An interventional study of Trauma-Informed Psychosocial Competence (TIPC) Program in Nonsuicidal Self-Injury, sponsored by Han Wu. Not yet recruiting. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Han Wu · Not applicable, Interventional, and Prevention
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.
This study will evaluate a school-based Trauma-Informed Psychosocial Competence (TIPC) intervention using a randomized controlled design. The intervention combines trauma-informed principles with practical skills training to address modifiable emotional and interpersonal processes relevant to adolescent nonsuicidal self-injury.
The program was developed through a review of the literature, qualitative work, expert consultation using the Delphi method, and preliminary feasibility work. Its content focuses on self-awareness and self-acceptance, perspective-taking and empathy, emotion regulation, active coping and relaxation, communication and social interaction, support-seeking, and mental health literacy. The existing curriculum comprises eight adolescent group sessions and one caregiver-adolescent activity intended to strengthen supportive family interactions.
The trial will test whether participation in the program reduces nonsuicidal self-injury compared with the comparison condition. Changes in psychological symptoms, resilience, and social and behavioral functioning will also be evaluated to characterize the broader effects of the intervention.
Outcome assessments will use standardized self-report questionnaires administered to both study groups. The evaluation will focus on between-group differences in change from baseline, rather than changes within the intervention group alone.
The findings will inform the use of trauma-informed psychosocial skills education for adolescent self-injury prevention in school settings.
259 studies on the registry are indexed under Self-Injurious Behavior; 95 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 66 across 219 interventional studies indexed under Self-Injurious Behavior.
Browse Self-Injurious Behavior studies →This is the only study on the registry with Han Wu as lead sponsor.
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Exclusion Criteria:
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
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.
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.
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.
Time frame: 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.
Time frame: Baseline and Week 8/ Week 16
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). Each item is scored from 0 to 3, giving a total score of 0-27. Higher scores indicate more severe depressive symptoms. Change is calculated as the post-assessment score minus the baseline score; negative values indicate improvement.
Time frame: Baseline and Week 8 & Week 16
Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score
Anxiety symptoms will be assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7). Each item is scored from 0 to 3, giving a total score of 0-21. Higher scores indicate more severe anxiety symptoms. Change is calculated as the post-assessment score minus the baseline score; negative values indicate improvement.
Time frame: Baseline and Week 8 & Week 16
Change From Baseline in Connor-Davidson Resilience Scale-10 (CD-RISC-10) Total Score
Resilience will be assessed using the 10-item Connor-Davidson Resilience Scale (CD-RISC-10). Each item is scored from 0 to 4, giving a total score of 0-40. Higher scores indicate greater resilience. Change is calculated as the post-assessment score minus the baseline score; positive values indicate improvement.
Time frame: Baseline and Week 8 & Week 16
No study locations are listed for this record.
Plan to share: Undecided — There is no plan to share individual participant data with researchers outside the study team. The study involves adolescents and collects sensitive information on self-injury, childhood adversity, and mental health. This decision is intended to protect participant privacy and minimize the risk of re-identification. Study findings will be reported in aggregate form.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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