WithdrawnNot Applicable

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

Stopped: logistic problem and absence of coordinating Investigator

France, Reunion0Started 2023-01

Plain-language 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.

Who can participate

Age range7 Years – 13 Years

SexALL

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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

What they're measuring

effectiveness of cognitive behavioral therapy program

Timeframe: 7 months after inclusion

Trial details

NCT IDNCT05273918

SponsorCentre Hospitalier Universitaire de la Réunion

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07

View on ClinicalTrials.gov More Fetal Alcohol Spectrum Disorders trials