Clinical trial NCT03085108: A Study to Assess the Validation and Mapping of the Suicide Ideation and Behavior Assessment
Official title: Validation and Mapping of the Suicide Ideation and Behavior Assessment Tool in Subjects at Various Levels of Risk for Suicide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicidality
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2017-03-21
Enrollment: 130
Sex: ALL
Minimum age (years): 12
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants in this study will be selected from emergency room, acute inpatient psychiatric hospital unit, or psychiatry clinical research office settings. Participants who agree to be interviewed regarding their symptoms of suicidality will be screened and selected if they meet selection criteria for this study. Participants with various levels of suicidality will be included based on the severity of their suicidality assessed globally (without extensive interview).

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical Global Impression of Severity of Suicidality (Revised) (CGI-SS-R)
timeFrame: Day 1
measure: Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I)
timeFrame: Day 1
measure: Clinical Global Impression of Long Term Suicide Risk (CGI-SR-LT)
timeFrame: Day 1
measure: Frequency of Suicidal Thinking (FoST)
timeFrame: Day 1
measure: Columbia-Suicide Severity Rating Scale [C-SSRS])
timeFrame: Day 1
measure: Sheehan-Suicidality Tracking Scale Clinically Meaningful Change Measure [S-STS CMCM]
timeFrame: Day 1
Secondary outcomes:
measure: Suicide Ideation and Behavior Assessment-My Risk/Protective Factors
timeFrame: Day 1
measure: Suicide Ideation and Behavior Assessment: My Current Thinking
timeFrame: Day 1
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Garden Grove
country: United States
facility: CNS Network
state: California
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References: