Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000934549p
Ethics application status
Submitted, not yet approved
Date submitted
10/07/2024
Date registered
1/08/2024
Date last updated
1/08/2024
Date data sharing statement initially provided
1/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Facts and Fiction in the Internet Age: A trial on online myths and education about important social issues.
Scientific title
Randomised controlled trial evaluating the effectiveness of an online misinformation inoculation game in improving vaccine attitudes, institutional trust, and misinformation recognition among with Arabic speakers in Australia
Secondary ID [1] 312496 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaccine attitudes 334357 0
Condition category
Condition code
Public Health 331001 331001 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Procedure:
1. Participants will be recruited from paper flyers, social media community groups and community chat groups that are specific to, or have majority membership of, Arabic-Australians. The flyers and posts will provide a link and/or QR code to the REDCap landing page of the baseline survey. The landing page will provide information about the project, a downloadable participant information sheet, and consent form.
2. Consenting participants will complete screening questions (1-2 minutes) and, if they are eligible, the baseline survey (appox 10 minutes). On completion of the baseline survey, participants will be automatically randomly allocated to the intervention or control condition. This will appear relatively seamless to participants as links and randomisation will be embedded in the survey.
3. Participants allocated to the intervention condition by the algorithm upon completion of the baseline survey will be taken to the Cranky Uncle Vaccine – Arabic game (Arabic language). Participants will be required to complete at least eight of the ten misinformation tricks (also 'game levels'; approximately 20-40 minutes of play). After eight tricks are completed, a pop-up will inform the player of their progress and give the option to complete all ten tricks or proceed to the post-intervention survey. If the player chooses to continue the game, the post-intervention survey will begin immediately after the ten tricks of the game are completed. The tricks are not randomised. It is possible for a participant to stop playing the game before level 8 and return to it later. This will not disqualify them from the trial. Deidentified meta data will provide insights into game completion rates and times.
4. Participants allocated to the control condition by the algorithm upon completion of the baseline survey will be taken to a YouTube video that is embedded within the Cranky Uncle Vaccine – Arabic game’s programming architecture. This will be an English-language with Arabic subtitles documentary about the effects of climate change, of approximately 12 minutes duration. When the video finishes, the player will be instructed to click a button on screen that takes them to the post-intervention survey.
5. The post-intervention survey has the same outcome measures as the baseline survey, wihout demographic questions. It takes approximately 8-10 minutes to complete.
6. A $15 electronic gift card will be emailed or texted (at the participant's discretion) to the participant to reimburse them for their time.
7. Three weeks after completion of the post-trial survey, an email and/or text (mode is participant's choice) will be sent to participants via REDCap inviting them to the follow-up survey. Participants will click the link to complete the survey.
8. The follow-up survey includes the same outcome measures as surveys 1 and 2, as well as 2 satisfaction questions about their 'activity'.
9. An electronic gift card will be emailed or texted to the participant upon completion of the follow-up survey to reimburse participants for their time. This will mark the end of their participation in the trial.


Intervention description: The Cranky Uncle Vaccine – Arabic game is available through any web browser via URL which will be automatically linked from the REDCap baseline survey following randomisation. The game begins with several onboarding screens, where the player is introduced to the characters as they learn how to play the game. The main characters are Cranky Uncle and the Health Worker. Cranky Uncle is an older man who believes conspiracy theories and spreads misinformation about vaccines by applying ten different psychological techniques, which he calls “tricks”. These include tricks like “False cause”, where he implies that two things that occur close in time must be related, and “Fake experts”, where he suggests that people with expertise in one area must be reliable experts in another unrelated field. The Health Worker responds to Cranky Uncle, sharing vaccine information and helping explain his tricks to the player. Several other characters also appear throughout the game to share vaccine facts or listen to Cranky Uncle’s tricks. Each screen is a static graphic, like a comic book, with a speech bubble of one to two sentences of text written in Modern Standard Arabic. Participants click “Next” after they read each screen to move ahead in the game.
After completing the onboarding section, participants enter the first level of the game, where they learn the first trick. Each trick level includes a definition and example of the trick, as well as two quizzes to test the player’s understanding of the concept. The quizzes are multiple choice or true/false. When the player gets a quiz answer correct, they earn “Cranky Points” and make Cranky Uncle angrier because they are learning to see through his misinformation. When they get an answer wrong, they lose points and return to the quiz question to try again. Players progress through all the trick levels and earn points by completing quizzes throughout the game.
There are ten levels in the game, each comprising a misinformation trick. Participants will be required to complete at least eight of the ten misinformation tricks (approximately 20-40 minutes of play). After eight tricks are completed, a pop-up will inform the player of their progress and give the option to complete all ten tricks or proceed to the post-intervention survey. If the player chooses to continue the game, the post-intervention survey will begin immediately after the ten tricks of the game are completed. The game’s server retains no identifying player data.
Intervention code [1] 329018 0
Behaviour
Comparator / control treatment
Control: Participants allocated to the control condition by the algorithm upon completion of the baseline survey will be taken to a YouTube video that is embedded within the Cranky Uncle Vaccine – Arabic game’s programming architecture. This will be an English-language documentary about the effects of climate change, of approximately 15 minutes duration. Arabic subtitles are automatically also displayed on the video. When the video finishes, the player will be instructed to click a button on screen that takes them to the post-intervention survey.

