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Clinical Trials/NCT03299140
NCT03299140
Terminated
Not Applicable

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

University Hospital, Montpellier0 sites43 target enrollmentJune 18, 2014
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ConditionsBipolar Disorder

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bipolar Disorder
Sponsor
University Hospital, Montpellier
Enrollment
43
Primary Endpoint
CBCL-DP (Child Behavior Checklist - Dysregulation Profile) score variation
Status
Terminated
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 18, 2014
End Date
November 2, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

CBCL-DP (Child Behavior Checklist - Dysregulation Profile) score variation

Time Frame: up to 12 months

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