Evaluation of a Prevention Program in Children and Teenagers at High Risk for Bipolar Disorder (Bipokid)
Sponsor
University Hospital, Montpellier (Other)
Overall Status
Terminated
CT.gov ID
NCT03299140
Collaborator
(none)
43
1
40.5
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
43 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Evaluation of a Prevention Program in Children and Teenagers at High Risk for Bipolar Disorder
Actual Study Start Date
:
Jun 18, 2014
Actual Primary Completion Date
:
Nov 2, 2017
Actual Study Completion Date
:
Nov 2, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Family Focused Therapy Only 1 arm |
Behavioral: Family Focused Therapy
|
Outcome Measures
Primary Outcome Measures
- CBCL-DP (Child Behavior Checklist - Dysregulation Profile) score variation [up to 12 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Years
to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Montpellier
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT03299140
Other Study ID Numbers:
- UF 9359
First Posted:
Oct 2, 2017
Last Update Posted:
May 14, 2018
Last Verified:
Sep 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier
Additional relevant MeSH terms: