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

NCT07720063 | Not Yet Recruiting DMC

• 4 other identifiers: 2025-08964-012025-068822025-003472026-03899-02
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

emotion regulation group therapy; non-suicidal self-injury (NSSI); randomized controlled trial

Outcome Measures

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

Secondary Outcomes (15)

• Clinical Global Impression - Severity (CGI-S)

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

• Clinical Global Impression - Improvement (CGI-I)

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

• Children's Global Assessment Scale (CGAS)

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

• Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7)

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

• Borderline Symptom List, supplement (BSL-23, suppl)

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

Other Outcomes (3)

• Child Health Utility 9D (CHU9D)

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

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

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

• Negative effects questionnaire

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

Study Arms (2)

Emotion Regulation Adolescents (ERA).

EXPERIMENTAL

Manualized 12-week group intervention for adolescents with NSSI and a parallel five-session parent program.

Behavioral: Emotion Regulation Group Therapy for Self-harming Adolescents, ERA

Functional habits for mental health (FUNK)

ACTIVE COMPARATOR

Active comparator: Active Control Condition (FUNK) Manualized psychoeducational group intervention with family participation, individualized safety planning, and weekly risk monitoring.

Behavioral: Functional habits for mental health, FUNK

Interventions

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.

Functional habits for mental health (FUNK)

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.

Emotion Regulation Adolescents (ERA).

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Västra Götalandsregionen: collaborator
• Region Stockholm: collaborator

MeSH Terms

Conditions

Self-Injurious Behavior

Interventions

Mental Health

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Study Officials

• Hanna J Sahlin, PhD, Ass Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Sahlin, PhD, Ass Prof

CONTACT

+46706005920; Hanna.Sahlin@ki.se

Ann Rosén, PhD

CONTACT

+46733500371; Ann.Rosen@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd, Associate Professor

Model Details: Interventional Model Description: Single-blind parallel-group randomised controlled trial. Following completion of the primary endpoint assessment, participants in the active control condition may be offered crossover to ERA upon request.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): August 17, 2026
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2034
• Last Updated: July 22, 2026

Record last verified: 2026-07