Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000318684
Ethics application status
Approved
Date submitted
15/03/2023
Date registered
24/03/2023
Date last updated
24/03/2023
Date data sharing statement initially provided
24/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot of a group cognitive behavioural therapy (CBT) program for trans young people experiencing minority stress
Scientific title
Evaluation of a group cognitive behavioural therapy (CBT) program for trans young people experiencing minority stress: A pilot randomised controlled trial of the Trans Adolescent Group ThErapy for Alleviating Minority stress (TAG TEAM) intervention
Secondary ID [1] 309213 0
N/A
Universal Trial Number (UTN)
U1111-1289-7722
Trial acronym
N/A
Linked study record
ACTRN12623000302651 is a linked study. The present study represents a pilot trial of the TAG TEAM program, following-up from the evaluation of its acceptability in a feasibility trial.

Health condition
Health condition(s) or problem(s) studied:
Depression 329356 0
Anxiety 329357 0
Minority Stress 329358 0
Condition category
Condition code
Mental Health 326299 326299 0 0
Depression
Mental Health 326300 326300 0 0
Anxiety
Mental Health 326301 326301 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the Trans Adolescent Group ThErapy for Alleviating Minority stress (TAG TEAM) program, which is a group cognitive behavioural therapy (CBT) program that focuses on experiences of minority stress.

The TAG TEAM program was developed with trans young people in a co-design process. Trans young people who had attended the Royal Children’s Hospital Gender Service (RCHGS) participated in one 2-hour workshop and two 1.5-hour workshops over 6 weeks, during which they shared their experiences of being on the waitlist for and attending RCHGS, experiences of being a transgender young person, preferences for the content and delivery of a mental health intervention, and their opinions on the proposed mental health intervention.

The TAG TEAM program sessions focus on themes related to minority stress and factors that protect against minority stress (e.g., community connectedness, discrimination and rejection, internalised stigma, pride), and CBT principles that will assist young people to manage their cognitive, emotional, and behavioural responses to minority stress (e.g., assigning and reviewing between-session activities, learning, and practicing techniques).

The TAG TEAM program sessions are designed to include group discussion of the session themes, psychoeducation on CBT principles, activities practicing CBT techniques and skills, videos of trans adults exploring the session themes, and the assigning of between-session activities. Between-session activities will take approximately 1-2 hours per week during the program.

The program consists of six two-hour sessions conducted weekly, either in-person at the Royal Children’s Hospital, Victoria or online via teleconferencing software. The program will be delivered and facilitated by a psychologist and trans peer worker with experience working with young people. 8 participants will be allocated to each group.

The TAG TEAM program is manualised, and the facilitators will be trained in the treatment protocol by a senior clinician in the research team. The fidelity to the treatment protocol will be assessed by facilitators using a checklist at the end of each session to indicate whether each activity in the protocol was (0) not completed, and if so, a reason for non-completion, (1) partially completed, and if so, a reason for partial completion, or (2) completed. The fidelity ratings will be collated by a member of the research team and the facilitators will review their adherence to the protocol in fortnightly supervision sessions with a senior clinician in the research team.
Intervention code [1] 325659 0
Treatment: Other
Intervention code [2] 325660 0
Behaviour
Comparator / control treatment
There will be a waitlist control group. The participants assigned to the waitlist control group will not receive treatment from the Royal Children’s Hospital Gender Service while on the waitlist. The participants will be invited to attend the TAG TEAM program after the completion of the 3-month follow-up assessment, which will be 4.5 months after being assigned to the waitlist control group.
Control group
Active

Outcomes
Primary outcome [1] 334163 0
Trial eligibility rate via recruitment logs. Assessed via audit of study logs.
Timepoint [1] 334163 0
Post-completion of treatment period
Primary outcome [2] 334164 0
Trial participation rate via recruitment logs. Assessed via audit of study logs.
Timepoint [2] 334164 0
Post-completion of treatment period
Primary outcome [3] 334165 0
Trial non-participation rate after randomisation via participation logs. Assessed via audit of study logs.
Timepoint [3] 334165 0
Post-completion of treatment period
Secondary outcome [1] 419615 0
Trial lost to follow-up rate via participation logs. Assessed via audit of study logs.
This is an additional primary outcome.
Timepoint [1] 419615 0
Post-completion of treatment period
Secondary outcome [2] 419616 0
Trial outcome measure completion rate via outcome measure data. Assessed via audit of study logs.
This is an additional primary outcome.
Timepoint [2] 419616 0
Post-completion of treatment period
Secondary outcome [3] 419617 0
Treatment protocol adherence via facilitator logs. Assessed via audit of study logs.
This is an additional primary outcome.
Timepoint [3] 419617 0
Post-completion of treatment period

