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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive Behavorial Therapy (CBT)
Body mediation
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

7 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU MontpellierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

CBT Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

:* Variation of total score on CBCL and score on " Dysregulation profile " (CBCL-DP) on Child Behavior Checklist
The Questionnaire is completed by parents
Variation of scores on " Strengths and Difficulties Questionnaire "
Description: The Questionnaire is completed by parents and teachers
Variation of scores on " Parenting Stress Index "
The Questionnaire is completed by parents
Variation of score on " Beck Depression Inventory "
The Questionnaire is completed by parents
Variation of scores on " Kidscreen-27 "
The Questionnaire is completed by parents
Variation of score on " PAR-ENT-Qol "
The Questionnaire is completed by parents
Variation of score on " Children's Global Assessment Scale " (C-GAS)
The Questionnaire is completed by the evaluator who receive parents and their child.

Full Information

First Posted
May 30, 2017
Last Updated
January 20, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03176108
Brief Title
Evaluation of a Parent/Child Cognitive-Behaviorial Therapy Program in ADHD Children With Emotional Dysregulation Profile
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
March 28, 2024 (Anticipated)
Study Completion Date
March 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity, Attention-Deficit-Disordered Children

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavorial Therapy (CBT)
Intervention Description
Cognitive Behaviorial Therapy (CBT)
Intervention Type
Behavioral
Intervention Name(s)
Body mediation
Intervention Description
Body mediation (theatre)
Primary Outcome Measure Information:
Title
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)
Description
The Questionnaire is completed by parents
Time Frame
Evaluation at inclusion, 6 months and 12 months
Secondary Outcome Measure Information:
Title
:* Variation of total score on CBCL and score on " Dysregulation profile " (CBCL-DP) on Child Behavior Checklist
Description
The Questionnaire is completed by parents
Time Frame
Evaluation at inclusion, 6 months and 12 months
Title
Variation of scores on " Strengths and Difficulties Questionnaire "
Description
Description: The Questionnaire is completed by parents and teachers
Time Frame
Evaluation at inclusion, 6 months and 12 months
Title
Variation of scores on " Parenting Stress Index "
Description
The Questionnaire is completed by parents
Time Frame
Evaluation at inclusion, 6 months and 12 months
Title
Variation of score on " Beck Depression Inventory "
Description
The Questionnaire is completed by parents
Time Frame
Evaluation at inclusion, 6 months and 12 months
Title
Variation of scores on " Kidscreen-27 "
Description
The Questionnaire is completed by parents
Time Frame
Evaluation at inclusion, 6 months and 12 months
Title
Variation of score on " PAR-ENT-Qol "
Description
The Questionnaire is completed by parents
Time Frame
Evaluation at inclusion, 6 months and 12 months
Title
Variation of score on " Children's Global Assessment Scale " (C-GAS)
Description
The Questionnaire is completed by the evaluator who receive parents and their child.
Time Frame
Evaluation at inclusion, 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cecile VACHER, Psychologist
Phone
+33.4.64.33.71.97
Email
c-vacher@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elodie COURTABESSIS, MD PHD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile VACHER, PHD
Email
VACHER CECILE <c-vacher@chu-montpellier.fr>
First Name & Middle Initial & Last Name & Degree
Elodie COURTABESSIS, MD PHD
Email
COURTABESSIS ELODIE <e-courtabessis@chu-montpellier.fr>

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35130934
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.
Results Reference
derived

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

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