Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001785190
Ethics application status
Approved
Date submitted
10/12/2019
Date registered
17/12/2019
Date last updated
17/12/2019
Date data sharing statement initially provided
17/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Talking about Aboriginal Gambling: Examining the effectiveness of Facebook groups to reduce gambling harm within Aboriginal communities in New South Wales, Australia
Scientific title
Examining the effectiveness of Facebook groups to reduce gambling harm within Aboriginal communities in New South Wales, Australia
Secondary ID [1] 300046 0
Nil known
Universal Trial Number (UTN)
U1111-1237-1361
Trial acronym
TAG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gambling harm 315549 0
Gambling addiction 315604 0
Condition category
Condition code
Mental Health 313838 313838 0 0
Addiction
Public Health 313894 313894 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The impact of Facebook online health communities to address gambling harm in Aboriginal communities in NSW, Australia.

This project will evaluate the effectiveness of a community-developed, co-designed online health promotion platform in reducing harm from gambling in NSW Aboriginal communities. The proposed evaluation methodology is a Randomised Control Trial (RCT) stepped-wedge design, as well as a mixed-methods process evaluation. The trial will consist of 10 steps, spaced 2 weeks apart.

Materials utilised for the trial will include Facebook, with all participants having their own personal account. This will be accessed through participant’s personal digital devices. The online content will consist of discussion prompts about gambling, information about the harms of gambling, information about gambling odds, and support services available in the community. This will be conveyed through community-generated videos, informational posts and forum discussion. A schedule for the Facebook content has been developed, whereby each fortnight focuses on a different theme. The six themes are strength, drivers, awareness, alternatives, helping and reflection. Every 2-3 days a new post will be made to the group. The groups will be moderated by the research team for 12 weeks, after which the Facebook group will continue to exist, but content will not continue to be posted routinely.

Recruitment will be conducted through Facebook advertising, and though word-of-mouth within the communities. All individuals that are over the age of 18 and live in the participating communities are able to join the group. While the focus is Aboriginal communities in NSW, individuals who do not identify as Indigenous are still in scope of the study.

The treatment is exposure to the Facebook group, and therefore there is no individual providing the treatment. Frequency of access to the group is to the participant’s discretion. Data on interaction with the group will be collected. Participants will access the online resource in any location where they feel comfortable.

Treatment will not be personalised or adapted to individuals within the study. Adherence will be assessed by asking participants the frequency with which they accessed the Facebook group. Only those who are in the Facebook group will be eligible to participate in the study.
Intervention code [1] 316316 0
Behaviour
Intervention code [2] 316351 0
Treatment: Other
Comparator / control treatment
A stepped-wedge RCT design is being implemented, with timing of treatment staggered amongst participating communities. The ordering of treatment is randomised. The “comparison” group is those who have not yet received the treatment.
Control group
Active

Outcomes
Primary outcome [1] 322232 0
Classification of being at risk of problem/moderate/low risk gambling. This will be measured by the PGSI (Problem Gambling Severity Index), gauged through baseline and survey data.
Timepoint [1] 322232 0
Baseline (at commencement of study) and 10-12 weeks following set-up of the specific community Facebook group. The Facebook groups for each community will be set up on a rolling basis through the stepped-wedge approach.
Secondary outcome [1] 377806 0
Gambling frequency (by activity). This is measured through a question:
Over the last 3 months, how many days per week, on average, have you….
01. Played poker machines or gaming machines at a venue
02. Played table games such as Blackjack, poker or Roulette at a casino?
03. Played pokie games or other casino games online for money?
04. Bet on horse or greyhound races excluding sweeps?
05. Bought instant scratch tickets?
06. Played a lottery game like Tattslotto or Powerball?
07. Played Keno
08. Played bingo or housie?
09. Bet on a sporting or special event like football, cricket, tennis, a TV show, or election (excluding sweeps)?
10. Played informal games like darts, cards, mah-jong or snooker privately for money?
11. Bought raffles tickets
This scale has been used previously in the ACT Gambling Prevalence Survey.

This scale will be incorporated into baseline and follow-up surveys,
Timepoint [1] 377806 0
Baseline (at commencement of study) and 10-12 weeks following set-up of the specific community Facebook group. The Facebook groups for each community will be set up on a rolling basis through the stepped-wedge approach.
Secondary outcome [2] 377807 0
Gambling expenditure (by activity), gauged through the question:
"Subtracting any winnings, how much money, in dollars, were you out of pocket across all these activities in the last 3 months?". The response format is comprised of price brackets. This scale has been used previously in the ACT Gambling Prevalence Survey.

