TerminatedNCT03299140BipokidUpdated May 14, 2018

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

An interventional study of Family Focused Therapy in Bipolar Disorder, sponsored by University Hospital, Montpellier. Terminated. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2018-05-14.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Prevention

Why this study was terminated

Difficult recruitment, and investigators did not want to extend the recruitment period, so study stopped at theoretical date but number of subjects not reached

Phase: Not applicable
Study type: Interventional
Enrollment: 43
Allocation: Not applicable
Ages: 6 Years to 16 Years
Sex: All

Study 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.

Conditions studied

Bipolar Disorder

Browse trials for

Bipolar Disorder 1,599

Keywords

Bipolar disorder
Children
Family Focused Therapy
CBT

Who can participate

Ages eligible: 6 Years to 16 Years
Sexes eligible: 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

Exclusion Criteria:

Active severe thymic episode
Autism spectrum disorders
Intellectual disability

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 43 participants (actual)

Study arms

Other
Family Focused Therapy
Only 1 arm
Behavioral: Family Focused Therapy

Interventions

BehavioralFamily Focused Therapy

What researchers measure

Primary outcomes

CBCL-DP (Child Behavior Checklist - Dysregulation Profile) score variation
Time frame: up to 12 months

Study locations

No study locations are listed for this record.

Registry details

Key details

Study ID: NCT03299140
Lead sponsor: University Hospital, Montpellier
Responsible party: Sponsor
First posted: Oct 2, 2017
Start date: Jun 18, 2014
Primary completion: Nov 2, 2017
Completion: Nov 2, 2017
Last update: May 14, 2018

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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