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Набор скоро начнётся NCT07722455

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

Без фазы С лечением Suicide Suicide Awareness Mental Health Suicide Prevention

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Xie Shou Gong Jin, Regular psychoeducation class.
Кому может быть актуально
Состояния в реестре: Suicide, Suicide Awareness, Mental Health, Suicide Prevention. Базовые параметры: от 11 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

  • Поведенческое 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.
  • Поведенческое Regular psychoeducation class
    Psychoeducation classroom as usual in schools, provided by teachers to students as part of the regular school curriculum

Первичные конечные точки

  • Suicide Ideation Attributes Scale (SIDAS) [Срок оценки: Baseline, 4 months (post-intervention) and 8 months follow-up]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [Срок оценки: Baseline, 4 months (post-intervention) and 8 months follow-up]
  • Session Evaluation Form (SEF) [Срок оценки: 4 months (post-intervention)]
  • Client Satisfaction Survey (CSQ-8) [Срок оценки: 4 months (post-intervention)]
Вторичные конечные точки (12)
  • Patient Health Questionnaire (PHQ-9) [Срок оценки: Baseline, 4 months (post-intervention) and 8 months follow-up]
  • Generalized Anxiety Disorder (GAD-7) [Срок оценки: Baseline, 4 months (post-intervention) and 8 months follow-up]
  • Attitudes Toward Seeking Professional Psychological Help [Срок оценки: Baseline, 4 months (post-intervention) and 8 months follow-up]
  • Perceived Devaluation Discrimination (PDD) scale [Срок оценки: Baseline, 4 months (post-intervention) and 8 months follow-up]
  • Stigma of Suicide Scale (SOSS)-short form [Срок оценки: Baseline, 4 months (post-intervention) and 8 months follow-up]
  • Adapted Delaware School Climate Survey [Срок оценки: Baseline, 4 months (post-intervention) and 8 months follow-up]
  • Rosenberg Self-Esteem Scale [Срок оценки: Baseline, 4 months (post-intervention) and 8 months follow-up]
  • Suicide Prevention Gatekeeper Self-Efficacy Scale (GKSES) [Срок оценки: Baseline, 4 months (post-intervention) and 8 months follow-up]
  • Brief Difficulties in Emotion Regulation Scale (DERS-16) [Срок оценки: Baseline, 4 months (post-intervention) and 8 months follow-up.]
  • WHO-5 Well-Being Index [Срок оценки: Baseline, 4 months (post-intervention) and 8 months follow-up]
  • Child and Adolescent Mindfulness Measure (CAMM) [Срок оценки: Baseline, 4 months (post-intervention) and 8 months follow-up.]
  • Children's Hope Scale [Срок оценки: Baseline, 4 months (post-intervention) and 8 months follow-up.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • Six middle schools — Linquan County

Идентификаторы

NCT: NCT07722455 · STUDY00001434

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