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NCT Number: NCT07720063

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

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Key information

Conditions

Self-Harm Behavior Behavioral Symptoms Non-Suicidal Self Injury Non-suicidal Self-injury (NSSI) Self-Harm, Deliberate Self-Injurious Behavior Self-harm Behavior

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Primary and secondary objectives

Primary objective:

To determine the clinical efficacy of Emotion Regulation group therapy for Adolescents (ERA) in reducing NSSI frequency, as assessed by the clinician-rated Deliberate Self-Harm Inventory, Youth Version (DSHI-Y) in adolescents with NSSI, compared to an active control condition (FUNK). The primary endpoint is 1-month post-treatment.

Secondary objectives:

  • To determine the efficacy of ERA compared to an active control condition (FUNK) in reducing NSSI severity, increasing NSSI abstinence, reducing impulsive and destructive behaviours, emotion dysregulation and self-criticism anxiety and depressive symptoms; and improving general functioning at 1-month post-treatment.
  • To evaluate the durability of the treatment effects at 12-month follow-up
  • To investigate whether improvements in emotion regulation and reductions in self-criticism mediate reductions in NSSI at the primary endpoint (1-month post-treatment).
  • To conduct a health-economic evaluation of ERA compared with FUNK at 12-month follow-up from the perspectives of the healthcare payer; healthcare system resource use, and society.

Research questions:

  • Is ERA more efficacious than FUNK in reducing NSSI frequency?
  • Is ERA more efficacious than FUNK in reducing NSSI severity, increasing NSSI abstinence, reducing impulsive destructive behaviours, emotion dysregulation and self-criticism, anxiety and depressive symptoms; and improving global functioning?
  • Are the treatment effects of ERA maintained at 12-month follow-up?
  • Do improvements in emotion regulation and reductions in self-criticism mediate effects on NSSI?
  • Is ERA more cost-effective than FUNK from healthcare and societal perspectives?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change from baseline in clinician-rated scores on Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7)

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

    Used to assess frequency, abstinence and severity of non-suicidal self-injury. Clinician-rated. Lower scores means better outcome.

Secondary outcomes

  1. Clinical Global Impression - Severity (CGI-S)

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

    Used to provide an overall rating of non-suicidal self-injury severity. Clinician-rated. Range: 1-7. Lower scores mean less severe symptoms.

  2. Clinical Global Impression - Improvement (CGI-I)

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

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

  3. Children's Global Assessment Scale (CGAS)

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

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

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

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

    Used to assess frequency, abstinence and severity of non-suicidal self-injury. Adolescent-rated. Lower scores mean better outcome.

  5. Borderline Symptom List, supplement (BSL-23, suppl)

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

    Used to assess frequency of impulsive self-destructive behaviors. Adolescent-rated. Lower scores mean better outcome.

  6. Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)

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

    Used to assess difficulties in emotion regulation. Adolescent-rated. Parent-rated. Range: 16-80, Higher scores mean greater difficulties.

  7. Everyday Adolescent Emotion Regulation-scale (EARS)

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

    Brief measure of emotion regulation developed for this project. Adolescent-rated. Lower scores indicate better outcomes

  8. Self-criticism And Kindness Scale (SAK)

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

    Brief measure of self-criticism and self-compassion, developed for this project. Adolescent-rated. Lower scores indicate better outcomes.

  9. Short Revised Children's Anxiety and Depression Scale - Short version (RCADS-S)

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

    Used to assess depression and anxiety symptoms. 25 items. Adolescent- and parent-rated. Range: 0-75, Lower scores mean better outcome.

  10. The Work and Social Adjustment Scale - Youth Version (WSAS-Y)

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

    Used to assess functional impairment. Adolescent and parent-rated. Range: 0-40. Lower scores means better outcome.

  11. The Coping with Children's Negative Emotions Scale Adolescent Version (CANES-P).

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

    Used to assess parents' perceived ability to cope with children's negative emotions. Parent-rated. Six subscales: minimization; punitive; emotion-focused coping; problem-focused coping; encourage emotion expression; personal distress. Range: 1-7, higher scores in minimization and punitive subsclaes mean more difficulties. Higher scores in the rest mean better outcome.

  12. Me as a parent (MaaP)

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

    Questionnaire used to assess parents' beliefs about their locus of control (personal agency) and ability to self-monitor and self-manage. Four subscales: self efficacy; personal agency; self sufficiency; self management. Parent-rated. Range:4-16/ 1-4 (subscales). Higher scores mean better outcome.

  13. Working Alliance Inventory - Group version (WAI-S)

    Time frame: [Time Frame: Mid-treatment (3 weeks post-baseline)]

    Used to assess perceived working alliance. Adolesent-rated. Parent-rated. Range: 0-30. Higher scores means better outcome.

  14. The Client Satisfaction Questionnaire (CSQ-8)

    Time frame: [Time Frame: 12 weeks post baseline]

    Used to assess client satisfaction with treatment. Adolescent-rated. Parent-rated. Range: 8-32. Higher scores mean better outcome.

  15. Treatment Credibility and Expectancy Scale (TCES)

    Time frame: [Time Frame: Mid-treatment (3 weeks post-baseline)]

    Questionnaire revised by the research team. Used to assess treatment credibility and expectations. Adolescent-rated. Parent-rated. Range: 0-40. Higher scores means better outcome

Other outcomes

  1. Child Health Utility 9D (CHU9D)

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

    Used to assess health-related quality of life for health economic evaluation. Adolescent reported. Higher scores indicate better health-related quality of life.

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

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

    Used to assess healthcare and societal resource use Parent reported.

  3. Negative effects questionnaire

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

    Questionnaire developed by the research team. Used to assess adverse events for the adolescent. Adolescent-reported. Parent-reported. Lower scores means better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Ann Rosén, PhD

CONTACT

[email protected]

+46733500371

Hanna Sahlin, PhD, Ass Prof

CONTACT

[email protected]

+46706005920

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm
  • Västra Götalandsregionen

Registry information

Official study title

A Randomised Controlled Trial of Group Emotion Regulation for Adolescent Self-harm (the ERA-study)

Acronym: ERA

Important dates

Study start
2026
Primary completion
2032
Study completion
2034
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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