Novel Delivery Method of Transgender Voice Therapy Using a Mobile Application

Study Overview
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Brief Summary
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The investigators hypothesize that the mobile application they developed for transgender and gender diverse individuals (TGGD) will be equivalent or better than traditional speech therapy in improving voice quality. The investigators will measure both how the participants feel about their voices and how their voice actually sounds to see if the app is effective.

Detailed Description
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The ultimate objective of this study is to use Community-Based Participatory Research (CBPR) methods to develop an effective user-friendly, health literate, inclusive and accessible mobile application (app) to improve access to gender affirming voice modification training for transgender and gender diverse (TGGD) individuals. The immediate objectives are to understand the needs of TGGD individuals in voice care,and identify barriers to creating a pilot app with evidence-based educational content for VCMT and to evaluate subjective and objective voice outcomes of TGGD participants with app use compared to standard behavioral intervention with a speech pathologist.

Official Title
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Novel Delivery Method of Transgender Voice Therapy Using a Mobile Application

Conditions
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Transitioning Voice of Transgender and Gender Diverse People

Intervention / Treatment
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* Other: Attuned: A mobile application
* Other: In-Person Voice Modification Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Identify as a transgender individual Be 18 years or older Be able to read and write in English Have an IOS Device Exclusion Criteria: Identify as cis gender Experience hoarseness Experiencing any physical pain related to voice use

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transgender and gender diverse (TGGD) individuals using the pilot app<br>The investigators will develop Attuned, an open access voice and communication modification training (VCMT) app based on standard of care. Participants will undergo VCMT via the mobile application, Attuned. Participants will include healthy transgender and gender diverse (TGGD) individuals seeking voice modification to better reflect their identity. | Other: Attuned: A mobile application<br>* Subjects will undergo voice and communication modification therapy via the Attuned application. This consists of an 11 week program consisting of different modules to learn how to modify voice (e.g., pitch, intonation, resonance). At the end of each module, participants will be given exercises to practice what they learned.<br>|
| Active Comparator: Transgender and gender diverse (TGGD) individuals receiving standard voice modification<br>VCMT via speech pathology will be compared to the efficacy of an app-based VCMT program. Participants will undergo VCMT in-person. Participants will include healthy transgender and gender diverse (TGGD) individuals seeking voice modification to better reflect their identity. | Other: In-Person Voice Modification Therapy<br>* Subjects will undergo standard of care in-person voice modification therapy at Ithaca College.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Transsexual Voice Questionnaire (TVQ) Scores | The Transsexual Voice Questionnaire (TVQ) is a 30-item questionnaire that assesses self-perception of voice in transgender individuals. Responses range from (1) rarely or never to (4) usually or always. Scores range from 30 (no perceived voice difficulty) to 120 (high perceived voice difficulty). | Baseline, Week 4, Week 11 | 
| Change in Transgender Self Evaluation Questionnaire (TSEQ) Scores | The Transgender Self Evaluation Questionnaire (TSEQ) is a 30-item questionnaire that assesses self perception in transgender and gender diverse individuals. Responses range from (1) never (4) always. Scores range from 30 (low voice satisfaction) to 120 (high voice satisfaction) | Baseline, Week 4, Week 11 | 
| Change in Fundamental Frequency | The acoustic measure fundamental frequency will be obtained by analyzing participant's voice recordings via multi-speech acoustic analyses program of Kay-Pentax | Baseline, Week 4, Week 11 | 
| Change in Formants | The acoustic measure formants will be obtained by analyzing participant's voice recordings via multi-speech acoustic analyses program of Kay-Pentax | Baseline, Week 4, Week 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of Mobile Application as measured by the Mobile Application Rating Scale (MARS) | The Mobile Application Rating Scale (MARS) is a 19-item scale that allows app users to rate the usability of a mobile application. Responses range from 1 (inadequate) to 5 (excellent). Scores range from 19-95 with a score of 19 corresponding to a poor and inadequate app and 95 of an excellent apps with great usability. | Week 11 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transgender, Voice therapy, Mobile Application