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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000388
First Posted: November 3, 1999
Last Update Posted: September 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
New York University School of Medicine
November 2, 1999
November 3, 1999
September 29, 2015
September 1998
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Complete list of historical versions of study NCT00000388 on ClinicalTrials.gov Archive Site
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Multimodal Treatment Study of Children With Attention Deficit and Hyperactivity Disorder (MTA)
Multimodal Treatment Study of Children With ADHD

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).

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.

Interventional
Phase 4
Allocation: Randomized
Primary Purpose: Treatment
  • Attention Deficit Disorder With Hyperactivity
  • Substance-related Disorders
  • Dyssocial Behavior
  • Behavioral: Psychosocial treatment
  • Drug: Anti-ADHD medication
  • Behavioral: Assessment-and-Referral
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 1999
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Inclusion Criteria:

Patients must have:

Rigorously diagnosed Attention Deficit Hyperactivity Disorder (ADHD).

Sexes Eligible for Study: All
7 Years to 9 Years   (Child)
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Contact information is only displayed when the study is recruiting subjects
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NCT00000388
U01MH050453( U.S. NIH Grant/Contract )
U01MH050453 ( U.S. NIH Grant/Contract )
MH50447
MH50454
MH50461
MH50467
MH50440
DSIR CT
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New York University School of Medicine
National Institute of Mental Health (NIMH)
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
New York University School of Medicine
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP