Early Family-Focused Treatment for Youth at Risk for Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title: Family-Focused Therapy as Early Treatment for Youth at Risk for Bipolar Disorder

Status Completed

Clinical Trial Summary

This study will test a family-based therapy aimed at preventing or reducing the symptoms of bipolar disorder in at-risk children.

Clinical Trial Description

Early-onset bipolar disorder (BD) is a chronic, recurrent disorder that starts before age

18. In addition to the debilitating effects of BD, which include episodes of lethargic depression and exhausting mania, children and adolescents with BD often have co-occurring disorders, such as attention deficit hyperactivity disorder, conduct disorder, substance abuse disorders, and anxiety disorders. Early interventions may lead to better mental health by preventing BD from ever fully expressing itself. This study will test an early intervention for BD called family-focused treatment (FFT), which targets children and adolescents who are at risk for developing BD. FFT will include education about BD and training in communication strategies and problem-solving skills. It will focus on the family, because family environmental factors are related to the course and recurrence of BD. By reducing risk factors and teaching coping skills, FFT aims to prevent expression of BD, delay the onset or reduce the severity of manic episodes, and ensure that the first treatment received is appropriate.

Participation in this study will last 1 year and include three parts. In the first part, participating children and their families will complete research interviews and questionnaires about the child's mood, behavior, beliefs, and problems. Parent participants will also provide information on the family background of mood or anxiety problems. In the second part, participants will be randomly assigned to receive one of two treatments: FFT or brief educational treatment. Participants receiving FFT will complete 12 therapy sessions in which parents, children, and siblings learn how to cope with mood disorders, new ways to talk to each other, and strategies for solving family problems. FFT sessions will occur weekly for the first 8 weeks and then every other week for the next 8 weeks. Participants receiving brief educational treatment will complete diagnostic assessments and a 1-hour individualized feedback session, and they will be given a workbook about childhood mood disorders. A counselor will be available to all participants, in case of emergencies, for the full study year. All participants will also be provided with standard pharmacotherapy as needed. In the third part of the study, participants will complete follow-up assessments every 4 months for 1 year. Assessments will include interviews and questionnaires similar to those completed in the first part of the study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bipolar Disorder

• NCT number: NCT00943085
• Study type: Interventional
• Source: University of California, Los Angeles
• Status: Completed
• Phase: N/A
• Start date: April 2007
• Completion date: August 2011