Improving Efficacy of Voice Therapy Concepts Via Telepractice and Mobile App Technology

Not Applicable

Recruiting

• Conditions: Voice Disorders
• Interventions: Behavioral: Modified Conversation Training Therapy; Behavioral: Global Voice Prevention and Therapy Model; Behavioral: Conversation Training Therapy; Behavioral: Modified Global Voice Prevention and Therapy Model

• Registration Number: NCT05220982
• Lead Sponsor: West Chester University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-02
• Study Start: 2022-08-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Conversation Training Therapy	Modified Conversation Training Therapy	-
Global Voice Prevention and Therapy Model	Global Voice Prevention and Therapy Model	-
Conversation Training Therapy	Conversation Training Therapy	-
Modified Global Voice Prevention and Therapy Model	Modified Global Voice Prevention and Therapy Model	-

Primary Outcome Measures

Name	Time	Method
Change in Voice Handicap Index 10	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.	The VHI-10 is a client reported outcome measure related to voice impact on quality of life across 10 questions. Each question is rated on a scale from 0-4 with 0 as never, 1 as almost never, 2 as sometimes, 3 as almost always, and 4 as always.
Change in Vocal Fatigue Index (VFI) factor 1 and 2	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.	The VFI is a client reported outcome measure related to tiredness and avoidance of voice in factor 1 and physical voice discomfort in factor 2. Factor 1 has 11 questions and factor 2 has 5 questions. Each question is rated on a scale from 0-4 with 0 as never, 1 as almost never, 2 as sometimes, 3 as almost always, and 4 as always.

Secondary Outcome Measures

Name	Time	Method
Change in cepstral peak prominence	One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.	Cepstral peak prominence will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
Change in Jitter%	One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.	Jitter% will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
Change in Borg Category Ratio (CR)10 scale for vocal effort	One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured once a day in PM sessions during a 5 day period via the VoiceEvalU8 app.	The Borg CR10 scale rates vocal effort on a scale from 0-10 with 0 as no effort and 10 as maximum effort.
Change in Fundamental Frequency	One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.	Fundamental frequency will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
Student researcher (SR) voice therapy satisfaction surveys	Collected immediately after intervention in the fall via Qualtrics online software.	The voice therapy satisfaction survey will rate the student researchers' (SR) perceptions after completing the voice therapy conditions. The questions are rated on a scale from 1-5 with 1 as strongly disagree and 5 as strongly agree.; There are also some open ended responses. The SR survey has 17 questions.
Change in noise-to-harmonic ratio	One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.	Noise-to-harmonic ratio will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
Change in smoothed cepstral peak prominence	One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.	Smoothed cepstral peak prominence will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
Change in Borg Category Ratio (CR)10 scale for mental effort	One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured once a day in PM sessions during a 5 day period via the VoiceEvalU8 app.	The Borg CR10 scale rates mental effort on a scale from 0-10 with 0 as no effort and 10 as maximum effort.
Change in acoustic voice quality index	One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.	Acoustic voice quality index will be measured during 1 trial of the 5-sec sustained /a/ and the phrase, "we were away a year ago,"
Participant voice therapy satisfaction surveys	Collected immediately after intervention in the fall via Qualtrics online software.	The voice therapy satisfaction surveys will rate the participants' perceptions after completing the voice therapy conditions. The questions are rated on a scale from 1-5 with1 as strongly disagree and 5 as strongly agree.; There are also some open ended responses. The participant survey has 12 questions.

Trial Locations

Locations (1)

Elizabeth Grillo; 🇺🇸 West Chester, Pennsylvania, United States