- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07722455
Hand in Hand, We Rise (Xie Shou Gong Jin)
July 20, 2026 updated by: 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
1680
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shufang Sun, PhD
- Phone Number: 401-484-0012
- Email: flourishing@brown.edu
Study Locations
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Anhui
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Linquan County, Anhui, China
- Six middle schools
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Contact:
- Pingping Zhao
- Phone Number: 19908091587
- Email: Zpp087@foxmail.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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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Active Comparator: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suicide Ideation Attributes Scale (SIDAS)
Time Frame: 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)
Time Frame: 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)
Time Frame: 4 months (post-intervention)
|
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)
Time Frame: 4 months (post-intervention)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline, 4 months (post-intervention) and 8 months follow-up
|
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)
Time Frame: Baseline, 4 months (post-intervention) and 8 months follow-up
|
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, 4 months (post-intervention) and 8 months follow-up
|
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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Childhood Experience
Time Frame: 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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
July 20, 2026
First Submitted That Met QC Criteria
July 20, 2026
First Posted (Actual)
July 23, 2026
Study Record Updates
Last Update Posted (Actual)
July 23, 2026
Last Update Submitted That Met QC Criteria
July 20, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001434
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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 Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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