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

Primary Purpose

Bipolar Disorder

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Family Focused Therapy
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bipolar Disorder focused on measuring Bipolar disorder, Children, Family Focused Therapy, CBT

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Family Focused Therapy

    Arm Description

    Only 1 arm

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    September 27, 2017
    Last Updated
    May 7, 2018
    Sponsor
    University Hospital, Montpellier
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03299140
    Brief Title
    Evaluation of a Prevention Program in Children and Teenagers at High Risk for Bipolar Disorder (Bipokid)
    Acronym
    Bipokid
    Official Title
    Evaluation of a Prevention Program in Children and Teenagers at High Risk for Bipolar Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Terminated
    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
    Study Start Date
    June 18, 2014 (Actual)
    Primary Completion Date
    November 2, 2017 (Actual)
    Study Completion Date
    November 2, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Montpellier

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bipolar Disorder
    Keywords
    Bipolar disorder, Children, Family Focused Therapy, CBT

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Family Focused Therapy
    Arm Type
    Other
    Arm Description
    Only 1 arm
    Intervention Type
    Behavioral
    Intervention Name(s)
    Family Focused Therapy
    Primary Outcome Measure Information:
    Title
    CBCL-DP (Child Behavior Checklist - Dysregulation Profile) score variation
    Time Frame
    up to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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