Non-suicidal Self-injury (NSSI)NCT06885749
Clinical and Psychosocial Characteristics of Adolescent Patients With Non-Suicidal Self-Injury
An observational study of Non-suicidal Self-injury (NSSI) and Adolescent, run by Xijing Hospital at 1 site in China.
Trial summary
The overall objective of this study is to explore the social and clinical psychological characteristics of adolescents with depression accompanied or not accompanied by non-suicidal self-harm. This is an observational study. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-suicidal Self-injury (NSSI), Adolescent, Depression
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Outpatients or inpatients at Xijing Hospital, the First Affiliated Hospital of the Air Force Medical University, Xi'an, China.
Who may be able to join
- meet the ICD-11 criteria for emotional and behavioral disorders typically originating in childhood and adolescence; aged 12-18 years; exhibiting non-suicidal self-injury behaviors; having obtained informed consent from the patients or their guardians, with signed informed consent forms.
Who cannot join
- currently having severe physical illnesses that researchers deem unsuitable for participation in this study; meeting ICD-11 Axis I diagnostic criteria for other mental disorders; and other conditions judged by researchers as unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The overall objective of this study is to explore the social and clinical psychological characteristics of adolescents with depression accompanied or not accompanied by non-suicidal self-harm.
This is an observational study. A total of 90 cases were included, with 30 cases in each of the case study group, case control group and healthy control group.
Read the detailed description
This project aims to explore the socio-psychological characteristics of children and adolescents with emotional disorders, with or without non-suicidal self-injury (NSSI). The study is designed as an observational research, enrolling a total of 90 cases divided into three groups: the case study group, the case control group, and the healthy control group, with 30 cases in each group.
The inclusion criteria for the case study group are: outpatients or inpatients who meet the ICD-10 criteria for emotional and behavioral disorders typically originating in childhood and adolescence; aged 12-18 years; exhibiting non-suicidal self-injury behaviors; and having obtained informed consent from the patients or their guardians, with signed informed consent forms. The inclusion criteria for the case control group are similar to those of the case study group, but require no history of non-suicidal self-injury. The inclusion criteria for the healthy group are: not meeting any ICD-10 diagnostic criteria for mental disorders; aged 12-18 years; no history of non-suicidal self-injury; and informed consent obtained from both the participants and their guardians.
Exclusion criteria include: currently having severe physical illnesses that researchers deem unsuitable for participation in this study; meeting ICD-10 Axis I diagnostic criteria for other mental disorders; having a history of suicidal behavior; and other conditions judged by researchers as unsuitable for participation in the study.
Outcome assessment is conducted through observational clinical research. After enrollment, participants undergo multiple questionnaire assessments, including the Hamilton Depression Scale, Hamilton Anxiety Scale, Adolescent Non-Suicidal Self-Injury and Function Scale (ANSAQ), Prosocial Tendency Measure for Adolescents (PTM), Center for Epidemiological Studies Depression Scale for Children (CES-DC), Self-Rating Anxiety Scale (SAS), Self-Rating Scale of Systemic Family Dynamics (SSFD), Chinese Big Five Personality Inventory Brief Version (CBF-PI-15), Perceived Social Support Scale (PSSS), Hong Kong Psychological Resilience Scale for Adolescents (HKRA), and Self-Compassion Scale (SCS). The primary outcome measure is the difference in scores on the Prosocial Tendency Measure for Adolescents among the case study group, case control group, and healthy control group. Secondary outcome measures include differences in scores on the aforementioned other questionnaires among the three groups.
Statistical analysis is performed using SPSS 23.0 statistical software. All statistical tests are two-sided, with a P-value of less than or equal to 0.05 considered statistically significant.
- Conditions
- Non-suicidal Self-injury (NSSI), Adolescent, Depression
- Keywords
- Non-Suicidal Self-Injury, Adolescent, Depression, Psychosocial Characteristics
- Medical subject headings
- Self-Injurious Behavior, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case Study Group | Outpatients or inpatients who meet the ICD-11 criteria for emotional and behavioral disorders typically originating in childhood and adolescence; aged 12-18 years; exhibiting non-suicidal self-injury behaviors | |
| Case Control Group | Outpatients or inpatients who meet the ICD-11 criteria for emotional and behavioral disorders typically originating in childhood and adolescence; aged 12-18 years; no non-suicidal self-injury behaviors | |
| Healthy Control Group | Healthy adolescents |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the differences in score on the Prosocial Tendency Measure for Adolescents among the case study group, case control group, and healthy control group.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Apr 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-suicidal Self-injury (NSSI)Studies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885749
- Sponsor's protocol ID
- KY20232397-F-1
- Status last verified
- May 2024
- First submitted
- 14 Mar 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Psychosocial Characteristics of Adolescent Patients With Non-Suicidal Self-Injury
- ClinicalTrials.gov ID
- NCT06885749
- Acronym / sponsor ID
- KY20232397-F-1
- Conditions
- Non-suicidal Self-injury (NSSI), Adolescent, Depression
- Keywords
- Non-Suicidal Self-Injury, Adolescent, Depression, Psychosocial Characteristics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Mar 2025 (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 overall objective of this study is to explore the social and clinical psychological characteristics of adolescents with depression accompanied or not accompanied by non-suicidal self-harm.
