Parent Training for the Treatment of Irritability in Children and Adolescents: a Multisite Randomized Controlled, 3-parallel-group, Evaluator-blinded, Superiority Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Irritability is defined as developmentally inappropriate proneness to anger. Irritability is a symptom of several mental health conditions in children and adolescents such as attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), conduct disorder (CD), depressive disorders, anxiety disorders.Irritability has been associated with poor functional outcomes across the lifespan and was found to be specifically associated with concurrent and longitudinal emotional disorders, suicidality and impaired academic and socio-professional functioning. Children with high irritability also have distinct physiological profiles with hyper-reactivity to stress and perceived threats. Despite the high prevalence and health issues related to irritability, there is little treatment research on this topic. Developing evidence-based non-pharmacological treatment options for children suffering from severe, chronic irritability is therefore a particularly important target for clinical research.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 15
Healthy Volunteers: f
View:

• Male and female subject between 6 and 15 years-old.

• Express informed consent f by at least one of the parents or legal representative, and oral consent of the child.

• A confirmed K-SADS DSM-5 diagnosis of ADHD, ODD, CD, mood/anxiety disorder or DMDD, or a clinical diagnosis of IED. The request of a concomitant mental disorder allows to restrict this intervention to a clinical population.

• A Parental-rated ARI total score of 4 or above at baseline.

• A Clinical Global Impression-Severity score (CGI-S) of 4 or above (=at least moderately ill).

• Persistence of irritability symptoms 6 month or above at baseline (this avoids including children with transitory irritability).

• stable treatment regimen (pharmacological and non-pharmacological) for 2 weeks prior to inclusion and during the trial

• RESIST-QUAL : Same inclusion criteria as above with specific informed consent form signed by the participating parent.

Locations
Other Locations
France
UH of Montpellier
RECRUITING
Montpellier
Contact Information
Primary
Diane Pr PURPER-OUAKIL
d-purper_ouakil@chu-montpellier.fr
04.67.33.60.09
Time Frame
Start Date: 2023-04-25
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 270
Treatments
Other: Non-Violent Resistance (NVR) program
The Non-Violent Resistance (NVR) parent group-format program has been designed to develop a positive form of authority based on parental presence, a parental support network, strategies of nonviolent responses which avoid escalation and reconciliation gestures.
Other: Parent Management Training (PMT) program based on Barkley's program for defiant children
The Parent Management Treatment (PMT) program is an evidence-based treatment for disruptive behaviour disorder in which the child's social environment is modified according to principles of operant conditioning and contingency management. The parental response to the child's behaviour increases or decreases the likelihood of targeted behaviour.
Other: Treatment as usual (TAU)
The TAU group receives non-pharmacological and pharmacological therapies as usually provided in the participating centres but without having had a structured parent program.
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov