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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00000388 |
Purpose
This trial is a continuation of the Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (MTA Study). Continuation Aim 1 is to track the persistence of intervention-related effects as the MTA sample matures into mid-adolescence, including subsequent mental-health and school-related service utilization patterns as a function of MTA treatment experience (treatment assignment) and outcome (degree of treatment success at 14 mo.). Aim 2 is to test specific hypotheses about predictors, mediators, and moderators of long-term outcome among children with ADHD (e.g., comorbidity; family functioning; cognitive skills; peer relations) that may influence adolescent functioning (either independent of or through initial treatment assignment and/or 14-month treatment outcomes); and to compare how these predictors, mediators, and moderators are similar or dissimilar within the normal comparison group. Aim 3 is to track the patterns of risk and protective factors (including their mediation or moderation by initial treatment assignment and/or outcome) involved in early and subsequent stages of developing substance-related disorders and antisocial behavior. Aim 4 is to examine the effect of initial treatment assignment and degree of treatment success on later academic performance, achievement, school conduct, tendency to drop out, and other adverse school outcomes.
In the original MTA design, patients were randomly assigned to 1 of 4 treatment conditions: (1) medication only; (2) psychosocial only; (3) combined (medication and psychosocial); or (4) Assessment-and-Referral condition. All but the latter were treated intensively for 14 months, with assessments for all subjects at baseline, 3, 9, 14, and 24 months. The original MTA design thus provides short-term (10 months post-treatment) follow-up at 24 months. This continuation extends the follow-up to assessments at 36, 60, and 84 months after treatment.
A child may be eligible for this study if he/she:
Is 7 - 9 years old, and has Attention Deficit Hyperactivity Disorder (ADHD).
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Disorder With Hyperactivity Substance-Related Disorders Dyssocial Behavior |
Behavioral: Psychosocial treatment Drug: Anti-ADHD medication Behavioral: Assessment-and-Referral |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | Multimodal Treatment Study of Children With ADHD |
| Study Start Date: | September 1998 |
| Estimated Study Completion Date: | November 1999 |
This trial is a continuation of the Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (MTA Study). Continuation Aim 1 is to track the persistence of intervention-related effects as the MTA sample matures into mid-adolescence, including subsequent mental-health and school-related service utilization patterns as a function of MTA treatment experience (treatment assignment) and outcome (degree of treatment success at 14 mo.). Aim 2 is to test specific hypotheses about predictors, mediators, and moderators of long-term outcome among children with ADHD (e.g., comorbidity; family functioning; cognitive skills; peer relations) that may influence adolescent functioning (either independent of or through initial treatment assignment and/or 14-month treatment outcomes); and to compare how these predictors, mediators, and moderators are similar or dissimilar within the normal comparison group. Aim 3 is to track the patterns of risk and protective factors (including their mediation or moderation by initial treatment assignment and/or outcome) involved in early and subsequent stages of developing substance-related disorders and antisocial behavior. Aim 4 is to examine the effect of initial treatment assignment and degree of treatment success on later academic performance, achievement, school conduct, tendency to drop out, and other adverse school outcomes.
In the original MTA design, patients were randomly assigned to 1 of 4 treatment conditions: (1) medication only; (2) psychosocial only; (3) combined (medication and psychosocial); or (4) Assessment-and-Referral condition. All but the latter were treated intensively for 14 months, with assessments for all subjects at baseline, 3, 9, 14, and 24 months. The original MTA design thus provides short-term (10 months post-treatment) follow-up at 24 months. This continuation extends the follow-up to assessments at 36, 60, and 84 months after treatment.
Eligibility| Ages Eligible for Study: | 7 Years to 9 Years |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
-
Patients must have:
Rigorously diagnosed Attention Deficit Hyperactivity Disorder (ADHD).
Contacts and Locations| Principal Investigator: | Howard B. Abikoff, PhD | |
| Principal Investigator: | C. Keith Conners | |
| Principal Investigator: | Laurence L. Greenhill, MD | |
| Principal Investigator: | Stephen P. Hinshaw, PhD | |
| Principal Investigator: | William E. Pelham, PhD | |
| Principal Investigator: | James M. Swanson, PhD |
More Information
| Study ID Numbers: | MH50453, MH50447, MH50454, MH50461, MH50467, MH50440, DSIR CT |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000388 |
| Health Authority: | United States: Federal Government |
|
Attention Deficit Disorder with Hyperactivity Adolescence Child Cognition Combined Modality Therapy Female Human |
Male Peer Group Risk Factors Treatment Outcome Attention Deficit Disorder with Hyperactivity -- *therapy Attention Deficit Disorder with Hyperactivity -- drug therapy Attention Deficit Disorder with Hyperactivity -- psychology |
|
Attention Deficit and Disruptive Behavior Disorders Disorders of Environmental Origin Antisocial personality disorder Dyskinesias Signs and Symptoms Attention Deficit Disorder with Hyperactivity Mental Disorders |
Mental Disorders Diagnosed in Childhood Substance-Related Disorders Hyperkinesis Neurologic Manifestations Antisocial Personality Disorder Personality Disorders |
|
Pathologic Processes Disease Nervous System Diseases |
