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临床试验/NCT05225103
NCT05225103已完成不适用

Brief Suicide Intervention for Youth in Juvenile Detention Settings

Duke University4 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年4月7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
8
试验地点
4
主要终点
Number of Participants Who Reported Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)

研究概览

简要总结

This is an intervention development study and therefore is not designed or powered to test hypotheses. Following initial development and refinement of intervention and protocol, an open trial will be conducted at one juvenile detention facility (n=20). Following further refinement, six juvenile detention sites will be randomized to first or second wave of intervention implementation. All youth at an implementation site in suicidal crises will receive the intervention. Data will only be collected from youth with prior assent/consent. Youth will be assessed at the time of the suicidal/self-harm crisis, and at 2 and 4 weeks after initial intervention, and at a two-month follow-up assessment. We will preliminarily examine feasibility of the intervention and associated patterns of suicidal thoughts and behavior and non-suicidal self-injury, linkage to care following release, and presumed mechanisms of change such as hopelessness, self-efficacy to remain safe, urgency to act on suicidal thoughts, and acceptance.

详细描述

The primary objective of this phase of the study is to develop and refine procedures for the new multi-faceted intervention for trauma-informed suicide prevention (brief cognitive-behavioral and trauma-informed strategies and safety planning for youth who are suicidal and/or self-harming, as well as training of staff in trauma-informed crisis management and de-escalation strategies) for youth in juvenile detention settings. An associated objective is to develop procedures for training staff working with youth in short-term juvenile detention settings to conduct the new intervention for reducing suicidal thoughts and behavior. A third objective is to examine the feasibility of this trauma-informed suicide prevention intervention in terms of initial participant recruitment, fidelity to the treatment model, treatment acceptability, and monitoring of adverse events in an open trial (n=20). This intervention will be iteratively refined during this open trial based on feedback from youth and staff, and experiences using the intervention in juvenile detention. We will also gather information regarding the presumed mechanisms of action and targeted outcomes for this intervention (although the small open trial will not be able to statistically examine effects).

As an intervention development study, this study is not powered to test hypotheses. Rather, the purpose of this study is to demonstrate feasibility and acceptability of the intervention and procedures, and to demonstrate viability of the proof of concept.

The study is a collaboration between Duke and Wake Forest investigators, and Juvenile Justice in the NC Department of Public Safety.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • English speaking
  • At least 13 years of age or older and 18 years old or younger
  • Without evidence from school or other records of intellectual disability
  • Without evidence of active psychosis
  • Not wards of the state
  • Risk for suicidal behavior or non-suicidal self-harm behavior

排除标准

  • Not English-speaking or caregivers are not English-speaking
  • Wards of the state
  • Younger than 13 years old or older than 18 years of age
  • Evidence from school or other records or suspected intellectual disability
  • Active psychosis

结局指标

主要结局

Number of Participants Who Reported Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)

时间窗: Up to 2 month follow-up assessment

Determined by a response of "yes" to question #6 on the C-SSRS: "Have you done anything, started to do anything, or prepared to do anything to end your life?"

Number of Participants Who Reported Non-Suicidal Self Injury

时间窗: Up to 2 month follow-up assessment

Assessed with Questions from the Self-Injurious Thoughts and Behavior Interview.

Number of Participants Who Were Linked to Mental Health Services After Release

时间窗: Up to 2 month follow-up assessment

Assessed by CASA (Child and Adolescent Services Assessment) Parent Interview.

次要结局

  • Number of Participants Reporting Urgency to Act on Suicidal Thoughts(Up to 2-month follow-up assessment)
  • Number of Participants Reporting Hope and Reasons for Living After Leaving the Facility(Up to 2-month follow-up assessment)
  • Number of Participants Who Report Acceptance of Their Current Situation(Up to 2-month follow-up assessment)
  • Number of Participants Reporting Self-Efficacy in Keeping Safe(Up to 2-month follow-up assessment)
  • Number of Individuals With Emergency Mental Health Services (ED Visits and Hospitalizations)(Up to 2-month follow-up assessment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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