NCT05273918

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Centre Hospitalier Universitaire de la Réunion · Academic / Other
• Sex: All
• Age: 7 Years – 13 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	cognitivo-comportmental therapy	15 workshops once a week during 90 minutes
OTHER	body mediation	15 workshops once a week during 90 minutes

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-07-01
• Completion: 2028-10-01
• First posted: 2022-03-10
• Last updated: 2023-10-02

Locations

3 sites across 2 countries: France, Reunion