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临床试验/NCT03092271
NCT03092271已完成不适用

Randomized Trial of Stepped Care for Suicide Prevention in Teens and Young Adults

University of California, Los Angeles4 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2017年4月3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
301
试验地点
4
主要终点
Suicide Attempt Behavior

研究概览

简要总结

This randomized controlled trial will evaluate two approaches to achieving the aspirational goal of Zero Suicide within a health system: 1) Zero Suicide Best Practices initiated through a zero suicide quality improvement initiative within a health system; and 2) Zero Suicide Best Practices plus an innovative stepped care for suicide prevention intervention for adolescents and young adults that matches treatment intensity with risk levels for suicide/self-harm. ..

详细描述

We propose a rigorous randomized trial to evaluate an innovative stepped care for suicide prevention intervention for adolescents and young adults, compared to a zero suicide program initiated by a health system. An effective zero suicide strategy for this age group is critically needed because this is a developmental period when: 1) suicide is the second leading cause of death, accounting for more deaths than any medical illness; 2) suicidal tendencies and behaviors often first occur in this age span; 3) rates of suicide and suicide attempts increase dramatically; and 4) effective intervention can reduce risk, suffering, and costs over lifetimes.

The project combines a partnership with a health system that has strong infrastructure and commitment to quality improvement for zero suicide with a research team that has successfully implemented collaborative stepped care interventions in health systems and has expertise in clinical, health services, economics, and policy research and dissemination. We will identify and enroll 300 youths ages 12-24 with elevated suicide and suicide attempt risk using a multi-stage screening process. Eligible youths will be randomized to: 1) zero suicide best practices, which emphasizes health system quality improvement (ZSQI); or 2) ZSQI plus stepped care for suicide prevention, which integrates evidence-based suicide prevention with primary care and emergency services. Prior research demonstrates the value of similar integrated medical-behavioral health interventions for improving patient outcomes, rates of care, and continuity of care- a critical issue for zero suicide efforts, as many youths discontinue care prematurely despite continuing risk. The ZSQI plus stepped care for suicide prevention approach uses: 1) risk assessments to triage youths to appropriate care levels; 2) care managers to deliver cognitive behavior therapy and dialectical behavior therapy skills training and support primary care and emergency clinicians with patient evaluation and treatment; 3) internet-delivered cognitive-behavior therapy and dialectical behavior therapy treatment components plus access to coaching support for lower risk youths, with stepped up in-person group and/or individual treatment added for higher risk youths; and 4) regular monitoring of patient outcomes, with feedback to clinicians to facilitate decision-making and use of the stepped care algorithms. The intervention period is 12 months: 6 months of acute treatment; and 6 months of continuation treatment. Results will provide critical information for health systems and science regarding the potential to achieve zero suicide goals by integrating state of the art science with practice quality improvement.

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)

盲法说明

Assessments will be conducted by assessors who are naive to randomization assignment. Every effort will be made to conceal all information regarding randomization and randomization assignment to staff involved in assessment, recruitment, or other study activities that could lead to bias. It is not possible to conceal randomization status from intervention staff, as they will be delivering the intervention.

入排标准

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

入选标准

  • Presence during past year of a suicide attempt, interrupted suicide attempt, aborted suicide attempt, or active suicidal ideation with a plan; or 2) past year depression, plus a history of a suicide attempt and/or recurrent self-harm;
  • Age 12-24 years

排除标准

  • Mental health/behavioral symptoms that would preclude productive engagement in study assessments or intervention (e.g., active psychosis; drug dependence)
  • Life threatening medical illness or other characteristics that would impede study participation (e.g. plans to move from Oregon during study period; plans for placement out of the home, insufficient locator information for follow-up)
  • Youth receives majority of mental health care outside of the Kaiser-Permanente health system.

结局指标

主要结局

Suicide Attempt Behavior

时间窗: 12-month observation period

fatal and nonfatal suicide attempts/suicide attempt behaviors

次要结局

  • Suicide Events(12-month observation period)
  • Self Harm Episodes(12-month observation period)
  • Suicidality(12-month observation period)
  • Depression(12-month observation period)

研究者

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

Joan Asarnow

Principal Investigator

University of California, Los Angeles

研究点 (4)

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