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
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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COMPLETED
130 participants
OBSERVATIONAL
2017-03-31
2017-11-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
No Intervention
SIBAT
Participants who are not videotaped for the 3 interviews will only be assessed by SIBAT.
No Intervention
No Intervention
Interventions
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No Intervention
No Intervention
Eligibility Criteria
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Inclusion Criteria
* 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
12 Years
85 Years
ALL
No
Sponsors
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Janssen Scientific Affairs, LLC
INDUSTRY
Responsible Party
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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
CNS Network
Garden Grove, California, United States
Rutgers University
Piscataway, New Jersey, United States
University of Cincinnati
Cincinnati, Ohio, United States
Countries
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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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