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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Suicidality

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT03085108

54135419SUI0001 (Other Identifier)

CR108248

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 12 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

130 participants in 2 patient groups

SIBAT, the S-STS CMCM, and the C-SSRS + CGI-SS-R

Description:

Participants randomized to Cohort A will be consented for video-recorded interviews on 3 distinct suicide assessment instruments (the Suicide Ideation and Behavior Assessment Tool \[SIBAT\], the Sheehan-Suicidality Tracking Scale Clinically Meaningful Change Measure \[S-STS CMCM\] and the Columbia-Suicide Severity Rating Scale \[C-SSRS\] + Clinical Global Impression of Severity of Suicidality (Revised) \[CGI SS-R\]). These participants will be interviewed 3 times within the single study visit by 3 different trained clinical raters, using semi-structured interviews that have been developed for each of the 3 suicide assessment instruments.

Treatment:

Other: No Intervention

SIBAT

Description:

Participants who are not videotaped for the 3 interviews will only be assessed by SIBAT.

Treatment:

Other: No Intervention