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Clinical Trials/NCT06603389
NCT06603389
Completed
Not Applicable

The Development of Psychiatric Non-Suicidal Self-Injury Risk Assessment Scale (PNSSI-RAS)

Shantou University Medical College1 site in 1 country330 target enrollmentNovember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non Suicidal Self Injury
Sponsor
Shantou University Medical College
Enrollment
330
Locations
1
Primary Endpoint
Delphi Expert Consultation
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
May 28, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Shantou University Medical College
Responsible Party
Principal Investigator
Principal Investigator

Tang Hao

Master of Nursing Specialist

Shantou University Medical College

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • The patient's clinical profile was incomplete and her medical history was not detailed.

Outcomes

Primary Outcomes

Delphi Expert Consultation

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • The Barratt Impulsiveness Scale (BIS-11)(Through study completion, an average of 1 year)

Study Sites (1)

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