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Trial registered on ANZCTR


Registration number
ACTRN12612000384853
Ethics application status
Approved
Date submitted
26/03/2012
Date registered
4/04/2012
Date last updated
27/01/2023
Date data sharing statement initially provided
27/01/2023
Date results information initially provided
27/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Strengthening community partnerships to promote adolescent school engagement and prevent problems such as alcohol misuse
Scientific title
Strengthening community partnerships to promote adolescent school engagement and prevent problems such as alcohol misuse
Secondary ID [1] 280110 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uptake of alcohol by adolescents, and alcohol consumption by adolescents 286027 0
Condition category
Condition code
Public Health 286217 286217 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Information outlining the Australian National Health and Medical Research Council (NHMRC) safe drinking guidelines for children will be circulated. These guidelines recommend that children under the age of 18 should not consume alcohol (message 1).

Information will be provided to children and their parents/guardians (via their school). This information will promote delaying the consumption of alcohol by adolescents until the age of 18.

Via this information, we will also encourage parents to set a rule with their child that alcohol is not to be consumed by their child until the age of 18 (message 2). Parents will also be encouraged not to provide alcohol to their children until they are 18 years of age (message 3).

The three key messages identified above will be reinforced via school classes and and schools will develop activities with their broader communities to help further promotion of these key messages.

Printed resources will provide information on the NHMRC drinking guidelines and the three key messages. These will take the form of booklets, brochures, posters and bookmarks. These resources have been developed by the intervention team and have been tested for clarity and appeal with focus groups.

Within each community a coalition of commuinity individuals will work with the schools to help deliver and reinforce the key messages. The coaltion will also try and spread these messages to the broader community.

Specifically the coaltion will develop a social marketing plan that will outlne activities that will take place through the school and the broader community.

The social marketing plan will identify strategies that each school and community will use to promote the three key messages. For example they may choose to promote the drinking guidelines at key community events; they may place posters around the community highlighting the drinking guidelines, and the need for parents to set a rule about drinking. They may circulate printed resources through existing community services.

Each community will document their activites, and this will be provided in a formal social marketing plan to the research and evaluation team. Coalitions will be provided with a total $5000 dollars to implement social marketing activities.

Schools will use the information for approximately one school year, and the broader community will use the information for approximately one calender year.

Communities will be audited to ensure that ther submitted social marketing plan is being implemented faithfully.

Liqour outlets (stores that sell alcohol to) will also be monitored for the sale of alcohol to indiviudals under the age of 18. As this against the law, the research team will provide feedback to these outlets, and encourage them to change their selling practices. Feedback to stores who are breaking the law will only be provided to stores in the intervention communities.
Intervention code [1] 284440 0
Prevention
Intervention code [2] 284605 0
Behaviour
Intervention code [3] 284606 0
Lifestyle
Comparator / control treatment
Control communities will not receive any of the project activities.
Control group
Active

Outcomes
Primary outcome [1] 286690 0
Reduction in the reported number of standard alcoholic drinks by Adolescents in the last week and last 30 days.

This information will be gathered by a questionnaire.
Timepoint [1] 286690 0
Baseline measures in each of the communities have been done between 2006 and 2009. Measures will be repeated in all the communities, after the intervention in 2013.

The questionnaire used in 2013 (after the intervention), will be the same one that has been used to assess baseline measures for the communities between 2006-2009.
Secondary outcome [1] 296469 0
A reduction in the self-report of adolescents receiving alcohol from parents.

This information will be gathered by a questionnaire.
Timepoint [1] 296469 0
Baseline measures in each of the communities have been done between 2006 and 2011. Measures will be repeated in all the communities, after the intervention in 2013.

The questionnaire used in 2013 (after the intervention), will be the same one that has been used to assess baseline measures for the communities between 2006-2009.
Secondary outcome [2] 296838 0
A reduction in the intention to consume alcohol before the age of 18.

This information will be gathered by a questionnaire.
Timepoint [2] 296838 0
Baseline measures in each of the communities have been done between 2006 and 2011. Measures will be repeated in all the communities, after the intervention in 2013.

The questionnaire used in 2013 (after the intervention), will be the same one that has been used to assess baseline measures for the communities between 2006-2009.

Eligibility
Key inclusion criteria
The key inclusion criteria are as follows:

(i) regions with large numbers of children and adolescents; (ii) no proximal boundaries;
(iii) a representation of Australia’s national variation in socioeconomic disadvantage; and
(iv) variation in metropolitan versus non-metropolitan location.

A large survey of primary and secondary school students in these communities (N=8,500) was used to inform 14 matched community pairs, random assignment was then used to allocate half into the intervention. The design accords with the CONSORT guidelines for non-pharmacological trials.
Minimum age
11 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

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)
Matched on the selection criteria above (see section - Key inclusion criteria), 14 community pairs from three states (Victoria, Queensland & Western Australia) will be determined.

