Bipolar DisorderBipokidNCT03299140
Evaluation of a Prevention Program in Children and Teenagers at High Risk for Bipolar Disorder (Bipokid)
A study testing Family Focused Therapy in people with Bipolar Disorder, run by University Hospital, Montpellier.
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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Family Focused Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 18 Jun 2014to 2 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Active severe thymic episode
- Autism spectrum disorders
- Intellectual disability
About this study
Official title: Evaluation of a Prevention Program in Children and Teenagers at High Risk for Bipolar Disorder
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
- Bipolar Disorder
- Being tested
- Family Focused Therapy
- Keywords
- Bipolar disorder, Children, Family Focused Therapy, CBT
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Focused TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Family Focused Therapy | Other | Only 1 arm Receives: Behavioral: Family Focused Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CBCL-DP (Child Behavior Checklist - Dysregulation Profile) score variation
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start18 Jun 2014
- Primary completion2 Nov 2017
- Study completion2 Nov 2017
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299140
- Sponsor's protocol ID
- UF 9359
- Acronym
- Bipokid
- Status last verified
- Sep 2017
- First submitted
- 27 Sep 2017
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fongaro E, Pupier F, Picot MC, Franc N, Soler M, Olie E, Maurice V, Purper-Ouakil D, Kerbage H. Changes in emotional dysregulation profile among offspring of parents with bipolar disorder: a family-based intervention pilot study. Int J Bipolar Disord. 2025 Nov 3;13(1):31. doi: 10.1186/s40345-025-00398-3.
PubMed 41182531
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Prevention Program in Children and Teenagers at High Risk for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT03299140
- Acronym / sponsor ID
- Bipokid / UF 9359
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorder, Children, Family Focused Therapy, CBT
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 18 Jun 2014 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 2 Nov 2017 (actual)
- First posted
- 2 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family Focused Therapy | Other | Behavioral: Family Focused TherapyOnly 1 arm |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Active severe thymic episode
- Autism spectrum disorders
- Intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Focused Therapy | Behavioural | Family Focused Therapy |
Primary outcome
CBCL-DP (Child Behavior Checklist - Dysregulation Profile) score variation
Time frame: up to 12 months
Results and safety
The study was stopped early (reason given: Difficult recruitment, and investigators did not want to extend the recruitment period, so study stopped at theoretical date but number of subjects not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Derived from this study: PubMed 41182531Fongaro E, Pupier F, Picot MC, Franc N, Soler M, Olie E, Maurice V, Purper-Ouakil D, Kerbage H. Changes in emotional dysregulation profile among offspring of parents with bipolar disorder: a family-based intervention pilot study. Int J Bipolar Disord. 2025 Nov 3;13(1):31. doi: 10.1186/s40345-025-00398-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Family Focused Therapy in people with Bipolar Disorder, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficult recruitment, and investigators did not want to extend the recruitment period, so study stopped at theoretical date but number of subjects not reached). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CBCL-DP (Child Behavior Checklist - Dysregulation Profile) score variation (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03299140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.