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CompletedNCT03538860Updated Oct 14, 2021

Validation of an Automated Online Language Interpreting Tool - Phase Two.

An interventional study of Active comparator: Human interpreter and Intervention: Asynchronous Telepsychiatry in Mood Disorder, Anxiety Disorder and Substance Use Disorder, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-14.

Sponsored by University of California, Davis · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Nov 2017, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

There is a pressing national need to provide higher-quality, more effectively accessible language interpretation services to improve the health outcomes of Americans who have limited English proficiency (LEP). This project addresses a critical component of this problem: The need to improve access to high quality, mental health services for diverse populations by improving the flow of clinical work across care settings (primary care and specialty care) through the use of innovative online asynchronous methods of language interpretation and clinical communication. The investigators are conducting a two phase study. The first phase is completed and involved developing and testing the interpreting tool. The second phase of the research is a clinical trial to compare two methods of cross-language psychiatric assessment.

Read the detailed description

The investigators propose to develop and test a novel automated asynchronous interpretation tool. The proposed project builds on previous research, piloting the automated asynchronous interpretation tool. This 5-year project will be conducted in two phases. In Phase 1 the investigators iteratively evaluate and refine the automated asynchronous interpretation tool already developed in prior studies. In Phase 2, the investigators evaluate this tool using a two-group randomized cross-over trial. Investigators compare:

  • Method A (current gold standard of in-person real-time interpreting practice). A Spanish-speaking patient is diagnostically assessed in-person by an English-speaking psychiatrist through a Spanish-speaking interpreter.
  • Method B (comparative practice - ATP). A Spanish-speaking patient is interviewed in Spanish by a trained mental health interviewer. The interview is recorded in real time, translated into English using the automatic interpretation tool and adding sub-titles to the video file, and sent to an English-speaking psychiatrist to asynchronously - that is, at a later time - review the video and make a diagnosis.

All patients will undergo evaluation by both methods. Half of the patients will be randomized to be assessed by Method A first, followed by Method B and half to be assessed by Method B first, followed by Method A. The specific aims of the study are :

  • Aim 1: To iteratively evaluate and refine the automated asynchronous interpretation tool already developed in prior studies.
  • Aim 2: To compare patient satisfaction of Method A vs. Method B.
  • Aim 3: To compare the diagnostic accuracy and psychiatrist inter-rater reliability of Method A vs. Method B and demonstrate psychiatrist inter-rater reliability for Method B.
  • Aim 4: To compare the interview and language interpretation quality and accuracy of Method A vs. Method B.
02

Conditions studied

  • Mood Disorder
  • Anxiety Disorder
  • Substance Use Disorder
  • Chronic Medical Condition

Keywords

  • Telepsychiatry
  • AsynchronousTelepsychiatry
  • Automated Translation
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 114 is close to the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria: Inclusion Criteria: Hispanic patients with significant Limited English proficiency (LEP)

  • aged 18 or older
  • diagnosis of a mood disorder, anxiety disorder, or substance/alcohol abuse disorder(s)
  • Diagnosis of a chronic medical condition
  • referred by PCP or self-referral with PCP informed

Exclusion Criteria: Criteria:

  • less than 18 years
  • imminent suicidal ideation and/or plans
  • immediate violent intentions or plans
  • significant cognitive deficits
  • patient who's PCP recommends not participating.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
114 participants (actual)

Study arms

  • Other
    Method A first then Method B

    Conventional in-person interview with a psychiatrist with a live human interpreter with crossover to asynchronous telepsychiatry

    Behavioral: Active comparator: Human interpreter · Behavioral: Intervention: Asynchronous Telepsychiatry

  • Other
    Method B first then Method A

    Asynchronous telepsychiatry - that is, video-recorded interviews that are subsequently processed with automated speech recognition and machine translation technologies, with crossover to conventional in-person interview with a psychiatrist with a live human interpreter

    Behavioral: Active comparator: Human interpreter · Behavioral: Intervention: Asynchronous Telepsychiatry

Interventions

  • BehavioralActive comparator: Human interpreter

    A Spanish-speaking patient is diagnostically assessed in-person by an English-speaking psychiatrist through a Spanish-speaking interpreter.

  • BehavioralIntervention: Asynchronous Telepsychiatry

    A Spanish-speaking patient is interviewed in Spanish by a trained mental health interviewer. The interview is video-recorded in real-time, automatically translated into English with sub-titles added to the video file, and sent to a psychiatrist and to 3 English-speaking psychiatrists to asynchronously review the video and make a diagnosis.

06

What researchers measure

Primary outcomes

  1. Diagnostic accuracy

    Diagnosis accuracy with respect to gold standard SCID for Method B will be evaluated against Method A.

    Time frame: Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day

  2. Diagnostic Inter-rater reliability

    Using independent assessments from four psychiatrists for each of the 100 method B interviews the investigators will also examine inter-rater reliability of Method B diagnosis.

    Time frame: Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day

Secondary outcomes

  1. Satisfaction ratings

    Satisfaction ratings from patients' questionnaires

    Time frame: Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day

  2. Interview and language interpretation quality

    All 200 interviews in both methods will be video recorded and the audio transcribed. The investigators will measure and compare the two interview methods interpretation quality through perception of interpretation quality

    Time frame: Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day

  3. Interview and language interpretation accuracy

    All 200 interviews in both methods will be video recorded and the audio transcribed. The investigators will measure and compare the two interview methods accuracy through the presence of medical errors, and the presence of language errors

    Time frame: Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day

07

Study locations

1 site
  • UC Davis Medical Center
    Sacramento, California 95817, United States
08

References and documents

Publications

  • Tougas H, Chan S, Shahrvini T, Gonzalez A, Chun Reyes R, Burke Parish M, Yellowlees P. The Use of Automated Machine Translation to Translate Figurative Language in a Clinical Setting: Analysis of a Convenience Sample of Patients Drawn From a Randomized Controlled Trial. JMIR Ment Health. 2022 Sep 6;9(9):e39556. doi: 10.2196/39556. PubMed 36066959 ↗
  • Parish MB, Gonzalez A, Hilty D, Chan S, Xiong G, Scher L, Liu D, Sciolla A, Shore J, McCarron R, Kahn D, Iosif AM, Yellowlees P. Asynchronous Telepsychiatry Interviewer Training Recommendations: A Model for Interdisciplinary, Integrated Behavioral Health Care. Telemed J E Health. 2021 Sep;27(9):982-988. doi: 10.1089/tmj.2020.0076. Epub 2021 Jan 12. PubMed 33434453 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 3, 2019
  • Informed consent form · Nov 14, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03538860
Lead sponsor
University of California, Davis
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
Responsible party
Sponsor
First posted
May 29, 2018
Start date
Nov 14, 2017
Primary completion
Jul 31, 2021
Completion
Jul 31, 2021
Last update
Oct 14, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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