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CAMS-RAS: for Suicide Prevention

CAMS Relational Agent System for Suicide Prevention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03072875
Acronym
CAMS-RAS
Enrollment
26
Registered
2017-03-07
Start date
2015-12-18
Completion date
2017-12-17
Last updated
2018-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide

Keywords

Suicidality, Collaborative Assessment and Management of Suicidality, Technology, Suicide Prevention, Suicide Intervention

Brief summary

This Phase I feasibility study endeavors to create a prototype of a tool to determine its feasibility with suicidal patients in emergency departments (EDs). This is not a clinical trial. The overarching goal of this research is to create a tool that could reduce suicide rates, increase delivery of efficacious suicide interventions, and decrease overall costs associated with suicidal behaviors. SBIR Phase I project aims include: (1) creating an advisory board to guide the development of CAMS-RAS; (2) iteratively design and develop relational agent (Dr. Dave) modeled after the gestures, expressions, and mannerisms of CAMS treatment developer, David Jobes, PhD; and (3) conduct feasibility tests to determine whether CAMS-RAS is acceptable, easy to use, and liked by target end-users: acutely suicidal patients admitted to hospital EDs, psychiatric inpatient units, and medical floors for treatment of injuries sustained during a suicide attempt; hospital medical personnel, administrators, and other stakeholders including peer advocates; and outpatient suicidal patients, clinicians and administrators.

Interventions

DEVICECAMS-RAS

Sponsors

The Catholic University of America
CollaboratorOTHER
University of Florida
CollaboratorOTHER
Evidence-Based Practice Institute, Seattle, WA
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patient Inclusion Criteria: * English fluency * 18 years or older * receiving clinical care in a hospital or outpatient clinic for suicidality * Suicidal patients currently admitted to EDs, psychiatric inpatient units, and medical floors, or patient with past (last 6 months) suicidality receiving outpatient treatment Patient

Exclusion criteria

* Acutely psychotic * severely agitated (as determined by care team)

Design outcomes

Primary

MeasureTime frameDescription
Usability Satisfaction and Acceptability Questionnaire (USAQ)up to one dayA brief face-valid, self-report measure that the PI derived from the System Usability Scale and has been successfully used in previous studies. Items are rated on a 5-point Likert Scale (1=poor; 3=good; 5=excellent). Includes open-ended questions to better understand what was most and least helpful with respect to each category and also measures users' acceptance.
Number of ED Patient Participants Who Completed Semi-Structured InterviewAfter interacting with the technology (length: approximately 1 hour), subjects were then asked to complete the semi-structured interview conducted by the research assistant. On average, the interview lasted approximately 15 minutes.A semi-structured interview was conducted following use of the CAMS-RAS tool to assess users' likes, dislikes, and other preferences. Questions included: What were your experiences in using 'Dr. Dave' and the CAMS-RAS system? and What suggestions would you have for improvement? All subjects indicated that they found the tool helpful to them. They described the tool using adjectives similar to those used to describe Nurse Louise - a discharge nurse avatar on which the investigator's avatar was based: He's kind and asks me really practical, helpful questions; He speaks to me directly in a compassionate way; and He is kind and invested.

Countries

United States

Participant flow

Participants by arm

ArmCount
CAMS-RAS
In this single-arm study design, all enrolled patient and non-patient participants are asked to provide feedback on the CAMS-RAS prototype as it is developed for this study. Feedback will be gathered via survey measure and interview. CAMS-RAS
26
Total26

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up1

Baseline characteristics

CharacteristicCAMS-RAS
Age, Continuous39.38 Years
STANDARD_DEVIATION 12.76
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
Race (NIH/OMB)
White
18 Participants
Sex/Gender, Customized
Female
16 Participants
Sex/Gender, Customized
Male
6 Participants
Sex/Gender, Customized
Other
1 Participants
Sex/Gender, Customized
Unknown
3 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 26
other
Total, other adverse events
0 / 26
serious
Total, serious adverse events
0 / 26

Outcome results

Primary

Number of ED Patient Participants Who Completed Semi-Structured Interview

A semi-structured interview was conducted following use of the CAMS-RAS tool to assess users' likes, dislikes, and other preferences. Questions included: What were your experiences in using 'Dr. Dave' and the CAMS-RAS system? and What suggestions would you have for improvement? All subjects indicated that they found the tool helpful to them. They described the tool using adjectives similar to those used to describe Nurse Louise - a discharge nurse avatar on which the investigator's avatar was based: He's kind and asks me really practical, helpful questions; He speaks to me directly in a compassionate way; and He is kind and invested.

Time frame: After interacting with the technology (length: approximately 1 hour), subjects were then asked to complete the semi-structured interview conducted by the research assistant. On average, the interview lasted approximately 15 minutes.

Population: The qualitative information from the semi-structured interviews tells us subjects' general opinions and preferences concerning the avatar.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CAMS-RASNumber of ED Patient Participants Who Completed Semi-Structured Interview6 Participants
Primary

Usability Satisfaction and Acceptability Questionnaire (USAQ)

A brief face-valid, self-report measure that the PI derived from the System Usability Scale and has been successfully used in previous studies. Items are rated on a 5-point Likert Scale (1=poor; 3=good; 5=excellent). Includes open-ended questions to better understand what was most and least helpful with respect to each category and also measures users' acceptance.

Time frame: up to one day

Population: Suicidal ED Patients only

ArmMeasureValue (MEAN)Dispersion
CAMS-RASUsability Satisfaction and Acceptability Questionnaire (USAQ)4.5 units on a scaleStandard Deviation 0.41

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026