Viewing Study NCT00000388



Ignite Creation Date: 2024-05-05 @ 11:21 AM
Last Modification Date: 2024-10-26 @ 9:01 AM
Study NCT ID: NCT00000388
Status: COMPLETED
Last Update Posted: 2015-09-29
First Post: 1999-11-02

Brief Title: Multimodal Treatment Study of Children With Attention Deficit and Hyperactivity Disorder MTA
Sponsor: NYU Langone Health
Organization: NYU Langone Health

Study Overview

Official Title: Multimodal Treatment Study of Children With ADHD
Status: COMPLETED
Status Verified Date: 2015-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: MTA
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 eg comorbidity family functioning cognitive skills peer relations that may influence adolescent functioning either independent of or through initial treatment assignment andor 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 andor 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 heshe

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 eg comorbidity family functioning cognitive skills peer relations that may influence adolescent functioning either independent of or through initial treatment assignment andor 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 andor 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
DSIR CT US NIH GrantContract None httpsreporternihgovquickSearchU01MH050453
U01MH050453 NIH None None
MH50447 None None None
MH50454 None None None
MH50461 None None None
MH50467 None None None
MH50440 None None None