Eligibility
Key inclusion criteria
Inclusion criteria are:

(1) Is trans or gender diverse
(2) Has been referred to the RCHGS but has not attended a Multidisciplinary Assessment Clinic (MDAC) appointment
(3) Is between the ages of 14 and 16 years at the time of enrolment into the study
(4) Has current depressive or anxious symptomology as determined by a total score of 8 or above on the Short Mood and Feelings Questionnaire (indicating elevated depressive symptomatology) or a T score of 60 or above on the Spence Children’s Anxiety Scale (indicating elevated anxious symptomatology)
(5) Ability and willingness of participant and legally acceptable representative to give written informed consent
Minimum age
14 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are:

(1) Has an Multidisciplinary Assessment Clinic (MDAC) appointment booked within 6 months
(2) Has current suicidal symptomology as determined by receiving a score of 3 or above on the Columbia-Suicide Severity Rating Scale
(3) Is actively having treatment with any other group psychological intervention at the time of enrolment into the study
(4) Is not proficient in English (as the group CBT program will be delivered in English and funds aren’t available for interpreters)
(5) Previous participation in a linked feasibility trial

Study design
Purpose of the study
Treatment
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
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
As the objective of the and pilot trial is to evaluate the feasibility and acceptability of the study design rather than to assess the efficacy of the intervention, there is no statistical justification of sample size needed. We determined the sample size through a consideration of what is necessary to determine feasibility and acceptability while accounting for attrition.

A sample size of 64 participants will allow us to evaluate the feasibility and acceptability of the study design. 32 participants allocated to the intervention arm will provide enough participants to evaluate retention of participants in the intervention and to 3-month follow-up. 32 participants allocated to the waitlist control arm will provide enough participants to evaluate retention of participants for the 4.5-month waitlist and through the intervention. We will aim to recruit 69 participants to reach the target of 64 participants randomised and treated, based on a 8-12% ineligibility rate found in similar studies of psychological interventions in young people (Pachankis et al., 2020, 2015).

The analysis will use the intention-to-treat population. The analysis will use descriptive statistics including means, medians, counts and proportions to assess the recruitment, baseline and outcome data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/08/2023
Actual
Date of last participant enrolment
Anticipated
6/11/2023
Actual
Date of last data collection
Anticipated
30/04/2024
Actual
Sample size
Target
69
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24293 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 39838 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 313400 0
Charities/Societies/Foundations
Name [1] 313400 0
Royal Children's Hospital Foundation
Country [1] 313400 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Murdoch Children's Research Institute
Address
Royal Children's Hospital
50 Flemington Road
Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 315168 0
None
Name [1] 315168 0
Address [1] 315168 0
Country [1] 315168 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312619 0
Royal Children’s Hospital Human Research Ethics Committee
Ethics committee address [1] 312619 0
Ethics committee country [1] 312619 0
Australia
Date submitted for ethics approval [1] 312619 0
27/10/2022
Approval date [1] 312619 0
19/12/2022
Ethics approval number [1] 312619 0
91162

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

Contacts
Principal investigator
Name 125306 0
A/Prof Ken Pang
Address 125306 0
Royal Children's Hospital
50 Flemington Road
Parkville, VIC 3052
Country 125306 0
Australia
Phone 125306 0
+613 9345 6991
Fax 125306 0
Email 125306 0
[email protected]
Contact person for public queries
Name 125307 0
Ken Pang
Address 125307 0
Royal Children's Hospital
50 Flemington Road
Parkville, VIC 3052
Country 125307 0
Australia
Phone 125307 0
+613 9345 6991
Fax 125307 0
Email 125307 0
[email protected]
Contact person for scientific queries
Name 125308 0
Ken Pang
Address 125308 0
Royal Children's Hospital
50 Flemington Road
Parkville, VIC 3052
Country 125308 0
Australia
Phone 125308 0
+613 9345 6991
Fax 125308 0
Email 125308 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
Not in ethical approval


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.