An interventional study of Cognitive Behavorial Therapy (CBT) and Body mediation in Attention Deficit Disorder With Hyperactivity and Attention-Deficit-Disordered Children, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Open to participants aged 7 Years to 13 Years. Per ClinicalTrials.gov, last updated 2023-01-23.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Supportive care
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.
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's planned enrollment of 92 is above the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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
Cognitive Behaviorial Therapy (CBT)
Body mediation (theatre)
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
Time frame: Evaluation at inclusion, 6 months and 12 months
:* Variation of total score on CBCL and score on " Dysregulation profile " (CBCL-DP) on Child Behavior Checklist
The Questionnaire is completed by parents
Time frame: 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
Time frame: Evaluation at inclusion, 6 months and 12 months
Variation of scores on " Parenting Stress Index "
The Questionnaire is completed by parents
Time frame: Evaluation at inclusion, 6 months and 12 months
Variation of score on " Beck Depression Inventory "
The Questionnaire is completed by parents
Time frame: Evaluation at inclusion, 6 months and 12 months
Variation of scores on " Kidscreen-27 "
The Questionnaire is completed by parents
Time frame: Evaluation at inclusion, 6 months and 12 months
Variation of score on " PAR-ENT-Qol "
The Questionnaire is completed by parents
Time frame: 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.
Time frame: Evaluation at inclusion, 6 months and 12 months
Plan to share: No
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity→
University Hospital, Montpellier