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

Attention Deficit Disorder With Hyperactivity Clinical Trial

— DP-KID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03176108
• Other study ID #: 9729
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2017
• Est. completion date: March 28, 2025

Study information

• Verified date: January 2023
• Source: University Hospital, Montpellier
• Contact: Cecile VACHER, Psychologist
• Phone: +33.4.64.33.71.97
• Email: c-vacher[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: March 28, 2025
• Est. primary completion date: March 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Attention-Deficit-Disordered Children

Intervention

Behavioral:
• Cognitive Behavorial Therapy (CBT)
Cognitive Behaviorial Therapy (CBT)
• Body mediation
Body mediation (theatre)

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	:* 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
Secondary	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
Secondary	Variation of scores on " Parenting Stress Index "	The Questionnaire is completed by parents	Evaluation at inclusion, 6 months and 12 months
Secondary	Variation of score on " Beck Depression Inventory "	The Questionnaire is completed by parents	Evaluation at inclusion, 6 months and 12 months
Secondary	Variation of scores on " Kidscreen-27 "	The Questionnaire is completed by parents	Evaluation at inclusion, 6 months and 12 months
Secondary	Variation of score on " PAR-ENT-Qol "	The Questionnaire is completed by parents	Evaluation at inclusion, 6 months and 12 months
Secondary	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