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

Centre Hospitalier Universitaire de la Réunion

Status: Withdrawn

Conditions: Hyperactivity Disorder; Fetal Alcohol Spectrum Disorders; Attention Deficit

Treatments: Other: body mediation; Other: cognitivo-comportmental therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05273918

2020/CHU/06

Details and patient eligibility

About

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.

Sex: All

Ages: 7 to 13 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Therapy cognitivo-comportmental

Experimental group

Description:

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

Treatment:

Other: cognitivo-comportmental therapy

Body mediation

Active Comparator group

Description:

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

Treatment:

Other: body mediation