RESist Against Irritability Superiority Trial — RESIST  

Irritable Mood Clinical Trial

Official title: Parent Training for the Treatment of Irritability in Children and Adolescents: a Multisite Randomized Controlled, 3-parallel-group, Evaluator-blinded, Superiority Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. Both tonic (e.g. negative quality of mood) and phasic (e.g. temper outbursts) irritability are criteria of the DSM-5 Disruptive Mood Dysregulation Disorder and the World Health Organization has considered the addition of a specifier to indicate whether ODD presents with chronic irritability and anger in the revision of the International Classification of Disease.

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. ;

Related Conditions & MeSH terms

• Irritable Mood

• NCT number: NCT05528926
• Study type: Interventional
• Source: University Hospital, Montpellier
• Contact: Diane Pr PURPER-OUAKIL
• Phone: 04.67.33.60.09
• Email: d-purper_ouakil@chu-montpellier.fr
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2023
• Completion date: September 1, 2026