- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07722455
Hand in Hand, We Rise (Xie Shou Gong Jin)
2026년 7월 20일 업데이트: Brown University
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.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
1680
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Shufang Sun, PhD
- 전화번호: 401-484-0012
- 이메일: flourishing@brown.edu
연구 장소
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Anhui
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Linquan County, Anhui, 중국
- Six middle schools
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연락하다:
- Pingping Zhao
- 전화번호: 19908091587
- 이메일: Zpp087@foxmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Hand in Hand, We Rise
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.
Students' intervention (YSSC) includes a 6-session course, with each session delivered by school mental health teachers approximately every 2 weeks.
Parents' intervention also includes 6-lesson course, with each lesson delivered approximately every 2 weeks.
Teachers' intervention will be a 1-to-2-day(s) training delivered right after the randomization.
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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.
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활성 비교기: Usual care
Psychoeducation classroom education for students as usual
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Psychoeducation classroom as usual in schools, provided by teachers to students as part of the regular school curriculum
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Suicide Ideation Attributes Scale (SIDAS)
기간: Baseline, 4 months (post-intervention) and 8 months follow-up
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Columbia-Suicide Severity Rating Scale (C-SSRS)
기간: Baseline, 4 months (post-intervention) and 8 months follow-up
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Session Evaluation Form (SEF)
기간: 4 months (post-intervention)
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The 13-item SEF measuring perceived feasibility, acceptability, and intervention utility of the intervention at 4 months follow-up/postintervention
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4 months (post-intervention)
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Client Satisfaction Survey (CSQ-8)
기간: 4 months (post-intervention)
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The 8-item CSQ assessing satisfaction will be used to measure intervention acceptability at 4 months follow-up/post-intervention.
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4 months (post-intervention)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient Health Questionnaire (PHQ-9)
기간: Baseline, 4 months (post-intervention) and 8 months follow-up
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Severity of depression as a secondary outcome will be measured by the Patient Health Questionnaire (PHQ-9) at baseline, 4 months and 8 months follow-up among adolescents.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Generalized Anxiety Disorder (GAD-7)
기간: Baseline, 4 months (post-intervention) and 8 months follow-up
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Severity of anxiety symptoms as a secondary outcome will be measured by the Generalized Anxiety Disorder (GAD-7), at baseline, 4 months and 8 months follow-up among adolescents.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Attitudes Toward Seeking Professional Psychological Help
기간: Baseline, 4 months (post-intervention) and 8 months follow-up
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Help-seeking attitude will be measured by the Attitudes Toward Seeking Professional Psychological Help, at baseline, 4 months and 8 months follow-up among adolescents, caregivers, and school teachers.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Perceived Devaluation Discrimination (PDD) scale
기간: Baseline, 4 months (post-intervention) and 8 months follow-up
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Perception of stigma against mental health will be measured by the Perceived DevaluationDiscrimination (PDD) scale, as a secondary outcome, at baseline, 4 months and 8 months follow-up among adolescents, caregivers, and school teachers.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Stigma of Suicide Scale (SOSS)-short form
기간: Baseline, 4 months (post-intervention) and 8 months follow-up
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Stigma against suicide will be measured by Stigma of Suicide Scale (SOSS)-short form, as a secondary outcome, at baseline, 4 months and 8 months follow-up among adolescents, caregivers, and school teachers.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Adapted Delaware School Climate Survey
기간: Baseline, 4 months (post-intervention) and 8 months follow-up
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Peer bullying will be measured by the Adapted Delaware School Climate Survey, as a secondary outcome, at baseline, 4 months and 8 months follow-up among adolescents.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Rosenberg Self-Esteem Scale
기간: Baseline, 4 months (post-intervention) and 8 months follow-up
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The 10-item Rosenberg Self-Esteem Scale will be used to assess self-esteem as a secondary outcome at baseline, 4 months (post-intervention) and 8 months follow-up.
This scale will be assessed among adolescents.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Suicide Prevention Gatekeeper Self-Efficacy Scale (GKSES)
기간: Baseline, 4 months (post-intervention) and 8 months follow-up
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The Suicide Prevention Gatekeeper Self-Efficacy Scale (GKSES) will be used to assess self-efficacy among teachers and caregivers as a secondary outcome at baseline, 4 months (post-intervention) and 8 months follow-up.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Brief Difficulties in Emotion Regulation Scale (DERS-16)
기간: Baseline, 4 months (post-intervention) and 8 months follow-up.
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The 16-item Brief Difficulties in Emotion Regulation Scale (DERS-16) will be used to assess difficulties in emotion regulation as a secondary outcome at baseline, 4 months (post-intervention) and 8 months follow-up among adolescents.
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Baseline, 4 months (post-intervention) and 8 months follow-up.
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WHO-5 Well-Being Index
기간: Baseline, 4 months (post-intervention) and 8 months follow-up
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The subjective psychological well-being will be measured by WHO-5 Well-Being Index as a secondary outcome at baseline, 4 months (post-intervention) and 8 months follow-up among adolescents.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Child and Adolescent Mindfulness Measure (CAMM)
기간: Baseline, 4 months (post-intervention) and 8 months follow-up.
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The 10-item Child and Adolescent Mindfulness Measure (CAMM) will be used to assess mindfulness as a secondary outcome among adolescents at baseline, 4 months (post-intervention) and 8 months follow-up.
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Baseline, 4 months (post-intervention) and 8 months follow-up.
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Children's Hope Scale
기간: Baseline, 4 months (post-intervention) and 8 months follow-up.
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Hope will be measured by the 6-item Children's Hope Scale (CHS) as a secondary outcome among adolescents at baseline, 4 months (post-intervention) and 8 months follow-up.
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Baseline, 4 months (post-intervention) and 8 months follow-up.
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Self-Compassion Scale Short Form
기간: Baseline, 4 months (post-intervention) and 8 months follow-up.
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Self-compassion among adolescents will be measured by the 12-item Self-Compassion Scale Short Form (SCS-SF) as a secondary outcome at baseline, 4 months (post-intervention) and 8 months follow-up.
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Baseline, 4 months (post-intervention) and 8 months follow-up.
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Resilience Scale (CYRM-R)
기간: Baseline, 4 months (post-intervention) and 8 months follow-up.
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The 12-item Child and Youth Resilience Measure-Revised (CYRM-R) will be used to assess resilience as a secondary outcome at baseline, 4 months (post-intervention) and 8 months follow-up among adolescents.
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Baseline, 4 months (post-intervention) and 8 months follow-up.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adverse Childhood Experience
기간: Baseline
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Adverse childhood experience will be measured by baseline as a potential intervention effect moderator.
This scale will be assessed among adolescents.
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Baseline
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2027년 7월 1일
연구 완료 (추정된)
2027년 7월 1일
연구 등록 날짜
최초 제출
2026년 7월 20일
QC 기준을 충족하는 최초 제출
2026년 7월 20일
처음 게시됨 (실제)
2026년 7월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 20일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Following data collection, cleaning, and analysis, we plan to publish de-identified quantitative data at an open science data repository (e.g., Open Science Framework).
De-identified qualitative data will be available upon request to the study PI.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .