Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour: A Multi-site Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 330
- 试验地点
- 8
- 主要终点
- Number of Suicide Risk Events (SREs) throughout 6 months of study engagement
研究概览
简要总结
Suicide is the leading cause of death due to illness among Canadian youth, claiming more lives than any medical illness, including cancer. Suicide prevention is possible, and early intervention is needed. The investigators will examine the effectiveness of a previously-piloted, ED-based suicide prevention intervention, across Canadian sites, using a randomized clinical trial design. The investigators will determine whether the patient- and family-centered intervention is more effective than enhanced usual care in reducing suicide-related behaviors in 330 youth at high-risk of suicide.
详细描述
This is a Multi-site Randomized Controlled Trial of a patient- and family-centered suicide prevention intervention added to usual care (SAFE + UC) for adolescents aged 12 to 17 years who present to the Emergency Department (ED) with suicidal ideation or suicide risk behaviours. The investigators will determine whether the SAFE + UC intervention is more effective than enhanced usual care (telephone navigation + UC) in reducing suicide-related behaviors in 330 youth at high-risk of suicide across Canadian sites.
SAFE + UC is a 6-week, standardized, manualized outpatient program that teaches participants to the skills to manage suicidal thoughts and impulses effectively. The family component addresses conflictual relationships that may be present in the family as well as improving family communication.
Telephone navigation (NAV) + UC consists of up to 6 weekly telephone calls to ensure that the participant has connected with community resources suggested by the ED team and provide additional resources as needed.
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
Study investigators and outcome assessors are blinded to allocation assignment.
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Youth presenting in the Emergency Department with SIQ-Jr score ≥ 31,
- •Has a participating parent or caregiver who is able to communicate easily in English, or is willing to communicate using a hospital-organized translator,
- •Between the ages 12-17 years old,
- •Living in the catchment area of one of the three hospital sites and access to a telephone.
排除标准
- •Score of 3 on KSADS screen for current psychosis or elevated mood
- •Moderate to severe intellectual disability, and/or autism based on clinical chart.
结局指标
主要结局
Number of Suicide Risk Events (SREs) throughout 6 months of study engagement
时间窗: Baseline, 6 weeks, 24 weeks
Suicide attempts and unscheduled ED/hospital re-visits (including hospitalization) for SREs, or death by suicide during the 6-month follow up period. SREs will be determined by participant and caregiver report using validated questions regarding suicide attempts from the Columbia-Suicide Severity Rating Scale (C-SSRS).
次要结局
- Centre for Epidemiological Studies Depression Scale for Children (CES-DC)(Baseline, 6 weeks, 24 weeks)
- Columbia Impairment Scale (CIS)(Baseline, 6 weeks, 24 weeks)
- Treatment Fidelity (Adherence and Competence) to the SAFE Intervention(Baseline, 6 weeks, 24 weeks)
- Schedule for Affective Disorders and Schizophrenia Depression Rating Scale (KSADS-DEPc)(Baseline, 6 weeks, 24 weeks)
- Screen for Child Anxiety Related Disorders (SCARED)(Baseline, 6 weeks, 24 weeks)
- Life Problems Inventory (LPI)(Baseline, 6 weeks, 24 weeks)
- Conflict Behaviour Questionnaire (CBQ)(Baseline, 6 weeks, 24 weeks)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline, 6 weeks, 24 weeks)
- Suicidal Ideation Questionnaire-Jr (SIQ-Jr)(Baseline, 6 weeks, 24 weeks)
- Cost-Effectiveness Ratio(Baseline, 6 weeks, 24 weeks)
研究者
Daphne Korczak
Associate Scientist
The Hospital for Sick Children