Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emotion Regulation for Children With Fetal Alcohol Spectrum Disorder (SEPAGE)
Primary Purpose
Fetal Alcohol Spectrum Disorders, Hyperactivity Disorder, Attention Deficit
Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
cognitivo-comportmental therapy
body mediation
Sponsored by
About this trial
This is an interventional supportive care trial for Fetal Alcohol Spectrum Disorders focused on measuring FASD, ADHD
Eligibility Criteria
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
Sites / Locations
- CHU de Bordeaux
- CHU de Montpellier - Hôpital Saint Eloi
- CHU de La Réunion
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Therapy cognitivo-comportmental
Body mediation
Arm Description
Each child will participate in a structured cognitive behavioral therapy program entitled "better manage your anger and frustration". 15 workshops is planned.
Each child will participate in sports, artistic or fun activities involving the body (physical, emotional and communicative dimensions)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05273918
First Posted
March 1, 2022
Last Updated
September 28, 2023
Sponsor
Centre Hospitalier Universitaire de la Réunion
1. Study Identification
Unique Protocol Identification Number
NCT05273918
Brief Title
Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emotion Regulation for Children With Fetal Alcohol Spectrum Disorder
Acronym
SEPAGE
Official Title
Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emotion Regulation for Children With Fetal Alcohol Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
logistic problem and absence of coordinating Investigator
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
October 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Spectrum Disorders, Hyperactivity Disorder, Attention Deficit
Keywords
FASD, ADHD
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapy cognitivo-comportmental
Arm Type
Experimental
Arm Description
Each child will participate in a structured cognitive behavioral therapy program entitled "better manage your anger and frustration". 15 workshops is planned.
Arm Title
Body mediation
Arm Type
Active Comparator
Arm Description
Each child will participate in sports, artistic or fun activities involving the body (physical, emotional and communicative dimensions)
Intervention Type
Other
Intervention Name(s)
cognitivo-comportmental therapy
Intervention Description
15 workshops once a week during 90 minutes
Intervention Type
Other
Intervention Name(s)
body mediation
Intervention Description
15 workshops once a week during 90 minutes
Primary Outcome Measure Information:
Title
effectiveness of cognitive behavioral therapy program
Description
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.
Time Frame
7 months after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel SPODENKIEWICZ, MD
Organizational Affiliation
CHU de La Réunion
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU de Montpellier - Hôpital Saint Eloi
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
CHU de La Réunion
City
Saint Pierre
ZIP/Postal Code
97448
Country
Réunion
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emotion Regulation for Children With Fetal Alcohol Spectrum Disorder
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