CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 target
Drug / intervention
Enhanced Care +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01483391
NCT01483391N/ACompleted

Early Intervention for Youth at Risk for Bipolar Disorder

University of California, Los Angeles·interventional·Posted Dec 1, 2011·Updated Oct 4, 2021

In Brief

A clinical study evaluating Enhanced Care and Family-Focused Treatment for Bipolar Disorder and Major Depressive Disorder. Completed, enrolled 150 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 1, 2011
Enrollment StartOct 6, 2011
Primary CompletionSep 15, 2016
Study CompletionSep 15, 2020
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 14.6 years ago

Interventions

Enhanced Carebehavioral

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.

Family-Focused Treatmentbehavioral

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.