This is an observational study. A total of 90 cases were included, with 30 cases in each of the case study group, case control group and healthy control group.
Detailed description
This project aims to explore the socio-psychological characteristics of children and adolescents with emotional disorders, with or without non-suicidal self-injury (NSSI). The study is designed as an observational research, enrolling a total of 90 cases divided into three groups: the case study group, the case control group, and the healthy control group, with 30 cases in each group.
The inclusion criteria for the case study group are: outpatients or inpatients who meet the ICD-10 criteria for emotional and behavioral disorders typically originating in childhood and adolescence; aged 12-18 years; exhibiting non-suicidal self-injury behaviors; and having obtained informed consent from the patients or their guardians, with signed informed consent forms. The inclusion criteria for the case control group are similar to those of the case study group, but require no history of non-suicidal self-injury. The inclusion criteria for the healthy group are: not meeting any ICD-10 diagnostic criteria for mental disorders; aged 12-18 years; no history of non-suicidal self-injury; and informed consent obtained from both the participants and their guardians.
Exclusion criteria include: currently having severe physical illnesses that researchers deem unsuitable for participation in this study; meeting ICD-10 Axis I diagnostic criteria for other mental disorders; having a history of suicidal behavior; and other conditions judged by researchers as unsuitable for participation in the study.
Outcome assessment is conducted through observational clinical research. After enrollment, participants undergo multiple questionnaire assessments, including the Hamilton Depression Scale, Hamilton Anxiety Scale, Adolescent Non-Suicidal Self-Injury and Function Scale (ANSAQ), Prosocial Tendency Measure for Adolescents (PTM), Center for Epidemiological Studies Depression Scale for Children (CES-DC), Self-Rating Anxiety Scale (SAS), Self-Rating Scale of Systemic Family Dynamics (SSFD), Chinese Big Five Personality Inventory Brief Version (CBF-PI-15), Perceived Social Support Scale (PSSS), Hong Kong Psychological Resilience Scale for Adolescents (HKRA), and Self-Compassion Scale (SCS). The primary outcome measure is the difference in scores on the Prosocial Tendency Measure for Adolescents among the case study group, case control group, and healthy control group. Secondary outcome measures include differences in scores on the aforementioned other questionnaires among the three groups.
Statistical analysis is performed using SPSS 23.0 statistical software. All statistical tests are two-sided, with a P-value of less than or equal to 0.05 considered statistically significant.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case Study Group | – | –Outpatients or inpatients who meet the ICD-11 criteria for emotional and behavioral disorders typically originating in childhood and adolescence; aged 12-18 years; exhibiting non-suicidal self-injury behaviors |
| Case Control Group | – | –Outpatients or inpatients who meet the ICD-11 criteria for emotional and behavioral disorders typically originating in childhood and adolescence; aged 12-18 years; no non-suicidal self-injury behaviors |
| Healthy Control Group | – | –Healthy adolescents |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Outpatients or inpatients at Xijing Hospital, the First Affiliated Hospital of the Air Force Medical University, Xi'an, China.
Key inclusion criteria (1 listed)
- meet the ICD-11 criteria for emotional and behavioral disorders typically originating in childhood and adolescence; aged 12-18 years; exhibiting non-suicidal self-injury behaviors; having obtained informed consent from the patients or their guardians, with signed informed consent forms.
Key exclusion criteria (1 listed)
- currently having severe physical illnesses that researchers deem unsuitable for participation in this study; meeting ICD-11 Axis I diagnostic criteria for other mental disorders; and other conditions judged by researchers as unsuitable for participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome measure is the differences in score on the Prosocial Tendency Measure for Adolescents among the case study group, case control group, and healthy control group.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-suicidal Self-injury (NSSI) and Adolescent, run by Xijing Hospital at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
The primary outcome measure is the differences in score on the Prosocial Tendency Measure for Adolescents among the case study group, case control group, and healthy control group. (time frame: Baseline). 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 24 Apr 2025.