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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Non-Violent Resistance
Other interventionThe 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).
Parent Management Training
Other interventionThe 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).
Treatment As Usual
DrugThe 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.
Treatment groups
270 Participants
are divided into 3 treatment groupsGroup A: Non-Violent Resistance (NVR) programOther 1 intervention
Group B: Parent Management Training (PMT) program based on Barkley's program for defiant childrenOther 1 intervention
Group C: Treatment as usual (TAU)Other 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline level that measure pleasure and arousal
Change from baseline at 3 months after completion of the program of the Clinician-rated Affective Rating Scale (CL-ARI) assessed by blinded evaluators. This scale gives a range of possible scores from 0 to 12, with frequency and duration of temper outbursts quantified across three different levels of severity: mild, moderate and severe the higher the score.
Time frame
After 3 months follow-upSecondary outcomes
1
Secondary efficacy endpoint at 1-month follow-up
Change from baseline at 1 month after completion of the program of the Clinician-rated Affective Rating Scale (CL-ARI) by blinded evaluators. This scale gives a range of possible scores from 0 to 12, with frequency and duration of temper outbursts quantified across three different levels of severity: mild, moderate and severe the higher the score.
Time frame
After 1 month follow-up2
Secondary efficacy endpoints at 1 and 3-month follow-up
Clinical Global Impression Improvement (CGI-I) scale from 1 to 7. the CGI-I 7-point scale to rate the patients' total improvement based on comparison with their baseline assessment from 1 = very much improved to 7 = very much worse.
Time frame
Between 1 and 3-month follow-up3
Secondary efficacy endpoints at 1 and 3-month follow-up
Change from baseline in the Parenting and Familial Adjustement Scale (PAFAS)
Time frame
Between 1 and 3-month follow-up4
Secondary efficacy endpoints at 1 and 3-month follow-up
Change from baseline in Parent-rated ARI and Child-rated Cranky thermometers
Time frame
Between 1 and 3-month follow-upSponsors and contacts
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Source ClinicalTrials.gov