RESist Against Irritability Superiority Trial

NCT05528926 | Recruiting

• 1 other identifier: RECHMPL20_0038
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Mood

Keywords

Irritability; Parent Management Training (PMT); Non-Violent Resistance (NVR)

Outcome Measures

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.

  After 3 months follow-up

Secondary Outcomes (13)

• Secondary efficacy endpoint at 1-month follow-up

  After 1 month follow-up

• Secondary efficacy endpoints at 1 and 3-month follow-up

  Between 1 and 3-month follow-up

• Secondary efficacy endpoints at 1 and 3-month follow-up

  Between 1 and 3-month follow-up

• Secondary efficacy endpoints at 1 and 3-month follow-up

  Between 1 and 3-month follow-up

• Exploratory efficacy endpoints and putative moderators and mediators.

  After 3-month follow-up

Study Arms (3)

Non-Violent Resistance (NVR) program

OTHER

The Non-Violent Resistance (NVR) parent group-format program has been designed to develop a positive form of authority based on parental presence, a parental support network, strategies of nonviolent responses which avoid escalation and reconciliation gestures.

Other: Non-Violent Resistance

Parent Management Training (PMT) program based on Barkley's program for defiant children

OTHER

The Parent Management Treatment (PMT) program is an evidence-based treatment for disruptive behaviour disorder in which the child's social environment is modified according to principles of operant conditioning and contingency management. The parental response to the child's behaviour increases or decreases the likelihood of targeted behaviour.

Other: Parent Management Training

Treatment as usual (TAU)

OTHER

The TAU group receives non-pharmacological and pharmacological therapies as usually provided in the participating centres but without having had a structured parent program.

Drug: Treatment As Usual

Interventions

Non-Violent Resistance OTHER

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).

Also known as: NVR program

Non-Violent Resistance (NVR) program

Parent Management Training OTHER

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).

Also known as: PMT program

Parent Management Training (PMT) program based on Barkley's program for defiant children

Treatment As Usual DRUG

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.

Also known as: TAU

Treatment as usual (TAU)

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UH of Montpellier

Montpellier, 34295, France

RECRUITING

Related Publications (1)

• Fongaro E, Picot MC, Stringaris A, Belloc C, Verissimo AS, Franc N, Purper-Ouakil D. Parent training for the treatment of irritability in children and adolescents: a multisite randomized controlled, 3-parallel-group, evaluator-blinded, superiority trial. BMC Psychol. 2022 Nov 22;10(1):273. doi: 10.1186/s40359-022-00984-5.

  PMID: 36414963 DERIVED

MeSH Terms

Interventions

Therapeutics

Central Study Contacts

Diane Pr PURPER-OUAKIL

CONTACT

04.67.33.60.09; d-purper_ouakil@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In the RESIST trial, independent evaluators will be blinded to the type of program received by the parents; this aspect will be monitored throughout the study and parents will be instructed before every assessment to avoid disclosing the type of therapy received.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 parallel groups to compare: * Non-Violent Resistance parent training (NVR) * Parent Management Training (PMT) * Treatment As Usual (TAU)

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 6, 2022
• Study Start: April 25, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

FR (1)