NCT03299140

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2014

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2017

Completed
Last Updated

May 14, 2018

Status Verified

September 1, 2017

Enrollment Period

3.4 years

First QC Date

September 27, 2017

Last Update Submit

May 7, 2018

Conditions

Bipolar Disorder

Keywords

Bipolar disorderChildrenFamily Focused TherapyCBT

Outcome Measures

Primary Outcomes (1)

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

    up to 12 months

Study Arms (1)

Family Focused Therapy

OTHER

Only 1 arm

Behavioral: Family Focused Therapy

Interventions

Family Focused TherapyBEHAVIORAL
Family Focused Therapy

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fongaro E, Pupier F, Picot MC, Franc N, Soler M, Olie E, Maurice V, Purper-Ouakil D, Kerbage H. Changes in emotional dysregulation profile among offspring of parents with bipolar disorder: a family-based intervention pilot study. Int J Bipolar Disord. 2025 Nov 3;13(1):31. doi: 10.1186/s40345-025-00398-3.

    PMID: 41182531DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 2, 2017

Study Start

June 18, 2014

Primary Completion

November 2, 2017

Study Completion

November 2, 2017

Last Updated

May 14, 2018

Record last verified: 2017-09