Nonsuicidal Self-InjuryTIPC-ChinaNCT07891754
Effects of a School-Based Trauma-Informed Psychosocial Competence Intervention on Nonsuicidal Self-Injury in Adolescents
A study testing Trauma-Informed Psychosocial Competence (TIPC) Program in people with Nonsuicidal Self-Injury, run by Han Wu.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nonsuicidal Self-Injury
- What is being tested?
- Trauma-Informed Psychosocial Competence (TIPC) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Effects of a School-Based Trauma-Informed Psychosocial Competence Intervention on Nonsuicidal Self-Injury in Adolescents: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Nonsuicidal Self-Injury
- Being tested
- Trauma-Informed Psychosocial Competence (TIPC) Program
- Keywords
- Adolescent, School-Based Intervention, Trauma-Informed Care, Psychosocial Competence, Emotion Regulation, Self-Injury Prevention, Randomized Controlled Trial, TIPC
- Medical subject headings
- Self-Injurious Behavior, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Informed Psychosocial Competence (TIPC) ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and Week 8/ Week 16
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 8 & Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsuicidal Self-InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Han Wu
- Sponsor type
- University, hospital or other
- Collaborators
- School of Medicine, Chongqing University
- Responsible party
- Sponsor-investigator, Han Wu, Tokyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891754
- Sponsor's protocol ID
- 2025245-2NI
- Acronym
- TIPC-China
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a School-Based Trauma-Informed Psychosocial Competence Intervention on Nonsuicidal Self-Injury in Adolescents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07891754
- Acronym / sponsor ID
- TIPC-China / 2025245-2NI
- Conditions
- Nonsuicidal Self-Injury
- Keywords
- Adolescent, School-Based Intervention, Trauma-Informed Care, Psychosocial Competence, Emotion Regulation, Self-Injury Prevention, Randomized Controlled Trial, TIPC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Han WuUniversity, hospital or other
- Collaborators
- School of Medicine, Chongqing University
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIPC Intervention Group | Experimental | Behavioral: Trauma-Informed Psychosocial Competence (TIPC) ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma-Informed Psychosocial Competence (TIPC) ProgramA 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. | Behavioural | TIPC Intervention Group |
Primary outcome
Change From Baseline in Past-Month Nonsuicidal Self-Injury Behavior Frequency Score
Time frame: Baseline and Week 8/ Week 16
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.
Change From Baseline in Past-Month Nonsuicidal Self-Injury Thought Frequency Score
Time frame: Baseline and Week 8/ Week 16
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.
3 secondary outcomes
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score
Time frame: Baseline and Week 8 & Week 16
Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score
Time frame: Baseline and Week 8 & Week 16
Change From Baseline in Connor-Davidson Resilience Scale-10 (CD-RISC-10) Total Score
Time frame: Baseline and Week 8 & Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-Informed Psychosocial Competence (TIPC) Program in people with Nonsuicidal Self-Injury, run by Han Wu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Past-Month Nonsuicidal Self-Injury Behavior Frequency Score (time frame: Baseline and Week 8/ Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.