Hand in Hand, We Rise (Xie Shou Gong Jin)
20 de julho de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
1680
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Shufang Sun, PhD
- Número de telefone: 401-484-0012
- E-mail: flourishing@brown.edu
Locais de estudo
-
-
Anhui
-
Linquan County, Anhui, China
- Six middle schools
-
Contato:
- Pingping Zhao
- Número de telefone: 19908091587
- E-mail: Zpp087@foxmail.com
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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 Ativo: Usual care
Psychoeducation classroom education for students as usual
|
Psychoeducation classroom as usual in schools, provided by teachers to students as part of the regular school curriculum
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Suicide Ideation Attributes Scale (SIDAS)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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.
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adverse Childhood Experience
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de agosto de 2026
Conclusão Primária (Estimado)
1 de julho de 2027
Conclusão do estudo (Estimado)
1 de julho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
20 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de julho de 2026
Primeira postagem (Real)
23 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
23 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00001434
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .