RESist Against Irritability Superiority Trial
ConditionIrritable Mood
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-15
SponsorUniversity Hospital, Montpellier
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Non-Violent Resistance
- Parent Management Training
- Treatment As Usual
Treatment groups
270 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov