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

2026年8月17日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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?

研究类型

介入性

注册 (估计的)

180

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Hanna Sahlin, PhD, Ass Prof
  • 电话号码：+46706005920
  • 邮箱：Hanna.Sahlin@ki.se

研究联系人备份

  • 姓名：Ann Rosén, PhD
  • 电话号码：+46733500371
  • 邮箱：Ann.Rosen@ki.se

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Emotion Regulation Adolescents (ERA).
Manualized 12-week group intervention for adolescents with NSSI and a parallel five-session parent program.
行为的：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.
有源比较器：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.
行为的：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change from baseline in clinician-rated scores on Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7)
大体时间：[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.]

次要结果测量

结果测量
措施说明
大体时间
Clinical Global Impression - Severity (CGI-S)
大体时间：[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)
大体时间：[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)
大体时间：[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)
大体时间：[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)
大体时间：[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)
大体时间：[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)
大体时间：[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)
大体时间：[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)
大体时间：[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)
大体时间：[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).
大体时间：[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)
大体时间：[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)
大体时间：[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)
大体时间：[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)
大体时间：[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)]

其他结果措施

结果测量
措施说明
大体时间
Child Health Utility 9D (CHU9D)
大体时间：[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)
大体时间：[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
大体时间：[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]

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Karolinska Institutet

合作者

Region Stockholm
Västra Götalandsregionen

调查人员

  • 首席研究员：Hanna Sahlin, PhD, Ass Professor、Karolinska Institutet
  • 学习椅：Mats J Olsson, Professor、Karolinska Institutet

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月17日

初级完成 (估计的)

2032年12月31日

研究完成 (估计的)

2034年12月31日

研究注册日期

首次提交

2026年7月17日

首先提交符合 QC 标准的

2026年7月17日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年8月18日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2025-08964-01
  • 2025-06882 (其他赠款/资助编号：Swedish Research Council)
  • 2025-00347 (其他赠款/资助编号：Swedish Research Council for Health, working life and welfare)
  • 2026-03899-02 (其他标识符：Ethical amendment)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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