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

20 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

1680

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Chiny
    • Anhui
      • Linquan County, Anhui, Chiny
        • Six middle schools
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Aktywny komparator: Usual care
Psychoeducation classroom education for students as usual
Behawioralne: Regular psychoeducation class
Psychoeducation classroom as usual in schools, provided by teachers to students as part of the regular school curriculum

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Suicide Ideation Attributes Scale (SIDAS)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Patient Health Questionnaire (PHQ-9)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Adverse Childhood Experience
Ramy czasowe: Baseline
Adverse childhood experience will be measured by baseline as a potential intervention effect moderator. This scale will be assessed among adolescents.
Baseline

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Brown University

Współpracownicy

Beijing Normal University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 sierpnia 2026

Zakończenie podstawowe (Szacowany)

1 lipca 2027

Ukończenie studiów (Szacowany)

1 lipca 2027

Daty rejestracji na studia

Pierwszy przesłany

20 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 lipca 2026

Pierwszy wysłany (Rzeczywisty)

23 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • STUDY00001434

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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