NCT06299384

Brief 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. This research study's 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Apr 2024Aug 2026

First Submitted

Initial submission to the registry

February 14, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

April 2, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

2.2 years

First QC Date

February 14, 2024

Last Update Submit

November 8, 2024

Conditions

Keywords

Crisis Counseling988Artificial IntelligenceAI

Outcome Measures

Primary Outcomes (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (2)

Lyssn Crisis

EXPERIMENTAL

To compare LyssnCrisis to SAU, researchers will use a standard randomized design in which call-takers will have services-as-usual (SAU) and LyssnCrisis phases. All call-takers will start with a 4-week baseline period of SAU where LyssnCrisis is operating in the background, but does not provide AI feedback on suicide risk assessment. Lyssn team members will on-board and train the participating call-takers on the Lyssn software (i.e., reviewing calls, sharing and accessing calls for supervision), using a similar method used in the pilot field trial. After a 4-week baseline phase, call-takers will be randomly assigned to continue SAU or begin feedback with LyssnCrisis (LC) for 12 weeks. LC arm participants will have access to LyssnCrisis feedback tools for the duration of the 12 week period and will receive onboarding support for LyssnCrisis fidelity feedback tools.

Other: LyssnCrisis

Services As Usual

NO INTERVENTION

To compare LyssnCrisis to SAU, researchers will use a standard randomized design in which call-takers will have services-as-usual (SAU) and LyssnCrisis phases. All call-takers will start with a 4-week baseline period of SAU where LyssnCrisis is operating in the background, but does not provide AI feedback on suicide risk assessment. Lyssn team members will on-board and train the participating call-takers on the Lyssn software (i.e., reviewing calls, sharing and accessing calls for supervision), using a similar method used in the pilot field trial. After a 4-week baseline phase, call-takers will be randomly assigned to continue SAU or begin feedback with LyssnCrisis (LC) for 12 weeks. Participants in the SAU arm will continue services-as-usual for an additional 12-week period,where participants receive ProtoCall's regular supervision and feedback. Following this period (16 total weeks of SAU), SAU arm participants will receive LyssnCrisis for 12 weeks.

Interventions

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

Lyssn Crisis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be employed at Protocall Services, Inc.

You may not qualify if:

  • Call-takers who participated in Stage 2 research will not be able to participate in Stage 3 research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ProtoCall Services, Inc.

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

SuicideSelf-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • David C Atkins, PhD

    Lyssn.io, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roisin Slevin, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Executive Officer/ Research Professor

Study Record Dates

First Submitted

February 14, 2024

First Posted

March 7, 2024

Study Start

April 2, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

The data collected during the development and evaluation of LyssnCrisis will be critical in refining the technology and improving crisis counseling fidelity algorithms and software design. Thus, Lyssn considers this proprietary and does not plan to share this data outside of Lyssn.io and ProtoCall based colleagues. However, dissemination of findings from this research and development effort can be accomplished through publications and presentations; researchers are targeting conferences such as the Ubiquitous Computing (UbiComp) and Computer Human Interaction (CHI) and journals such as Crisis, Implementation Science, and Journal of Consulting and Clinical Psychology.

Locations