<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03299140</url>
  </required_header>
  <id_info>
    <org_study_id>UF 9359</org_study_id>
    <nct_id>NCT03299140</nct_id>
  </id_info>
  <brief_title>Evaluation of a Prevention Program in Children and Teenagers at High Risk for Bipolar Disorder (Bipokid)</brief_title>
  <acronym>Bipokid</acronym>
  <official_title>Evaluation of a Prevention Program in Children and Teenagers at High Risk for Bipolar Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bipolar disorder is an early onset chronic disorder. Children of bipolar parents are at high&#xD;
      risk of developping the same disorder and/or a psychopathology. Early intervention focused on&#xD;
      emotion and problem solving strategies could improve their prognosis.&#xD;
&#xD;
      The main objective of this trial is to evaluate the FFT (Family Focused Therapy) efficacity.&#xD;
      Children emotional dysregulation profile will be compared before and after this CBT&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficult recruitment, and investigators did not want to extend the recruitment period, so&#xD;
    study stopped at theoretical date but number of subjects not reached&#xD;
  </why_stopped>
  <start_date type="Actual">June 18, 2014</start_date>
  <completion_date type="Actual">November 2, 2017</completion_date>
  <primary_completion_date type="Actual">November 2, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CBCL-DP (Child Behavior Checklist - Dysregulation Profile) score variation</measure>
    <time_frame>up to 12 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Family Focused Therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Only 1 arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family Focused Therapy</intervention_name>
    <arm_group_label>Family Focused Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children and teenagers from 6 to 16 years-old&#xD;
&#xD;
          -  At least one biological parent with bipolar disorder&#xD;
&#xD;
          -  T-score CBCL-Total ≥ 60&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active severe thymic episode&#xD;
&#xD;
          -  Autism spectrum disorders&#xD;
&#xD;
          -  Intellectual disability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>May 7, 2018</last_update_submitted>
  <last_update_submitted_qc>May 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bipolar disorder</keyword>
  <keyword>Children</keyword>
  <keyword>Family Focused Therapy</keyword>
  <keyword>CBT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03299140
org study id: UF 9359
nct id: NCT03299140
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: CBCL-DP (Child Behavior Checklist - Dysregulation Profile) score variation
time frame: up to 12 months
arm group label: Family Focused Therapy
arm group type: Other
description: Only 1 arm
intervention type: Behavioral
intervention name: Family Focused Therapy
arm group label: Family Focused Therapy
criteria: 
gender: All
minimum age: 6 Years
maximum age: 16 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Bipolar Disorder