Novel Delivery Method of Transgender Voice Modification Training Using a Mobile Application
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Attuned: A mobile application, In-Person Voice Modification Therapy.
- Who it may be relevant to
- Registry conditions: Transitioning Voice of Transgender and Gender Diverse People. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
Interventions
- Other Attuned: A mobile application
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. - Other In-Person Voice Modification Therapy
Subjects will undergo standard of care in-person voice modification therapy at Ithaca College.
Primary outcome measures
- Change in Transsexual Voice Questionnaire (TVQ) Scores [Time frame: Baseline, Week 4, Week 11]
- Change in Transgender Self Evaluation Questionnaire (TSEQ) Scores [Time frame: Baseline, Week 4, Week 11]
- Change in Fundamental Frequency [Time frame: Baseline, Week 4, Week 11]
- Change in Formants [Time frame: Baseline, Week 4, Week 11]
Secondary outcome measures (1)
- Usability of Mobile Application as measured by the Mobile Application Rating Scale (MARS) [Time frame: Week 11]
Eligibility criteria
Inclusion criteria
- Identify as a transgender individual
- Be 18 years or older
- Be able to read and write in English
- Have an iOS or Android Device
Exclusion criteria
- Identify as cisgender
- Experience hoarseness
- Experiencing any physical pain related to voice use
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Ithaca College — Ithaca
- Weill Cornell Medicine — New York
Identifiers
NCT: NCT05815810 · 21-12024240