Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Trauma-Informed School Intervention for Adolescent Mental Health and Self-Injury Prevention in China (TISI-China)

6. května 2026 aktualizováno: WU Han

Development and Implementation of a Psychosocial Adaptive Capacity Enhancement Program for Adolescents With Childhood Household Dysfunction

This study evaluated a school-based psychosocial adaptive capacity enhancement program for Chinese adolescents. The program was developed to support students who may have experienced childhood household dysfunction or other adverse childhood experiences, while being delivered as a universal school-based mental health education program.

The intervention aimed to improve students' psychosocial skills, including emotional awareness, emotion regulation, stress coping, self-understanding, interpersonal communication, peer support, resilience, and mental health literacy. The study assessed whether the program was associated with improvements in adolescent mental health and psychosocial adaptation, including symptoms of depression and anxiety, rumination, dissociative experiences, resilience, behavioral difficulties, and non-suicidal self-injury-related thoughts and behaviors.

Participants were students from collaborating middle schools, high schools, and vocational secondary schools in Hongjiang, Hunan Province, China. Students in the intervention group received the structured school-based psychosocial program, while students in the control group continued their usual school education and routine mental health education. Outcomes were measured using self-report questionnaires at baseline and follow-up assessments.

This study was conducted as an international collaborative project, with ethical approval obtained in Japan and China. The intervention and data collection were conducted in China, and the Japanese research team was mainly responsible for study design, data management, statistical analysis, and manuscript preparation.

Přehled studie

Typ studie

Intervenční

Zápis (Aktuální)

5787

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Hunan
      • Huaihua, Hunan, Čína, 413507
        • Hongjiang Furong Middle School

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ano

Popis

Inclusion Criteria:

Students enrolled in participating middle schools, high schools, or vocational secondary schools in Hongjiang, Hunan Province, China Adolescents aged approximately 12 to 18 years Students who were able to understand and complete self-report questionnaires Students who provided assent or consent to participate Students whose parent, guardian, or appropriate custodian provided informed consent Students who were expected to remain enrolled at the participating school during the intervention and follow-up period

Exclusion Criteria:

Students with severe psychiatric disorders, developmental disorders, or cognitive impairment that made it difficult to complete questionnaires or participate in the intervention Students who were unable to understand the study explanation or complete self-report measures Students for whom assent/consent from the student or informed consent from a parent, guardian, or appropriate custodian could not be obtained Students who transferred school, withdrew from school, had long-term absence, or were otherwise unable to complete follow-up assessments Students who withdrew from the study during the study period, either by their own decision or by the decision of their parent, guardian, or appropriate custodian

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: School-Based Psychosocial Intervention
Participants in this arm received a structured school-based psychosocial adaptive capacity enhancement program. The program was informed by childhood household dysfunction, adverse childhood experiences, trauma-informed principles, and life-skills education. It included modules on emotional awareness, emotion regulation, stress coping, self-understanding, interpersonal communication, peer support, resilience, and mental health literacy. The program was delivered in routine school settings by trained school mental health staff or psychologists under the guidance of the research team.
The intervention is a structured school-based psychosocial adaptive capacity enhancement program for adolescents. It was developed based on trauma-informed principles related to childhood household dysfunction and adverse childhood experiences, life-skills education, and psychosocial competence enhancement. The program aims to support students' mental health and psychosocial adaptation by strengthening emotional awareness, emotion regulation, stress coping, self-understanding, interpersonal communication, peer support, resilience, and mental health literacy. The program was delivered in routine school settings by trained school mental health staff or psychologists under the guidance of the research team. Students in the control arm continued usual school education and routine mental health education and did not receive this structured program during the study period.16-session version: The program consisted of 16 sessions, delivered once weekly, approximately 45 minutes per session.
Žádný zásah: Usual School Education Control
Participants in this arm continued usual school education, routine class management, and standard school mental health education activities. They did not receive the structured psychosocial adaptive capacity enhancement program developed for this study during the study period. They could continue to access existing school counseling, homeroom teacher support, and routine campus mental health services as usual. Outcomes were assessed at the same time points as in the intervention arm.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Depressive Symptoms
Časové okno: Baseline and post-intervention after 16 weeks
Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report scale assessing depressive symptom severity, with higher scores indicating more severe depressive symptoms. The primary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks
Change in Anxiety Symptoms
Časové okno: Baseline and post-intervention after 16 weeks
Anxiety symptoms were assessed using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report measure of anxiety symptom severity. Higher scores indicate more severe anxiety symptoms. The primary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks
Change in Borderline Personality Features
Časové okno: Baseline and post-intervention after 16 weeks
Borderline personality features were assessed using the Borderline Personality Features Scale (BPFS), a self-report measure of borderline personality features. Higher scores indicate greater levels of borderline personality features. The primary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks
Change in Non-Suicidal Self-Injury Thoughts
Časové okno: Baseline and post-intervention after 16 weeks
Non-suicidal self-injury thoughts were assessed using self-report items on the frequency of NSSI-related thoughts during the past month. Higher values indicate more frequent NSSI thoughts. The primary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks
Change in Non-Suicidal Self-Injury Behaviors
Časové okno: Baseline and post-intervention after 16 weeks
Non-suicidal self-injury behaviors were assessed using self-report items on the frequency of NSSI actions during the past month. Higher values indicate more frequent NSSI behaviors. The primary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Behavioral Difficulties
Časové okno: Baseline and post-intervention after 16 weeks
Behavioral difficulties were assessed using the Strengths and Difficulties Questionnaire (SDQ). The SDQ is a self-report measure of emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Higher difficulty scores indicate greater behavioral and emotional difficulties. The secondary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks
Change in Dissociative Experiences
Časové okno: Baseline and post-intervention after 16 weeks
Dissociative experiences were assessed using the Adolescent Dissociative Experiences Scale-II (A-DES-II), a self-report measure of dissociative symptoms among adolescents. Higher scores indicate greater levels of dissociative experiences. The secondary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks
Change in Peer Victimization
Časové okno: Baseline and post-intervention after 16 weeks
Peer victimization was assessed using the Multidimensional Peer Victimisation Scale (MPVS), a self-report measure of different forms of peer victimization. Higher scores indicate greater exposure to peer victimization. The secondary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks
Change in Prosocial Behavior
Časové okno: Baseline and post-intervention after 16 weeks
Prosocial behavior was assessed using the prosocial behavior subscale of the Strengths and Difficulties Questionnaire (SDQ). Higher scores indicate greater prosocial behavior. The secondary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks
Change in Resilience
Časové okno: Baseline and post-intervention after 16 weeks
Resilience was assessed using the Connor-Davidson Resilience Scale-10 (CD-RISC-10), a 10-item self-report measure of psychological resilience. Higher scores indicate greater resilience. The secondary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

10. listopadu 2025

Primární dokončení (Aktuální)

30. dubna 2026

Dokončení studie (Aktuální)

5. května 2026

Termíny zápisu do studia

První předloženo

6. května 2026

První předloženo, které splnilo kritéria kontroly kvality

6. května 2026

První zveřejněno (Aktuální)

13. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 2025245NI

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Psychosociální adaptace

Předplatit