Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000654459
Ethics application status
Approved
Date submitted
2/06/2025
Date registered
20/06/2025
Date last updated
20/06/2025
Date data sharing statement initially provided
20/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the feasibility, acceptability, and preliminary efficacy of a peer support program for trans people on a waitlist to access gender affirming care (‘Thriving Transitions’): a randomised controlled trial
Scientific title
Randomised controlled trial evaluation of the feasibility, acceptability, and preliminary efficacy of a peer support program for reducing suicidality, depressive symptoms, and improving quality of life among trans people on a waitlist to access gender affirming care relative to standard care (‘Thriving Transitions’)
Secondary ID [1] 314579 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 337685 0
Condition category
Condition code
Mental Health 334019 334019 0 0
Depression
Public Health 334020 334020 0 0
Health promotion/education
Public Health 334021 334021 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to evaluate the feasibility, acceptability, and preliminary efficacy of an online peer support program (‘Thriving Transitions’) for reducing suicidal ideation, depressive symptoms, and improving quality of life, among trans people on a waitlist for initiating gender affirming hormone therapy, compared to standard care as usual.
Participants will be allocated to intervention (‘Thriving Transitions’) or standard care (no intervention). Intervention is a peer support program consisting of 7 x 1.5 hr once weekly sessions over a 7 week period. This will be delivered online via videoconference by two peer facilitators (both trained in providing support to trans people experiencing suicidal thoughts.
The peer support program will cover the following topics:
1. Introductions, group agreement
2. Medical gender affirmation
3. Hoping and coping
4. Coming out or ‘inviting in’
5. Sex, dating, and intimacy
6. Gender embodiment goals
7. Trans futures

Facilitators will be provided with a comprehensive facilitator training and delivery manual which outlines key details about the background and co-development of the Thriving Transitions intervention, in addition to week-by-week aims, learning objectives, key topics to be discussed and explored, and relevant local resources and services as they pertain to the topic. Additionally, this document outlines the schedule of activities (including discussion activities) to be facilitated for each week, including prompts, follow-up questions, implementation considerations to be planned and anticipated. All facilitators will receive a half-day (~4hr equivalent) of training at least 4 weeks prior to the program commencement date delivered by 1-2 independent member(s) of the research team. Training day will involve orientation, introductions and fostering collegiality and familiaritiy, going through content, asking questions, with optional practical (e.g., role-play) activities for targeted training about specific scenarios or anticipated concerns of facilitators. Each week, co-facilitators with debrief together. Facilitators will also have access to a weekly supervision session provided a trans peer.

To monitor adherence and fidelity, facilitators will be required to complete weekly implementation and debrief logbooks within which attendance will be annotated. Within 48 hours following a session, facilitators will send a ‘wrap-up’ style email summarising the previous week and, additionally, an ‘orientation’ style email will send at least 48 hours in advance an ‘orientation’ style email providing an overview of the upcoming session, including notices and reminders of attendance. This logbook will also allow facilitators to reflexively denote any facilitators and barriers to participant engagement and participation among attendees from that week. From participant enrolment stage, to be eligible for this study participants must be able to confirm that they do not foresee any difficulty to regularly attending the 7-week Thriving Transitions program in the event that they are randomly allocated to receive the program.
Intervention code [1] 331202 0
Prevention
Comparator / control treatment
Participants randomly allocated to the control trial arm will receive standard care as usual (i.e., resumed occupation of waitlist for initiating gender affirming hormone treatment). There are no current plans to offer the intervention to the control group during this study.
Control group
Active

