Status:
WITHDRAWN
Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emotion Regulation for Children With Fetal Alcohol Spectrum Disorder
Lead Sponsor:
Centre Hospitalier Universitaire de la Réunion
Conditions:
Fetal Alcohol Spectrum Disorders
Hyperactivity Disorder
Eligibility:
All Genders
7-13 years
Phase:
NA
Brief 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 ve...
Eligibility Criteria
Inclusion
- 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
- non-french speaking child or parents / non-creole speaking child or parents
- child who already participate to CBT or body mediation groups
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05273918
Start Date
January 1 2023
End Date
October 1 2028
Last Update
October 2 2023
Active Locations (3)
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1
CHU de Bordeaux
Bordeaux, France, 33076
2
CHU de Montpellier - Hôpital Saint Eloi
Montpellier, France, 34070
3
CHU de La Réunion
Saint-Pierre, Reunion, 97448