Recruiting

Voice Therapy

Sponsor:

West Chester University of Pennsylvania

Code:

NCT05220982

Conditions

Voice Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Conversation Training Therapy

Global Voice Prevention and Therapy Model

Modified Conversation Training Therapy

Modified Global Voice Prevention and Therapy Model

Study Details

Brief summary:

Due to the COVID-19 pandemic, telepractice has grown rapidly. To date, synchronous telepractice (i.e., in real-time videoconferencing) has been the focus of most research with asynchronous telepractice (i.e. information stored and accessed later) being used minimally only to record synchronous encounters. Descriptions of voice therapy concepts are minimally available in the literature with no standard reporting framework and no clinical efficacy or effectiveness data. Thus, the proposed study will address these barriers. First, an asynchronous method will be developed that will impact both in-person and telepractice services by offering repeated learning opportunities in the client's environment. The method includes ecological momentary intervention (EMI) through a daily voice therapy practice app, server, and web portal that is flexible in its programming to meet the needs of the client, offers performance feedback, and charts results over time. Second, voice therapy concepts will be tested improving our knowledge about such concepts that facilitate successful client-centered outcomes for both prevention and treatment of voice problems. The participants in the study will be teachers who have a high prevalence of voice problems, impact the healthcare system when treatment is needed, and negatively affect students' learning abilities in the classroom when communicating with a voice problem. Third, the Rehabilitation Treatment Specification System (RTSS) framework will be used to describe the voice therapy concepts. The concepts include: training multiple voices to meet all the clients' vocal needs, defining voice qualities by the anatomy and physiology of the voice production system, generalizing voice targets into hierarchical speech tasks, and using "new" vs "other/old" voice to help the client become their own clinician. Vocally healthy student teachers and professional teachers with voice complaints will be randomized into one of four voice therapy conditions delivered via telepractice. Both groups of teachers are needed to assess the concepts for prevention and treatment. Condition 2, which fully represents the proposed voice therapy concepts, will be superior to the other three conditions, which do not fully represent the concepts, by demonstrating a greater decrease in client-reported primary outcome measures of the Voice Handicap Index-10 and factor 1 and 2 of the Vocal Fatigue Index. Secondary outcomes of acoustic measures, Borg Category Ratio-10 scales for vocal and mental effort, and voice therapy satisfaction surveys will also be investigated. The results will be useful at a practical level by advancing asynchronous telepractice and by improving efficacy of voice therapy concepts. In addition, the results will lay the groundwork for future studies involving development of EMI platforms in other areas of speech-language pathology and testing additional voice therapy concepts that facilitate successful client-centered outcomes.

Conditions

Voice Disorders

Study ID

NCT05220982

Start date

Aug 31, 2022

Status verified date

Aug, 2024

Completion date

Aug 31, 2025

Anticipated

Primary completion date

Aug 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Vocally healthy student in a bachelor of education program with student teaching planned for spring
  • Professional teacher who is currently working as a teacher with voice complaints, but has not sought help for the complaints
  • Owner of either an android or iOS smartphone or tablet.

Exclusion Criteria:

  • Not a student teacher
  • Not a professional teacher.
  • Does not own a smartphone.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Conversation Training Therapy

experimental: Global Voice Prevention and Therapy Model

experimental: Modified Conversation Training Therapy

experimental: Modified Global Voice Prevention and Therapy Model

Interventions

Conversation Training Therapy

Training clear speech in conversation with new vs old voice. Training will occur over four weekly synchronous telepractice sessions. Each session lasts 45-60 minutes. The ecological momentary intervention (EMI) platform (app, server, web portal) will reflect the goals of the intervention. Participants will use the EMI platform to practice voice targets three times a day.

Global Voice Prevention and Therapy Model

Training of four new voices (i.e., resonant voice in connected speech, falsetto for quiet talking, oral twang for talking over noise, and belt for healthy yelling) defined and trained by the anatomy and physiology of the system (i.e., Estill Voice Training's Figures). Training occurs in a bottom-up speech hierarchy with new vs other or old voice at each step. Additional methods are used in asynchronous telepractice to support the new voices during week 1 (e.g., vocal hygiene and education). Training will occur over three weekly synchronous telepractice sessions. Each session lasts 45-60 minutes. The ecological momentary intervention (EMI) platform (app, server, web portal) will reflect the goals of the intervention. Participants will use the EMI platform to practice voice targets three times a day.

Modified Conversation Training Therapy

Training clear speech in conversation with no use of new vs old voice. Training will occur over four weekly synchronous telepractice sessions. Each session lasts 45-60 minutes. The ecological momentary intervention (EMI) platform (app, server, web portal) will reflect the goals of the intervention. Participants will use the EMI platform to practice voice targets three times a day.

Modified Global Voice Prevention and Therapy Model

Training of a new resonant voice in connected speech defined and trained by the anatomy and physiology of the system (i.e., Estill Voice Training's Figures). Training occurs in a bottom-up speech hierarchy with no use of new vs old voice. Additional methods are used in asynchronous telepractice to support the new voices during week 1 (e.g., vocal hygiene and education). Training will occur over three weekly synchronous telepractice sessions. Each session lasts 45-60 minutes. The ecological momentary intervention (EMI) platform (app, server, web portal) will reflect the goals of the intervention. Participants will use the EMI platform to practice voice targets three times a day.

Primary outcome measure

  • Change in Voice Handicap Index 10 [ Time Frame: One time at pre & one time at post condition in fall (4 weeks between pre and post) and once weekly for 15 weeks in spring. Captured on day 4 in the PM for a 5 day period via the VoiceEvalU8 app. ]
  • Change in Vocal Fatigue Index (VFI) factor 1 and 2 [ Time Frame: One time at pre & one time at post condition in fall (4 weeks between pre and post) and once weekly for 15 weeks in spring. Captured on day 5 in the PM for a 5 day period via the VoiceEvalU8 app. ]

Central Contacts and Locations

Central contacts

Elizabeth U Grillo, Ph.D.

6104362132egrillo@wcupa.edu

Locations

Elizabeth Grillo

Recruiting

West Chester, Pennsylvania, United States, 19383

Contacts

Elizabeth U Grillo, Ph.D.

610-436-2132egrillo@wcupa.edu

More Information

Sponsor

West Chester University of Pennsylvania

Last update posted

Aug 28, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by West Chester University of Pennsylvania on 2024-08-28.