Actively Recruiting
RESist Against Irritability Superiority Trial
Led by University Hospital, Montpellier · Updated on 2023-08-14
270
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RESist Against Irritability Superiority Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female children between 6 and 15 years old
- Informed consent given by at least one parent or legal representative and oral consent by the child
- Confirmed diagnosis of ADHD, ODD, CD, mood/anxiety disorder, DMDD, or clinical diagnosis of intermittent explosive disorder
- Parental-rated irritability score of 4 or above at baseline
- Clinical Global Impression-Severity score of 4 or above (moderately ill or worse)
- Irritability symptoms persisting for 6 months or longer at baseline
- Stable treatment regimen for at least 2 weeks before and during the study
- For RESIST-QUAL, same criteria with specific informed consent
You will not qualify if you...
- Parents or legal representatives unavailable during the study period
- Diagnosis or history of schizophrenia, psychotic disorders, or acute manic episodes
- Non-verbal Autism Spectrum Disorder with 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
- No informed consent from parent/legal representative or child
- Inability to speak or understand French
- Unable to comply with the study protocol
- Participation in a structured parent program within the last 6 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UH of Montpellier
Montpellier, France, 34295
Actively Recruiting
Research Team
D
Diane Pr PURPER-OUAKIL
CONTACT
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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