Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emotion Regulation for Children With Fetal Alcohol Spectrum Disorder
NCT ID: NCT05273918
Last Updated: 2023-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-01-31
2028-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Therapy cognitivo-comportmental
Each child will participate in a structured cognitive behavioral therapy program entitled "better manage your anger and frustration". 15 workshops is planned.
cognitivo-comportmental therapy
15 workshops once a week during 90 minutes
Body mediation
Each child will participate in sports, artistic or fun activities involving the body (physical, emotional and communicative dimensions)
body mediation
15 workshops once a week during 90 minutes
Interventions
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cognitivo-comportmental therapy
15 workshops once a week during 90 minutes
body mediation
15 workshops once a week during 90 minutes
Eligibility Criteria
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Inclusion Criteria
* 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
* child who already participate to CBT or body mediation groups
7 Years
13 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de la Réunion
OTHER
Responsible Party
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Principal Investigators
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Michel SPODENKIEWICZ, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de La Réunion
Locations
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CHU de Bordeaux
Bordeaux, , France
CHU de Montpellier - Hôpital Saint Eloi
Montpellier, , France
CHU de La Réunion
Saint-Pierre, , Reunion
Countries
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Other Identifiers
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2020/CHU/06
Identifier Type: -
Identifier Source: org_study_id
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