A trial to improve management of irritability in children and adolescents
Parent Training for the Treatment of Irritability in Children and Adolescents: a Multisite Randomized Controlled, 3-parallel-group, Evaluator-blinded, Superiority Trial
This study is testing new ways to help children and teenagers with severe irritability feel better and manage their emotions without using medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 6 Years to 15 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05528926 on ClinicalTrials.gov |
What this trial studies
This trial focuses on developing non-pharmacological treatment options for children and adolescents suffering from severe, chronic irritability, which is often associated with various mental health conditions. The study employs interventions such as Non-Violent Resistance and Parent Management Training to address irritability symptoms. Participants will be assessed for their irritability levels and receive tailored management strategies over the course of the trial. The goal is to provide evidence-based approaches to improve emotional regulation and overall functioning in affected youth.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6 to 15 years with a confirmed diagnosis of ADHD, ODD, CD, mood/anxiety disorders, or DMDD, who exhibit persistent irritability.
Not a fit: Patients who do not meet the age criteria or do not have a confirmed diagnosis of the specified mental health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could lead to effective non-drug treatments for children with chronic irritability, improving their emotional well-being and daily functioning.
How similar studies have performed: While there is limited research specifically targeting irritability, similar non-pharmacological interventions have shown promise in managing related behavioral and emotional disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Unavailability of parents or legal representative during the study period. * Subjects with a DSM-5 diagnosis (clinical presentation or history) that is consistent with Schizophrenia or psychotic disorders or acute manic episodes. * Diagnosis of Autism Spectrum Disorder (ASD) in patients who are non-verbal and with IQ lower than 70. * Known or estimated IQ\<70 or clinical diagnosis of intellectual disability. * Subjects with severe irritability that are better accounted for by another factor, e.g.: general medical condition(s) or direct effect of a substance (i.e., medication, illicit drug use), as determined by the clinical judgment of the investigator, or related to child abuse and/or neglect. * absence of informed consent give by at least one of the parents or legal representatives, and oral consent of the child * inability to speak and comprehend French * deemed unable to comply with the trial protocol * participation in a structured parent program during the last 6 months
Where this trial is running
Montpellier
- UH of Montpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Diane Pr PURPER-OUAKIL
- Email: d-purper_ouakil@chu-montpellier.fr
- Phone: 04.67.33.60.09
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.