Parent training for the treatment of irritability in children and adolescents: a multisite randomized controlled, 3-parallel-group, evaluator-blinded, superiority trial.
E Fongaro, M C Picot, A Stringaris...
https://pubmed.ncbi.nlm.nih.gov/36414963Actively Recruiting
Phase Not Applicable
Age: 6Years - 15Years
All Genders
ID05528926
Parent Training for the Treatment of Irritability in Children and Adolescents: a Multisite Randomized Controlled, 3-parallel-group, Evaluator-blinded, Superiority Trial
Led by University Hospital, Montpellier · Updated on 2023-08-14
270
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Irritability, characterized by an inappropriate tendency to anger, is common in children and adolescents with mental health conditions such as ADHD, oppositional defiant disorder, conduct disorder, depressive and anxiety disorders. It is linked to poor outcomes including emotional disorders, suicidality, and impaired academic and social functioning. Despite its impact, there is limited research on treatments for severe, chronic irritability in young people, making the development of evidence-based non-drug therapies a key research goal. This trial compares two parent training programs designed to help manage irritability in children aged 6 to 15. The Non-Violent Resistance (NVR) program focuses on parental self-control, support, and nonviolent responses over 10 sessions including boosters at 1 and 3 months. The Parent Management Training (PMT) program teaches parents operant conditioning techniques to reduce problematic child behavior with a similar session structure. A third group receives usual care without a structured parent program. Participants will attend sessions and follow-up visits over 3 months, with assessments including emotional testing and autonomic nervous system measures in an ancillary study. Researchers will measure changes in pleasure and arousal levels as the primary outcome, along with secondary and exploratory outcomes at 1 and 3 months. Qualitative interviews with parents will explore program experiences. The study aims to understand treatment effects and mechanisms for irritability management in children.
CONDITIONS
Brief Title
RESist Against Irritability Superiority Trial
Who Can Participate
Age: 6Years - 15Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male and female children aged between 6 and 15 years old
- Informed consent given by at least one parent or legal representative, plus the child's oral consent
- Confirmed diagnosis of ADHD, ODD, conduct disorder, mood or anxiety disorder, disruptive mood dysregulation disorder, or intermittent explosive disorder
- Parental-rated ARI total score of 4 or higher at baseline
- Clinical Global Impression-Severity score of 4 or higher (moderately ill or worse)
- Irritability symptoms persisting for 6 months or longer at baseline
- Stable pharmacological and non-pharmacological treatment for at least 2 weeks before and during the trial
- For RESIST-QUAL ancillary study, same criteria plus specific informed consent from participating parent
You will not qualify if you...
- Parents or legal representatives unavailable during the study period
- Diagnosis of schizophrenia, psychotic disorders, or acute manic episodes
- Autism Spectrum Disorder with non-verbal status and IQ below 70
- Known or estimated IQ below 70 or intellectual disability diagnosis
- Severe irritability caused by medical conditions, substance effects, or child abuse/neglect
- Lack of informed consent from parent/legal representative or child
- Inability to speak and understand French
- Unable to comply with the trial protocol
- Participation in a structured parent program within the last 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 3 months
Participants attend parent training programs consisting of 10 sessions: 5 sessions per day for 2 consecutive days, followed by two booster sessions at 1 and 3 months after completion. Alternatively, participants in the Treatment As Usual group receive non-pharmacological and pharmacological therapies as usually provided in the participating centres without structured parent programs.
Initial 2 consecutive days of sessions plus 2 booster sessions at 1 and 3 months
Follow-up
Duration - 3 months post-treatment
Participants are evaluated at 1 and 3 months after treatment to assess changes in irritability and other secondary outcomes.
Visits at 1 month and 3 months post-treatment
Trial Site Locations
Total: 1 location
1
UH of Montpellier
Montpellier, France, 34295
Actively Recruiting
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Research Team
D
Diane Pr PURPER-OUAKIL
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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