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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06299384
Other study ID # R44MH133517
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date August 2026

Study information

Verified date February 2024
Source Lyssn.io, Inc.
Contact Layal Bou Harfouch, MBiotech
Phone 2482528856
Email layal@lyssn.io
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Effective training requires repeated opportunities for skills practice with performance-based feedback, which is challenging to provide at scale. This research study focuses on developing an AI-based, coding and feedback tool ("LyssnCrisis") for implementation in a nationally utilized crisis call center, training counselors (call-takers) in suicide risk assessment skills, and evaluating LyssnCrisis to improve services and client outcomes. Our goal is to maximize the human capacity of call-takers to help assess their callers for risk of suicidality, and thus, a core aspect of the current research is developing a novel training process that supports human call-taker capacities.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date August 2026
Est. primary completion date June 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Must be employed at Protocall Services, Inc. Exclusion Criteria: Call-takers who participated in Stage 2 research will not be able to participate in Stage 3 research.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
LyssnCrisis
LyssnCrisis is an AI-based coding and feedback tool for implementation in crisis counseling settings, training counselors (call-takers) in suicide risk assessment skills.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Lyssn.io, Inc. ProtoCall Services, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Post-Call Survey 9 item survey utilizing LifeLine crisis call questions that measures changes in distress, perceived helpfulness, and call-taker relationship at the conclusion of a crisis call. The survey is completed by callers to ProtoCall's 988 crisis line, facilitated by the call-taker. . Through study completion, an average of 22 weeks.
Primary Call-taker crisis counseling fidelity Crisis counseling fidelity will be assessed by AI-generated scores for every recorded call, which will be analyzed via Lyssn during both SAU and LyssnCrisis phases of the study. Key fidelity metrics will include empathy, use of active listening skills, and whether the counselor asked any of the 7 key risk assessment questions (e.g., ideation, plan, past attempts). Through study completion, an average of 22 weeks.
Primary System Usability Scale (SUS) 10 item survey that is a general measure of technology usability [ Rated from 1-5, 1= strongly disagree, 5 = strongly agree] Through study completion, an average of 22 weeks.
Primary Acceptability of Intervention Measure; AIM The Acceptability of Intervention (AIM) to measure target core implementation outcomes and assess if crisis tool is acceptable, appropriate, or feasible for its stated goals. A brief, 4-item measure of a mental health professional's perception of how acceptable an innovation would be for use in their context. Each statement about the acceptability of the innovation is rated on a 5-point ordinal scale ranging from "completely disagree" to "completely agree," where higher scores indicate higher levels of acceptability. For Pilot: at end of 2 week LyssnCrisis period; for RCT, at end of 12-week LyssnCrisis period.
Primary Intervention Appropriateness Measure; IAM The Intervention Appropriateness (IAM) to measure target core implementation outcomes and assess if crisis tool is acceptable, appropriate, or feasible for its stated goals. A brief, 4-item measure of a mental health professional's perception of how appropriate an innovation would be for use in their context. Each statement about the appropriateness of the innovation is rated on a 5-point ordinal scale ranging from "completely disagree" to "completely agree," where higher scores indicate higher levels of appropriateness. Through study completion, an average of 22 weeks.For Pilot: at end of 2 week LyssnCrisis period; for RCT, at end of 12-week LyssnCrisis period.
Primary Feasibility of Intervention Measure; FIM The Feasibility of Intervention (FIM) to measure target core implementation outcomes and assess if crisis tool is acceptable, appropriate, or feasible for its stated goals. A brief, 4-item measure of a mental health professional's perception of how feasible an innovation would be for use in their context. Each statement about the feasibility of the innovation is rated on a 5-point ordinal scale ranging from "completely disagree" to "completely agree," where higher scores indicate higher levels of feasibility. For Pilot: at end of 2 week LyssnCrisis period; for RCT, at end of 12-week LyssnCrisis period.
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