NCT07891754

Brief Summary

The purpose of this randomized controlled trial is to evaluate whether a school-based Trauma-Informed Psychosocial Competence (TIPC) intervention can reduce nonsuicidal self-injury among adolescents in China. Nonsuicidal self-injury means deliberately injuring oneself without intending to die. The TIPC program aims to help adolescents understand and accept themselves, manage difficult emotions, cope with stress, communicate with others, and seek support. It uses a trauma-informed approach that recognizes how stressful or adverse experiences may affect young people and emphasizes safety, respect, and supportive relationships. The main question is whether adolescents receiving the TIPC program show a greater reduction in nonsuicidal self-injury than those in the comparison group. The study will also examine changes in emotional well-being and psychosocial functioning. Participants will be assigned to an intervention group or a comparison group through random allocation. Adolescents in the intervention group will take part in structured school-based sessions. Participants in both groups will complete questionnaires before and after the intervention to assess self-injury and related psychological and social outcomes.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
6,000

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Nov 2026

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

October 11, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

7 months

First QC Date

October 11, 2026

Last Update Submit

October 16, 2026

Conditions

Keywords

AdolescentSchool-Based InterventionTrauma-Informed CarePsychosocial CompetenceEmotion RegulationSelf-Injury PreventionRandomized Controlled TrialTIPC

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in Past-Month Nonsuicidal Self-Injury Behavior Frequency Score

    Past-month nonsuicidal self-injury (NSSI) behavior will be assessed using a self-report item measuring the frequency of deliberate self-injury without suicidal intent. Responses are scored from 0 to 4: 0 = never, 1 = once, 2 = 2-3 times, 3 = 4-5 times, and 4 = 6 or more times. Higher scores indicate more frequent NSSI behavior. Change will be calculated as the post-assessment score minus the baseline score; negative values indicate improvement. Changes will be compared between the intervention and control groups.

    Baseline and Week 8/ Week 16

  • Change From Baseline in Past-Month Nonsuicidal Self-Injury Thought Frequency Score

    Past-month thoughts of nonsuicidal self-injury will be assessed using a self-report item about thoughts of deliberately injuring oneself without suicidal intent. Responses are scored from 0 to 4: 0 = never, 1 = once, 2 = 2-3 times, 3 = 4-5 times, and 4 = 6 or more times. Higher scores indicate more frequent NSSI thoughts. Change will be calculated as the post-assessment score minus the baseline score; negative values indicate improvement. Changes will be compared between the intervention and control groups.

    Baseline and Week 8/ Week 16

Secondary Outcomes (3)

  • Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score

    Baseline and Week 8 & Week 16

  • Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score

    Baseline and Week 8 & Week 16

  • Change From Baseline in Connor-Davidson Resilience Scale-10 (CD-RISC-10) Total Score

    Baseline and Week 8 & Week 16

Study Arms (2)

TIPC Intervention Group

EXPERIMENTAL

Participants in this group will receive the school-based Trauma-Informed Psychosocial Competence (TIPC) program. The program comprises eight adolescent group sessions and one caregiver-adolescent activity. Sessions address self-awareness and self-acceptance, empathy, emotion regulation, stress management, communication, support-seeking, and mental health literacy.

Behavioral: Trauma-Informed Psychosocial Competence (TIPC) Program

Usual School Provision Control Group

NO INTERVENTION

Participants in this group will continue to receive the education and support ordinarily available at their schools. No additional study-specific intervention will be provided to this group during the intervention period.

Interventions

A structured school-based psychosocial skills program guided by trauma-informed principles. The program aims to strengthen adolescents' emotional and interpersonal skills through eight adolescent group sessions and one caregiver-adolescent activity. Content includes self-awareness, self-acceptance, perspective-taking, empathy, emotion regulation, active coping, relaxation, communication, support-seeking, and mental health literacy. The caregiver-adolescent activity focuses on supportive family interactions.

TIPC Intervention Group

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled as a student in a participating school and within the grade levels selected for recruitment.
  • Able to understand the Chinese-language study materials and participate in the intervention activities and questionnaire assessments, with reasonable support where needed.
  • Willing to participate and provide informed assent or consent, as appropriate for age.
  • Written informed consent provided by a parent or legal guardian for participants below the applicable age of legal consent.

You may not qualify if:

  • A condition that prevents informed assent or consent, participation in the intervention, or completion of the study assessments despite reasonable support.
  • Concurrent participation in another structured intervention trial targeting nonsuicidal self-injury that would conflict with participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Self-Injurious BehaviorEmotional Regulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-ControlSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

October 11, 2026

First Posted

October 23, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

October 23, 2026

Record last verified: 2026-10