This scale will be incorporated into baseline and follow-up surveys,
Timepoint [2] 377807 0
Baseline (at commencement of study) and 10-12 weeks following set-up of the specific community Facebook group. The Facebook groups for each community will be set up on a rolling basis through the stepped-wedge approach.
Secondary outcome [3] 377808 0
Harm experienced by someone else’s gambling. This can be measured through the Short Gambling Harms Scale for Affected Others
Timepoint [3] 377808 0
Baseline (at commencement of study) and 10-12 weeks following set-up of the specific community Facebook group. The Facebook groups for each community will be set up on a rolling basis through the stepped-wedge approach.
Secondary outcome [4] 377981 0
What themes and content are most engaging and impactful for participants? This will be measured through 'reactions' to content and posts as shown through Facebook Analytics. We will also analyse the Facebook posts qualitatively by assessing how people have engaged and responded to the material.
Timepoint [4] 377981 0
Data is collected throughout the 10-12 weeks of implementation. The data for each community will be collated and analysed following the completion of that community's involvement in the study.

Eligibility
Key inclusion criteria
10 communities in NSW have been chosen for inclusion in the study based on a high representation of Aboriginal and/or Torres Strait Islander people, and known gambling concerns in the community. These communities are:
1. Dubbo and Wellington
2. Wollongong
3. Campbelltown
4. Redfern
5. South Coast
6. Wagga Wagga
7. Bourke, Brewarrina and Walgett
8. Taree
9. Mt Druitt
10. Newcastle

All adults who live in the participating communities are eligible to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Under 18
• Individuals not residing in the trial communities
• Individuals who cannot speak English adequately and would be unable to engage in the online platform and respond to the surveys
• People with a disability such that they are unable to engage in the online platform, and respond to the surveys

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)
Simple randomisation using random number generator in Excel.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The order in which the 10 participating communities are exposed to the program is randomised. This randomisation has already been conducted using a random number generator in Excel.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was determined by modelling two scenarios according to whether we are considering the proportion of people at risk of problem or moderate risk gambling (estimated to be 36%) or the proportion at risk of problem gambling (approx.. 20%).
Outcome:
Proportion of people classified as at risk of problem or moderate risk gambling
P(PG or MR) = 0.36 (based on Hing et al study (Hing, Breen et al. 2013))
Beta (Power)= 0.8 (NOTE reducing Beta to 0.70 reduces detectable difference to 0.077)
Alpha (p-value) = 0.05
Rho (Intra-cluster correlation) = 0.02
Clusters (communities) = 10
Detectable difference = 0.104
Total observations = 1000 (500 before and 500 after with 50 in each cluster).
NOTES: Increasing cluster to 60 decreases the detectable difference to 0.097
Decreasing cluster to 40 increases the detectable difference to 0.115
Reducing Beta to 0.70 reduces detectable difference to 0.092
Outcome:
Proportion of people classified as at risk of problem gambling
P(PG) = 0.20 (based on Hing et al study (Hing, Breen et al. 2013))
Beta (Power)= 0.8
Alpha (p-value) = 0.05
Rho (Intra-cluster correlation) = 0.02
Clusters (communities) = 10
Detectable difference = 0.087
Total observations = 1000 (500 before and 500 after with 50 in each cluster)
NOTES: Increasing cluster to 60 decreases the detectable difference to 0.081
Decreasing cluster to 40 increases the detectable difference to 0.095
Reducing Beta to 0.70 reduces detectable difference to 0.077
As shown in the above calculations, the proposed sample size of 1,000 (100 participants in each community) will obtain the required confidence for the treatment effect.

For analysis of the data, firstly descriptive statistics on the characteristics of individuals and clusters (communities) will be compared between exposed and unexposed to assess if there is any selection bias resulting from differences in communities and selection of individuals between communities. At its simplest, the analysis of the RCT will compare the distribution of outcomes across the unexposed (control) observation period with the exposed (health promotion and app) period, controlling for estimated change through time across NSW that is not attributable to the program.
It is likely that two measures will be calculated. The first is an Intention to Treat Effect (ITTE) which measures the effect on survey outcomes from having access to the program. The second measure is a Local Average Treatment Effect (LATE), which is an estimate of the direct effect of the program for those who opt-in to using it. Under certain assumptions, the LATE is the ITTE divided by the proportion of people in the sample who opt-in. Both the ITTE and the LATE are informative for policy.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/03/2020
Actual
Date of last participant enrolment
Anticipated
20/07/2020
Actual
Date of last data collection
Anticipated
27/11/2020
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 28771 0
2016 - Redfern
Recruitment postcode(s) [2] 28772 0
2770 - Mount Druitt
Recruitment postcode(s) [3] 28773 0
2560 - Campbelltown
Recruitment postcode(s) [4] 28774 0
2830 - Dubbo
Recruitment postcode(s) [5] 28775 0
2430 - Taree
Recruitment postcode(s) [6] 28776 0
2820 - Wellington
Recruitment postcode(s) [7] 28777 0
2300 - Newcastle
Recruitment postcode(s) [8] 28778 0
2302 - Newcastle West
Recruitment postcode(s) [9] 28779 0
2500 - Wollongong
Recruitment postcode(s) [10] 28780 0
2839 - Brewarrina
Recruitment postcode(s) [11] 28781 0
2832 - Walgett
Recruitment postcode(s) [12] 28782 0
2840 - Bourke
Recruitment postcode(s) [13] 28783 0
2650 - Wagga Wagga
Recruitment postcode(s) [14] 28784 0
2540 - Jervis Bay

