Hand in Hand, We Rise (Xie Shou Gong Jin)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11+
SponsorBrown University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Xie Shou Gong Jin
BehavioralSix 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.
Regular psychoeducation class
BehavioralPsychoeducation classroom as usual in schools, provided by teachers to students as part of the regular school curriculum
Treatment groups
1,680 Participants
are divided into 2 treatment groupsGroup A: Hand in Hand, We RiseExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 4 months (post-intervention) and 8 months follow-up2
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.
Time frame
Baseline, 4 months (post-intervention) and 8 months follow-up3
Session Evaluation Form (SEF)
The 13-item SEF measuring perceived feasibility, acceptability, and intervention utility of the intervention at 4 months follow-up/postintervention
Time frame
4 months (post-intervention)4
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.
Time frame
4 months (post-intervention)Secondary outcomes
1
Patient Health Questionnaire (PHQ-9)
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.
Time frame
Baseline, 4 months (post-intervention) and 8 months follow-up2
Generalized Anxiety Disorder (GAD-7)
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.
Time frame
Baseline, 4 months (post-intervention) and 8 months follow-up3
Attitudes Toward Seeking Professional Psychological Help
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.
Time frame
Baseline, 4 months (post-intervention) and 8 months follow-up4
Perceived Devaluation Discrimination (PDD) scale
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.
Time frame
Baseline, 4 months (post-intervention) and 8 months follow-upOther outcomes
1
Adverse Childhood Experience
Adverse childhood experience will be measured by baseline as a potential intervention effect moderator. This scale will be assessed among adolescents.
Time frame
BaselineLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Six middle schools Status unavailable Linquan County, Anhui
China
ChinaSponsors and contacts
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Brown University
Lead sponsor
Beijing Normal University
Collaborator
Source ClinicalTrials.gov
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