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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00632619 |
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.
Condition | Intervention |
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Attention Deficit Disorder With Hyperactivity |
Behavioral: Group-based behavior therapy Drug: Stimulant medication therapy Behavioral: Community-based psychosocial treatment |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Novel Multimodal Intervention for Children With ADHD and Impaired Mood |
Estimated Enrollment: | 72 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
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Drug: Stimulant medication therapy
All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 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.
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2: Experimental
Participants will receive stimulant medication therapy and group-based behavior therapy.
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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 4 to 8 weeks prior to therapy assignment.
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There has been increasing recognition that many children with attention deficit hyperactivity disorder (ADHD) exhibit depressive and manic-like symptoms suggestive of major depressive disorder (MDD) and bipolar disorder (BP). Many children with ADHD plus impairments in mood display symptoms of irritability, affective instability, and reactive aggression, but they typically lack the hallmark symptoms, such as extreme mood cycles and sustained depressed mood, that lead to a BD or MDD diagnosis. Significant debate exists as to whether these children have a true comorbid mood disorder, making treatment of mood symptoms in ADHD children controversial. ADHD is traditionally treated with stimulant medications and/or behavior modification therapy. However, little is known about the safety of stimulants in ADHD children with manic symptoms. Also, no treatments exist that are designed to simultaneously improve both ADHD and mood problems in children. Psychosocial treatments hold particular promise for ADHD children with impairments in mood because they are well-studied pediatric treatments with little risk of worsening mood symptoms. This study will develop an integrative psychosocial treatment that includes aspects of cognitive behavioral therapy (CBT) and psychoeducational techniques for pediatric and adult mood disorders. The study will then evaluate the effectiveness of the integrative psychosocial treatment, called group behavior therapy, combined with stimulant medication in improving moods and enhancing treatment responses in children with ADHD and impairments in mood.
Participation in the study will last between 5 and 6 months. All eligible participants will begin treatment with stimulant medications for 4 to 8 weeks, or until an optimal medication dosage has been determined. During this medication dosing phase, study staff will collect weekly ratings of the child participant's behavior at home and school, and participants will be seen weekly by study doctors to monitor medication dosage. Upon achieving an optimal dose, child participants will answer questions about their mood and behavior.
Participants who are still exhibiting mood problems will then be assigned randomly to receive 12 weeks of either group behavior therapy or community-based psychosocial treatment, while still continuing on their prescribed medications. Group behavior therapy sessions for child participants will focus on improving mood and ability to maintain friendships, practicing ways to better control emotions, and learning effective problem solving skills.
Child participants will also be given weekly homework assignments to practice learned therapy skills. Group behavior therapy sessions for parent participants will teach parents 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. Participants assigned to community-based psychosocial treatment will not receive any counseling services as part of the study, but they will be referred to community services.
Every 6 weeks during the therapy phase, all participants will answer repeat questions about their mood and behavior. Six weeks after completing the therapy phase, participants will return for a final follow-up visit, which will include repeat questions, rating of the child participant's mood and symptoms, and meeting with a study doctor to check medications.
Ages Eligible for Study: | 7 Years to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Center for Children and Families at State University of New York at Buffalo | Recruiting |
Buffalo, New York, United States, 14214 | |
Contact: James G. Waxmonsky, MD 716-829-2244 jgw@buffalo.edu | |
Principal Investigator: James G. Waxmonsky, MD |
Principal Investigator: | James G. Waxmonsky, MD | State University of New York at Buffalo |
Responsible Party: | State University of New York at Buffalo ( James G. Waxmonsky, MD ) |
Study ID Numbers: | R34 MH080791, DDTR B2-NDH |
Study First Received: | March 7, 2008 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00632619 History of Changes |
Health Authority: | United States: Federal Government |
Subthreshold Manic States in Children ADHD |
Signs and Symptoms Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Neurologic Manifestations Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias |
Signs and Symptoms Pathologic Processes Disease Attention Deficit Disorder with Hyperactivity Mental Disorders Nervous System Diseases |
Mental Disorders Diagnosed in Childhood Neurologic Manifestations Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias |