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

20 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

1680

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Porcelana
    • Anhui
      • Linquan County, Anhui, Porcelana
        • Six middle schools
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Conductual: 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.
Comparador activo: Usual care
Psychoeducation classroom education for students as usual
Conductual: Regular psychoeducation class
Psychoeducation classroom as usual in schools, provided by teachers to students as part of the regular school curriculum

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Suicide Ideation Attributes Scale (SIDAS)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient Health Questionnaire (PHQ-9)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Adverse Childhood Experience
Periodo de tiempo: Baseline
Adverse childhood experience will be measured by baseline as a potential intervention effect moderator. This scale will be assessed among adolescents.
Baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Brown University

Colaboradores

Beijing Normal University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

1 de julio de 2027

Finalización del estudio (Estimado)

1 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

20 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

20 de julio de 2026

Publicado por primera vez (Actual)

23 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

20 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STUDY00001434

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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 de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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