NCT07722455

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,680

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

July 20, 2026

Last Update Submit

July 20, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Suicide Ideation Attributes Scale (SIDAS)

    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.

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

  • Columbia-Suicide Severity Rating Scale (C-SSRS)

    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.

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

  • Session Evaluation Form (SEF)

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

    4 months (post-intervention)

  • Client Satisfaction Survey (CSQ-8)

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

    4 months (post-intervention)

Secondary Outcomes (14)

  • 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

  • +9 more secondary outcomes

Other Outcomes (1)

  • Adverse Childhood Experience

    Baseline

Study Arms (2)

Hand in Hand, We Rise

EXPERIMENTAL

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.

Behavioral: Xie Shou Gong Jin

Usual care

ACTIVE COMPARATOR

Psychoeducation classroom education for students as usual

Behavioral: Regular psychoeducation class

Interventions

Psychoeducation classroom as usual in schools, provided by teachers to students as part of the regular school curriculum

Usual care

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.

Hand in Hand, We Rise

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Six middle schools

Linquan County, Anhui, China

Location

MeSH Terms

Conditions

SuicideSuicide PreventionPsychological Well-Being

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorPersonal Satisfaction

Central Study Contacts

Shufang Sun, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 23, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP

Locations