Hand in Hand, We Rise (Xie Shou Gong Jin)
20 июля 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Оцененный)
1680
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Shufang Sun, PhD
- Номер телефона: 401-484-0012
- Электронная почта: flourishing@brown.edu
Места учебы
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Anhui
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Linquan County, Anhui, Китай
- Six middle schools
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Контакт:
- Pingping Zhao
- Номер телефона: 19908091587
- Электронная почта: Zpp087@foxmail.com
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
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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.
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Активный компаратор: Usual care
Psychoeducation classroom education for students as usual
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Psychoeducation classroom as usual in schools, provided by teachers to students as part of the regular school curriculum
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Suicide Ideation Attributes Scale (SIDAS)
Временное ограничение: Baseline, 4 months (post-intervention) and 8 months follow-up
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Временное ограничение: Baseline, 4 months (post-intervention) and 8 months follow-up
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Session Evaluation Form (SEF)
Временное ограничение: 4 months (post-intervention)
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The 13-item SEF measuring perceived feasibility, acceptability, and intervention utility of the intervention at 4 months follow-up/postintervention
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4 months (post-intervention)
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Client Satisfaction Survey (CSQ-8)
Временное ограничение: 4 months (post-intervention)
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The 8-item CSQ assessing satisfaction will be used to measure intervention acceptability at 4 months follow-up/post-intervention.
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4 months (post-intervention)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Patient Health Questionnaire (PHQ-9)
Временное ограничение: Baseline, 4 months (post-intervention) and 8 months follow-up
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Generalized Anxiety Disorder (GAD-7)
Временное ограничение: Baseline, 4 months (post-intervention) and 8 months follow-up
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Attitudes Toward Seeking Professional Psychological Help
Временное ограничение: Baseline, 4 months (post-intervention) and 8 months follow-up
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Perceived Devaluation Discrimination (PDD) scale
Временное ограничение: Baseline, 4 months (post-intervention) and 8 months follow-up
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Stigma of Suicide Scale (SOSS)-short form
Временное ограничение: Baseline, 4 months (post-intervention) and 8 months follow-up
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Adapted Delaware School Climate Survey
Временное ограничение: Baseline, 4 months (post-intervention) and 8 months follow-up
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Rosenberg Self-Esteem Scale
Временное ограничение: Baseline, 4 months (post-intervention) and 8 months follow-up
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Suicide Prevention Gatekeeper Self-Efficacy Scale (GKSES)
Временное ограничение: Baseline, 4 months (post-intervention) and 8 months follow-up
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Brief Difficulties in Emotion Regulation Scale (DERS-16)
Временное ограничение: Baseline, 4 months (post-intervention) and 8 months follow-up.
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up.
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WHO-5 Well-Being Index
Временное ограничение: Baseline, 4 months (post-intervention) and 8 months follow-up
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up
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Child and Adolescent Mindfulness Measure (CAMM)
Временное ограничение: Baseline, 4 months (post-intervention) and 8 months follow-up.
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up.
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Children's Hope Scale
Временное ограничение: Baseline, 4 months (post-intervention) and 8 months follow-up.
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up.
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Self-Compassion Scale Short Form
Временное ограничение: Baseline, 4 months (post-intervention) and 8 months follow-up.
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up.
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Resilience Scale (CYRM-R)
Временное ограничение: Baseline, 4 months (post-intervention) and 8 months follow-up.
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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.
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Baseline, 4 months (post-intervention) and 8 months follow-up.
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Adverse Childhood Experience
Временное ограничение: Baseline
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Adverse childhood experience will be measured by baseline as a potential intervention effect moderator.
This scale will be assessed among adolescents.
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Baseline
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 августа 2026 г.
Первичное завершение (Оцененный)
1 июля 2027 г.
Завершение исследования (Оцененный)
1 июля 2027 г.
Даты регистрации исследования
Первый отправленный
20 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
20 июля 2026 г.
Первый опубликованный (Действительный)
23 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
23 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
20 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- STUDY00001434
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана 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.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .