Group-Based Behavioral Therapy Combined With Stimulant Medication for Treating Children With Attention Deficit Hyperactivity Disorder and Impaired Mood
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

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.
    

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 2 to 6 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.
    

Intervention name(s): Group-based behavior therapy; Stimulant medication therapy; Community-based psychosocial treatment
Intervention type(s): Behavioral; Drug; Behavioral
Intervention description(s): 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.; All participants will be stabilized on an FDA-approved stimulant medication for 2 to 6 weeks prior to therapy assignment.; Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression.
Intervention MeSH terms: Central Nervous System Stimulants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Subthreshold Manic States in Children; ADHD