Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

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

NCT number NCT03176108
Study type Interventional
Source University Hospital, Montpellier
Contact Cecile VACHER, Psychologist
Phone +33.4.64.33.71.97
Email c-vacher@chu-montpellier.fr
Status Recruiting
Phase N/A
Start date June 28, 2017
Completion date March 28, 2025

See also
  Status Clinical Trial Phase
Completed NCT00202605 - Safety and Efficacy of SPD465 in Adults With ADHD Phase 2
Not yet recruiting NCT02677519 - A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD Phase 4
Completed NCT02730572 - Concerta (Methylphenidate) -To-Generic Switch Study N/A
Completed NCT01681082 - Psychological Effects of Tai Chi Training N/A
Active, not recruiting NCT01330693 - Cortical Excitability: Phenotype and Biomarker in Attention-deficit, Hyperactivity Disorder (ADHD) Therapy Phase 3
Completed NCT00830700 - Children's Attention Deficit Disorder With Hyperactivity (ADHD) Telemental Health Treatment Study N/A
Completed NCT01012622 - An Efficacy and Safety Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention Deficit Hyperactivity Disorder (ADHD) Phase 4
Completed NCT00626236 - Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems Phase 2
Completed NCT00598182 - Adherence and Long-term Effect of OROS Methylphenidate (CONCERTA): A Follow-up Study N/A
Completed NCT00381407 - Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder N/A
Completed NCT00247572 - Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories Phase 2
Completed NCT00178503 - Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children Phase 2/Phase 3
Completed NCT00118911 - Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder N/A
Completed NCT00218322 - Effectiveness of ATMX in Treating Adolescents With ADHD and SUD Phase 4
Completed NCT00557011 - NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD Phase 2
Completed NCT00071656 - Psychosocial Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Type I N/A
Active, not recruiting NCT00057668 - Preventing Behavior Problems in Children With ADHD Phase 2
Completed NCT00050050 - Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder Phase 1
Completed NCT00050622 - Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD) N/A
Completed NCT00031395 - Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children Phase 3