|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||||||||||||||||||||||
| Brief Title † | Multimodal Treatment Study of Children With Attention Deficit and Hyperactivity Disorder (MTA) | ||||||||||||||||||||||||
| Official Title † | 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). |
||||||||||||||||||||||||
| 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. |
||||||||||||||||||||||||
| Study Phase | Phase IV | ||||||||||||||||||||||||
| Study Type † | Interventional | ||||||||||||||||||||||||
| Study Design † | Treatment, Randomized | ||||||||||||||||||||||||
| Primary Outcome Measure † | |||||||||||||||||||||||||
| Secondary Outcome Measure † | |||||||||||||||||||||||||
| Condition † | Attention Deficit Disorder With Hyperactivity Substance-Related Disorders Dyssocial Behavior |
||||||||||||||||||||||||
| Intervention † | Behavioral: Psychosocial treatment Drug: Anti-ADHD medication Behavioral: Assessment-and-Referral |
||||||||||||||||||||||||
| MEDLINE PMIDs | 10591283 | ||||||||||||||||||||||||
| Links | |||||||||||||||||||||||||
| Recruitment Information Fields | |||||||||||||||||||||||||
| Recruitment Status † | Completed | ||||||||||||||||||||||||
| Enrollment † | |||||||||||||||||||||||||
| Start Date † | September 1998 | ||||||||||||||||||||||||
| Completion Date | November 1999 | ||||||||||||||||||||||||
| Eligibility Criteria † | Inclusion Criteria: - Patients must have: Rigorously diagnosed Attention Deficit Hyperactivity Disorder (ADHD). |
||||||||||||||||||||||||
| Gender | Both | ||||||||||||||||||||||||
| Ages | 7 Years to 9 Years | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | |||||||||||||||||||||||||
| Contacts †† | |||||||||||||||||||||||||
| Location Countries † | |||||||||||||||||||||||||
| Administrative Information Fields | |||||||||||||||||||||||||
| NCT ID † | NCT00000388 | ||||||||||||||||||||||||
| Organization ID | MH50453 | ||||||||||||||||||||||||
| Secondary IDs †† | MH50447, MH50454, MH50461, MH50467, MH50440, DSIR CT | ||||||||||||||||||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||||||||||||||||||
| Collaborators †† | |||||||||||||||||||||||||
| Investigators † |
|
||||||||||||||||||||||||
| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||||||||||||||||||
| Verification Date | March 2008 | ||||||||||||||||||||||||
| First Received Date † | November 2, 1999 | ||||||||||||||||||||||||
| Last Updated Date | March 26, 2008 | ||||||||||||||||||||||||