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

NCT03176108 | Unknown

• 1 other identifier: 9729
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• :* Variation of total score on CBCL and score on " Dysregulation profile " (CBCL-DP) on Child Behavior Checklist

  Evaluation at inclusion, 6 months and 12 months

• Variation of scores on " Strengths and Difficulties Questionnaire "

  Evaluation at inclusion, 6 months and 12 months

• Variation of scores on " Parenting Stress Index "

  Evaluation at inclusion, 6 months and 12 months

• Variation of score on " Beck Depression Inventory "

  Evaluation at inclusion, 6 months and 12 months

• Variation of scores on " Kidscreen-27 "

  Evaluation at inclusion, 6 months and 12 months

Study Arms (2)

CBT Group

EXPERIMENTAL

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)

Control Group

SHAM COMPARATOR

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

Interventions

Cognitive Behavorial Therapy (CBT) BEHAVIORAL

Cognitive Behaviorial Therapy (CBT)

CBT Group

Body mediation BEHAVIORAL

Body mediation (theatre)

Control Group

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34295, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 35130934 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Elodie COURTABESSIS, MD PHD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecile VACHER, Psychologist

CONTACT

+33.4.64.33.71.97; c-vacher@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 5, 2017
• Study Start: June 28, 2017
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2025
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)