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

NCT07720063 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-08-18

No results posted yet for this study

Summary

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.

Conditions

  • Self-Harm
  • Self-Harm, Deliberate
  • Self-harm Behavior
  • Non-Suicidal Self Injury
  • Non-suicidal Self-injury (NSSI)

Interventions

BEHAVIORAL

Emotion Regulation Group Therapy for Self-harming Adolescents, ERA

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.

BEHAVIORAL

Functional habits for mental health, FUNK

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.

Sponsors & Collaborators

  • Västra Götalandsregionen

    collaborator OTHER
  • Region Stockholm

    collaborator OTHER_GOV
  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Hanna Sahlin, PhD, Ass Professor · Karolinska Institutet

  • Mats J Olsson, Professor · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-17
Primary Completion
2032-12-31
Completion
2034-12-31

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07720063 on ClinicalTrials.gov