Clinical trial NCT00632619: Group-Based Behavioral Therapy Combined With Stimulant Medication for Treating Children With Attention Deficit Hyperactivity Disorder and Impaired Mood
Official title: A Novel Multimodal Intervention for Children With ADHD and Impaired Mood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Subthreshold Manic States in Children
ADHD
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-03-11
Enrollment: 68
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Mood Severity Index Measures Severity of Mood Symptoms (MSI).Range of 0-116; Clinicians Give to Parents and Child to Get Composite Score; Higher Scores=Greater Severity; 0-10=no Symptoms, 11-20=Mild Symptoms, 21to 35 =Moderate Symptoms and >35 is Severe
timeFrame: measured at week 12 (endpoint)
Secondary outcomes:
measure: Young Mania Rating Scale (YMRS) Score
timeFrame: Measured at weeks 12 (endpoint)
measure: Disruptive Behavior Disorder Scale Score for ADHD Symptoms
timeFrame: Measured at Week12 (endpoint)
measure: Children's Depression Rating Scale-Revised (CDRS-R) Total Score
timeFrame: Measured at Week 12 (endpoint)
measure: Disruptive Behavior Disorder Scale Score for ODD Symptoms
timeFrame: week 12 (endpoint)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Center for Children and Families at Florida International University
state: Florida
Study officials:
affiliation: Florida International University
name: James G. Waxmonsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waxmonsky JG, Waschbusch DA, Belin P, Li T, Babocsai L, Humphery H, Pariseau ME, Babinski DE, Hoffman MT, Haak JL, Mazzant JR, Fabiano GA, Pettit JW, Fallahazad N, Pelham WE. A Randomized Clinical Trial of an Integrative Group Therapy for Children With Severe Mood Dysregulation. J Am Acad Child Adolesc Psychiatry. 2016 Mar;55(3):196-207. doi: 10.1016/j.jaac.2015.12.011. Epub 2015 Dec 28.