Fetal Alcohol Spectrum DisordersSEPAGENCT05273918
Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emotion Regulation for Children With Fetal Alcohol Spectrum Disorder
A study testing cognitivo-comportmental therapy and body mediation in people with Fetal Alcohol Spectrum Disorders and Hyperactivity Disorder, run by Centre Hospitalier Universitaire de la Réunion at 3 sites in 2 countries.
Trial summary
This is a multi-center, prospective, randomized, open-label, controlled trial with two parallel arms and blinded endpoint assessment. It aims yo compare the 6-month efficacy of a group CBT program versus body-mediated intervention (meditation) children (7-13 years) with ADHD-associated FASD and emotional dysregulation… Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders, Hyperactivity Disorder, Attention Deficit
- What is being tested?
- cognitivo-comportmental therapy and body mediation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2023to Oct 2028
- 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 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child with fetal alcohol spectrum disorder
- child with attention deficit disorder with / without hyperactivity
- child with a score upper than or equal to 180 points on the "Aggressive behavior", "Anxiety / Depression" and "Concentration problems" subscales of the CBCL
- child followed in La Reunion, Montpellier or Bordeaux University Hospital
- child whose parents are affiliated with social security
- child who accepts to participate and whose parents have given their consent
Who cannot join
- non-french speaking child or parents / non-creole speaking child or parents
- child who already participate to CBT or body mediation groups
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
CHU de Bordeaux
Bordeaux, 33076
CHU de Montpellier - Hôpital Saint Eloi
Montpellier, 34070
About this study
This is a multi-center, prospective, randomized, open-label, controlled trial with two parallel arms and blinded endpoint assessment.
It aims yo compare the 6-month efficacy of a group CBT program versus body-mediated intervention (meditation) children (7-13 years) with ADHD-associated FASD and emotional dysregulation via a measurement of the Aggressive Behaviors subscale score of the Dysregulation Profile subset of the CBCL scale.
- Being tested
- cognitivo-comportmental therapy, body mediation
- Keywords
- FASD, ADHD
- Medical subject headings
- Fetal Alcohol Spectrum Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitivo-comportmental therapyOther
15 workshops once a week during 90 minutes
body mediationOther
15 workshops once a week during 90 minutes
| Study group | Role | What they receive |
|---|---|---|
| Therapy cognitivo-comportmental | Experimental | Each child will participate in a structured cognitive behavioral therapy program entitled "better manage your anger and frustration". 15 workshops is planned. Receives: Other: cognitivo-comportmental therapy |
| Body mediation | Active comparator | Each child will participate in sports, artistic or fun activities involving the body (physical, emotional and communicative dimensions) Receives: Other: body mediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of cognitive behavioral therapy program
score on Child Behavior Check List (CBCL) scale. Minimum value = 50 (normal) and maximal value = 100 (pathologic). Score between 50 and 65 is mormal and score between 70 and 100 is pathologic and needs patients medical care.
Measured: 7 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study startJan 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionOct 2028 (estimated)
Why it stopped: logistic problem and absence of coordinating Investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel SPODENKIEWICZ, MD, Principal investigator, CHU de La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273918
- Sponsor's protocol ID
- 2020/CHU/06
- Acronym
- SEPAGE
- Status last verified
- Sep 2023
- First submitted
- 1 Mar 2022
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emotion Regulation for Children With Fetal Alcohol Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05273918
- Acronym / sponsor ID
- SEPAGE / 2020/CHU/06
- Keywords
- FASD, ADHD
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: logistic problem and absence of coordinating Investigator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 10 Mar 2022 (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.
This is a multi-center, prospective, randomized, open-label, controlled trial with two parallel arms and blinded endpoint assessment.
It aims yo compare the 6-month efficacy of a group CBT program versus body-mediated intervention (meditation) children (7-13 years) with ADHD-associated FASD and emotional dysregulation via a measurement of the Aggressive Behaviors subscale score of the Dysregulation Profile subset of the CBCL scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy cognitivo-comportmental | Experimental | Other: cognitivo-comportmental therapyEach child will participate in a structured cognitive behavioral therapy program entitled "better manage your anger and frustration". 15 workshops is planned. |
| Body mediation | Active comparator | Other: body mediationEach child will participate in sports, artistic or fun activities involving the body (physical, emotional and communicative dimensions) |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- child with fetal alcohol spectrum disorder
- child with attention deficit disorder with / without hyperactivity
- child with a score upper than or equal to 180 points on the "Aggressive behavior", "Anxiety / Depression" and "Concentration problems" subscales of the CBCL
- child followed in La Reunion, Montpellier or Bordeaux University Hospital
- child whose parents are affiliated with social security
Key exclusion criteria (2 listed)
- non-french speaking child or parents / non-creole speaking child or parents
- child who already participate to CBT or body mediation groups
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 |
|---|---|---|
| cognitivo-comportmental therapy15 workshops once a week during 90 minutes | Other | Therapy cognitivo-comportmental |
| body mediation15 workshops once a week during 90 minutes | Other | Body mediation |
Primary outcome
effectiveness of cognitive behavioral therapy program
Time frame: 7 months after inclusion
score on Child Behavior Check List (CBCL) scale. Minimum value = 50 (normal) and maximal value = 100 (pathologic). Score between 50 and 65 is mormal and score between 70 and 100 is pathologic and needs patients medical care.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Michel SPODENKIEWICZ, MD principal investigator
CHU de La Réunion
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitivo-comportmental therapy and body mediation in people with Fetal Alcohol Spectrum Disorders and Hyperactivity Disorder, run by Centre Hospitalier Universitaire de la Réunion at 3 sites in 2 countries.
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 6 inclusion and 2 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: withdrawn, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
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 withdrawn before enrolling participants, so there are no results.
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?
effectiveness of cognitive behavioral therapy program (time frame: 7 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2023.