Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emot… (NCT05273918) | Clinical Trial Compass
WithdrawnNot Applicable
Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emotion Regulation for Children With Fetal Alcohol Spectrum Disorder
Stopped: logistic problem and absence of coordinating Investigator
France, Reunion0Started 2023-01
Plain-language 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 via a measurement of the Aggressive Behaviors subscale score of the Dysregulation Profile subset of the CBCL scale.
Who can participate
Age range
7 Years – 13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* non-french speaking child or parents / non-creole speaking child or parents
* child who already participate to CBT or body mediation groups
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
effectiveness of cognitive behavioral therapy program
Timeframe: 7 months after inclusion
Trial details
NCT IDNCT05273918
SponsorCentre Hospitalier Universitaire de la Réunion