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

Официальное название

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

Обзор

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.

Подробное описание

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?

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (12)

• Clinical Global Impression - Severity (CGI-S) [Срок оценки: [Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]]
• Clinical Global Impression - Improvement (CGI-I) [Срок оценки: [Time Frame: Week 12 post baseline; 1-, 6- and 12-month follow-up.]]
• Children's Global Assessment Scale (CGAS) [Срок оценки: [Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]]
• Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7) [Срок оценки: [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) [Срок оценки: [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) [Срок оценки: [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) [Срок оценки: [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) [Срок оценки: [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) [Срок оценки: [Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]]
• The Work and Social Adjustment Scale - Youth Version (WSAS-Y) [Срок оценки: [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). [Срок оценки: [Time Frame: Baseline; week 12 post baseline, 1-, 6- and 12-month follow-up.]]
• Me as a parent (MaaP) [Срок оценки: [Time Frame: Baseline; week 12 post baseline, 1-, 6- and 12-month follow-up.]]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07720063 · 2025-08964-01 · 2025-06882 · 2025-00347 · 2026-03899-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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