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

NCT ID: NCT03085108

Last Updated: 2025-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-31

Study Completion Date

2017-11-14

Brief Summary

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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.

Detailed Description

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Conditions

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Suicidality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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

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.

No Intervention

Intervention Type OTHER

No Intervention

SIBAT

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

No Intervention

Intervention Type OTHER

No Intervention

Interventions

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No Intervention

No Intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Scientific Affairs, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Scientific Affairs, LLC

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

CNS Network

Garden Grove, California, United States

Site Status

Rutgers University

Piscataway, New Jersey, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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54135419SUI0001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108248

Identifier Type: -

Identifier Source: org_study_id

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