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

6 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

5787

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

Sí

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Depressive Symptoms
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Behavioral Difficulties
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

10 de noviembre de 2025

Finalización primaria (Actual)

30 de abril de 2026

Finalización del estudio (Actual)

5 de mayo de 2026

Fechas de registro del estudio

Enviado por primera vez

6 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de mayo de 2026

Publicado por primera vez (Actual)

13 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2025245NI

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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