Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000578606
Ethics application status
Approved
Date submitted
15/05/2023
Date registered
25/05/2023
Date last updated
22/05/2025
Date data sharing statement initially provided
25/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Gender diverse people’s psychological wellbeing and identity in the context of gender affirming speech therapy practices: A qualitative study
Scientific title
Gender diverse people’s psychological wellbeing and identity in the context of gender affirming speech therapy practices: A qualitative study
Secondary ID [1] 309621 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wellbeing 329938 0
(Gender) Identity 329939 0
Voice production 329940 0
Psychosocial development 330096 0
Condition category
Condition code
Mental Health 326846 326846 0 0
Studies of normal psychology, cognitive function and behaviour
Physical Medicine / Rehabilitation 326847 326847 0 0
Speech therapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1. Conduction of interviews with gender diverse people
Gender diverse study participants will participate each in a single one-on-one online episodic interview which combines open-end questions and narrative prompts to encourage the interviewee to tell stories about their daily lives. Interview topics will cover the gender diverse person’s wellbeing, their identity, their voice as well as their experiences with speech therapy.
Each interview will last about 90 mins.

2. Conduction of focus group discussions with speech therapists
Speech therapists will participate in a single online focus group (5 participants per group) to discuss their beliefs about and perspectives on gender diverse people’s wellbeing and gender diverse people’s identity, the speech therapists' ways of working with gender diverse clients and their attitudes about providing health care for gender diverse clients.
Each focus group discussion will last about 90 mins.

Interviews and focus group discussions will be conducted and facilitated in German with German speaking study participants located in Germany. Interviews and focus group discussions will be audio-recorded and recordings will be transcribed verbatim.
For the interviews: Analysed data will be sent to the study participants for feedback during data analysis (member reflections); study participants will be contacted to review the study results, ask for their consent and provide clarifications on their data before submitting the manuscript to a journal.
For the focus groups: Study participants will be contacted to review the study results, ask for their consent and provide clarifications on their data before submitting the manuscript to a journal.
Intervention code [1] 326046 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334744 0
From gender diverse people's perspective: What enables gender diverse people, who seek support from a speech pathologist, to experience their identity as positive? Interviews with gender diverse people will explore the participant's perspectives and lived experiences regarding the outcome.
Timepoint [1] 334744 0
Each gender diverse study participant will be interviewed once for approx. 90 minutes.
Primary outcome [2] 334745 0
From gender diverse people's perspective: What do gender diverse people, who seek support from a speech pathologist, experience as valuable in a speech pathology setting? Interviews with gender diverse people will explore the participant's perspectives and lived experiences regarding the outcome.
Timepoint [2] 334745 0
Each gender diverse study participant will be interviewed once for approx. 90 minutes.
Primary outcome [3] 334830 0
From gender diverse people's perspective: What do gender diverse people, who seek support from a speech pathologist, experience as not valuable in a speech pathology setting? Interviews with gender diverse people will explore the participant's perspectives and lived experiences regarding the outcome.
Timepoint [3] 334830 0
Each gender diverse study participant will be interviewed once for approx. 90 minutes.
Secondary outcome [1] 422202 0
From speech therapists' perspective: How do speech therapists see their role in supporting gender diverse clients’ psychological wellbeing? Focus group discussions with speech therapists working with gender diverse people will explore speech therapists' perspectives regarding the outcome.
Timepoint [1] 422202 0
Each speech therapist will participate in a focus group discussion with 4 other speech therapists once for approx. 90 minutes
Secondary outcome [2] 422203 0
From speech therapists' perspective: How do speech therapists see their role in supporting gender diverse clients’ perspective on identity? Focus group discussions with speech therapists working with gender diverse people will explore speech therapists' perspectives regarding the outcome.
Timepoint [2] 422203 0
Each speech therapist will participate in a focus group discussion with 4 other speech therapists once for approx. 90 minutes.

Eligibility
Key inclusion criteria
Inclusion criteria for gender diverse people
- People who are fluent in German
- People who do not or not exclusively identify with their gender category presumed at birth
- People who have worked or are currently working with speech therapist(s) in regard to their gender diverse identity

Inclusion criteria for speech therapists
- People who are fluent in German
- People who are qualified to practice as a speech therapist in Germany
- People who have worked or are currently working with gender diverse clients in regard to the clients’ gender diverse identity
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria
- Gender diverse people or speech therapists well known to the researcher(s) of this study

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Each gender diverse study participant and each participating speech therapist will participate once in a 20 min preliminary meeting to collect sociodemographic data.

