Evaluation of a Prevention Program in Children and Teenagers at High Risk for Bipolar Disorder (Bipokid)

Not Applicable

Terminated

• Conditions: Bipolar Disorder

• Registration Number: NCT03299140
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Bipolar disorder is an early onset chronic disorder. Children of bipolar parents are at high risk of developping the same disorder and/or a psychopathology. Early intervention focused on emotion and problem solving strategies could improve their prognosis.

The main objective of this trial is to evaluate the FFT (Family Focused Therapy) efficacity. Children emotional dysregulation profile will be compared before and after this CBT intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-18
• Status Verified: 2017-09
• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-10-02
• Primary Completion: 2017-11-02
• Study Completion: 2017-11-02
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Children and teenagers from 6 to 16 years-old
• At least one biological parent with bipolar disorder
• T-score CBCL-Total ≥ 60
• Written informed consent

Exclusion Criteria

• Active severe thymic episode
• Autism spectrum disorders
• Intellectual disability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
CBCL-DP (Child Behavior Checklist - Dysregulation Profile) score variation	up to 12 months