Evaluation of a Parent/Child Cognitive-Behaviorial Therapy Program in ADHD Children With Emotional Dysregulation Profile

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of a Parent/Child Cognitive-Behaviorial Therapy Program in ADHD Children With Emotional Dysregulation Profile : a Study Prospective, Controlled and Randomized

Conditions
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Attention Deficit Disorder With Hyperactivity, Attention-Deficit-Disordered Children

Intervention / Treatment
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* Behavioral: Cognitive Behavorial Therapy (CBT)
* Behavioral: Body mediation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children and adolescents aged 7-13 years ; Children with a diagnostic of ADHD (diagnostics criteria from DSM-V); Score CBCL-DP ≥ 180 ( Aggressive behavior ,  Anxious-depression  and  Attention problems ) ; Children follow-up in Montpellier University Hospital ; Parents and children benefit of social security. Exclusion Criteria: Children with a developmental delay or severe language disorder ; Families non-french speaking ; Absence of consent signed by parents and child ; Children not living with at least one parent.

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: CBT Group<br>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. | Behavioral: Cognitive Behavorial Therapy (CBT)<br>* Cognitive Behaviorial Therapy (CBT)<br>|
| Sham Comparator: Control Group<br>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. | Behavioral: Body mediation<br>* Body mediation (theatre)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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  | 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 |