The video, titled "Arabic - Climate Change 2014: Impacts, Adaptation and Vulnerability (Arabic)" was created by the Intergovernmental Panel on Climate Change (IPCC). It is publicly available on YouTube: https://youtu.be/TxhyePAcyus?si=pBGjsENK0ZTv7ul2.
Control group
Placebo

Outcomes
Primary outcome [1] 338768 0
Vaccine attitudes
Timepoint [1] 338768 0
Baseline; immediately post-intervention; 3 week follow-up
Secondary outcome [1] 437382 0
Vaccine Misinformation Discernment
Timepoint [1] 437382 0
Baseline; immediately post-intervention; 3 week follow-up.
Secondary outcome [2] 437383 0
Institutional Trust
Timepoint [2] 437383 0
Baseline; immediately post-intervention; 3 week follow-up.

Eligibility
Key inclusion criteria
Eligibility will be determined with screening questions at the beginning of the baseline survey. The first three eligibility criteria listed below will be asked after the participant gives consent in the baseline survey. If all these criteria are not met, the participant exits the survey and cannot be allocated to either condition. The remaining three criteria are assumed through the participant’s ability to navigate the online recruitment and baseline survey process:
• Primary residence in Australia
• Is aged 16 years or older at the time of randomisation.
• Can read Modern Standard Arabic.
• Has the technical skills to independently play an online educational game (e.g., can click on multiple choice answers, navigate the game using ‘next’ and ‘home’ buttons).
• Has the technical skills to independently complete an online survey in REDCap.
• Reads the participant information and consent form and gives active informed consent by completing the e-consent form in REDCap.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no criteria that would exclude individuals who meet all inclusion criteria.

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)
The recruitment materials will present the project’s aim as investigating “people’s attitudes to significant issues such as vaccines and climate change” to blind participants to their condition allocation.
The researchers will not be privy to participants’ individual condition allocation. The condition allocation variable will be set as an ‘identifier field’ in REDCap and will not be exported by researchers when compiling contact details to send honoraria to participants. The link to the follow-up survey will be sent via REDCap.
Participants will be allocated to the intervention or control condition via an algorithm created and embedded in the baseline survey by external teams, namely the Murdoch Children's Research Institute's (MCRI) Clinical Epidemiology and Biostatistics Unit (CEBU) and REDCap teams. The research team will not be privy to the specifics of this randomisation process at any stage of the data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random generation algorithm not developed or implemented by the research team but by the Clinical Epidemiology and Biostatistics Unit (CEBU), who are an independent team experienced with randomisation for clinical trials. Permuted block randomisation will be used to randomly allocate participants to the intervention and control conditions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

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
Not yet recruiting
Date of first participant enrolment
Anticipated
12/08/2024
Actual
Date of last participant enrolment
Anticipated
9/09/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316919 0
Government body
Name [1] 316919 0
Victorian Department of Health
Country [1] 316919 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Children’s Trials Centre
Address
Country
Australia
Secondary sponsor category [1] 319166 0
None
Name [1] 319166 0
Address [1] 319166 0
Country [1] 319166 0
Other collaborator category [1] 283110 0
University
Name [1] 283110 0
University of Melbourne
Address [1] 283110 0
Country [1] 283110 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315674 0
The Royal Children’s Hospital Human Research Ethics Committee
Ethics committee address [1] 315674 0
Ethics committee country [1] 315674 0
Australia
Date submitted for ethics approval [1] 315674 0
19/07/2024
Approval date [1] 315674 0
Ethics approval number [1] 315674 0

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

Contacts
Principal investigator
Name 135462 0
Dr Jessica Kaufman
Address 135462 0
Vaccine Uptake Group, MCRI, 50 Flemington Rd, Parkville, VIC. 3052
Country 135462 0
Australia
Phone 135462 0
+6139345 4890
Fax 135462 0
Email 135462 0
jess.kaufman@mcri.edu.au
Contact person for public queries
Name 135463 0
Jessica Kaufman
Address 135463 0
Vaccine Uptake Group, MCRI, 50 Flemington Rd, Parkville, VIC. 3052
Country 135463 0
Australia
Phone 135463 0
+6139345 4890
Fax 135463 0
Email 135463 0
jess.kaufman@mcri.edu.au
Contact person for scientific queries
Name 135464 0
Jessica Kaufman
Address 135464 0
Vaccine Uptake Group, MCRI, 50 Flemington Rd, Parkville, VIC. 3052
Country 135464 0
Australia
Phone 135464 0
+6139345 4890
Fax 135464 0
Email 135464 0
jess.kaufman@mcri.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified numerical self-complete attitudinal survey responses. Trial protocol. Statistical Analysis Plan.
The data will not be re-identifiable.
When will data be available (start and end dates)?
Beginning 6 months following analysis and article publication data will be available long-term.
Available to whom?
future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI’s conditions for access.
Available for what types of analyses?
Analyses that have ethically reviewed and approved by an independent committee and who accept MCRI’s conditions for access.
How or where can data be obtained?
Until entered to a data repository, equiries about IPD must be emailed to Sophia Vasiliadis, at sophia.vasiliadis@mcri.edu.au.
Data may be stored in Figshare data repository.
6 months after analysis and publication, data will be available long-term to researchers from recognised institutions whose study is ethically approved by an independent committee and who accept MCRI’s conditions for access.


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.