Outcomes
Primary outcome [1] 341676 0
Feasibility
Timepoint [1] 341676 0
Facilitator weekly logbooks: Seven assessments weekly over course of 7-week Thriving Transitions program Facilitator experience survey: 7-weeks post-baseline (T1) Participant experience survey: 7-weeks post-baseline (T1)
Primary outcome [2] 341677 0
Acceptability
Timepoint [2] 341677 0
Facilitator weekly logbooks: Seven assessments weekly over course of 7-week Thriving Transitions program Facilitator experience survey: 7-weeks post-baseline (T1) Participant experience survey: 7-weeks post-baseline (T1)
Primary outcome [3] 341678 0
Preliminary efficacy - suicidal ideation
Timepoint [3] 341678 0
Suicidal ideation Assessment Method: Suicidal Ideation Attributes Scale (SIDAS) Timepoint: Baseline (T0), 7-weeks post-baseline (T1), 3-months post-baseline (T2)
Secondary outcome [1] 448309 0
Hope
Timepoint [1] 448309 0
Baseline (T0), 7-weeks post-baseline (T1), 3-months post-baseline (T2)
Secondary outcome [2] 448310 0
Anxiety symptoms
Timepoint [2] 448310 0
Baseline (T0), 7-weeks post-baseline (T1), 3-months post-baseline (T2)
Secondary outcome [3] 448311 0
Social functioning
Timepoint [3] 448311 0
Baseline (T0), 7-weeks post-baseline (T1), 3-months post-baseline (T2)
Secondary outcome [4] 448312 0
Nicotine use
Timepoint [4] 448312 0
Baseline (T0), 7-weeks post-baseline (T1), 3-months post-baseline (T2)
Secondary outcome [5] 448313 0
Vaping use
Timepoint [5] 448313 0
Baseline (T0), 7-weeks post-baseline (T1), 3-months post-baseline (T2)
Secondary outcome [6] 448314 0
Cannabis use
Timepoint [6] 448314 0
Baseline (T0), 7-weeks post-baseline (T1), 3-months post-baseline (T2)
Secondary outcome [7] 448315 0
Wellbeing
Timepoint [7] 448315 0
Baseline (T0), 7-weeks post-baseline (T1), 3-months post-baseline (T2)
Secondary outcome [8] 448316 0
Trans community connectedness
Timepoint [8] 448316 0
Baseline (T0), 7-weeks post-baseline (T1), 3-months post-baseline (T2)
Secondary outcome [9] 448317 0
Social isolation
Timepoint [9] 448317 0
Baseline (T0), 7-weeks post-baseline (T1), 3-months post-baseline (T2)
Secondary outcome [10] 448318 0
Trans health literacy
Timepoint [10] 448318 0
Baseline (T0), 7-weeks post-baseline (T1), 3-months post-baseline (T2)
Secondary outcome [11] 448319 0
Service utilisation
Timepoint [11] 448319 0
Baseline (T0), 7-weeks post-baseline (T1), 3-months post-baseline (T2)
Secondary outcome [12] 448320 0
Resilience
Timepoint [12] 448320 0
Baseline (T0), 7-weeks post-baseline (T1), 3-months post-baseline (T2)
Secondary outcome [13] 448726 0
Depressive symptoms
Timepoint [13] 448726 0
Baseline (T0), 7-weeks post-baseline (T1), 3-months post-baseline (T2)
Secondary outcome [14] 448727 0
Health-related quality of life
Timepoint [14] 448727 0
Baseline (T0), 7-weeks post-baseline (T1), 3-months post-baseline (T2)

Eligibility
Key inclusion criteria
1. have a gender different to the one presumed for them at birth (often termed ‘trans’)
2. aged 18+ years at time of study, and
3. seeking initiation of gender affirming hormone therapy (GAHT) at Austin Health Gender Clinic or North-Eastern Urology
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. has the same gender that was presumed for them at birth (often termed ‘cisgender’)
2. Aged <18 years
3. people who have ever undertaken a regime of GAHT
4. people seeking to re-initiate GAHT (or who have taken GAHT previously)
5. people who foresee difficulty to regularly attend seven weekly sessions of a trans peer support group program and complete health and evaluation surveys over a three month period
6. people who are experiencing mental ill-health difficulties which may make them unable to take care of themselves and keep themselves safe throughout the study duration
7. people who feel that their level of English language proficiency may negatively impact their ability to participate and experience an English language-run trans peer support group program run across six fortnightly sessions over three months

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319096 0
Charities/Societies/Foundations
Name [1] 319096 0
Suicide Prevention Australia
Country [1] 319096 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 321560 0
None
Name [1] 321560 0
Address [1] 321560 0
Country [1] 321560 0
Other collaborator category [1] 283535 0
University
Name [1] 283535 0
The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney
Address [1] 283535 0
Country [1] 283535 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317696 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 317696 0
Ethics committee country [1] 317696 0
Australia
Date submitted for ethics approval [1] 317696 0
04/05/2025
Approval date [1] 317696 0
27/05/2025
Ethics approval number [1] 317696 0

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

Contacts
Principal investigator
Name 141842 0
Prof Ada Cheung
Address 141842 0
Austin Health, 145 Studley Road, Heidelberg, VIC, 3084.
Country 141842 0
Australia
Phone 141842 0
+61 03 9496 5000
Fax 141842 0
Email 141842 0
[email protected]
Contact person for public queries
Name 141843 0
Dr Sasha Bailey
Address 141843 0
Austin Health, 145 Studley Road, Heidelberg, VIC, 3084.
Country 141843 0
Australia
Phone 141843 0
+61 03 9496 5000
Fax 141843 0
Email 141843 0
[email protected]
Contact person for scientific queries
Name 141844 0
Ada Cheung
Address 141844 0
Austin Health, 145 Studley Road, Heidelberg, VIC, 3084.
Country 141844 0
Australia
Phone 141844 0
+61 03 9496 5000
Fax 141844 0
Email 141844 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.