SuicideNCT06299384
The Use of Voice-Based AI in 988 Crisis Counseling
A study testing LyssnCrisis in people with Suicide and Suicide and Self-harm, run by Lyssn.io, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Suicide and Self-harm
- What is being tested?
- LyssnCrisis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be employed at Protocall Services, Inc.
Who cannot join
- Call-takers who participated in Stage 2 research will not be able to participate in Stage 3 research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Voice-Based AI to Scale Evaluation of Crisis Counseling in 988 Rollout
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.
- Conditions
- Suicide, Suicide and Self-harm
- Being tested
- LyssnCrisis
- Keywords
- Crisis Counseling, 988, Artificial Intelligence, AI
- Medical subject headings
- Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LyssnCrisisOther
LyssnCrisis is an AI-based coding and feedback tool for implementation in crisis counseling settings, training counselors (call-takers) in suicide risk assessment skills.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. .
Measured: 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).
Measured: 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]
Measured: 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.
Measured: 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.
Measured: 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.
Measured: For Pilot: at end of 2 week LyssnCrisis period; for RCT, at end of 12-week LyssnCrisis period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start2 Apr 2024
- Primary completion5 Sep 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyssn.io, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ProtoCall Services, Inc.
- Responsible party
- Principal investigator, David Atkins, Lyssn.io, Inc.
- Investigators
- David C Atkins, PhD, Principal investigator, Lyssn.io, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299384
- Sponsor's protocol ID
- R44MH133517
- Status last verified
- Apr 2026
- First submitted
- 14 Feb 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice-Based AI to Scale Evaluation of Crisis Counseling in 988 Rollout
- ClinicalTrials.gov ID
- NCT06299384
- Acronym / sponsor ID
- R44MH133517
- Conditions
- Suicide, Suicide and Self-harm
- Keywords
- Crisis Counseling, 988, Artificial Intelligence, AI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Lyssn.io, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ProtoCall Services, Inc.
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lyssn Crisis | Experimental | Other: LyssnCrisisTo 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be employed at Protocall Services, Inc.
Key exclusion criteria (1 listed)
- Call-takers who participated in Stage 2 research will not be able to participate in Stage 3 research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LyssnCrisisLyssnCrisis is an AI-based coding and feedback tool for implementation in crisis counseling settings, training counselors (call-takers) in suicide risk assessment skills. | Other | Lyssn Crisis |
Primary outcome
Post-Call Survey
Time frame: Through study completion, an average of 22 weeks.
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. .
Call-taker crisis counseling fidelity
Time frame: Through study completion, an average of 22 weeks.
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).
System Usability Scale (SUS)
Time frame: Through study completion, an average of 22 weeks.
10 item survey that is a general measure of technology usability [ Rated from 1-5, 1= strongly disagree, 5 = strongly agree]
Acceptability of Intervention Measure; AIM
Time frame: For Pilot: at end of 2 week LyssnCrisis period; for RCT, at end of 12-week LyssnCrisis period.
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.
Intervention Appropriateness Measure; IAM
Time frame: 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.
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.
Feasibility of Intervention Measure; FIM
Time frame: For Pilot: at end of 2 week LyssnCrisis period; for RCT, at end of 12-week LyssnCrisis period.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Atkins, PhD principal investigator
Lyssn.io, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LyssnCrisis in people with Suicide and Suicide and Self-harm, run by Lyssn.io, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Call Survey (time frame: Through study completion, an average of 22 weeks.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.