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Attention Deficit Disorder (ADD) with or without Hyperactivity/Impulsivity (ADHD) is a neurodevelopmental syndrome that has a lasting impact on the child's daily lifestyle and leads to functional impairment. ADHD is recognized as the most common psychiatry disorder in children and it's considered as a public health problem.
ADHD is frequently associated with a new diagnostic entity " Disruptive Disorder with Emotional dysregulation ". This disorder is characterized by crisis of anger with verbal or physical aggression, intensity disproportionate to the context and developmental age.
Few studies have examined the elements of emotional dysregulation in ADHD in children. Many studies have shown the interest of CBT in multimodal management of ADHD symptoms and associated disorders.
The main objective is to evaluate the effectiveness of a Cognitive-Behavioral Therapy Parent/Child program versus a body mediation focused on emotional and behaviorial aspects in ADD children aged 7-13 years with dimensional emotional dysregulation at 6 months after intervention. Secondary objectives are to evaluate the impact of this program, at short-term (at the end of CBT) and at 6 months after intervention, on socio-communicative capacities, quality of life, children's functioning and parental stress.
It's a biomedical research, prospective, controlled, randomized, monocentric, two parallels, with an evaluation of the criteria of blind judgment.
68 patients (parents and children) will be recruited within Montpellier University Hospital. They will be divided into a CBT group and a control group (body mediation).
The CBT group benefits from an intervention based on the program "Better manage its anger and its frustrations" of 15 sessions for the children.
The control group participates in an intervention of body mediation (theatre) of 15 session for the children.
The parents of CBT and Control groups participate in an CBT intervention of 8 sessions every 15 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT Group | Experimental | The CBT group benefits of an intervention based on the program "Better manage its anger and its frustrations" of 15 sessions for the children. Parents participate in an CBT intervention of 8 sessions every 15 days. The session allow to develop adapted behaviors, to manage the disruptive behaviors and to improve the relations parents/children. |
|
| Control Group | Sham Comparator | The control group participates in an intervention of body mediation (theatre) of 15 session for the children. Parents participate in an CBT intervention of 8 sessions every 15 days. The session allow to develop adapted behaviors, to manage the disruptive behaviors and to improve the relations parents/children. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavorial Therapy (CBT) | Behavioral | Cognitive Behaviorial Therapy (CBT) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Variation between the initial assessment and the month evaluation atfer the end of the intervention on the score of the " Aggressive behavior " subscale at the CBCL (Child Behavior Checklist) | The Questionnaire is completed by parents | Evaluation at inclusion, 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| :* Variation of total score on CBCL and score on " Dysregulation profile " (CBCL-DP) on Child Behavior Checklist | The Questionnaire is completed by parents | Evaluation at inclusion, 6 months and 12 months |
| Variation of scores on " Strengths and Difficulties Questionnaire " |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cecile VACHER, Psychologist | Contact | +33.4.64.33.71.97 | c-vacher@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Elodie COURTABESSIS, MD PHD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Montpellier | Recruiting | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35130934 | Derived | Vacher C, Romo L, Dereure M, Soler M, Picot MC, Purper-Ouakil D. Efficacy of cognitive behavioral therapy on aggressive behavior in children with attention deficit hyperactivity disorder and emotion dysregulation: study protocol of a randomized controlled trial. Trials. 2022 Feb 7;23(1):124. doi: 10.1186/s13063-022-05996-5. |
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| Body mediation |
| Behavioral |
Body mediation (theatre) |
|
Description: The Questionnaire is completed by parents and teachers |
| Evaluation at inclusion, 6 months and 12 months |
| Variation of scores on " Parenting Stress Index " | The Questionnaire is completed by parents | Evaluation at inclusion, 6 months and 12 months |
| Variation of score on " Beck Depression Inventory " | The Questionnaire is completed by parents | Evaluation at inclusion, 6 months and 12 months |
| Variation of scores on " Kidscreen-27 " | The Questionnaire is completed by parents | Evaluation at inclusion, 6 months and 12 months |
| Variation of score on " PAR-ENT-Qol " | The Questionnaire is completed by parents | Evaluation at inclusion, 6 months and 12 months |
| Variation of score on " Children's Global Assessment Scale " (C-GAS) | The Questionnaire is completed by the evaluator who receive parents and their child. | Evaluation at inclusion, 6 months and 12 months |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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