Group Treatment for Self-harming Adolescents and Their Parents: a Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorKarolinska Institutet

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Emotion Regulation Group Therapy for Self-harming Adolescents, ERA

    Behavioral

    Manualized 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

    Behavioral

    Active 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

180 Participants
are divided into 2 treatment groups
Group A: Emotion Regulation Adolescents (ERA).Experimental treatment 1 intervention
Group B: Functional habits for mental health (FUNK)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
[Time Frame: Baseline; week 12 post baseline; 1 [PRIMARY ENDPOINT]-, 6- and 12-month follow-up.]

Secondary outcomes

1

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.

Time frame
[Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
2

Clinical Global Impression - Improvement (CGI-I)

Used to assess global improvement. Clinician-rated. Range: 1-7. Lower scores mean better outcome.

Time frame
[Time Frame: Week 12 post baseline; 1-, 6- and 12-month follow-up.]
3

Children's Global Assessment Scale (CGAS)

Used to assess global psychosocial functioning. Clinician-rated. Range: 1-100. Higher scores means better outcome.

Time frame
[Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
4

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.

Time frame
[Time Frame: Baseline; Mid-treatment: once every week (0-12 weeks post baseline); 1-, 6- and 12-month follow-up.]

Other outcomes

1

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.

Time frame
[Time Frame: Baseline; 1- and 12-month follow-up.]
2

Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)

Used to assess healthcare and societal resource use Parent reported.

Time frame
[Time Frame: Baseline; 1- and 12-month follow-up.]
3

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.

Time frame
[Time Frame: Week 6; Week 12 post baseline; 1-, 6- and 12-month follow-up]

Locations

This trial has no locations.

Sponsors and contacts

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Karolinska Institutet

Lead sponsor

Västra Götalandsregionen

Collaborator

Region Stockholm

Collaborator

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