Clinical trial NCT06603389: The Development of Psychiatric Non-Suicidal Self-Injury Risk Assessment Scale
Official title: The Development of Psychiatric Non-Suicidal Self-Injury Risk Assessment Scale (PNSSI-RAS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Suicidal Self Injury
Keywords: Non-Suicidal Self-Injury
Risk Assessment
Scale development
Delphi method
Reliability
Validity
Nursing
Lead sponsor: Shantou University Medical College
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 330
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study, conducted between March and October 2023 at Shantou University Mental Health Center, enrolled 330 patients.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Delphi Expert Consultation
timeFrame: Up to 8 weeks
measure: Reliability
timeFrame: Through study completion, an average of 1 year
measure: Validity
timeFrame: Through study completion, an average of 1 year
measure: Diagnostic Thresholds
timeFrame: Up to 2 weeks.
measure: Risk Stratification
timeFrame: Up to 2 weeks.
Secondary outcomes:
measure: The Barratt Impulsiveness Scale (BIS-11)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Shantou
country: China
facility: Shantou University Mental Health Center
state: Guangdong
Study officials:
affiliation: Shantou University Mental Health Center
name: Jingfang Chen, Bachelor
role: STUDY_DIRECTOR
References: