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

Fetal Alcohol Spectrum Disorders Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05273918
• Other study ID #: 2020/CHU/06
• Status: Withdrawn
• Phase: N/A
• Start date: January 2023
• Est. completion date: October 2028

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2028
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit
• Fetal Alcohol Spectrum Disorders
• Hyperactivity Disorder

Intervention

Other:
• cognitivo-comportmental therapy
15 workshops once a week during 90 minutes
• body mediation
15 workshops once a week during 90 minutes

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	CHU de Montpellier - Hôpital Saint Eloi	Montpellier
Réunion	CHU de La Réunion	Saint Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Countries where clinical trial is conducted

France,  Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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