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临床试验/NCT07722455
NCT07722455尚未招募不适用

Hand in Hand, We Rise (Xie Shou Gong Jin)

Brown University1 个研究点 分布在 1 个国家目标入组 1,680 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,680
试验地点
1
主要终点
Suicide Ideation Attributes Scale (SIDAS)

研究概览

简要总结

This study aims to conduct a cluster randomized controlled trial to assess the feasibility of implementing the "Hand in Hand, We Rise" (Xie Shou Gong Jin) multi-stakeholder collaborative school-based suicide prevention program in rural public junior high schools. Six schools will be randomly assigned in a 1:1 ratio to either the intervention group or the control group; the intervention group will simultaneously implement the "Youth Strengths & Skills Curriculum (YSSC)" curriculum for students, "Life Gatekeeper" training for teachers, and mental health information dissemination for caregivers. The primary objectives are to evaluate recruitment, retention, adherence, implementation fidelity, acceptability, and safety within real-world school settings, and to preliminarily estimate changes in indicators such as suicidal ideation, depression, anxiety, loneliness, help-seeking attitudes, mental health stigma, self-esteem, school climate, and bullying. The findings will provide parameters and an implementation basis for a subsequent large-scale, multi-school cluster randomized controlled trial.

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
None

入排标准

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

入选标准

  • Adolescent inclusion criteria include: (a) is a registered student at one of the participating schools, (b) be between the ages of 11-15, (c) fluent in reading Chinese during the consent process, (d) be willing to participate in the YSSC curriculum during their psychoeducation class.
  • Caregiver inclusion criteria include: (a) age 18 or above, (b) can read and speak Chinese, (c) be a primary caregiver of an adolescent enrolled in the participating schools, and (d) willing to discuss perceived needs related to adolescent suicide prevention.
  • Teacher inclusion criteria include: (a) age 18 or above, (b) can read and speak Chinese, (c) be a full-time teacher of the participating schools.

排除标准

  • Individuals will be excluded from the study if they are determined to have symptoms that would prevent them from giving meaningful consent or participate in study activities, such as significant cognitive impairment.

结局指标

主要结局

Suicide Ideation Attributes Scale (SIDAS)

时间窗: Baseline, 4 months (post-intervention) and 8 months follow-up

Frequency and severity of suicide ideation will be evaluated by SIDAS at baseline, 4 months and 8 months follow-up to evaluate suicide ideation as one of the primary outcomes among adolescents.

Columbia-Suicide Severity Rating Scale (C-SSRS)

时间窗: Baseline, 4 months (post-intervention) and 8 months follow-up

Severity of suicide risk will be assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) at baseline, 4 months and 8 months follow-up to evaluate the overall risk of suicide as one of the primary outcomes among adolescents.

Session Evaluation Form (SEF)

时间窗: 4 months (post-intervention)

The 13-item SEF measuring perceived feasibility, acceptability, and intervention utility of the intervention at 4 months follow-up/postintervention

Client Satisfaction Survey (CSQ-8)

时间窗: 4 months (post-intervention)

The 8-item CSQ assessing satisfaction will be used to measure intervention acceptability at 4 months follow-up/post-intervention.

次要结局

  • Patient Health Questionnaire (PHQ-9)(Baseline, 4 months (post-intervention) and 8 months follow-up)
  • Generalized Anxiety Disorder (GAD-7)(Baseline, 4 months (post-intervention) and 8 months follow-up)
  • Attitudes Toward Seeking Professional Psychological Help(Baseline, 4 months (post-intervention) and 8 months follow-up)
  • Perceived Devaluation Discrimination (PDD) scale(Baseline, 4 months (post-intervention) and 8 months follow-up)
  • Stigma of Suicide Scale (SOSS)-short form(Baseline, 4 months (post-intervention) and 8 months follow-up)
  • Adapted Delaware School Climate Survey(Baseline, 4 months (post-intervention) and 8 months follow-up)
  • Rosenberg Self-Esteem Scale(Baseline, 4 months (post-intervention) and 8 months follow-up)
  • Suicide Prevention Gatekeeper Self-Efficacy Scale (GKSES)(Baseline, 4 months (post-intervention) and 8 months follow-up)
  • Brief Difficulties in Emotion Regulation Scale (DERS-16)(Baseline, 4 months (post-intervention) and 8 months follow-up.)
  • WHO-5 Well-Being Index(Baseline, 4 months (post-intervention) and 8 months follow-up)
  • Child and Adolescent Mindfulness Measure (CAMM)(Baseline, 4 months (post-intervention) and 8 months follow-up.)
  • Children's Hope Scale(Baseline, 4 months (post-intervention) and 8 months follow-up.)
  • Self-Compassion Scale Short Form(Baseline, 4 months (post-intervention) and 8 months follow-up.)
  • Resilience Scale (CYRM-R)(Baseline, 4 months (post-intervention) and 8 months follow-up.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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