Multimodal Treatment Study of Children With Attention Deficit and Hyperactivity Disorder (MTA)
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| First Received Date ICMJE | November 2, 1999 | ||||||||||||||||||||||||
| Last Updated Date | March 26, 2008 | ||||||||||||||||||||||||
| Start Date ICMJE | September 1998 | ||||||||||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00000388 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||
| Brief Title ICMJE | Multimodal Treatment Study of Children With Attention Deficit and Hyperactivity Disorder (MTA) | ||||||||||||||||||||||||
| Official Title ICMJE | Multimodal Treatment Study of Children With ADHD | ||||||||||||||||||||||||
| Brief Summary | 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). |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||||||||||||||||||||||
| Study Phase | Phase 4 | ||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||||||||||||||||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||
| Enrollment ICMJE | Not Provided | ||||||||||||||||||||||||
| Completion Date | November 1999 | ||||||||||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Patients must have: Rigorously diagnosed Attention Deficit Hyperactivity Disorder (ADHD). |
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| Gender | Both | ||||||||||||||||||||||||
| Ages | 7 Years to 9 Years | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||
| Location Countries ICMJE | Not Provided | ||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||
| NCT Number ICMJE | NCT00000388 | ||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | MH50453, MH50447, MH50454, MH50461, MH50467, MH50440, DSIR CT | ||||||||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||||||||||
| Responsible Party | Not Provided | ||||||||||||||||||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||||||||||||||||||
| Verification Date | March 2008 | ||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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