Preventing Suicide With Safe Alternatives for Teens and Youths (SAFETY) - A Randomized Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of completed assessments at week 12
研究概览
简要总结
Suicide is the leading cause of death in the age span 10-19 years in Sweden. The most robust predictor of future suicide attempt and suicide death is prior suicide attempt. Yet, most youths presenting with suicidal behavior to the Child and Adolescent Mental Health Services (CAMHS) in Stockholm, Sweden are not offered evidence-based care directly targeting suicide risk. Safe Alternatives for Teens and Youths (SAFETY) is a novel scalable suicide prevention program designed to fill this critical gap. SAFETY is a cognitive behavioral family treatment incorporating elements from Dialectical Behavior Therapy and Multisystemic Therapy. SAFETY has shown promise in reducing suicide attempts in two small-N trials. In a randomized controlled feasibility trial, the investigators will examine the feasibility of SAFETY and an active control condition named Supportive Therapy at post-treatment, 3 and 12 months after treatment on youth suicidal behavior. Evaluations of feasibility, acceptability, and safety based on data from this pilot trial will guide and inform the design of a full-scale randomized controlled trial.
详细描述
Research questions:
- Is it feasible (operationalized as participation in treatment, completed homework assignments, reported adverse events) to offer SAFETY to youths with suicidal behavior and their caregivers within the CAMHS?
- Is it feasible (operationalized as participation in treatment, completed homework assignments, reported adverse events) to offer Supportive Therapy as an active control treatment to youths with suicidal behavior and their caregivers within the CAMHS?
- Is the planned procedure and design (recruitment, blinded assessors, randomization and data attrition) of the study feasible?
- What are the proportions of suicidal behavior in the group randomized to SAFETY group and the group randomized to Supportive Therapy, respectively?
- Is participation in SAFETY and Supportive Therapy associated with improved emotion regulation, perceived social support, and family function, and how large are the effects (suggested treatment processes)?
- Is participation in SAFETY and Supportive Therapy associated with improvements in nonsuicidal self-injury, depression, anxiety, and other outcomes, and how large are the effects (outcomes)?
- How do the youths and caregivers experience participation in SAFETY and Supportive Therapy, respectively?
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)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suicidal behavior (defined as suicide attempt, interrupted suicide attempt, aborted suicide attempt, or preparatory behavior) in the last 3 months
- •Age 10-17 years
- •At least one primary caregiver willing to participate in treatment
排除标准
- •Symptoms requiring other immediate treatment (e.g. psychosis, severe anorexia nervosa)
- •Ongoing treatment with DBT
- •Individual or life circumstances that could complicate or make treatment participation impossible, or that require immediate intervention (e.g., violence in close relationships; intellectual disability)
- •Insufficient understanding of the Swedish language
结局指标
主要结局
Number of completed assessments at week 12
时间窗: week 12
Defined as number of completed assessments at end of intervention (week 12)
The fraction of eligible participants who consent to inclusion and randomization
时间窗: week 12
The fraction of potential participants will be determined as the number of eligible persons compared to the number of randomized persons.
Compliance
时间窗: week 12
Compliance will be defined as number of completed sessions.
Client Satisfaction Questionnaire (CSQ)
时间窗: week 12 (youth and parent reported)
The CSQ-8 is an 8-item self-rated 4-point scale, measuring different aspects of satisfaction with treatment, e.g. perception of quality of treatment, if the treatment adequately addressed their needs and overall satisfaction. Total range is 8 to 32, with higher values indicating higher satisfaction. Mean in total satisfaction scores on the CSQ-8 for each treatment group at end of treatment will be reported.
Adverse events
时间窗: week 12 (youth and parent reported)
Participants are asked to report and rate the discomfort of the eventual adverse events caused by their participation in the treatment.
Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
时间窗: 12 months after end of treatment (clinician reported)
See description above (outcome 9), The C-SSRS will be administered as a clinical interview.
Number of completed assessments at 3 months follow-up
时间窗: 3 months follow-up
Defined as number of completed assessments 3 months after end of intervention
Number of completed assessments at 12 months follow-up
时间窗: 12 months follow-up
Defined as number of completed assessments 12 months after end of intervention
Credibility/Expectancy Scale (CEQ)
时间窗: week 1 (youth and parent reported)
The CEQ is a 6-item measure of treatment credibility and expectancy. Scale points ranges from 0-9 and 0-100%, where a higher score indicates a better outcome.
次要结局
- 1-item version of the Perceived Criticism Measure (PCM - 1 item version)(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported))
- Dialectical Behavior Therapy - Ways of Coping Checklist (DBT-WCCL)(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported))
- CRAFFT(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported))
- Perth Alexithymia Questionnaire (PAQ)(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported))
- Systemic Clinical Outcome and Routine Evaluation, 15 item version (SCORE-15)(Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported))
- Borderline Symptom List Supplement (BSL-Supplement)(Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported))
- Brief 16-item Version of the Difficulties In Emotion Regulation Scale (DERS-16)(Change from baseline, once every week during treatment (week 1-11; youth reported))
- Cognitive Emotion Regulation Questionnaire (CERQ)(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported))
- Emotion Beliefs Questionnaire (EBQ)(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported))
- Pittsburgh Sleep Quality Index (PSQI)(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported))
- The Coping with Children's Negative Emotions Scale - Adolescent Version (CCNES-A)(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported))
- Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TIC-P)(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported))
- The Clinical Global Impressions -Severity and Improvement scales (CGI-S; CGI-I)(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (clinician reported))
- Behavioral Emotion Regulation Questionnaire (BERQ)(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported))
- Deliberate Self-Harm Inventory - Youth version (DSHI-Y)(Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported))
- Revised Children's Anxiety and Depression Scale, short (RCADS-S)(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported))
- Patient Health Questionnaire-9 (PHQ-9)(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported))
- Difficulties In Emotion Regulation Scale (DERS)(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth and parent reported))
- Multidimensional Scale of Perceived Social Support (MSPSS)(Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported))
- Beck's Hopelessness Scale (BHS)(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth and parent reported))
- Generalized anxiety disorder 7-item scale (GAD-7)(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported))
- The Work and Social Adjustment Scale, youth version (WSAS-Y) - adolescent and parent versions(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth and parent reported))
- Child Health Utility 9D (CHU-9D)(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported))
- Children's Global Assessment Scale (CGAS)(Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (clinician reported))
研究者
Johan Bjureberg
Associate Professor
Region Stockholm