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

Bipolar Disorder Clinical Trial

— Bipokid  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03299140
• Other study ID #: UF 9359
• Status: Terminated
• Phase: N/A
• Start date: June 18, 2014
• Est. completion date: November 2, 2017

Study information

• Verified date: September 2017
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: November 2, 2017
• Est. primary completion date: November 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Behavioral:
• Family Focused Therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CBCL-DP (Child Behavior Checklist - Dysregulation Profile) score variation		up to 12 months