CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed
Drug / intervention
Anti-ADHD medication +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT00000388
NCT00000388Phase 4Completed

Multimodal Treatment Study of Children With ADHD

NYU Langone Health·interventional·Posted Nov 3, 1999·Updated Sep 29, 2015

In Brief

A Phase 4 clinical trial evaluating Psychosocial treatment, Anti-ADHD medication, and 1 other intervention for Attention Deficit Disorder With Hyperactivity and 2 related conditions. Completed.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 4CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 3, 1999
Enrollment StartSep 1, 1998
Study CompletionNov 1, 1999
TodayJul 2, 2026
Posted 26.7 years ago

Interventions

Psychosocial treatmentbehavioral

Anti-ADHD medicationdrug

Assessment-and-Referralbehavioral