跳至主要内容
临床试验/NCT07214233
NCT07214233招募中不适用

Youth Empowerment and Safety Intervention for Systems-involved Sexual and Gender Minority Youth at Risk of Suicide

Case Western Reserve University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Youth-level changes in Recovery

研究概览

简要总结

This clinical trial will implement and evaluate the feasibility, acceptability, and initial impact of Peer Support Specialist (PSS) services for public system-involved sexual and gender minority (lesbian, gay, bisexual, queer and/or transgender) youth (SGMY) at risk of suicide.

详细描述

A sharp increase in U.S. youth mental health problems coupled with the national shortage in child behavioral health clinicians has identified peer providers as a cost- and impact-effective solution. Peer Support Specialists (PSS), paraprofessionals with lived experience who provide mutual and structured support, have been found to be effective in improving client engagement in mental health services. The study proposes to evaluate the feasibility, acceptability, and initial impact of a multi-level intervention, Youth Empowerment & Safety (YES), comprised of two coordinated components: 1) system-level improved identification and referral (I/R) of self-injurious thoughts and behaviors (SITB) among sexual and gender minority youth (SGMY), and 2) introduction of an SGMY-tailored support PSS to enhance engagement and support with behavioral health treatment and other support services.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • •Child Inclusion Criteria:
  • •12-17 years of age
  • •Self-identify as a sexual or gender minority (SGM)
  • •Involved in one or more system: juvenile justice, child welfare, and/or community-based mental health
  • •Personal experience with self-injurious thoughts and behaviors (SITB)
  • •English speaking
  • •Willing and able to provide informed assent

排除标准

  • •Less than 12 or greater than 17 years of age (0-11 or 18 and over)
  • •Do not self-identify as a sexual or gender minority (SGM)
  • •Not involved in the juvenile justice, child welfare, and/or community-based mental health systems
  • •No personal experience with self-injurious thoughts and behaviors (SITB)
  • •Not English speaking
  • •Unwilling and/or unable to provide informed assent
  • •Caregiver Inclusion Criteria:
  • •18-80 years of age
  • •Primary Caregiver of youth who meet child inclusion criteria listed above
  • •English speaking
  • •Willing and able to provide informed consent
  • •Caregiver Exclusion Criteria:
  • •Less than 18 or greater than 80 years of age (0-17 or 81 and over)
  • •Not the Primary Caregiver of youth who meet child inclusion criteria listed above
  • •Not English speaking
  • •Unwilling and/or unable to provide informed consent

研究组 & 干预措施

Pre-implementation Period

Active Comparator

Behavioral health treatment as usual

干预措施: Treatment as Usual (Behavioral)

Post-implementation Period

Experimental

Behavioral health treatment as usual + referral to and connection with Peer Support Services

干预措施: Peer Support Services (PSS) (Behavioral)

结局指标

主要结局

Youth-level changes in Recovery

时间窗: Baseline, Post-Intervention 3 Month, and Post Intervention 6 Month

The researchers will compare the change in treatment engagement as quantified by total score on two separate subscales of the Questionnaire about the Process of Recovery (the QPR). The QPR is a 22-item measure developed from service users' accounts of recovery in collaboration with local service users. Each item is scored using a 5-point Likert scale ranging from 0 (disagree strongly) to 4 (agree strongly). There are two subscales: 1) intrapersonal tasks involved in recovery (17 items, range 0-68) and 2) interpersonal factors that facilitate recovery (5 items, range 0-20) with higher scores indicating increased recovery on both subscales.

Youth Level Changes in Self-injurious thoughts and behaviors

时间窗: From enrollment (baseline), to 3- and 6 months follow ups post treatment at the end of 8-12 weeks.

The researchers will compare changes in suicidal ideation, planning, attempt and non-suicidal self-harm in a group of pre-intervention (nonrandomized) youth to post-intervention (nonrandomized youth) using the Columbia Suicide Severity Rating Scale (C-SSRS), a widely used and well-validated measure of suicidal ideation, planning, attempt, and non-suicidal self-harm.

Youth-level changes in Recovery

时间窗: Baseline, Post-Intervention 3 Month, and Post Intervention 6 Month

The researchers will compare the change in treatment engagement as quantified by total score on two separate subscales of the Questionnaire about the Process of Recovery (the QPR). The QPR is a 22-item measure developed from service users' accounts of recovery in collaboration with local service users. Each item is scored using a 5-point Likert scale ranging from 0 (disagree strongly) to 4 (agree strongly). There are two subscales: 1) intrapersonal tasks involved in recovery (17 items, range 0-68) and 2) interpersonal factors that facilitate recovery (5 items, range 0-20) with higher scores indicating increased recovery on both subscales.

Youth Level Changes in Self-injurious thoughts and behaviors

时间窗: From enrollment (baseline), to 3- and 6 months follow ups post treatment at the end of 8-12 weeks.

The researchers will compare changes in suicidal ideation, planning, attempt and non-suicidal self-harm in a group of pre-intervention (nonrandomized) youth to post-intervention (nonrandomized youth) using the Columbia Suicide Severity Rating Scale (C-SSRS), a widely used and well-validated measure of suicidal ideation, planning, attempt, and non-suicidal self-harm.

次要结局

  • Patient Health Questionnaire - Depression Scale - PHQ-9(Study enrollment (baseline) and 3- and 6-month follow-ups)
  • Youth level changes in minority stress(baseline, 3- month post, 6-month follow up)
  • Youth Level Changes in Perceived Parent Acceptance(baseline, 3-month post, 6 month follow up)
  • Patient Health Questionnaire - Depression Scale - PHQ-9(Study enrollment (baseline) and 3- and 6-month follow-ups)
  • Youth level changes in minority stress(baseline, 3- month post, 6-month follow up)
  • Youth Level Changes in Perceived Parent Acceptance(baseline, 3-month post, 6 month follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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