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Multimodal Treatment Study of Children With Attention Deficit and Hyperactivity Disorder (MTA)

This study has been completed.
Study NCT00000388.   Last updated on March 26, 2008.   Information provided by National Institute of Mental Health (NIMH)

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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 
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        
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

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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