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

20 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

1680

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Anhui
      • Linquan County, Anhui, China
        • Six middle schools
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: Xie Shou Gong Jin
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.
Actieve vergelijker: Usual care
Psychoeducation classroom education for students as usual
Gedragsmatig: Regular psychoeducation class
Psychoeducation classroom as usual in schools, provided by teachers to students as part of the regular school curriculum

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Suicide Ideation Attributes Scale (SIDAS)
Tijdsspanne: 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.
Baseline, 4 months (post-intervention) and 8 months follow-up
Columbia-Suicide Severity Rating Scale (C-SSRS)
Tijdsspanne: 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.
Baseline, 4 months (post-intervention) and 8 months follow-up
Session Evaluation Form (SEF)
Tijdsspanne: 4 months (post-intervention)
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)
Tijdsspanne: 4 months (post-intervention)
The 8-item CSQ assessing satisfaction will be used to measure intervention acceptability at 4 months follow-up/post-intervention.
4 months (post-intervention)

Secundaire uitkomstmaten

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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adverse Childhood Experience
Tijdsspanne: Baseline
Adverse childhood experience will be measured by baseline as a potential intervention effect moderator. This scale will be assessed among adolescents.
Baseline

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Brown University

Medewerkers

Beijing Normal University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

1 juli 2027

Studie voltooiing (Geschat)

1 juli 2027

Studieregistratiedata

Eerst ingediend

20 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

20 juli 2026

Eerst geplaatst (Werkelijk)

23 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

20 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY00001434

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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