A Study to Assess the Validation and Mapping of the Suicide Ideation and Behavior Assessment

Janssen Scientific Affairs, LLC130 enrolled

Overview

The main purpose of this cross-sectional study is to generate data to support the psychometric properties of the Suicide Ideation and Behavior Assessment Tool (SIBAT) and validate its use in participants at imminent risk of suicide.

Study Type

OBSERVATIONAL

Enrollment

130

Conditions

Suicidality

Interventions

No InterventionOTHER

No Intervention

Eligibility

Sex: ALLMin age: 12 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant must be able to speak, read, and write English sufficiently well to complete consent process and self-administer study questionnaires * Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of the interviews and, when applicable, the videotaping required for the study and are willing to participate in the study. Adolescents (minors) who in the judgment of the investigator are capable of understanding the nature of the study can be enrolled only after obtaining consent of a legally acceptable representative. Assent must be obtained from any participating adolescents (minors) * Each participant or legally acceptable representative must check a separate box on the consent form if he or she agrees to have interviews video-recorded. Participants who do not consent to video recording will only be administered the SIBAT Exclusion Criteria: \- Participant has any clinically relevant physical or mental conditions including, but not limited to vision problems, physical disability, severe mental illness, or cognitive impairment (such as from acute intoxication or dementia) which, in the opinion of the investigator, would interfere with ability to complete the study interviews

Locations (4)

University of Alabama at Birmingham

Birmingham, Alabama, United States

CNS Network

Garden Grove, California, United States

Rutgers University

Piscataway, New Jersey, United States

University of Cincinnati

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Clinical Global Impression of Severity of Suicidality (Revised) (CGI-SS-R)

The Clinical Global Impression - Severity of Suicidality - Revised (CGI-SS-R) was derived from the Clinical Global Impression Severity Scale (CGI-S), a global rating scale that gives an overall measure of the severity of a participants illness. The CGI-SS-R rating is scored on a 7-point scale from 0 (normal, not at all suicidal) to 6 (among the most extremely suicidal participants).

Time frame: Day 1

Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I)

CGI-SR-I describes aspects of participant's suicidal thinking, behavior and related contributory/protective factors, what is best clinical judgment of participant's imminent risk for suicide within the next 7 days. Scale indicates: 0 (No imminent suicide risk), 1 (Minimal imminent), 2 (Mild imminent), 3 (Moderate imminent), 4 (Marked imminent), 5 (Severely imminent), 6 (Extreme imminent).

Time frame: Day 1

Clinical Global Impression of Long Term Suicide Risk (CGI-SR-LT)

CGI-SR-I describes aspects of participant's suicidal thinking, behavior and related contributory/protective factors, what is best clinical judgment of participant's imminent risk for suicide (that is, they will likely end their life by suicide sometime in the future). Scale indicates : 0 (No suicide risk in the long term), 1 (Minimal suicide risk), 2 (Mild suicide risk), 3 (Moderate suicide risk), 4 (Marked suicide risk), 5 (Serious suicide risk), 6 (Extreme risk).

Time frame: Day 1

Frequency of Suicidal Thinking (FoST)

Frequency of Suicidal Thinking describes the clinician determined estimate of the frequency of the participant's suicidal thinking (The FoST rating is scored on a 6-point Likert scale : 0 (Never), 1 (Rarely), 2 (Sometimes), 3 (Often), 4 (Most of the time), 5 (All of the time).

Time frame: Day 1

Columbia-Suicide Severity Rating Scale [C-SSRS])

C-SSRS is a clinician rated assessment of suicidal behavior and / or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses are listed. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.

Data from ClinicalTrials.gov

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Secondary Outcomes

Suicide Ideation and Behavior Assessment-My Risk/Protective Factors

Patient-reported dynamic suicide risk and protective characteristics (My Risk/Protective Factors) will be assessed based on Suicide Ideation and Behavior Assessment Tool (SIBAT) with up to 31 items that best describes how participant have acted or felt in the past 7 days in terms of responses (Never, Rarely, Sometimes, Often, Most of the time, All the time). This best describes how participants are thinking or feeling right now in terms of Strongly Disagree, Disagree, Slightly Disagree, Slightly agree, Agree, Strongly Agree.

Time frame: Day 1

Suicide Ideation and Behavior Assessment: My Current Thinking

Patient-reported current suicide ideation (My current thinking) will be assessed based on SIBAT with 48 items. The best describes how participants are thinking or feeling right now in terms of Strongly Disagree, Disagree, Slightly Disagree, Slightly agree, Agree, Strongly Agree.

Time frame: Day 1