Funding & Sponsors
Funding source category [1] 304497 0
Government body
Name [1] 304497 0
NSW Office of Responsible Gambling
Country [1] 304497 0
Australia
Primary sponsor type
University
Name
Australian National University Centre for Gambling Research
Address
Centre for Gambling Research
Centre for Social Research and Methods
The Australian National University
Level 2, Beryl Rawson Building (#13)
Canberra ACT 2601
Australia
Country
Australia
Secondary sponsor category [1] 304766 0
Commercial sector/Industry
Name [1] 304766 0
NSW Aboriginal Safe Gambling Service
Address [1] 304766 0
8 Spence Street
Warners Bay
2282
Country [1] 304766 0
Australia
Other collaborator category [1] 281092 0
University
Name [1] 281092 0
Menzies School of Health Research
Address [1] 281092 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Country [1] 281092 0
Australia
Other collaborator category [2] 281093 0
Commercial sector/Industry
Name [2] 281093 0
Thinkplace
Address [2] 281093 0
50 Blackall St
Barton ACT 2600
Country [2] 281093 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304930 0
AIATSIS Research Ethics Committee
Ethics committee address [1] 304930 0
AIATSIS Research Ethics Committee
GPO Box 553
Canberra ACT 2601
Australia
Ethics committee country [1] 304930 0
Australia
Date submitted for ethics approval [1] 304930 0
04/09/2019
Approval date [1] 304930 0
16/12/2019
Ethics approval number [1] 304930 0
EO141-04092019

Summary
Brief summary
This project, Talking about Aboriginal Gambling (TAG), will evaluate the effectiveness of a community-developed, co-designed online health promotion platform in reducing harm from gambling in NSW Aboriginal communities. The proposed evaluation methodology is a Randomised Control Trial (RCT) stepped-wedge design, as well as a mixed-methods process evaluation. This proposal presents a unique partnership between the NSW Aboriginal Safe Gambling Service, Australian National University (ANU) Centre for Gambling Research, Menzies School of Health Research (MSHR) and ThinkPlace. The design of the online health promotion platform was developed through a community co-design process with ThinkPlace, the NSW Aboriginal Safe Gambling Service and Aboriginal communities in NSW.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98674 0
Dr Marisa Paterson
Address 98674 0
Centre for Gambling Research
Centre for Social Research and Methods
The Australian National University
Level 2, Beryl Rawson Building (#13)
Canberra ACT 2601
Country 98674 0
Australia
Phone 98674 0
+61 436 811 151
Fax 98674 0
Email 98674 0
[email protected]
Contact person for public queries
Name 98675 0
Dr Marisa Paterson
Address 98675 0
Centre for Gambling Research
Centre for Social Research and Methods
The Australian National University
Level 2, Beryl Rawson Building (#13)
Canberra ACT 2601
Country 98675 0
Australia
Phone 98675 0
+61 436 811 151
Fax 98675 0
Email 98675 0
[email protected]
Contact person for scientific queries
Name 98676 0
Dr Marisa Paterson
Address 98676 0
Centre for Gambling Research
Centre for Social Research and Methods
The Australian National University
Level 2, Beryl Rawson Building (#13)
Canberra ACT 2601
Country 98676 0
Australia
Phone 98676 0
+61 436 811 151
Fax 98676 0
Email 98676 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All participant data, after de-identification
When will data be available (start and end dates)?
Immediately following publication with no end date
Available to whom?
Only researchers/communities who provide a methodologically sound proposal
Available for what types of analyses?
Any analysis that is appropriate. The Primary Investigator will be responsible for approving access, through consultation with the research team.
How or where can data be obtained?
The data can be accessed through the Australian Data Archive's dataverse (https://dataverse.ada.edu.au/). This allows for individuals to apply for access to the data through an online portal. That request will be filtered through to the chief investigator, who can accept or reject the request based on the integrity of the requester's research proposal.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6111Study protocol    This document will be made available through an at... [More Details]
6112Ethical approval    378904-(Uploaded-17-12-2019-10-25-47)-Study-related document.pdf
6113Statistical analysis plan    This document will be made available through an at... [More Details]



Results publications and other study-related documents

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