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Group-Based Behavioral Therapy Combined With Stimulant Medication for Treating Children With Attention Deficit Hyperactivity Disorder and Impaired Mood

NCT00632619 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2013-05-21

Study results available
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Summary

This study will evaluate the effectiveness of an integrative group psychosocial therapy combined with stimulant medication in treating children with attention deficit hyperactivity disorder plus impairments in mood.

Conditions

  • Attention Deficit Disorder With Hyperactivity

Interventions

BEHAVIORAL

Group-based behavior therapy

Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems.

DRUG

Stimulant medication therapy

All participants will be stabilized on an FDA-approved stimulant medication for 2 to 6 weeks prior to therapy assignment.

BEHAVIORAL

Community-based psychosocial treatment

Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Florida International University

    lead OTHER

Principal Investigators

  • James G. Waxmonsky, MD · Florida International University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-06-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00632619 on ClinicalTrials.gov