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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fetal Alcohol Spectrum Disorders, Hyperactivity Disorder, Attention Deficit

Intervention / Treatment
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* Other: cognitivo-comportmental therapy
* Other: body mediation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy cognitivo-comportmental<br>Each child will participate in a structured cognitive behavioral therapy program entitled better manage your anger and frustration. 15 workshops is planned. | Other: cognitivo-comportmental therapy<br>* 15 workshops once a week during 90 minutes<br>|
| Active Comparator: Body mediation<br>Each child will participate in sports, artistic or fun activities involving the body (physical, emotional and communicative dimensions) | Other: body mediation<br>* 15 workshops once a week during 90 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FASD, ADHD