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

University Hospital Center (CHU)

Status: Enrolling

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

Treatments: Behavioral: Cognitive Behavorial Therapy (CBT); Behavioral: Body mediation

Study type: Interventional

Funder types: Other

Identifiers

NCT03176108

9729

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 estimated patients

Sex: All

Ages: 7 to 13 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

92 participants in 2 patient groups

CBT Group

Experimental group

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.

Treatment:

Behavioral: Cognitive Behavorial Therapy (CBT)

Control Group

Sham Comparator group

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.

Treatment:

Behavioral: Body mediation