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

20. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

1680

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Anhui
      • Linquan County, Anhui, Kina
        • Six middle schools
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Aktiv komparator: Usual care
Psychoeducation classroom education for students as usual
Atferdsmessig: Regular psychoeducation class
Psychoeducation classroom as usual in schools, provided by teachers to students as part of the regular school curriculum

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Suicide Ideation Attributes Scale (SIDAS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient Health Questionnaire (PHQ-9)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adverse Childhood Experience
Tidsramme: Baseline
Adverse childhood experience will be measured by baseline as a potential intervention effect moderator. This scale will be assessed among adolescents.
Baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Brown University

Samarbeidspartnere

Beijing Normal University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. juli 2027

Studiet fullført (Antatt)

1. juli 2027

Datoer for studieregistrering

Først innsendt

20. juli 2026

Først innsendt som oppfylte QC-kriteriene

20. juli 2026

Først lagt ut (Faktiske)

23. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY00001434

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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