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

NCT ID: NCT03176108

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-28
• Study Completion Date: 2025-03-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Behavorial Therapy (CBT)

Intervention Type: BEHAVIORAL

Cognitive Behaviorial Therapy (CBT)

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.

Group Type: SHAM_COMPARATOR

Body mediation

Intervention Type: BEHAVIORAL

Body mediation (theatre)

Interventions

Cognitive Behavorial Therapy (CBT)

Cognitive Behaviorial Therapy (CBT)

Intervention Type: BEHAVIORAL

Body mediation

Body mediation (theatre)

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elodie COURTABESSIS, MD PHD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

CHU Montpellier

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Cecile VACHER, Psychologist

Role: CONTACT

c-vacher@chu-montpellier.fr

+33.4.64.33.71.97

Facility Contacts

Cécile VACHER, PHD

Role: primary

VACHER CECILE <c-vacher@chu-montpellier.fr>

Elodie COURTABESSIS, MD PHD

Role: backup

COURTABESSIS ELODIE <e-courtabessis@chu-montpellier.fr>

References

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.

Reference Type: DERIVED

PMID: 35130934 (View on PubMed)

Other Identifiers

9729

Identifier Type: -

Identifier Source: org_study_id