Interviews with gender diverse people will be conducted based on a semi-structured interview guide for episodic interviews, an interview format that prompts narration. Focus group discussions will be facilitated based on a focus group discussion guide.
Both guides were developed based on existing literature and the identified research gap. The guides will be discussed with an advisory group, consisting of three members of the gender diverse community before data collection.

Interview data will be analysed with Reflexive Thematic Analysis (Braun & Clarke, 2022). The general steps of data analysis include: (1) Familiarising with the interviews/focus group data, (2) Coding the data, (3) creating candidate themes by combining, clustering or collapsing codes into bigger patterns, (4) Reviewing existing themes, (5) Defining and naming of themes, (6) Producing a report of the analysis incl. example quotations.
Data will be discussed with the research team throughout the data analysis process.

For the interviews, it is planned to include a total of 9 gender diverse people, three of them who identify within a feminine gender spectrum, three of them who identify within a masculine gender spectrum, and three of them who identify within a non-binary, genderqueer or a-gender spectrum. With the heterogeneous composition of the group of gender diverse study participants, we aim to capture diversity in the participants' lived experiences.
For the focus group discussions, it is planned to include a total of 15 speech therapists with at least some experience in working with gender diverse clients since it is assumed that the number of speech therapists working with gender diverse people is small.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2023
Actual
1/06/2023
Date of last participant enrolment
Anticipated
31/08/2023
Actual
16/01/2024
Date of last data collection
Anticipated
30/09/2023
Actual
24/01/2024
Sample size
Target
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 25536 0
Germany
State/province [1] 25536 0

Funding & Sponsors
Funding source category [1] 313801 0
University
Name [1] 313801 0
La Trobe University
Country [1] 313801 0
Australia
Primary sponsor type
Individual
Name
Jennifer Oates
Address
Discipline of Speech Pathology
School of Allied Health, Human Services and Sport
La Trobe University
Plenty Road & Kingsbury Dr
Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 315679 0
Individual
Name [1] 315679 0
Julia Tanase
Address [1] 315679 0
Discipline of Speech Pathology School of Allied Health, Human Services and Sport La Trobe University Plenty Road & Kingsbury Dr Bundoora VIC 3086
Country [1] 315679 0
Australia
Other collaborator category [1] 282680 0
University
Name [1] 282680 0
University of Applied Sciences Osnabrueck
Address [1] 282680 0
Albrechtstrasse 30 49076 Osnabrueck
Country [1] 282680 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312967 0
Human Research Ethics Committee La Trobe University
Ethics committee address [1] 312967 0
Ethics committee country [1] 312967 0
Australia
Date submitted for ethics approval [1] 312967 0
13/01/2023
Approval date [1] 312967 0
13/03/2023
Ethics approval number [1] 312967 0
HEC23004

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126518 0
Dr Jennifer Oates
Address 126518 0
Discipline of Speech Pathology School of Allied Health, Human Services and Sport La Trobe University Plenty Road & Kingsbury Dr Bundoora VIC 3086
Country 126518 0
Australia
Phone 126518 0
+61417577722
Fax 126518 0
Email 126518 0
[email protected]
Contact person for public queries
Name 126519 0
Julia Tanase
Address 126519 0
Discipline of Speech Pathology School of Allied Health, Human Services and Sport La Trobe University Plenty Road & Kingsbury Dr Bundoora VIC 3086
Country 126519 0
Australia
Phone 126519 0
+61491718229
Fax 126519 0
Email 126519 0
[email protected]
Contact person for scientific queries
Name 126520 0
Julia Tanase
Address 126520 0
Discipline of Speech Pathology School of Allied Health, Human Services and Sport La Trobe University Plenty Road & Kingsbury Dr Bundoora VIC 3086
Country 126520 0
Australia
Phone 126520 0
+61491718229
Fax 126520 0
Email 126520 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: No permission to do so.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
ProtocolYeshttps://doi.org/10.1371/journal.pone.0311402 Tanase, J., Quinn, S., Corsten, S., Hansen, H., & ... [More Details]

Documents added automatically
No additional documents have been identified.