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

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

Treatments tested in this trial

  • Emotion Regulation Group Therapy for Self-harming Adolescents, ERA
  • Functional habits for mental health, FUNK

Treatment groups

180 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Karolinska Institutet

Lead sponsor

Västra Götalandsregionen

Collaborator

Region Stockholm

Collaborator