The Development of Psychiatric Non-Suicidal Self-Injury Risk Assessment Scale (PNSSI-RAS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Delphi Expert Consultation
研究概览
简要总结
Non-suicidal self-injury (NSSI) is a growing global mental health challenge, distinct from suicidal behavior, with unique risk factors and mechanisms. Existing risk assessment tools do not focus on differentiating NSSI from suicidal self-harm or comprehensively evaluate risk and protective factors specific to NSSI. There is a lack of clinically applicable, validated scales dedicated to assessing NSSI risk, particularly in psychiatric populations. The present study is made to design the Psychiatric Non-Suicidal Self-Injury Risk Assessment Scale, a 39-item scale that evaluates static/dynamic risk factors and protective factors for NSSI in psychiatric patients.
详细描述
The initial item pool was created through literature review, semi-structured interviews, and group discussions. Two rounds of the Delphi were employed with twenty experts. We analyzed items using critical ratio, correlation coefficient, factor analysis, and Cronbach's α coefficient. Exploratory factor analysis determined item weights, while reliability analyses evaluated internal consistency, test-retest, inter-observer and split-half methods. In the validity analyses, CVI, construct validity and criterion validity were used. ROC curve established the optimal diagnostic threshold and the risk stratification was performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria for inclusion in the sample were individuals , diagnosed with various mental disorders according to the International Classification of Diseases, 10th Revision (ICD-10) diagnostic criteria;
- •Gender is not limited and aged is 12-30 years old;
- •The patient's clinical profile is complete and the medical history is detailed;
- •Informed consent from patients or guardians who signed a consent for.
排除标准
- •The patient's clinical profile was incomplete and her medical history was not detailed.
结局指标
主要结局
Delphi Expert Consultation
时间窗: Up to 8 weeks
Two rounds of Delphi consultation were conducted with twenty experts who had a bachelor's degree or higher, senior titles, and more than ten years of experience in clinical psychiatry, nursing, or education. The experts rated the importance of each issue on a Likert scale (1: strongly disagree to 5: strongly agree) and made appropriate change suggestions. 1. The authority coefficient (Cr) describes the expert's authority, and a value greater than 0.7 is deemed reliable. The formula is Cr=(Ca + Cs)/2; 2. Kendall's coefficient of co-ordination (Kendall's W) and a chi-square test were used to assess expert opinion coordination, with statistical significance at p \< 0.05; 3. Item screening criteria include a mean item importance assignment of ≥ 3.50 and CV of ≤ 0.25. Expert opinions are combined to determine the scale's items; 4. The questionnaire's recovery rate serves as a gauge for the experts' motivation.
Reliability
时间窗: Through study completion, an average of 1 year
The reliability was assessed using Cronbach α, test-retest reliability, inter-observer reliability, and split-half reliability methods. (1)Internal consistency: The higher the Cronbach α coefficient, the greater the reliability of the scale internal consistency.Cronbach α ≥ 0.9 indicates very good reliability, while 0.8 ≤ Cronbach α\< 0.9 indicates high reliability. Cronbach α above 0.6 indicates adequate reliability; (2) Test-retest reliability: The closer the retest correlation coefficient tends to 1, the higher the retest reliability; (3)Inter-observer reliability: Inter-rater reliability approaches 1, signifying greater reliability of the scale. Inter-rater reliability should be at least \> 0.6, and \> 0.75 indicates that the scale possesses relatively high reliability. (4)Split-half reliability: Split-half reliability coefficients greater than 0.70 for the scale as a whole and for each dimension are widely regarded as good.
Validity
时间窗: Through study completion, an average of 1 year
1. CVI: The I-CVI was the number of experts who rated 4-5 divided by the total number of experts; the S-CVI was separated into two parts: S-CVI/Ave and S-CVI/Ua; I-CVI \> 0.78 and S-CVI ≥ 0.9 indicate strong content validity； 2. Construct validity: The maximum variance approach was used in exploratory factor analysis to extract KMO values, Bartlett's test of sphericity values, component matrix (factor loading values), initial eigenvalues, percentage of variance for each component, and cumulative variance contribution ratio; 3. Criterion validity: The Barrett Impulsivity Scale (BIS-11) was used as a validity scale to assess the validity of the scale's correlational validity. The higher the correlation coefficient, the better the validity.
Diagnostic Thresholds
时间窗: Up to 2 weeks.
The Receiver Operator Characteristic (ROC) was used to characterize the subject and the maximum value of the Youden Index (YI) was used as a threshold to find the optimal diagnostic threshold.
Risk Stratification
时间窗: Up to 2 weeks.
Based on the optimal diagnostic threshold, true-positive patients were screened and the degree of risk of non-suicidal self-harm in patients with mental disorders was graded using the interquartile method, defining P0-P25 as grade I, P25-P75 as grade II, and P75-P100 as grade III.
次要结局
- The Barratt Impulsiveness Scale (BIS-11)(Through study completion, an average of 1 year)
研究者
Tang Hao
Master of Nursing Specialist
Shantou University Medical College