Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000123549
Ethics application status
Approved
Date submitted
14/12/2023
Date registered
12/02/2024
Date last updated
25/06/2024
Date data sharing statement initially provided
12/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effect of an online game on depression symptoms in trans young people
Scientific title
Evaluating the effect of an online game on depression symptoms in trans young people
Secondary ID [1] 309956 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 330439 0
Condition category
Condition code
Mental Health 327286 327286 0 0
Depression
Mental Health 327462 327462 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project aims to evaluate the efficacy, acceptability and feasibility of a mobile serious game adapted specifically for and with trans young people (SPARX-T) in preventing the onset and exacerbation of depressive symptoms, compared to a waitlist control.

SPARX is an online, serious game; an intervention that uses gaming for serious purposes. Developed by researchers at the University of Auckland, the program was designed to be unguided and interactive, using a fantasy game format to provide cognitive behavioural skills to treat mild to moderate symptoms of depression in young people. SPARX users choose and personalise an avatar and are led through the program by a virtual guide who provides context and links the content of the program to their real-life experiences. Prior research by members of this project’s investigation team has found that the use of personalised avatars to express and realise gender identity by trans young people in a virtual space confers benefits such as increased wellbeing (Morgan et al., 2020). In SPARX, the user navigates their way through a series of challenges within a fantasy world that has been overrun by GNATs (gloomy, negative, automatic thoughts), with the mission of restoring balance in the game world.

Phase I of this research project involved working with trans young people aged 11-18 to form focus groups that engaged in semi-structured group discussions. These young people were also given access to existing versions of SPARX (SPRAX-R and Rainbow SPARX) and were asked to maintain an online diary to track their experiences. This phase concluded with focus groups following this access period to discuss the games and determine the desired changes of the applications in order to create SPARX-T.

Following the processes in Phase I of this research project, in Phase II we determined the changes required to successfully adapt SPARX to the SPARX-T prototype and our developers produced the SPARX-T app for evaluation in Stage 3. Specifically, we adapted aspects of the game such as introducing a customisable avatar, including language, content and supportive resources tailored to the trans-specific context, and adapting the ‘notebook’ to allow personalised content to be added by users. These changes have been embedded throughout the game with the inclusion of characters that use they/them pronouns, example scenarios that have been adapted to be potential situations young trans people may face and the removal of gender options for the customisable avatar.

SPARX-T consists of 7 levels that take approximately 20 minutes to complete. Participants will be encouraged to complete 1/2 levels per week over a 5-week period and whilst this will be monitored, the user is able to complete the levels at their discretion. Adherence to the intervention will be monitored using app data and a single reminder text will be sent those in the intervention group 3 weeks into the intervention period to only participants who have not completed a module or only completed module 1.

The titles of the levels and a brief overview of the core focus are listed below:

Level 1—cave province: finding hope
Psychoeducation about depression and an introduction to the cognitive behavioural therapy model Introducing GNATs (Gloomy Negative Automatic Thoughts)

Level 2 ice province: being active
Activity scheduling and behavioural activation

Level 3—volcano province: dealing with emotions
Dealing with strong emotions: anger and hurt feelings

Level 4—mountain province: overcoming problems
Problem solving using STEPS: Say the problem, Think of solutions, Examine the pros and cons, Pick one and try it, See what happens

Level 5—swamp province: recognising unhelpful thoughts
Cognitive restructuring—recognising different types of GNATs

Level 6—bridgeland province: challenging unhelpful thoughts
Cognitive restructuring—learning to challenge or “swap” negative thoughts for helpful ones

Level 7—canyon province: bringing it all together
Recap of all skills

Intervention code [1] 326376 0
Prevention
Intervention code [2] 327735 0
Behaviour
Comparator / control treatment
Waitlist control compared to intervention group. Those in waitlist will receive intervention after the intervention group have completed the intervention and post-intervention and follow up surveys (approximately 13 weeks post baseline). Control group will receive usual care and will be able to access the app at follow up (13 week) time period. It is anticipated that many of the target population may be engaged with mental health care supports in both control and intervention groups due to the nature of the study. This care may include mental health support from a general practitioner (GP), psychologist, counsellor, school-based well-being service (psychologist, chaplain, counsellor etc) or from more informal supports such as family, peers and online communities.
Control group
Active

