The Development of Psychiatric Non-Suicidal Self-Injury Risk Assessment Scale

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

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.

Study Overview

• Status: Completed
• Conditions: Non Suicidal Self Injury
• Intervention / Treatment: Other: Psychiatric Non-Suicidal Self-Injury Risk Assessment Scale

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.

• Study Type: Observational
• Enrollment (Actual): 330

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shantou, Guangdong, China, 515000
      • Shantou University Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study, conducted between March and October 2023 at Shantou University Mental Health Center, enrolled 330 patients.

Description

Inclusion Criteria:

1. 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;
2. Gender is not limited and aged is 12-30 years old;
3. The patient's clinical profile is complete and the medical history is detailed;
4. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observation Group; Scales are used to get primary indicator and secondary indicators. The sample size should be set at 5 to 10 times the number of items, with a minimum total sample of 200. Additionally, an extra sample should be calculated to account for a potential 10-20% attrition rate, mitigating the impact of possible data loss. Given that the initial version scale consisted of 55 items, the minimum required sample size is 330.

Other: Psychiatric Non-Suicidal Self-Injury Risk Assessment Scale; sacles or questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delphi Expert Consultation	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.; 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;; 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;; 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;; The questionnaire's recovery rate serves as a gauge for the experts' motivation.	Up to 8 weeks
Reliability	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.	Through study completion, an average of 1 year
Validity	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；; 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;; 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.	Through study completion, an average of 1 year
Diagnostic Thresholds	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.	Up to 2 weeks.
Risk Stratification	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.	Up to 2 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Barratt Impulsiveness Scale (BIS-11)	Criterion validity. The 30 items in the revised Chinese version of the Barratt Impulsivity Scale are divided into three categories: Motor Impulsivity, Cognitive Impulsiveness and Non-Planning Impulsiveness. Each item is scored on a Likert scale (not, rarely, sometimes, often, always), with the Planning and Cognitive subscales reverse scored and the Motor subscale positive. The total scores range from 30 to 150, with higher scores denoting higher levels of impulsivity and high scores on the three subscales representing hyperactivity, inattention, and lack of planning.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Shantou University Medical College
• Investigators: Study Director: Jingfang Chen, Bachelor, Shantou University Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): May 28, 2024

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Validity; Reliability; Nursing; Risk Assessment; Delphi method; Non-Suicidal Self-Injury; Scale development
• Additional Relevant MeSH Terms: Behavioral Symptoms; Wounds and Injuries; Self-Injurious Behavior
• Other Study ID Numbers: 202305

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No