- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06885749
Clinical and Psychosocial Characteristics of Adolescent Patients With Non-Suicidal Self-Injury
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Shaanxi
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Xi'an, Shaanxi, China
- Department of Psychiatry, Xijing Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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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
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Healthy Control Group
Healthy adolescents
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20232397-F-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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