Clinical trial NCT03176108: Evaluation of a Parent/Child Cognitive-Behaviorial Therapy Program in ADHD Children With Emotional Dysregulation Profile
Official title: Evaluation of a Parent/Child Cognitive-Behaviorial Therapy Program in ADHD Children With Emotional Dysregulation Profile : a Study Prospective, Controlled and Randomized
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Attention-Deficit-Disordered Children
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 92
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Evaluation at inclusion, 6 months and 12 months
Secondary outcomes:
measure: :* Variation of total score on CBCL and score on " Dysregulation profile " (CBCL-DP) on Child Behavior Checklist
timeFrame: Evaluation at inclusion, 6 months and 12 months
measure: Variation of scores on " Strengths and Difficulties Questionnaire "
timeFrame: Evaluation at inclusion, 6 months and 12 months
measure: Variation of scores on " Parenting Stress Index "
timeFrame: Evaluation at inclusion, 6 months and 12 months
measure: Variation of score on " Beck Depression Inventory "
timeFrame: Evaluation at inclusion, 6 months and 12 months
measure: Variation of scores on " Kidscreen-27 "
timeFrame: Evaluation at inclusion, 6 months and 12 months
measure: Variation of score on " PAR-ENT-Qol "
timeFrame: Evaluation at inclusion, 6 months and 12 months
measure: Variation of score on " Children's Global Assessment Scale " (C-GAS)
timeFrame: Evaluation at inclusion, 6 months and 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Elodie COURTABESSIS, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.