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 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


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

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, see Learn About Clinical Studies.

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

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):

Fernández de la Cruz L, Simonoff E, McGough JJ, Halperin JM, Arnold LE, Stringaris A. Treatment of children with attention-deficit/hyperactivity disorder (ADHD) and irritability: results from the multimodal treatment study of children with ADHD (MTA). J Am Acad Child Adolesc Psychiatry. 2015 Jan;54(1):62-70.e3. doi: 10.1016/j.jaac.2014.10.006. Epub 2014 Oct 18.

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. doi: 10.1176/appi.ajp.2011.10111705.

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. doi: 10.1097/DBP.0b013e3181d5a2d8.

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. doi: 10.1097/CHI.0b013e31819c23d0.

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. doi: 10.1097/CHI.0b013e31819c23ed.


ClinicalTrials.gov Identifier:	NCT00000388 History of Changes
Other Study ID Numbers:	U01 MH050453, U01MH050453, MH50447, MH50454, MH50461, MH50467, MH50440, DSIR CT
Study First Received:	November 2, 1999
Last Updated:	June 27, 2013
Health Authority:	United States: Federal Government

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:


Attention Deficit Disorder with Hyperactivity Disease Hyperkinesis Substance-Related Disorders Attention Deficit and Disruptive Behavior Disorders Chemically-Induced Disorders Dyskinesias	Mental Disorders Mental Disorders Diagnosed in Childhood Nervous System Diseases Neurologic Manifestations Pathologic Processes Signs and Symptoms

ClinicalTrials.gov processed this record on March 03, 2015