RESist Against Irritability Superiority Trial
Parent Training for the Treatment of Irritability in Children and Adolescents: a Multisite Randomized Controlled, 3-parallel-group, Evaluator-blinded, Superiority Trial
University Hospital, Montpellier
270 participants
Apr 25, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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
Exclusion Criteria9
- 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
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Interventions
The program's core features are parental self-control and emotional support. In the NVR program, parents recruit supporters to help them deal with their children's problematic behaviours. Developing emotional control means that the parent opposes non-violent resistance to his child's behaviour, not escalating the explosive situation. 10 sessions (5 sessions per day for 2 consecutive days and two booster sessions at M1 and M3 after completion).
The gold-standard treatment for disruptive behaviour disorder in children and adolescents. The objective is to train parents to cope with the difficult situations they encounter, to teach them effective control strategies that are coherent and adapted to the 'deviant' behaviour of their children to reduce the intensity of events and their repercussions within the family. 10 sessions (5 sessions per day for 2 consecutive days and two booster sessions at M1 and M3 after completion).
The TAU group receives non-pharmacological and pharmacological therapies as usually provided in the participating centres but without having had a structured parent program in the last 6 months assessed at baseline, M1 and M3.
Locations(1)
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NCT05528926