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Motivational InterviewingNCT05479890

ClientBot: a Conversational Agent That Supports Skills Practice and Feedback for Motivational Interviewing

A study testing ClientBot in people with Motivational Interviewing and Alcohol Use Disorder, run by Lyssn.io, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This multi-stage study includes qualitative interviews, usability research, and a randomized training study of technology implementation in a real-world clinical setting. The proposed study will enhance and evaluate an artificial intelligence (AI) based, conversational agent (ClientBot) that simulates a realistic… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
ClientBot
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
1 siteUnited States
Study dates
31 Jan 2023to 10 Nov 2024
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Clinician trainee participating in training with Prevention Research Institute (PRI)

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Prevention Research Institute

    Lexington, Kentucky, 40503

Other trials in United States

About this study

Official title: ClientBot: a Conversational Agent That Supports Skills Practice and Feedback for Motivational Interviewing for Alcohol Use Disorder (AUD)

This multi-stage study includes qualitative interviews, usability research, and a randomized training study of technology implementation in a real-world clinical setting. The proposed study will enhance and evaluate an artificial intelligence (AI) based, conversational agent (ClientBot) that simulates a realistic client with alcohol concerns and provides performance-based feedback to support counselor training. The research is in collaboration with PRI, which focuses on training alcohol and substance use counselors.

Read the detailed description

Stage 1. Interviews with 5 PRI trainers will assess current PRI training goals, content, and format, but also how training practices are conducted, including what types of technologies are currently used for what purposes. Trainer participants will then be introduced to the prototype ClientBot platform, including an opportunity to use it, and will be asked to describe how they might integrate the prototype into their existing training practices. Trainers will roleplay with researchers to illustrate work processes, and data collection will include interview audio recordings and field notes. Trainer participants will also be interviewed regarding their use of MI skills and which are most relevant and/or in need of training for their typical trainees.

Stage 1 will also include trainees who have participated in a PRI training within the previous 3 months. Recent trainees will provide an informed perspective on the ClientBot platform relative to current PRI skills training practices, which include an MI skills focused workbook and role plays. Participant sessions will be conducted online, using an interview-based usability format. Research staff will provide a brief introduction to ClientBot as a computer-based skills training platform and then ask participants to complete specific tasks, using a 'think aloud' protocol (i.e., provide a self narration as they pursue each task). The goal of the lab-based usability analysis is to verify that the software functions as intended in a controlled setting. As part of the hour-long session, participants will have an opportunity to use 2-3 MI skills training modules.

Stage 2. PRI has a robust schedule of in-person and online trainings throughout each year. For stage 2 usability study, we will recruit 20 counselors who have participated in a PRI training within the previous 3 months. Following software engineering work to implement the Phase I ClientBot tool into Lyssn's HIPAA-compliant cloud-based platform, we will conduct a single-arm, 2-week field trial among 20 recent PRI trainees to better assess user workflow, system interaction, and general usability in a community AUD setting. Participants will be encouraged to use ClientBot for 10 minutes per work day. Participants will be contacted daily via email by research staff to inquire about technical reliability (e.g., difficulties operating the tool), functional reliability (e.g., experience using ClientBot functions), and experiences integrating the system into the day's workflow. ClientBot use will be captured automatically by the system, including: which modules were used, the number of times resources were accessed and repeated, time spent viewing introductory materials, fidelity feedback provided during skills practice, and time spent in review of NLP-generated feedback.

Following each practice session, participants will answer a brief set of likert questions on 0-10 scale, including: How coherent was the client's narrative and responses? How realistic was this simulated client relative to client's you have seen? How much of the client session focused on alcohol use ? How accurate was the feedback on MI skill usage? After completing all practice sessions, participants will complete the system usability scale (SUS). To gauge implementation readiness, we will also use the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Each are brief, 5-item measures targeting core implementation outcomes with strong psychometric properties. Trainees will evaluate the perceived accuracy of the ClientBot feedback, which will also be evaluated via objective human coding.

Stage 3. During Stage 3 PRI research members will identify 10-15 trainings to recruit from (assuming we will be able to recruit 50% of participants in each training, based on previous participation rates in PRI-based research). Individuals that have signed up for a PRI training will be recruited into the study approximately 6 weeks prior to the training via email invitation. Interested participants will complete informed consent online, and following consent, therapist participants will be randomized into ClientBot (CB) vs. training as usual (TAU) conditions. Participants will then be asked to complete the computer assessment of simulated patient interviews (CASPI), a computer-based, standardized assessment of MI skills that is highly correlated with objective measures of MI fidelity. We will recruit and randomize a total of 200 PRI trainees, using their ongoing online training. PRI trains approximately 1,200 individuals each year. Based on our pilot study, we anticipate a 30% recruitment rate, which would yield the required sample size of 200 in approximately 6-8 months. Research participants will be randomized to use ClientBot immediately following their PRI training, or training-as-usual (TAU), which involves no intervention immediately following training. Prior to the ClientBot intervention, participants in both arms will complete the Computer Assessment of Simulated Patient Interviews (CASPI). The CASPI presents brief client videos with prompts to use various MI skills after each video, which are recorded and then scored for MI fidelity. Participants in both arms will complete follow-up CASPI assessments after the ClientBot training period. After a 2 month washout period, the ClientBot arm will receive an additional follow-up CASPI. Both arms will then be asked to engage in standardized patient sessions to fulfill their PRI training requirements. After completion of SP sessions, participants in the TAU arm will be offered the ClientBot training intervention, followed by a final CASPI. The final months of Phase 2 / Year 2 will focus on data analyses and dissemination of findings via conference presentations and publications.

Being tested
ClientBot
Keywords
Motivational Interviewing, Chatbot, Alcohol Use Disorder
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClientBotOther

    ClientBot is an AI-based simulated client that supports skills improvement for providers learning and using Motivational Interviewing

Study groups in NCT05479890
Study groupRoleWhat they receive
Treatment as Usual (TAU)No interventionTAU will receive no training during the intervention period.
ClientBot (CB)ExperimentalCB trainees will engage in 5 weekly practice sessions with ClientBot
Receives: Other: ClientBot

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CASPI: Computer Assessment of Simulated Patient Interviews

    The CASPI measures clinician effective use of Motivational Interviewing

    Measured: Baseline

  2. CASPI: Computer Assessment of Simulated Patient Interviews

    The CASPI measures clinician effective use of Motivational Interviewing

    Measured: Post-training with ClientBot, an average of 1 month following Baseline

  3. CASPI: Computer Assessment of Simulated Patient Interviews

    The CASPI measures clinician effective use of Motivational Interviewing

    Measured: 2 months post-training with ClientBot, an average of 3 months following Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2022
  2. Study start31 Jan 2023
  3. Primary completion10 Nov 2024
  4. Study completion10 Nov 2024

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05479890
Sponsor's protocol ID
Pro00042065
Other IDs
1R44AA028463-01
Status last verified
Dec 2024
First submitted
25 Jul 2022
Last updated
13 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ClientBot in people with Motivational Interviewing and Alcohol Use Disorder, 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 13 Dec 2024. 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?

CASPI: Computer Assessment of Simulated Patient Interviews (time frame: Baseline). The study lists 3 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 13 Dec 2024.

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