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临床试验/NCT06885749
NCT06885749Enrolling By Invitation不适用

Clinical and Psychosocial Characteristics of Adolescent Patients With Non-Suicidal Self-Injury

Xijing Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
90
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

结局指标

主要结局

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.

时间窗: Baseline

次要结局

未报告次要终点

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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