Group Treatment for Self-harming Adolescents and Their Parents: a Randomized Controlled Trial | NCT07720063

NCT07720063

Overview

NCT ID: NCT07720063
Lead Sponsor: Karolinska InstitutetOTHER
Official Title: A Randomised Controlled Trial of Group Emotion Regulation for Adolescent Self-harm (the ERA-study)
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 22, 2026Actual
Start Date: Aug 17, 2026Estimated
Primary Completion Date: Dec 31, 2032Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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 If receiving antidepressant, central stimulants or neuroleptic medication, dose must be stable for ≥6 weeks prior to inclusion At least one participating caregiver Sufficient Swedish language proficiency (adolescent and caregiver) Regular access to a smartphone for SMS-based assessment

Exclusion Criteria:

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) Social circumstances preventing participation or require immediate action (e.g., domestic violence, abuse and/or neglect in the family, inpatient care) Ongoing structured psychological treatment targeting NSSI

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 180Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Hanna Sahlin, PhD, Ass ProfContact
Hanna.Sahlin@ki.se+46706005920

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Masking Description

Outcome assessors remain blinded to treatment allocation for all post-treatment and follow-up assessments. Identical assessment procedures and outcome measures are used accross groups to maintain blinding. Participants are reminded, at each assessment, not to disclose allocation. Assessors document any instances of accidental unblinding and and provide a guess of treatment allocation with rationale for their judgement after each assesment to evaluate blinding integrity. In cases of accidental unblinding, a new blinded assessor is assigned to conduct subsequent assessments and provide an independent treatment allocation guess. The proportion of correct guesses will be compared with chance level to assess masking success. Blinding is maintained until completion of the final follow-up assessment (12-month follow-up), and database lock, after which unblinding is performed for analysis.