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

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT00000388
Collaborator
National Institute of Mental Health (NIMH) (NIH)
14
Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Psychosocial treatment
  • Drug: Anti-ADHD medication
  • Behavioral: Assessment-and-Referral
 Phase 4

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 Design

Study Type:
Interventional
Allocation:
Randomized
Primary Purpose:
Treatment
Official Title:
Multimodal Treatment Study of Children With ADHD
Study Start Date :
Sep 1, 1998
Study Completion Date :
Nov 1, 1999

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 9 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    Patients must have:

    Rigorously diagnosed Attention Deficit Hyperactivity Disorder (ADHD).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • NYU Langone Health
    • National Institute of Mental Health (NIMH)

    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,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00000388
    Other Study ID Numbers:
    • U01MH050453
    • U01MH050453
    • MH50447
    • MH50454
    • MH50461
    • MH50467
    • MH50440
    • DSIR CT
    First Posted:
    Nov 3, 1999
    Last Update Posted:
    Sep 29, 2015
    Last Verified:
    Sep 1, 2015
    Keywords provided by , ,
    Attention Deficit Disorder with Hyperactivity
    Adolescence
    Child
    Cognition
    Combined Modality Therapy
    Female
    Human
    Male
    Peer Group
    Risk Factors
    Treatment Outcome
    Attention Deficit Disorder with Hyperactivity -- *therapy
    Attention Deficit Disorder with Hyperactivity -- drug therapy
    Attention Deficit Disorder with Hyperactivity -- psychology
    Additional relevant MeSH terms:
    Hyperkinesis
    Disease
    Substance-Related Disorders
    Attention Deficit Disorder with Hyperactivity
    Antisocial Personality Disorder

    Study Results

    No Results Posted as of Sep 29, 2015