NCT07103850

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

August 12, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

July 21, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

Suicidal Crisis Syndrome

Outcome Measures

Primary Outcomes (1)

  • Suicidal Event Within 30 Days Post-Discharge

    Description: Occurrence of a suicidal event within 30 days after discharge, defined as any of the following: 1. Deliberate self-inflicted violence resulting in actual or potential injury, with explicit or implicit evidence of suicidal intent; 2. Preparatory behaviors for suicide; 3. Aborted suicide attempts; 4. Interrupted suicide attempts; or 5. Suicidal ideation leading to emergency consultation or referral. Assessment Method: Patient phone follow-up and review of clinical records Measure Type: Clinical outcome (binary: presence/absence of suicidal event)

    30 days post-discharge

Secondary Outcomes (11)

  • Suicidal Event Within 7 Days Post-Discharge

    7 days post-discharge

  • Convergent Validity with the Sheehan Suicidality Tracking Scale (S-STS)

    Baseline

  • Convergent Validity with the Sheehan Disability Scale (SDS)

    Baseline

  • Discriminant Validity with Psychiatric Diagnoses on the MINI

    Baseline

  • Test-Retest Reliability of the SCS-2

    Up to 48 hours from baseline

  • +6 more secondary outcomes

Study Arms (2)

SCS+ Cohort

Definition: Patients who meet the diagnostic criteria for Suicidal Crisis Syndrome using the clinician-administered SCS-C.

Diagnostic Test: Suicidal Crisis Syndrome Checklist (SCS-C)Diagnostic Test: Suicide Crisis Inventory-Revised (SCS-2)

SCS- Cohort

Definition: Patients hospitalized for suicidal behavior who do not meet diagnostic criteria for SCS on the SCS-C.

Diagnostic Test: Suicidal Crisis Syndrome Checklist (SCS-C)Diagnostic Test: Suicide Crisis Inventory-Revised (SCS-2)

Interventions

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 traditional risk evaluations.

SCS+ CohortSCS- Cohort

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 discharge. It is currently undergoing cultural adaptation and psychometric validation in Spanish for use in high-risk psychiatric populations in Chile.

SCS+ CohortSCS- Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult psychiatric inpatients (≥18 years old) hospitalized in the Psychiatric Intensive Care Unit (UHCIP) of the Complejo Asistencial Dr. Sótero del Río (CASR), Santiago, Chile. All participants are admitted due to a recent suicidal event, including suicide attempts, preparatory behaviors, interrupted or aborted attempts, or suicidal ideation requiring emergency care. The sample includes individuals with diverse psychiatric diagnoses and varying levels of acute suicide risk. Participants must be clinically stable, capable of providing informed consent, and fluent in Spanish. The population is representative of high-risk individuals typically seen in public psychiatric emergency settings in Latin America.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Asistencial Sotero del Rio

Santiago, Santiago Metropolitan, Chile

RECRUITING

Central Study Contacts

Francisco Villalón, M.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 21, 2025

First Posted

August 5, 2025

Study Start

August 12, 2025

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations