A Randomised Controlled Trial of Group Emotion Regulation for Adolescent Self-harm (the ERA-study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Change from baseline in clinician-rated scores on Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors remain blinded to treatment allocation for all post-treatment and follow-up assessments. Identical assessment procedures and outcome measures are used accross groups to maintain blinding. Participants are reminded, at each assessment, not to disclose allocation. Assessors document any instances of accidental unblinding and and provide a guess of treatment allocation with rationale for their judgement after each assesment to evaluate blinding integrity. In cases of accidental unblinding, a new blinded assessor is assigned to conduct subsequent assessments and provide an independent treatment allocation guess. The proportion of correct guesses will be compared with chance level to assess masking success. Blinding is maintained until completion of the final follow-up assessment (12-month follow-up), and database lock, after which unblinding is performed for analysis.
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Emotion Regulation Adolescents (ERA).
Manualized 12-week group intervention for adolescents with NSSI and a parallel five-session parent program.
干预措施: Emotion Regulation Group Therapy for Self-harming Adolescents, ERA (Behavioral)
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.
干预措施: Functional habits for mental health, FUNK (Behavioral)
结局指标
主要结局
Change from baseline in clinician-rated scores on Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7)
时间窗: [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.
次要结局
- Clinical Global Impression - Severity (CGI-S)([Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.])
- Clinical Global Impression - Improvement (CGI-I)([Time Frame: Week 12 post baseline; 1-, 6- and 12-month follow-up.])
- Children's Global Assessment Scale (CGAS)([Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.])
- Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7)([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)([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)([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)([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)([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)([Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.])
- The Work and Social Adjustment Scale - Youth Version (WSAS-Y)([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).([Time Frame: Baseline; week 12 post baseline, 1-, 6- and 12-month follow-up.])
- Me as a parent (MaaP)([Time Frame: Baseline; week 12 post baseline, 1-, 6- and 12-month follow-up.])
- Working Alliance Inventory - Group version (WAI-S)([Time Frame: Mid-treatment (3 weeks post-baseline)])
- The Client Satisfaction Questionnaire (CSQ-8)([Time Frame: 12 weeks post baseline])
- Treatment Credibility and Expectancy Scale (TCES)([Time Frame: Mid-treatment (3 weeks post-baseline)])
研究者
Hanna Sahlin
Phd, Associate Professor
Karolinska Institutet