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

NCT05273918 | Withdrawn

• 1 other identifier: 2020/CHU/06
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 3

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.

Conditions

Fetal Alcohol Spectrum Disorders; Hyperactivity Disorder; Attention Deficit

Keywords

FASD; ADHD

Outcome Measures

Primary Outcomes (1)

• 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.

  7 months after inclusion

Study Arms (2)

Therapy cognitivo-comportmental

EXPERIMENTAL

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

Body mediation

ACTIVE COMPARATOR

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

Other: body mediation

Interventions

cognitivo-comportmental therapy OTHER

15 workshops once a week during 90 minutes

Therapy cognitivo-comportmental

body mediation OTHER

15 workshops once a week during 90 minutes

Body mediation

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• non-french speaking child or parents / non-creole speaking child or parents
• child who already participate to CBT or body mediation groups

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (3)

CHU de Bordeaux

Bordeaux, 33076, France

Location

CHU de Montpellier - Hôpital Saint Eloi

Montpellier, 34070, France

Location

CHU de La Réunion

Saint-Pierre, 97448, Reunion

Location

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Michel SPODENKIEWICZ, MD

  CHU de La Réunion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 10, 2022
• Study Start: January 1, 2023
• Primary Completion: July 1, 2023
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); RE (1)