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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]

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

Gambling addiction

Condition category

Condition code

Mental Health

Addiction

Public Health

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]

Behaviour

Intervention code [2]

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]

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]

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]

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]

Secondary outcome [2]

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]

Secondary outcome [3]

Harm experienced by someone else’s gambling. This can be measured through the Short Gambling Harms Scale for Affected Others

Timepoint [3]

Secondary outcome [4]

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]

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]

2016 - Redfern

Recruitment postcode(s) [2]

2770 - Mount Druitt

Recruitment postcode(s) [3]

2560 - Campbelltown

Recruitment postcode(s) [4]

2830 - Dubbo

Recruitment postcode(s) [5]

2430 - Taree

Recruitment postcode(s) [6]

2820 - Wellington

Recruitment postcode(s) [7]

2300 - Newcastle

Recruitment postcode(s) [8]

2302 - Newcastle West

Recruitment postcode(s) [9]

2500 - Wollongong

Recruitment postcode(s) [10]

2839 - Brewarrina

Recruitment postcode(s) [11]

2832 - Walgett

Recruitment postcode(s) [12]

2840 - Bourke

Recruitment postcode(s) [13]

2650 - Wagga Wagga

Recruitment postcode(s) [14]

2540 - Jervis Bay

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NSW Office of Responsible Gambling

Address [1]

Responsible Gambling Fund
PO Box 7060
Sydney, NSW 2001

Country [1]

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]

Commercial sector/Industry

Name [1]

NSW Aboriginal Safe Gambling Service

Address [1]

8 Spence Street
Warners Bay
2282

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

Menzies School of Health Research

Address [1]

Menzies School of Health Research
PO Box 41096
Casuarina NT 0811

Country [1]

Australia

Other collaborator category [2]

Commercial sector/Industry

Name [2]

Thinkplace

Address [2]

50 Blackall St
Barton ACT 2600

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

AIATSIS Research Ethics Committee

Ethics committee address [1]

AIATSIS Research Ethics Committee
GPO Box 553
Canberra ACT 2601
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/09/2019

Approval date [1]

16/12/2019

Ethics approval number [1]

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

Dr Marisa Paterson

Address

Centre for Gambling Research
Centre for Social Research and Methods
The Australian National University
Level 2, Beryl Rawson Building (#13)
Canberra ACT 2601

Country

Australia

Phone

+61 436 811 151

Fax

[email protected]

Contact person for public queries

Name

Marisa Paterson

Address

Centre for Gambling Research
Centre for Social Research and Methods
The Australian National University
Level 2, Beryl Rawson Building (#13)
Canberra ACT 2601

Country

Australia

Phone

+61 436 811 151

Fax

[email protected]

Contact person for scientific queries

Name

Marisa Paterson

Address

Centre for Gambling Research
Centre for Social Research and Methods
The Australian National University
Level 2, Beryl Rawson Building (#13)
Canberra ACT 2601

Country

Australia

Phone

+61 436 811 151

Fax

[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.	Type	Other Details	Attachment
6111	Study protocol	This document will be made available through an at... [More Details]
6112	Ethical approval		378904-(Uploaded-17-12-2019-10-25-47)-Study-related document.pdf
6113	Statistical analysis plan	This document will be made available through an at... [More Details]

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.

Trial Review

Documents added manually

Documents added automatically