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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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Multimodal Treatment Study of Children With ADHD

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

Patients must have:

Rigorously diagnosed Attention Deficit Hyperactivity Disorder (ADHD).

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000388


Sponsors and Collaborators
New York University School of Medicine
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
  More Information

Publications:
Arnold, L. E., Abikoff, H. B., Cantwell, D. P., Conners, C. K., Elliott, G. R., Greenhill, L. L.,Hechtman, L., Hinshaw, S.P., Hoza B., Jensen, P.S., Kraemer, H.C, March, J.S., Newcorn, J.H., Pelham, W.E., Richters, J.E., Schiller, E., Severe, J.B., Swanson, J.M., Vereen, D., Wells, K.C. (1997). NIMH collaborative multimodal treatment study of children with ADHD (MTA): Design, methodology, and protocol evolution. Journal of Attention Disorders, 2(3), 141-158.
Hinshaw, S. P., March, J. S., Abikoff, H., Arnold, L. E., Cantwell, D. P., Conners, C. K., . . . Wigal, T. (1997). Comprehensive assessment of childhood attention-deficit hyperactivity disorder in the context of a multisite, multimodal clinical trial. Journal of Attention Disorders, 1(4), 217-234.
Arnold, L. E., Elliott, M., Lindsay, R. L., Molina, B., Cornelius, M. D., Vitiello, B., . . . Wells, K. (2005). Gestational and postnatal tobacco smoke exposure as predictor of ADHD, comorbid ODD/CD, and treatment response in the MTA. Clinical Neuroscience Research, 5(5-6), 295-306.
Marcus, S. M., & Gibbons, R. D. (2001). Estimating the efficacy of receiving treatment in randomized clinical trials with noncompliance. Health Services and Outcomes Research Methodology, 2(3-4), 247-258.
Newcorn, J. H. (2004). Comorbidity of ADHD and disruptive behavior disorders: Prevalence, impact, and management options. Drug Benefit Trends, 16(8), 431-436.
Galanter, C. A., Pagar, D. L., Davies, M., Li, W., Carlson, G. A., Abikoff, H. B., . . . Jensen, P. S. (2005). ADHD and manic symptoms: Diagnostic and treatment implications. Clinical Neuroscience Research, 5(5-6), 283-294.
Hechtman, L., Etcovitch, J., Platt, R., Arnold, L. E., Abikoff, H. B., Newcorn, J. H., . . . Wigal, T. (2005). Does multimodal treatment of ADHD decrease other diagnoses? Clinical Neuroscience Research, 5(5-6), 273-282.
Santosh, P. J., Taylor, E., Swanson, J., Wigal, T., Chuang, S., Davies, M., . . . Posner, M. (2005). Refining the diagnoses of inattention and overactivity syndromes: A reanalysis of the multimodal treatment study of attention deficit hyperactivity disorder (ADHD) based on ICD-10 criteria for hyperkinetic disorder. Clinical Neuroscience Research, 5(5-6), 307-314.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00000388     History of Changes
Other Study ID Numbers: U01MH050453 ( U.S. NIH Grant/Contract )
MH50447
MH50454
MH50461
MH50467
MH50440
DSIR CT
First Submitted: November 2, 1999
First Posted: November 3, 1999
Last Update Posted: September 29, 2015
Last Verified: September 2015

Keywords provided by New York University School of Medicine:
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:
Antisocial Personality Disorder
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Substance-Related Disorders
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Chemically-Induced Disorders
Personality Disorders