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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Attention Deficit Disorder With Hyperactivity; Attention-Deficit-Disordered Children
• Intervention / Treatment: Behavioral: Cognitive Behavorial Therapy (CBT); Behavioral: Body mediation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cecile VACHER, Psychologist; Phone Number: +33.4.64.33.71.97; Email: c-vacher@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • CHU Montpellier
    • Contact: Cécile VACHER, PHD; Email: VACHER CECILE <c-vacher@chu-montpellier.fr>
    • Contact: Elodie COURTABESSIS, MD PHD; Email: COURTABESSIS ELODIE <e-courtabessis@chu-montpellier.fr>

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT Group; 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); Cognitive Behaviorial Therapy (CBT)
Sham Comparator: Control Group; 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; Body mediation (theatre)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Elodie COURTABESSIS, MD PHD, University Hospital, Montpellier

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2017
• Primary Completion (Anticipated): March 28, 2024
• Study Completion (Anticipated): March 28, 2025

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 9729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No