Novel Delivery Method of Transgender Voice Modification Training Using a Mobile Application
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Change in Transgender Self Evaluation Questionnaire (TSEQ) Scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Identify as a transgender individual
- •Be 18 years or older
- •Be able to read and write in English
- •Have an iOS or Android Device
排除标准
- •Identify as cisgender
- •Experience hoarseness
- •Experiencing any physical pain related to voice use
研究组 & 干预措施
Transgender and gender diverse (TGGD) individuals using the pilot app
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.
干预措施: Attuned: A mobile application (Other)
Transgender and gender diverse (TGGD) individuals receiving standard voice modification
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.
干预措施: In-Person Voice Modification Therapy (Other)
结局指标
主要结局
Change in Transgender Self Evaluation Questionnaire (TSEQ) Scores
时间窗: Baseline, Week 4, Week 11
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)
Change in Fundamental Frequency
时间窗: Baseline, Week 4, Week 11
The acoustic measure fundamental frequency will be obtained by analyzing participant's voice recordings via multi-speech acoustic analyses program of Kay-Pentax
Change in Transsexual Voice Questionnaire (TVQ) Scores
时间窗: Baseline, Week 4, Week 11
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).
Change in Formants
时间窗: Baseline, Week 4, Week 11
The acoustic measure formants will be obtained by analyzing participant's voice recordings via multi-speech acoustic analyses program of Kay-Pentax
次要结局
- Usability of Mobile Application as measured by the Mobile Application Rating Scale (MARS)(Week 11)