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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Withdrawn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
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fetal Alcohol Spectrum Disorders focused on measuring FASD, ADHD

Eligibility Criteria

7 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
March 1, 2022
Last Updated
September 28, 2023
Sponsor
Centre Hospitalier Universitaire de la Réunion
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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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