Multimodal Treatment Study of Children With Attention Deficit and Hyperactivity Disorder (MTA) - Full Text View

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:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

U.S. FDA Resources

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

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:

[No authors listed] A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. The MTA Cooperative Group. Multimodal Treatment Study of Children with ADHD. Arch Gen Psychiatry. 1999 Dec;56(12):1073-86.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Molina BS, Hinshaw SP, Eugene Arnold L, Swanson JM, Pelham WE, Hechtman L, Hoza B, Epstein JN, Wigal T, Abikoff HB, Greenhill LL, Jensen PS, Wells KC, Vitiello B, Gibbons RD, Howard A, Houck PR, Hur K, Lu B, Marcus S; MTA Cooperative Group. Adolescent substance use in the multimodal treatment study of Attention-Deficit/Hyperactivity Disorder (ADHD) (MTA) as a function of childhood ADHD, random assignment to childhood treatments, and subsequent medication. J Am Acad Child Adolesc Psychiatry. 2013 Mar;52(3):250-63. doi: 10.1016/j.jaac.2012.12.014. Epub 2013 Feb 8.

Vitiello B, Elliott GR, Swanson JM, Arnold LE, Hechtman L, Abikoff H, Molina BS, Wells K, Wigal T, Jensen PS, Greenhill LL, Kaltman JR, Severe JB, Odbert C, Hur K, Gibbons R. Blood pressure and heart rate over 10 years in the multimodal treatment study of children with ADHD. Am J Psychiatry. 2012 Feb;169(2):167-77.

Rabiner DL, Murray DW, Rosen L, Hardy K, Skinner A, Underwood M. Instability in teacher ratings of children's inattentive symptoms: implications for the assessment of ADHD. J Dev Behav Pediatr. 2010 Apr;31(3):175-80.

Molina BS, Hinshaw SP, Swanson JM, Arnold LE, Vitiello B, Jensen PS, Epstein JN, Hoza B, Hechtman L, Abikoff HB, Elliott GR, Greenhill LL, Newcorn JH, Wells KC, Wigal T, Gibbons RD, Hur K, Houck PR; MTA Cooperative Group. The MTA at 8 years: prospective follow-up of children treated for combined-type ADHD in a multisite study. J Am Acad Child Adolesc Psychiatry. 2009 May;48(5):484-500.

Pappadopulos E, Jensen PS, Chait AR, Arnold LE, Swanson JM, Greenhill LL, Hechtman L, Chuang S, Wells KC, Pelham W, Cooper T, Elliott G, Newcorn JH. Medication adherence in the MTA: saliva methylphenidate samples versus parent report and mediating effect of concomitant behavioral treatment. J Am Acad Child Adolesc Psychiatry. 2009 May;48(5):501-10.

ClinicalTrials.gov Identifier:	NCT00000388 History of Changes
Other Study ID Numbers:	MH50453, MH50447, MH50454, MH50461, MH50467, MH50440, DSIR CT
Study First Received:	November 2, 1999
Last Updated:	March 26, 2008
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

Additional relevant MeSH terms:

Antisocial Personality Disorder
Attention Deficit Disorder with Hyperactivity
Substance-Related Disorders
Hyperkinesis
Personality Disorders
Mental Disorders

Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013