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临床试验/NCT05304065
NCT05304065招募中2 期

Youth Partners in Care for Suicide Prevention

University of California, Los Angeles10 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2022年10月17日最近更新:

试验速览

阶段
2 期
状态
招募中
入组人数
1,600
试验地点
10
主要终点
Suicide Attempts: Primary Clinical Outcome

研究概览

简要总结

This randomized comparative effectiveness trial will compare two evidence-based approaches to emergency care for youth ages 13-24 who present to the Emergency Department (ED) with suicidal ideation or behavior. Outcomes will be monitored at baseline and at 3, 6 & 12 month follow-up assessments.

详细描述

Rationale and Importance of Study:

Suicide is currently the second leading cause of death for U.S. youth ages 13-24, responsible for more deaths than any major illness. Youth with serious suicidal behavior or thoughts often present to the nation's Emergency Departments (EDs), particularly youth who make potentially deadly suicide attempts. Evidence is limited regarding optimal interventions for reducing the risk of fatal and nonfatal suicide attempts in these youth, and tested interventions include multiple components. One dimension along which these interventions vary is timing. Some interventions are delivered in the ED, others focus on aftercare, and others combine ED and aftercare interventions. Current evidence supports effectiveness of some interventions for reducing later suicide attempts and improving the likelihood that youth will receive mental health treatment after leaving the ED. However, evidence gaps exist regarding: 1) whether it is sufficient to focus on providing an evidence-based intervention in the ED, or whether a post-ED aftercare intervention is needed to improve youth outcomes; and 2) for which patient subgroups a combined ED and aftercare treatment may be indicated. Answering these questions is vital for guiding resource allocation, as ED care emphasizes care in the ED with limited resources for aftercare.

Study Aims:

The study addresses this evidence gap by comparing two evidence-based interventions for reducing suicide attempts and improving outcomes for youth presenting to EDs with suicidal episodes: 1) Safety-Acute(A) integrated within ED care, a crisis therapy/safety planning intervention in the ED focused on enhancing safety (previously called Family Intervention for Suicide Prevention, FISP); and 2) SAFETY-A/ED care plus the Coping Long-term with Active Suicide Program (CLASP), comprised of brief therapeutic follow-up contacts after discharge from the ED/hospital. Evidence supports benefits of both interventions individually. SAFETY-A/FISP is listed in the National Register of Evidence-Based Practices, and CLASP is being implemented in some Veterans Administration Hospitals. The first aim is to evaluate whether SAFETY-A/ED Care combined with CLASP aftercare is superior to SAFETY- A/ED Care alone for reducing the risk of suicide attempts and increasing initiation of follow-up mental health treatment. Second, the investigators examine heterogeneity of treatment effects among subgroups, hypothesizing that in this large diverse sample the strongest benefits of the combined SAFETY-A/ED Care plus CLASP intervention will be seen in youth who are from ethnic or racial minority groups, socioeconomically disadvantaged, and from rural communities. Third, the investigators aim to increase the value and relevance of the study by engaging patients, parents, family members, providers, and health and mental healthcare system stakeholders in project leadership and activities throughout the study and implement a partnered dissemination plan to enhance the potential for study findings to inform clinical practice and health care delivery.

Study Description:

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
Double (Care Provider, Outcomes Assessor)

盲法说明

It is not possible to mask intervention condition from participants. Care providers in the ED will be masked to randomized condition. Outcomes assessors will be masked to randomized condition.

入排标准

年龄范围
13 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • age 13-24;
  • past-week suicidal behavior or ideation with plan or intent

排除标准

  • symptoms or illness that precludes informed consent or engagement in study procedures (e.g., active psychosis; drug dependence, no locator information);
  • youth not fluent in English
  • parent not fluent in English or Spanish.

结局指标

主要结局

Suicide Attempts: Primary Clinical Outcome

时间窗: Through 12 months of follow-up

suicide attempts fatal, nonfatal, and interrupted

Suicide Attempts: Primary Clinical Outcome

时间窗: Through 12 months of follow-up

suicide attempts fatal, nonfatal, and interrupted

Mental Health Treatment Initiation: Primary Service Use Outcome

时间窗: Observed through 12 months of follow-up, primary end point 6-month follow-up

initiation of mental health treatment after discharge from ED/hospital

次要结局

  • Self-Harm: Secondary Clinical Outcome(Through 12 months of follow-up)
  • Treatment engagement: Secondary Service Use Outcome(Through 12 months of follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joan Asarnow

Professor of Psychiatry & Biboehavioral Sciences

University of California, Los Angeles

研究点 (10)

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