Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000734561p
Ethics application status
Not yet submitted
Date submitted
27/05/2024
Date registered
14/06/2024
Date last updated
14/06/2024
Date data sharing statement initially provided
14/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Navigating parenting trans and gender diverse young people with a group-based program: A single blind RCT
Scientific title
Delivering a group-based therapeutic program for parents and caregivers of trans and gender diverse young people aimed at increasing parental knowledge regarding gender diversity to enable parents to build confidence, skills and capacity to support and advocate for their trans child.
Secondary ID [1] 312136 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parent-child connectedness 334009 0
Parenting skills 334010 0
Parenting confidence 334011 0
Parent capacity 334012 0
Depression 334013 0
Stress 334014 0
Anxiety 334015 0
Condition category
Condition code
Mental Health 330455 330455 0 0
Depression
Mental Health 330682 330682 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a group-based therapeutic intervention parenting program utilising evidence-based therapeutic approaches, such as cognitive behavioural therapy (CBT) and the affirmative care model, psychoeducation and relevant theoretical models such as minority stress theory, attachment theory and family systems theory. The program has been the subject of a pilot trial with results published and is manualised with training provided to facilitators.
The group-based intervention is delivered face-to-face in small groups.
The intervention will be delivered over 5 weeks and consists of 5 x 2 hour sessions. Attendance will be monitored to assess adherence to the program.
The intervention will be delivered at urban paediatric hospital sites nationally.
The program is delivered by a Clinical Psychologist with co-facilitation support.
Intervention code [1] 328597 0
Behaviour
Comparator / control treatment
The control group will be parents and caregivers who are on the waiting list to access a Specialized Paediatric Gender Diversity Service from a paediatric Hospital and receive treatment as usual.
Treatment as usual, usually involves parents and caregivers being sent information from the paediatric gender diversity service. Information can include lists of resource such as phone numbers and websites for mental health support for both children and parents/caregivers. The contact details for social support services relevant to each area are also included in the information sent to parents/caregivers who are wait listed to receive treatment and support from the gender services.
Control group
Active

Outcomes
Primary outcome [1] 338247 0
Parental knowledge, skills and confidence in parenting a gender diverse child measured by novel 4-item Likert-type scales due lack of existing measure. Scales measure parental self-rated;
1. knowledge of gender diversity.
2. confidence in supporting child's gender identity,
3. acceptance of gender diversity, and
4. acceptance of child's gender identity.

All measures will be assessed as a composite primary outcome.
Timepoint [1] 338247 0
T0: Baseline at beginning of Session 1, T1: End of Session 5 (primary timepoint), T2: 3 months post-intervention.
Secondary outcome [1] 435133 0
Parental quality of life as measured by the 21-item Depression, Anxiety and Stress (DASS) scale.
Timepoint [1] 435133 0
T0: Baseline at beginning of Session 1, T1: End of Session 5, T2: 3 months post-intervention.
Secondary outcome [2] 435567 0
Program acceptability.
Timepoint [2] 435567 0
T1: End of Session 5.
Secondary outcome [3] 435974 0
Custom consumer satisfaction survey comprising open-ended/multiple-choice/quantitative questions covering process evaluation.

Timepoint [3] 435974 0
T1: End of Session 5.
Secondary outcome [4] 435975 0
Custom consumer satisfaction survey comprising multiple-choice/quantitative questions covering feasibility.
Timepoint [4] 435975 0
T1: End of Session 5.

Eligibility
Key inclusion criteria
Parents and caregivers of trans and gender diverse children and young people who are wait listed to access or engage with a Specialised Paediatric Gender Service (also known as state-based paediatric gender service) for trans young people under 18 .

Participants aged 18 years and over with children aged 12-18 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents and caregivers of trans and gender diverse children and young people who are currently accessing or engaged with a state-wide paediatric specialist paediatric gender service,

Parents and caregivers of trans and gender diverse children and young people who access or engage with private paediatric gender service.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Mixed-model repeated measures analyses and descriptive statistics. Standardized scales responses will be analyzed in keeping with scale instructions.

In terms of power analysis, pilot data showed post-intervention improvements in primary outcomes (5-point likert scale) of >1-point (SD approximately 0.8). A sample of 320 (n=8/cluster; 5 intervention & 5 control clusters/site; 4 sites) with 20% attrition will give >85% power to detect a 0.5-point difference between groups (Significance level, 0.05; SD=1; ICC 0.1; mixed-model hierarchical design).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2025
Actual
Date of last participant enrolment
Anticipated
1/05/2026
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 316495 0
Government body
Name [1] 316495 0
Australian Department of Health and Aged Care
Country [1] 316495 0
Australia
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
Country
Australia
Secondary sponsor category [1] 318700 0
None
Name [1] 318700 0
Address [1] 318700 0
Country [1] 318700 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315289 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 315289 0
Ethics committee country [1] 315289 0
Australia
Date submitted for ethics approval [1] 315289 0
01/07/2024
Approval date [1] 315289 0
Ethics approval number [1] 315289 0

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

Contacts
Principal investigator
Name 134238 0
Dr Helen Morgan
Address 134238 0
Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA 6009
Country 134238 0
Australia
Phone 134238 0
+61 8 63191096
Fax 134238 0
Email 134238 0
[email protected]
Contact person for public queries
Name 134239 0
Jacinta Freeman
Address 134239 0
Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA 6009
Country 134239 0
Australia
Phone 134239 0
+61405335516
Fax 134239 0
Email 134239 0
[email protected]
Contact person for scientific queries
Name 134240 0
Helen Morgan
Address 134240 0
Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA 6009
Country 134240 0
Australia
Phone 134240 0
+61 8 63191096
Fax 134240 0
Email 134240 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.