Outcomes
Primary outcome [1] 335324 0
Any change in depression symptoms score on Patient Health Questionnaire 9 for Adolescents (PHQ-A)
Timepoint [1] 335324 0
Comparison of baseline (0 weeks), post intervention (5 weeks) (primary timepoint) and follow up (13 weeks)
Secondary outcome [1] 423950 0
Any change in score on Generalised Anxiety Disorder Assessment (GAD-7) compared to baseline
Timepoint [1] 423950 0
Baseline (0 weeks), Post intervention (5 weeks) and follow up (13 weeks)
Secondary outcome [2] 423951 0
Any change in score on Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) compared to baseline.
Timepoint [2] 423951 0
Baseline (0 weeks), Post intervention (5 weeks) and follow up (13 weeks)
Secondary outcome [3] 429999 0
Any change in score of Gender Preoccupation and Stability Questionnaire 2nd Edition (GPSQ-2)
Timepoint [3] 429999 0
Baseline (0 weeks), Post intervention (5 weeks) and follow up (13 weeks)
Secondary outcome [4] 430495 0
Acceptability assessed using scores on core module of Game Experience Questionnaire (GEQ).
Timepoint [4] 430495 0
Measured at post intervention (5 weeks) for intervention group.
Secondary outcome [5] 430496 0
Feasibility of intervention assessed using automated application data tracking partial, full and total module completion as well as participants enrolled vs participants accessing application.
Timepoint [5] 430496 0
Throughout intervention time period (0-5 weeks).

Eligibility
Key inclusion criteria
Inclusion Criteria
• 14-18 years old.
• Living in Australia
• Proficient in English.
• Own or have access to an iPhone
• Access to an internet connection
Minimum age
14 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Participant reports serious current suicidal ideation and/or intent at baseline

Study design
Purpose of the study
Prevention
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)
Randomised by Qualtrics software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/05/2024
Actual
3/05/2024
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
166
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314132 0
Government body
Name [1] 314132 0
Western Australian Future Health Research and Innovation Fund (Government of Western Australia, Department of Health)
Country [1] 314132 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Telethon Kids Institute
Address
Perth Children's Hospital, 15 Hospital Avenue, Nedlands WA 6008
Country
Australia
Secondary sponsor category [1] 317501 0
None
Name [1] 317501 0
Address [1] 317501 0
Country [1] 317501 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313267 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 313267 0
Ethics committee country [1] 313267 0
Australia
Date submitted for ethics approval [1] 313267 0
22/06/2023
Approval date [1] 313267 0
06/12/2023
Ethics approval number [1] 313267 0

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

Contacts
Principal investigator
Name 127542 0
A/Prof Yael Perry
Address 127542 0
Perth Childrens Hospital 15 Hospital AveNedlands 6009
Country 127542 0
Australia
Phone 127542 0
+61 411 894 613
Fax 127542 0
Email 127542 0
[email protected]
Contact person for public queries
Name 127543 0
Holly Moss
Address 127543 0
Perth Childrens Hospital 15 Hospital Ave Nedlands 6009
Country 127543 0
Australia
Phone 127543 0
+61 8 6319 1000
Fax 127543 0
Email 127543 0
[email protected]
Contact person for scientific queries
Name 127544 0
Holly Moss
Address 127544 0
Perth Childrens Hospital 15 Hospital AveNedlands 6009
Country 127544 0
Australia
Phone 127544 0
+61 8 6319 1000
Fax 127544 0
Email 127544 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19640Study protocol    386121-(Uploaded-12-12-2023-13-23-01)-Study-related document.docx
19641Informed consent form    386121-(Uploaded-09-01-2024-14-20-41)-Study-related document.docx
19642Ethical approval    386121-(Uploaded-09-01-2024-14-20-14)-Study-related document.pdf



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.