Group Treatment for Self-harming Adolescents and Their Parents: a Randomized Controlled Trial (ERA)
17 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
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?
Tipo de estudio
Intervencionista
Inscripción (Estimado)
180
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Hanna Sahlin, PhD, Ass Prof
- Número de teléfono: +46706005920
- Correo electrónico: Hanna.Sahlin@ki.se
Copia de seguridad de contactos de estudio
- Nombre: Ann Rosén, PhD
- Número de teléfono: +46733500371
- Correo electrónico: Ann.Rosen@ki.se
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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
- 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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Emotion Regulation Adolescents (ERA).
Manualized 12-week group intervention for adolescents with NSSI and a parallel five-session parent program.
|
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. |
|
Comparador activo: 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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline in clinician-rated scores on Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7)
Periodo de tiempo: [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.]
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Clinical Global Impression - Severity (CGI-S)
Periodo de tiempo: [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)
Periodo de tiempo: [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)
Periodo de tiempo: [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)
Periodo de tiempo: [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)
Periodo de tiempo: [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)
Periodo de tiempo: [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)
Periodo de tiempo: [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)
Periodo de tiempo: [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)
Periodo de tiempo: [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)
Periodo de tiempo: [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).
Periodo de tiempo: [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)
Periodo de tiempo: [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)
Periodo de tiempo: [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)
Periodo de tiempo: [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)
Periodo de tiempo: [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)]
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Child Health Utility 9D (CHU9D)
Periodo de tiempo: [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)
Periodo de tiempo: [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
Periodo de tiempo: [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]
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Hanna Sahlin, PhD, Ass Professor, Karolinska Institutet
- Silla de estudio: Mats J Olsson, Professor, Karolinska Institutet
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
17 de agosto de 2026
Finalización primaria (Estimado)
31 de diciembre de 2032
Finalización del estudio (Estimado)
31 de diciembre de 2034
Fechas de registro del estudio
Enviado por primera vez
17 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de julio de 2026
Publicado por primera vez (Actual)
22 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-08964-01
- 2025-06882 (Otro número de subvención/financiamiento: Swedish Research Council)
- 2025-00347 (Otro número de subvención/financiamiento: Swedish Research Council for Health, working life and welfare)
- 2026-03899-02 (Otro identificador: Ethical amendment)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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