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

17. července 2026 aktualizováno: Hanna Sahlin, Karolinska Institutet

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

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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:

  1. 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.
  2. To evaluate the durability of the treatment effects at 12-month follow-up
  3. To investigate whether improvements in emotion regulation and reductions in self-criticism mediate reductions in NSSI at the primary endpoint (1-month post-treatment).
  4. 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:

  1. Is ERA more efficacious than FUNK in reducing NSSI frequency?
  2. 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?
  3. Are the treatment effects of ERA maintained at 12-month follow-up?
  4. Do improvements in emotion regulation and reductions in self-criticism mediate effects on NSSI?
  5. Is ERA more cost-effective than FUNK from healthcare and societal perspectives?

Typ studie

Intervenční

Zápis (Odhadovaný)

180

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Hanna Sahlin, PhD, Ass Prof
  • Telefonní číslo: +46706005920
  • E-mail: Hanna.Sahlin@ki.se

Studijní záloha kontaktů

  • Jméno: Ann Rosén, PhD
  • Telefonní číslo: +46733500371
  • E-mail: Ann.Rosen@ki.se

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Emotion Regulation Adolescents (ERA).
Manualized 12-week group intervention for adolescents with NSSI and a parallel five-session parent program.
Behaviorální: 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.
Aktivní komparátor: Functional habits for mental health (FUNK)
Active comparator: Active Control Condition (FUNK) Manualized psychoeducational group intervention with family participation, individualized safety planning, and weekly risk monitoring.
Behaviorální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline in clinician-rated scores on Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7)
Časové okno: [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.
[Time Frame: Baseline; week 12 post baseline; 1 [PRIMARY ENDPOINT]-, 6- and 12-month follow-up.]

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Clinical Global Impression - Severity (CGI-S)
Časové okno: [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.
[Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
Clinical Global Impression - Improvement (CGI-I)
Časové okno: [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.
[Time Frame: Week 12 post baseline; 1-, 6- and 12-month follow-up.]
Children's Global Assessment Scale (CGAS)
Časové okno: [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.
[Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7)
Časové okno: [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.
[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)
Časové okno: [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.
[Time Frame: Baseline; Mid- treatment: once every week (0-12 weeks post baseline); 1-, 6- and 12-month follow-up.]
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
Časové okno: [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.
[Time Frame: Baseline, Mid-treatment: once every week (0-12 weeks post baseline), 1-,6- and 12- month follow-up.]
Everyday Adolescent Emotion Regulation-scale (EARS)
Časové okno: [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
[Time Frame: Baseline, Mid-treatment: once every week (0-12 weeks post baseline), 1-,6- and 12- month follow-up.]
Self-criticism And Kindness Scale (SAK)
Časové okno: [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.
[Time Frame: Baseline, week 12 post baseline, 1-,6- and 12- month follow-up.]
Short Revised Children's Anxiety and Depression Scale - Short version (RCADS-S)
Časové okno: [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.
[Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
The Work and Social Adjustment Scale - Youth Version (WSAS-Y)
Časové okno: [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.
[Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
The Coping with Children's Negative Emotions Scale Adolescent Version (CANES-P).
Časové okno: [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.
[Time Frame: Baseline; week 12 post baseline, 1-, 6- and 12-month follow-up.]
Me as a parent (MaaP)
Časové okno: [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.
[Time Frame: Baseline; week 12 post baseline, 1-, 6- and 12-month follow-up.]
Working Alliance Inventory - Group version (WAI-S)
Časové okno: [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.
[Time Frame: Mid-treatment (3 weeks post-baseline)]
The Client Satisfaction Questionnaire (CSQ-8)
Časové okno: [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.
[Time Frame: 12 weeks post baseline]
Treatment Credibility and Expectancy Scale (TCES)
Časové okno: [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
[Time Frame: Mid-treatment (3 weeks post-baseline)]

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Child Health Utility 9D (CHU9D)
Časové okno: [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.
[Time Frame: Baseline; 1- and 12-month follow-up.]
Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)
Časové okno: [Time Frame: Baseline; 1- and 12-month follow-up.]
Used to assess healthcare and societal resource use Parent reported.
[Time Frame: Baseline; 1- and 12-month follow-up.]
Negative effects questionnaire
Časové okno: [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.
[Time Frame: Week 6; Week 12 post baseline; 1-, 6- and 12-month follow-up]

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Karolinska Institutet

Spolupracovníci

Region Stockholm
Västra Götalandsregionen

Vyšetřovatelé

  • Vrchní vyšetřovatel: Hanna J Sahlin, PhD, Ass Professor, Karolinska Institutet

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

17. srpna 2026

Primární dokončení (Odhadovaný)

31. prosince 2032

Dokončení studie (Odhadovaný)

31. prosince 2034

Termíny zápisu do studia

První předloženo

17. července 2026

První předloženo, které splnilo kritéria kontroly kvality

17. července 2026

První zveřejněno (Aktuální)

22. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2025-08964-01
  • 2025-06882 (Jiné číslo grantu/financování: Swedish Research Council)
  • 2025-00347 (Jiné číslo grantu/financování: Swedish Research Council for Health, working life and welfare)
  • 2026-03899-02 (Jiný identifikátor: Ethical amendment)

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