About this trial
Adolescent non-suicidal self-injury (NSSI) is common, strongly associated with psychiatric comorbidity and an increased risk of future suicide attempt. Although interventions targeting emotion regulation have been shown to reduce NSSI in both adults and adolescents few, are available within routine child and adolescent mental health services (CAMHS). Emotion Regulation for Adolescents (ERA), adapted from an evidence-based adult intervention is a brief group-based treatment designed to increase access to effective, evidence-based care for adolescents with NSSI. A large-scale randomised controlled trial (RCT) is needed to establish its efficacy and strengthen the evidence base for emotion regulation interventions for adolescent NSSI.
The overall aim of this project is to increase the availability of evidence-based psychological treatments for adolescent NSSI by developing and evaluating Emotion Regulation for Adolescents (ERA), a novel behavioural and acceptance-based intervention. The main objectives are to establish the efficacy, cost-effectiveness, and long-term outcomes of ERA for adolesent NSSI in two arm RCT comparing ERA with an active control condition (FUNK) as well as to investigate potential mediators such as emotion regulation and self-criticism.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 13 - 17 years
At least 5 instances of NSSI in the past year, and at least one during the past month
≥5 episodes of NSSI in the past year, including ≥1 in the past month
If receiving antidepressant, central stimulants or neuroleptic medication, dose must be stable for least 6 weeks prior to inclusion
Disqualifiers
Intellectual disability or a severe psychiatric disorder requiring immediate treatment (e.g., psychosis, bipolar disorder type 1, anorexia nervosa, alcohol/substance dependence) or conditions that prevent participation (e.g., severe social anxiety, selective mutism)
Acute suicide risk (i.e., current suicide plans) or recent suicide attempt
Previous or ongoing structured emotion regulation treatment involving at least 3 sessions during the past 12 months
Previous or ongoing structured emotion regulation treatment (≥3 sessions within past 12 months)
Trial design
Parallel
Treatments tested in this trial
Emotion Regulation Group Therapy for Self-harming Adolescents, ERA
BehavioralManualized 12-week group intervention for adolescents with NSSI and a parallel five-session parent program. Experimental: ERA Participants receive ERA a 12-week manualized group intervention, targeting NSSI. The intervention focuses on increasing adaptive emotion regulation, reducing impulsive behaviours, and increasing acceptance of difficult emotions with integrated exercises to increase self-compassion and reduce self-criticism. Caregivers participate in a parallel five-session parent group focusing on preventing NSSI contagion, supporting emotion regulation and strengthening adaptive family communication and functioning.
Functional habits for mental health, FUNK
BehavioralActive comparator: Active Control Condition (FUNK) Participants receive a manualized active control condition FUNK consisting of: 1) ane individual family session to develop a personalized safety plan; 2) five group-based psychoeducation family sessions over 10 weeks, covering sleep, nutrition and physical activity, anxiety, depression and emotions; and 3) weekly suicide risk monitoring.
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline in clinician-rated scores on Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7)
Used to assess frequency, abstinence and severity of non-suicidal self-injury. Clinician-rated. Lower scores means better outcome.
Secondary outcomes
Clinical Global Impression - Severity (CGI-S)
Used to provide an overall rating of non-suicidal self-injury severity. Clinician-rated. Range: 1-7. Lower scores mean less severe symptoms.
Clinical Global Impression - Improvement (CGI-I)
Used to assess global improvement. Clinician-rated. Range: 1-7. Lower scores mean better outcome.
Children's Global Assessment Scale (CGAS)
Used to assess global psychosocial functioning. Clinician-rated. Range: 1-100. Higher scores means better outcome.
Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7)
Used to assess frequency, abstinence and severity of non-suicidal self-injury. Adolescent-rated. Lower scores mean better outcome.
Other outcomes
Child Health Utility 9D (CHU9D)
Used to assess health-related quality of life for health economic evaluation. Adolescent reported. Higher scores indicate better health-related quality of life.
Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)
Used to assess healthcare and societal resource use Parent reported.
Negative effects questionnaire
Questionnaire developed by the research team. Used to assess adverse events for the adolescent. Adolescent-reported. Parent-reported. Lower scores means better outcome.
Locations
Sponsors and contacts
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