Latin American Testing of the Inventory for Risk in Suicidal Crisis Syndrome (LATIR-SCS)

Официальное название

Suicidal Crisis Syndrome and the Suicide Crisis Inventory-Revised (SCS-2): Psychometric Properties of the Spanish Version

Обзор

The goal of this observational validation study is to assess the psychometric properties of the Spanish versions of the Suicide Crisis Inventory-Revised (SCS-2) and the Suicidal Crisis Syndrome Checklist (SCS-C) in adults recently hospitalized for suicidal behavior in Chile. The study aims to determine whether the Spanish versions of the SCS-2 and SCS-C demonstrate adequate internal consistency, construct validity, interrater reliability, and test-retest stability, and whether these tools validly assess imminent suicide risk in a Spanish-speaking psychiatric population. Clinical assessments using the SCS-2 and SCS-C will be compared with established diagnostic and functional measures, including the Mini International Neuropsychiatric Interview (MINI), the Sheehan Disability Scale (SDS), and the Sheehan Suicidality Tracking Scale (S-STS), to evaluate convergent and discriminant validity. Participants will complete the SCS-2 and SCS-C at both admission and discharge from a psychiatric intensive care unit, undergo structured interviews and functional assessments, be evaluated by two independent raters for interrater reliability, and be reassessed within a short time interval to measure test-retest reliability. Follow-up contacts at 7 and 30 days post-discharge will be used to assess suicidal behavior outcomes. This is the first study to culturally adapt and validate these suicide-specific instruments in Latin America.

Подробное описание

This is a three-phase, observational psychometric validation study of the Spanish versions of the Suicide Crisis Inventory-Revised (SCS-2) and the Suicidal Crisis Syndrome Checklist (SCS-C), administered to adult psychiatric inpatients hospitalized for recent suicidal behavior at the Complejo Asistencial Dr. Sótero del Río (CASR), Chile. The study follows established guidelines for the translation, cultural adaptation, and validation of health-related instruments. Phase one involves linguistic validation through forward-backward translation by bilingual experts. Phase two consists of a pilot test of the pre-final versions with 10 patients to assess item clarity and cultural relevance. Phase three uses a prospective cohort design with 60 participants to evaluate psychometric properties. Assessments are conducted at admission and discharge and include the SCS-2 and SCS-C (Spanish versions), the Mini International Neuropsychiatric Interview (MINI), the Sheehan Disability Scale (SDS), and the Sheehan Suicidality Tracking Scale (S-STS). A subset of participants will complete the SCS-2 twice within a short time interval to assess test-retest reliability and will be evaluated by two independent raters for interrater reliability. Follow-up at 7 and 30 days post-discharge includes phone interviews and chart reviews to assess suicidal behavior outcomes. A sample size of 60 was selected based on prior studies to ensure sufficient power to evaluate internal consistency (Cronbach's α ≥ 0.80), factor structure, and interrater reliability (Cohen's κ ≥ 0.60). Statistical analyses will include Cronbach's alpha and item-total correlations for internal consistency, exploratory and confirmatory factor analysis (EFA/CFA) for construct validity, Pearson or Spearman correlations with SDS and S-STS for convergent validity, point-biserial correlations with MINI diagnoses for discriminant validity, ICC and Cohen's kappa for interrater reliability, ICC for test-retest reliability, and ROC curve analysis for predictive validity. Data will be collected electronically via Qualtrics, which includes built-in logic checks and skip patterns. Source data verification will be performed through cross-checks with clinical records and dual entry of outcome events. A detailed data dictionary outlines all variables, coding schemes, and response formats. Procedures are standardized through SOPs covering recruitment, consent, data collection, follow-up, and confidentiality. Missing data will be addressed through multiple imputation and sensitivity analyses. Data monitoring is performed internally, and adverse events or protocol deviations are reported to the Institutional Ethics Committee. This is the first study to validate the SCS-2 and SCS-C in a Spanish-speaking Latin American population and is expected to contribute to scalable, evidence-based suicide risk assessments in acute psychiatric settings.

Вмешательства

• Диагностический тест Suicidal Crisis Syndrome Checklist (SCS-C)
  The Suicidal Crisis Syndrome Checklist (SCS-C) is a clinician-rated tool designed to diagnose Suicidal Crisis Syndrome (SCS), a suicide-specific state associated with imminent risk. It includes Criterion A (entrapment)-a required symptom-and Criterion B, which requires at least one symptom from each of four domains: affective disturbance, loss of cognitive control, hyperarousal, and social withdrawal. The checklist offers a structured assessment for identifying acute suicide risk, complementing
• Диагностический тест Suicide Crisis Inventory-Revised (SCS-2)
  The Suicide Crisis Inventory-Revised (SCS-2) is a 61-item self-report scale developed to assess the severity of Suicidal Crisis Syndrome (SCS), a clinical state associated with imminent suicide risk. Items are rated on a Likert scale and grouped into five empirically derived factors: entrapment, affective disturbance, loss of cognitive control, hyperarousal, and social withdrawal. The SCS-2 has shown strong internal consistency and predictive validity for suicidal behavior within weeks of discha

Первичные конечные точки

• Suicidal Event Within 30 Days Post-Discharge [Срок оценки: 30 days post-discharge]

Вторичные конечные точки (11)

• Suicidal Event Within 7 Days Post-Discharge [Срок оценки: 7 days post-discharge]
• Convergent Validity with the Sheehan Suicidality Tracking Scale (S-STS) [Срок оценки: Baseline]
• Convergent Validity with the Sheehan Disability Scale (SDS) [Срок оценки: Baseline]
• Discriminant Validity with Psychiatric Diagnoses on the MINI [Срок оценки: Baseline]
• Test-Retest Reliability of the SCS-2 [Срок оценки: Up to 48 hours from baseline]
• Interrater Reliability of the SCS-C (Spanish version) [Срок оценки: Up to 48 hours from baseline]
• Internal Consistency of the SCS-2 (Spanish Version) [Срок оценки: Baseline]
• Internal Consistency of the SCS-C (Spanish Version) [Срок оценки: Baseline]
• Construct Validity of the SCS-2 (Spanish Version) [Срок оценки: Baseline]
• Construct Validity of the SCS-C (Spanish Version) [Срок оценки: Baseline]
• Concurrent Validity of the SCS-2 and SCS-C (Spanish Versions) [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Currently hospitalized in the Psychiatric Intensive Care Unit (UHCIP) at Complejo Asistencial Dr. Sótero del Río (CASR)
• Hospitalization due to a recent suicidal event, defined as at least one of the following:

• Deliberate self-inflicted violence with actual or potential injury and explicit or implicit suicidal intent
• Preparatory behaviors for suicide
• Aborted suicide attempts
• Interrupted suicide attempts
• Suicidal ideation leading to emergency consultation or referral
• Able to provide informed consent
• Judged competent to participate by the treating psychiatrist
• Fluent in Spanish

Критерии исключения

• Presence of severe psychotic symptoms
• Qualitative or quantitative disturbance of consciousness (e.g., delirium, coma)
• Severe psychomotor agitation requiring mechanical restraint
• Inability to understand or complete study procedures (e.g., due to cognitive impairment or language barriers)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Чили · 1 центр

• Complejo Asistencial Sotero del Rio — Santiago

Идентификаторы

NCT: NCT07103850 · 071124

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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