SEPAGE: Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emotion Regulation for Children With Fetal Alcohol Spectrum Disorder

Sponsor

Centre Hospitalier Universitaire de la Réunion (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05273918

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fetal Alcohol Spectrum Disorders Hyperactivity Disorder Attention Deficit	Other: cognitivo-comportmental therapy Other: body mediation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emotion Regulation for Children With Fetal Alcohol Spectrum Disorder

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Therapy cognitivo-comportmental Each child will participate in a structured cognitive behavioral therapy program entitled "better manage your anger and frustration". 15 workshops is planned.	Other: cognitivo-comportmental therapy 15 workshops once a week during 90 minutes
Active Comparator: Body mediation Each child will participate in sports, artistic or fun activities involving the body (physical, emotional and communicative dimensions)	Other: body mediation 15 workshops once a week during 90 minutes

Arm

Intervention/Treatment

Experimental: Therapy cognitivo-comportmental

Each child will participate in a structured cognitive behavioral therapy program entitled "better manage your anger and frustration". 15 workshops is planned.

Other: cognitivo-comportmental therapy

15 workshops once a week during 90 minutes

Active Comparator: Body mediation

Each child will participate in sports, artistic or fun activities involving the body (physical, emotional and communicative dimensions)

Other: body mediation

15 workshops once a week during 90 minutes

Outcome Measures

Primary Outcome Measures

effectiveness of cognitive behavioral therapy program [6 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 13 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU de Bordeaux	Bordeaux	France	33076
2	CHU de Montpellier - Hôpital Saint Eloi	Montpellier	France	34070
3	CHU de La Réunion	Saint Pierre	Réunion	97448

Sponsors and Collaborators

Centre Hospitalier Universitaire de la Réunion

Investigators

Principal Investigator: Michel SPODENKIEWICZ, MD, CHU de La Réunion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de la Réunion

ClinicalTrials.gov Identifier:

NCT05273918

Other Study ID Numbers:

2020/CHU/06

First Posted:

Mar 10, 2022

Last Update Posted:

Mar 31, 2022

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de la Réunion

FASD

ADHD

Additional relevant MeSH terms:

Fetal Alcohol Spectrum Disorders

Disease

Study Results

No Results Posted as of Mar 31, 2022