- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07583524
Trauma-Informed School Intervention for Adolescent Mental Health and Self-Injury Prevention in China (TISI-China)
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
Postavení
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Hunan
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Huaihua, Hunan, Čína, 413507
- Hongjiang Furong Middle School
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
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
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 |
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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.
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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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Depressive Symptoms
Časové okno: Baseline and post-intervention after 16 weeks
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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.
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Baseline and post-intervention after 16 weeks
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Change in Anxiety Symptoms
Časové okno: Baseline and post-intervention after 16 weeks
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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.
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Baseline and post-intervention after 16 weeks
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Change in Borderline Personality Features
Časové okno: Baseline and post-intervention after 16 weeks
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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.
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Baseline and post-intervention after 16 weeks
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Change in Non-Suicidal Self-Injury Thoughts
Časové okno: Baseline and post-intervention after 16 weeks
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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.
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Baseline and post-intervention after 16 weeks
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Change in Non-Suicidal Self-Injury Behaviors
Časové okno: Baseline and post-intervention after 16 weeks
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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.
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Baseline and post-intervention after 16 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Behavioral Difficulties
Časové okno: Baseline and post-intervention after 16 weeks
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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.
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Baseline and post-intervention after 16 weeks
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Change in Dissociative Experiences
Časové okno: Baseline and post-intervention after 16 weeks
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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.
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Baseline and post-intervention after 16 weeks
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Change in Peer Victimization
Časové okno: Baseline and post-intervention after 16 weeks
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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.
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Baseline and post-intervention after 16 weeks
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Change in Prosocial Behavior
Časové okno: Baseline and post-intervention after 16 weeks
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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.
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Baseline and post-intervention after 16 weeks
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Change in Resilience
Časové okno: Baseline and post-intervention after 16 weeks
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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.
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Baseline and post-intervention after 16 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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