration of MPH hydrochloride, using 5 randomly ordered repeats each of placebo, 5, 10, and 15 or 20 mg, with the higher dose, 15 mg versus 20 mg, being determined on the basis of the child's weight (threshold Q26 kg).”
From Medication Adherence in the MTA: Saliva Methylphenidate Samples Versus Parent Report and Mediating Effect of Concomitant Behavioral Treatment (2009) · cites this paper as [4]
There were no completed suicides in the MTA reports.
“There were no completed suicides.”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [1]
In terms of severity and impact, most reports to the Multimodal Treatment Study of Children with ADHD (MTA) were of mild and transient symptoms that did not require hospitalisation.
“In terms of severity and impact, most reports to the Multimodal Treatment Study of Children with ADHD (MTA) were of mild and transient symptoms that did not require hospitalisation [1].”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [1]
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- Authors
- The MTA Cooperative Group
- Corresponding author
- The MTA Cooperative Group
- Venue
- Archives of General Psychiatry
- Publisher
- American Medical Association (AMA)
- Published
- 1999-12-01
- Volume
- 56
- Issue
- 12
- Pages
- 1073
- ISSN
- 0003-990X (ISSN-L)
- OpenAlex
- W2601578636
- Cited by
- 3,372
- References
- 35
- Citations by year
- 2026: 32 · 2025: 50 · 2024: 49 · 2023: 47 · 2022: 71 · 2021: 97 · 2020: 125 · 2019: 113 · 2018: 99 · 2017: 134 · 2016: 147 · 2015: 136 · 2014: 156 · 2013: 146 · 2012: 164
- FWCI
- 74.27
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of General Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion)
- Funders
- National Institute of Mental Health (UO1 MH50461, UO1 MH50440, U01MH050447, U01MH050440, UO1 MH50447, U01MH050461)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Social Sciences › Psychology › Developmental and Educational Psychology › Behavioral and Psychological Studies
- Social Sciences › Psychology › Clinical Psychology › Child and Adolescent Psychosocial and Emotional Development
- Keywords
- attention deficit hyperactivity disorder, combined type ADHD, medication management, community-based care, children, long-term treatment efficacy, parent training, school-based intervention, reading achievement, social skills, parent-child relationship, internalizing problems
- MeSH terms
- Central Nervous System Stimulants, Anxiety Disorders, Attention Deficit Disorder with Hyperactivity, Behavior Therapy, Child, Combined Modality Therapy, Community Mental Health Services, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Methylphenidate, Patient Acceptance of Health Care, Patient Compliance, Referral and Consultation, Regression Analysis, Comorbidity, Treatment Outcome
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