跳至主要内容
临床试验/NCT03227991
NCT03227991已完成不适用

Safety Planning Intervention to Reduce Short Term Risk

New York State Psychiatric Institute5 个研究点 分布在 1 个国家目标入组 422 人开始时间: 2017年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
422
试验地点
5
主要终点
Suicide, attempted and suicide

研究概览

简要总结

This study will determine the efficacy of Safety Planning Intervention (SPI) compared to receiving risk factors and warning sign information (RWI) in recent suicide attempters during the 6 months following an acute care visit on: (1) suicidal behaviors; (2) mental health/substance use treatment engagement; (3) suicide-related coping strategies; (4) suicidal ideation; and (5) use of means restriction.

详细描述

There is a pressing need for improved acute care setting suicide prevention interventions. The Safety Planning Intervention (SPI) is a protocol driven, brief suicide prevention strategy that is a good fit for acute care settings (i.e., emergency departments (ED) and inpatient units). The SPI involves a clinician working collaboratively with the patient to build a personalized safety plan that is documented using a templated paper form and includes warning sign identification, means restriction and personalized strategies to deescalate a suicide crisis. It is easy to learn and administer, acceptable to patients, brief, firmly rooted in an empirical base and has preliminary studies supporting its feasibility and potential to impact patient outcomes, including suicidal behavior and treatment engagement. However, while it is being adopted widely, it lacks a randomized controlled trial (RCT) to definitively determine its efficacy. The purpose of this study to conduct a randomized control trial of the Safety Planning Intervention (SPI) compared with receiving risk factors and warning sign information (RWI) in acute care settings.

All participants in this study will complete some baseline assessments, following which they will be randomly assigned to one of two study conditions: Safety Plan Intervention (SPI) or receiving risk factors and warning sign information (RWI). If assigned to SPI, participants will receive the assigned intervention by the research clinician. They will receive a paper copy of their safety plan while in the ED or on the inpatient unit and a back-up copy will be sent approximately 1 week after discharge to participants. For RWI participants, ED and inpatient unit care will be delivered as usual, with the addition of a printed information sheet listing suicide risk factors and crisis hotlines. In addition to the baseline assessment, multi-method outcome assessment will be conducted at 1, 3, and 6 months. This will include telephone evaluations by a blinded assessor (not the research clinician), medical record review, and vital statistics registry review.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presented for an acute care visit within 8 weeks of a suicide attempt, interrupted or aborted attempt, or suicidal ideation with intent and plan within 4 weeks.
  • Are 18 years of age or older
  • Able to speak and read English
  • Able to understand the nature of the study, provide written informed consent, and complete study procedures
  • Have been evaluated by a health care professional who provides permission for research staff to approach the patient.

排除标准

  • Under 18 years of age
  • Cannot speak or read English
  • Unable to understand the nature of the study, provide written informed consent, or complete study procedures
  • Unable or unwilling to provide a personal phone number for follow up purposes.

结局指标

主要结局

Suicide, attempted and suicide

时间窗: 6 months

As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe

次要结局

  • Suicide related coping(6 months)
  • Suicidal ideation intensity(6 months)
  • Suicidal ideation severity(6 months)
  • Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior(6 months)
  • Means restriction(6 months)
  • Treatment engagement(6 months)

研究者

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

Beth Brodsky

Associate Director

New York State Psychiatric Institute

研究点 (5)

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