NCT07583524

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,787

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 6, 2026

Last Update Submit

May 6, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change in Depressive Symptoms

    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

    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

    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

    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

    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

Secondary Outcomes (5)

  • Change in Behavioral Difficulties

    Baseline and post-intervention after 16 weeks

  • Change in Dissociative Experiences

    Baseline and post-intervention after 16 weeks

  • Change in Peer Victimization

    Baseline and post-intervention after 16 weeks

  • Change in Prosocial Behavior

    Baseline and post-intervention after 16 weeks

  • Change in Resilience

    Baseline and post-intervention after 16 weeks

Study Arms (2)

School-Based Psychosocial Intervention

EXPERIMENTAL

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.

Behavioral: School-Based Psychosocial Adaptive Capacity Enhancement Program

Usual School Education Control

NO INTERVENTION

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.

Interventions

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.

School-Based Psychosocial Intervention

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hongjiang Furong Middle School

Huaihua, Hunan, 413507, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study used a parallel-group, school-based, non-randomized controlled design. Students in the intervention schools received the structured psychosocial adaptive capacity enhancement program, while students in the control school continued usual school education and routine mental health education. Outcomes were assessed using self-report questionnaires at baseline and follow-up time points in both groups. Group allocation was determined at the school level based on school collaboration willingness and implementation feasibility, rather than by random assignment.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 13, 2026

Study Start

November 10, 2025

Primary Completion

April 30, 2026

Study Completion

May 5, 2026

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations