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Group-Based Behavioral Therapy Combined With Stimulant Medication for Treating Children With Attention Deficit Hyperactivity Disorder and Impaired Mood
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), March 2009
First Received: March 7, 2008   Last Updated: March 12, 2009   History of Changes
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00632619
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Young Mania Rating Scale (YMRS) score [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disruptive Behavior Disorder Scale score for ADHD symptoms [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
  • Children's Depression Rating Scale-Revised (CDRS-R) total score [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]

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
1: Active Comparator
Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
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.
2: Experimental
Participants will receive stimulant medication therapy and group-based behavior therapy.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ADHD combined subtype with evidence of depressive or manic-like symptoms, as assessed by CDRS, YMRS, and Washington University in St. Louis Kiddie Schedule for Affective Disorders and Schizophrenia, that persist after stimulant treatment

Exclusion Criteria:

  • Full Scale IQ less than 80
  • Current seizure disorder or history of seizures requiring treatment or other significant neurological problems
  • History of other medical problems for which stimulant treatment may involve considerable risk, including cardiac arrhythmias, hypertension, Tourette's disorder, or history of severe tic exacerbations caused by stimulant exposure (Note: child with uncomplicated tic disorders or a family history of tic disorders will not be excluded as stimulants are well tolerated in a majority of such cases)
  • Meets full criteria for Type I or II bipolar disorder or any child manifesting mood symptoms (manic or depressive), such as significant suicidal ideation or psychotic symptoms that require emergent pharmacological treatment or hospitalization
  • History or concurrent diagnosis of any of the following disorders: pervasive developmental disorder, schizophrenia or other psychotic disorders, post-traumatic stress disorder, sexual disorders, organic mental disorder, or eating disorder
  • No longer manifests impairing manic/depressive symptoms after stimulant therapy based on CDRS-R greater than 27 or YMRS greater than 11 with Clinical Global Impressions-Severity 3 or greater
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632619

Locations
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            
Sponsors and Collaborators
Investigators
Principal Investigator: James G. Waxmonsky, MD State University of New York at Buffalo
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Institute of Mental Health (NIMH):
Subthreshold Manic States in Children
ADHD

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 10, 2009