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

NCT06603389 | Completed

• 1 other identifier: 202305
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Suicidal Self Injury

Keywords

Non-Suicidal Self-Injury; Risk Assessment; Scale development; Delphi method; Reliability; Validity; Nursing

Outcome Measures

Primary Outcomes (5)

• 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. 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.

  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

  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.

  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 Outcomes (1)

• The Barratt Impulsiveness Scale (BIS-11)

  Through study completion, an average of 1 year

Study Arms (1)

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

Interventions

Psychiatric Non-Suicidal Self-Injury Risk Assessment Scale OTHER

sacles or questionnaires

Observation Group

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shantou University Medical College: lead

Study Sites (1)

Shantou University Mental Health Center

Shantou, Guangdong, 515000, China

Location

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jingfang Chen, Bachelor

  Shantou University Mental Health Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Nursing Specialist

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: November 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: May 28, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)