Evaluation of a Prevention Program in Children and Teenag... | NCT03299140

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

NCT03299140

Sponsor

University Hospital, Montpellier

Status

Terminated

Last Update Posted

May 14, 2018Actual

Enrollment

43Actual

Phase

Not Applicable

Conditions

Bipolar Disorder

Interventions

Family Focused Therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficult recruitment, and investigators did not want to extend the recruitment period, so study stopped at theoretical date but number of subjects not reached

Expanded Access Info

Start Date

Jun 18, 2014Actual

Primary Completion Date

Nov 2, 2017Actual

Completion Date

Nov 2, 2017Actual

First Submitted Date

Sep 27, 2017

First Submission Date that Met QC Criteria

Sep 27, 2017

First Posted Date

Oct 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2018

Last Update Posted Date

May 14, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Family Focused Therapy	Other	Only 1 arm	Behavioral: Family Focused Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Family Focused Therapy	Behavioral		Family Focused Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CBCL-DP (Child Behavior Checklist - Dysregulation Profile) score variation		up to 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41182531	Derived	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.

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders