Early Intervention for Youth at Risk for Bipolar Disorder
NCT01483391 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2021-10-04
Summary
Children or teens with mood swings or depression who have a parent with bipolar disorder are at high risk for developing bipolar disorder themselves. This study will test a family-based therapy aimed at preventing or reducing the early symptoms of bipolar disorder in high-risk children (ages 9-17). In a randomized trial, the investigators will compare two kinds of family-based treatment (one more and one less intensive) on the course of early mood symptoms and social functioning among high-risk children followed for up to 4 years. The investigators will examine the effects of family treatment on measures of neural activation using functional magnetic resonance imaging.
Conditions
Interventions
- BEHAVIORAL
-
Enhanced Care
The 3 family sessions involve the youth and all family members. These sessions will help the child and family members with mood charting and developing a mood management plan. Families will rehearse mood regulation strategies for current family, social or academic problems. Clinicians then meet with the child individually every month for the next 3 mos. to provide support, assist with problem-solving, and troubleshoot use of the mood management plan.
- BEHAVIORAL
-
Family-Focused Treatment
12 therapy sessions involving the at-risk child or adolescent, parents, and available siblings. Therapy will include psychoeducation about mood disorders, communication enhancement training, and problem-solving skills training. The goal of this intervention is to improve the child's ability to regulate moods and to reduce tension and conflict in the family.
Sponsors & Collaborators
- collaborator OTHER
-
University of Colorado, Boulder
collaborator OTHER -
University of California, Los Angeles
lead OTHER
Principal Investigators
-
David J Miklowitz, PhD · UCLA Department of Psychiatry
-
Kiki D Chang, MD · Stanford University
-
Christopher D Schneck, MD · University of Colorado, Denver
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 9 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-10-06
- Primary Completion
- 2016-09-15
- Completion
- 2020-09-15
Countries
- United States
Study Locations
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