NCT05479890

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

January 31, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2024

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

1.8 years

First QC Date

July 25, 2022

Last Update Submit

December 10, 2024

Conditions

Keywords

Motivational InterviewingChatbotAlcohol Use Disorder

Outcome Measures

Primary Outcomes (3)

  • CASPI: Computer Assessment of Simulated Patient Interviews

    The CASPI measures clinician effective use of Motivational Interviewing

    Baseline

  • CASPI: Computer Assessment of Simulated Patient Interviews

    The CASPI measures clinician effective use of Motivational Interviewing

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

  • CASPI: Computer Assessment of Simulated Patient Interviews

    The CASPI measures clinician effective use of Motivational Interviewing

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

Study Arms (2)

Treatment as Usual (TAU)

NO INTERVENTION

TAU will receive no training during the intervention period.

ClientBot (CB)

EXPERIMENTAL

CB trainees will engage in 5 weekly practice sessions with ClientBot

Other: ClientBot

Interventions

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

ClientBot (CB)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prevention Research Institute

Lexington, Kentucky, 40503, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2022

First Posted

July 29, 2022

Study Start

January 31, 2023

Primary Completion

November 10, 2024

Study Completion

November 10, 2024

Last Updated

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations