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

20 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

1680

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Anhui
      • Linquan County, Anhui, Cina
        • Six middle schools
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: Usual care
Psychoeducation classroom education for students as usual
Comportamentale: Regular psychoeducation class
Psychoeducation classroom as usual in schools, provided by teachers to students as part of the regular school curriculum

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Suicide Ideation Attributes Scale (SIDAS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient Health Questionnaire (PHQ-9)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Adverse Childhood Experience
Lasso di tempo: Baseline
Adverse childhood experience will be measured by baseline as a potential intervention effect moderator. This scale will be assessed among adolescents.
Baseline

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Brown University

Collaboratori

Beijing Normal University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 luglio 2027

Completamento dello studio (Stimato)

1 luglio 2027

Date di iscrizione allo studio

Primo inviato

20 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 luglio 2026

Primo Inserito (Effettivo)

23 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY00001434

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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