- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07722455
Hand in Hand, We Rise (Xie Shou Gong Jin)
maanantai 20. heinäkuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
1680
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Shufang Sun, PhD
- Puhelinnumero: 401-484-0012
- Sähköposti: flourishing@brown.edu
Opiskelupaikat
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Anhui
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Linquan County, Anhui, Kiina
- Six middle schools
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Ottaa yhteyttä:
- Pingping Zhao
- Puhelinnumero: 19908091587
- Sähköposti: Zpp087@foxmail.com
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Joo
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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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Active Comparator: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Suicide Ideation Attributes Scale (SIDAS)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Patient Health Questionnaire (PHQ-9)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Adverse Childhood Experience
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
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Lauantai 1. elokuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Torstai 1. heinäkuuta 2027
Opintojen valmistuminen (Arvioitu)
Torstai 1. heinäkuuta 2027
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 20. heinäkuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 20. heinäkuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Torstai 23. heinäkuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Torstai 23. heinäkuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 20. heinäkuuta 2026
Viimeksi vahvistettu
Keskiviikko 1. heinäkuuta 2026
Lisää tietoa
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Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- STUDY00001434
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
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.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
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