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

NCT ID: NCT03299140

Last Updated: 2018-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-18

Study Completion Date

2017-11-02

Brief Summary

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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

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Family Focused Therapy

Only 1 arm

Group Type OTHER

Family Focused Therapy

Intervention Type BEHAVIORAL

Interventions

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Family Focused Therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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UF 9359

Identifier Type: -

Identifier Source: org_study_id

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