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

This study has been completed.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00000388
  Purpose

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 Intervention Phase
Attention Deficit Disorder With Hyperactivity
Substance-Related Disorders
Dyssocial Behavior
Behavioral: Psychosocial treatment
Drug: Anti-ADHD medication
Behavioral: Assessment-and-Referral
Phase IV

MedlinePlus related topics:   Attention Deficit Hyperactivity Disorder    Child Mental Health    Mental Health   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   Multimodal Treatment Study of Children With ADHD

Further study details as provided by National Institute of Mental Health (NIMH):

Study Start Date:   September 1998
Estimated Study Completion Date:   November 1999

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.

  Eligibility
Ages Eligible for Study:   7 Years to 9 Years
Genders Eligible for Study:   Both

Criteria

Inclusion Criteria:

-

Patients must have:

Rigorously diagnosed Attention Deficit Hyperactivity Disorder (ADHD).

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000388

Sponsors and 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    
  More Information

Publications of Results:

Study ID Numbers:   MH50453, MH50447, MH50454, MH50461, MH50467, MH50440, DSIR CT
First Received:   November 2, 1999
Last Updated:   March 26, 2008
ClinicalTrials.gov Identifier:   NCT00000388
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
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

Study placed in the following topic categories:
Attention Deficit and Disruptive Behavior Disorders
Disorders of Environmental Origin
Antisocial personality disorder
Dyskinesias
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Substance-Related Disorders
Hyperkinesis
Neurologic Manifestations
Antisocial Personality Disorder
Personality Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on September 08, 2008




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