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logistic problem and absence of coordinating Investigator
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy cognitivo-comportmental | Experimental | Each child will participate in a structured cognitive behavioral therapy program entitled "better manage your anger and frustration". 15 workshops is planned. |
|
| Body mediation | Active Comparator | Each child will participate in sports, artistic or fun activities involving the body (physical, emotional and communicative dimensions) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitivo-comportmental therapy | Other | 15 workshops once a week during 90 minutes |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel SPODENKIEWICZ, MD | CHU de La Réunion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33076 | France | |||
| CHU de Montpellier - HĂ´pital Saint Eloi |
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| body mediation | Other | 15 workshops once a week during 90 minutes |
|
| Montpellier |
| 34070 |
| France |
| CHU de La Réunion | Saint-Pierre | 97448 | Reunion |
| ID | Term |
|---|---|
| D063647 | Fetal Alcohol Spectrum Disorders |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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