Study Results
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Basic Information
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RECRUITING
NA
270 participants
INTERVENTIONAL
2023-04-25
2026-09-01
Brief Summary
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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.
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Detailed Description
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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.
Irritability is included in the negative valence system of RDoC as "frustrative non-reward". According to this neuroscience-based classification, irritability is an excessive response of an individual faced with the impossibility to achieve an expected goal and has been linked to dysregulations of the autonomic nervous system and the reward network. Another pathophysiological line of research conceptualizes irritability as an aberrant response to threat (e.g. irritable individuals may attack more rapidly and in broader contexts).
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. One of the first steps in achieving this goal includes testing new therapies against extant interventions. Parent training programs decrease aggressive behaviours in children and are therefore good candidates for the improvement of irritability. Low parental warmth, lack of positive parental emotion socialization and high parental Expressed Emotions have been linked with irritability in children and could therefore be targeted in parental programs.
Research on the biological and psychological mechanisms mediating irritability is also needed to further improve specificity of therapeutic actions.
The project includes two ancyllary studies : RESIST-EXP and RESIST-QUAL.
* RESIST-EXP: Investigate improvement of irritability in both programs throughout emotional testing while collecting ANS functioning measurements.
* RESIST-QUAL: A qualitative interview planned after treatment completion with parents from both parent programme groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Non-Violent Resistance parent training (NVR)
* Parent Management Training (PMT)
* Treatment As Usual (TAU)
OTHER
SINGLE
Study Groups
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Non-Violent Resistance (NVR) program
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.
Non-Violent Resistance
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).
Parent Management Training (PMT) program based on Barkley's program for defiant children
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.
Parent Management Training
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).
Treatment as usual (TAU)
The TAU group receives non-pharmacological and pharmacological therapies as usually provided in the participating centres but without having had a structured parent program.
Treatment As Usual
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.
Interventions
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Parent Management Training
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).
Treatment As Usual
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.
Non-Violent Resistance
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
6 Years
15 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Locations
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UH of Montpellier
Montpellier, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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RECHMPL20_0038
Identifier Type: -
Identifier Source: org_study_id
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