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

NCT00632619 | Completed Results DMC

• 2 other identifiers: R34MH080791DDTR B2-NDH
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Subthreshold Manic States in Children; ADHD

Outcome Measures

Primary Outcomes (1)

• 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

  averaged Composite of endpoint ratings from the Children's Depression Rating Scale (CDRS used to measure depressive symptoms) and Young mania rating scale (MRS used to measure manic like symptoms) that has been used before as primary outcome in treatment studies of children with a mixture of affective symptoms (Fristad, et al., 2009). Prior to commencement of data collection, we elected to use it as the primary mood measure for the therapy phase of the trial over the initially selected YMRS as subjects either had to have elevations on the YMRS or CDRS but not necessarily both to be eligible. Hence, some subjects had very low YMRS scores at baseline which is why we chose the MSI over the YMRS.

  measured at week 12 (endpoint)

Secondary Outcomes (4)

• Young Mania Rating Scale (YMRS) Score

  Measured at weeks 12 (endpoint)

• Disruptive Behavior Disorder Scale Score for ADHD Symptoms

  Measured at Week12 (endpoint)

• Children's Depression Rating Scale-Revised (CDRS-R) Total Score

  Measured at Week 12 (endpoint)

• Disruptive Behavior Disorder Scale Score for ODD Symptoms

  week 12 (endpoint)

Study Arms (2)

1

ACTIVE COMPARATOR

Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.

Drug: Stimulant medication therapy; Behavioral: Community-based psychosocial treatment

2

EXPERIMENTAL

Participants will receive stimulant medication therapy and group-based behavior therapy.

Behavioral: Group-based behavior therapy; Drug: Stimulant medication therapy

Interventions

Group-based behavior therapy BEHAVIORAL

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.

2

Stimulant medication therapy DRUG

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

1; 2

Community-based psychosocial treatment BEHAVIORAL

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

1

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida International University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Center for Children and Families at Florida International University

Miami, Florida, 33199, United States

Location

Related Publications (1)

• 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.

  PMID: 26903253 DERIVED

Related Links

• Click here for more information on this study at the Center for Children and Families at State University of New York at Buffalo

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

relatively small sample size, the lack of a gold standard measurement for mood dysregulation in children, run at a specialty mental health research center and therapy subjects had more contact with study staff which may have impacted results.

Results Point of Contact

• Title: James G Waxmonsky
• Organization: Florida International University

jwaxmons@fiu.edu

305 348 3258

Study Officials

• James G. Waxmonsky, MD

  Florida International University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 11, 2008
• Study Start: March 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 21, 2013
• Results First Posted: May 21, 2013

Record last verified: 2013-04

Locations

US (1)