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

Primary Purpose

Attention Deficit Disorder With Hyperactivity, Substance-related Disorders, Dyssocial Behavior

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Psychosocial treatment
Anti-ADHD medication
Assessment-and-Referral
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring 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

Eligibility Criteria

7 Years - 9 Years (Child)All Sexes

Inclusion Criteria: - Patients must have: Rigorously diagnosed Attention Deficit Hyperactivity Disorder (ADHD).

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 2, 1999
    Last Updated
    September 28, 2015
    Sponsor
    NYU Langone Health
    Collaborators
    National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000388
    Brief Title
    Multimodal Treatment Study of Children With Attention Deficit and Hyperactivity Disorder (MTA)
    Acronym
    MTA
    Official Title
    Multimodal Treatment Study of Children With ADHD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1998 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 1999 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    NYU Langone Health
    Collaborators
    National Institute of Mental Health (NIMH)

    4. Oversight

    5. 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention Deficit Disorder With Hyperactivity, Substance-related Disorders, Dyssocial Behavior
    Keywords
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychosocial treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Anti-ADHD medication
    Intervention Type
    Behavioral
    Intervention Name(s)
    Assessment-and-Referral

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    9 Years
    Eligibility Criteria
    Inclusion Criteria: - Patients must have: Rigorously diagnosed Attention Deficit Hyperactivity Disorder (ADHD).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Howard B. Abikoff, PhD
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    C. Keith Conners
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Laurence L. Greenhill, MD
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Stephen P. Hinshaw, PhD
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    William E. Pelham, PhD
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    James M. Swanson, PhD
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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