Communities will be matched then be randomly allocated to the intervention and the other community allocated to the control condition.

Students within each community will be anonymously approached, based upon the postcode in which their primary school or high school resides.

Alllocation to groups was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using a computer program, communities were matched to similar communities based on the criteria described above:


(i) regions with large numbers of children and adolescents; (ii) no proximal boundaries;
(iii) a representation of Australia’s national variation in socioeconomic disadvantage; and
(iv) variation in metropolitan versus non-metropolitan location.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2012
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
2/09/2013
Date of last data collection
Anticipated
Actual
2/12/2013
Sample size
Target
8500
Accrual to date
Final
3377
Recruitment in Australia
Recruitment state(s)
QLD,WA,VIC
Recruitment postcode(s) [1] 5099 0
3550
Recruitment postcode(s) [2] 5100 0
3978
Recruitment postcode(s) [3] 5101 0
3810
Recruitment postcode(s) [4] 5102 0
3152
Recruitment postcode(s) [5] 5103 0
3220
Recruitment postcode(s) [6] 5104 0
3280
Recruitment postcode(s) [7] 5105 0
3364
Recruitment postcode(s) [8] 5106 0
4226
Recruitment postcode(s) [9] 5107 0
6430
Recruitment postcode(s) [10] 5108 0
6210
Recruitment postcode(s) [11] 5109 0
3630
Recruitment postcode(s) [12] 5110 0
3631
Recruitment postcode(s) [13] 5111 0
7307
Recruitment postcode(s) [14] 5112 0
4670
Recruitment postcode(s) [15] 5113 0
4350
Recruitment postcode(s) [16] 5114 0
4157
Recruitment postcode(s) [17] 5115 0
4161
Recruitment postcode(s) [18] 5116 0
4285
Recruitment postcode(s) [19] 5117 0
4558
Recruitment postcode(s) [20] 5118 0
4556
Recruitment postcode(s) [21] 5119 0
6065
Recruitment postcode(s) [22] 5126 0
4114
Recruitment postcode(s) [23] 5127 0
4020
Recruitment postcode(s) [24] 5128 0
3047
Recruitment postcode(s) [25] 5129 0
6021

Funding & Sponsors
Funding source category [1] 284872 0
Government body
Name [1] 284872 0
Australian Research Council
Country [1] 284872 0
Australia
Funding source category [2] 284967 0
Hospital
Name [2] 284967 0
Centre for Adolescent Health at the Murdoch Childrens Research Institute (MCRI), Royal Childrens Hospital
Country [2] 284967 0
Australia
Funding source category [3] 284968 0
Charities/Societies/Foundations
Name [3] 284968 0
Communities That Care Ltd.
Country [3] 284968 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Waterfront Campus, Locked Bag 20000 Geelong, Victoria 3220
Country
Australia
Secondary sponsor category [1] 283750 0
Hospital
Name [1] 283750 0
Centre for Adolescent Health at the Murdoch Childrens Research Institute (MCRI), Royal Childrens Hospital
Address [1] 283750 0
Flemington Road, Parkville, 3052
Country [1] 283750 0
Australia
Secondary sponsor category [2] 283751 0
Charities/Societies/Foundations
Name [2] 283751 0
Communities That Care Ltd.
Address [2] 283751 0
50 Flemington Rd, Parkville, Victoria, 3052.
Country [2] 283751 0
Australia
Other collaborator category [1] 260614 0
Charities/Societies/Foundations
Name [1] 260614 0
Keep em Safe Inc
Address [1] 260614 0
474 Ryrie St, East Geelong, Victoria, 3219
Country [1] 260614 0
Australia
Other collaborator category [2] 260615 0
Charities/Societies/Foundations
Name [2] 260615 0
Australian Drug Foundation
Address [2] 260615 0
PO Box 818 North Melbourne 3051, Victoria.
Country [2] 260615 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286857 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 286857 0
Human Research Ethics Office, Deakin Research Integrity, Deakin University, 221 Burwood Hwy, Burwood, Victoria 3125
Ethics committee country [1] 286857 0
Australia
Date submitted for ethics approval [1] 286857 0
Approval date [1] 286857 0
24/06/2011
Ethics approval number [1] 286857 0
EC00213

Summary
Brief summary
This study will identify whether promotiong the NHMRC safe drinking guidelines for children - not drinking before the age of 18 - has an impact on the uptake an overall alcohol consumption levels of children.

Relative to the 14 control communities the adolescent children (age 11 to 17) in the 14 communities that have been randomly assigned to participate in the intervention process will demonstrate an average 15% greater decrease (relative to controls) in the prevalence of alcohol use.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33895 0
Prof John Toumbourou
Address 33895 0
1 Gheringhap Street, Geelong VIC 3220, Deakin University
Country 33895 0
Australia
Phone 33895 0
+61 352278278
Fax 33895 0
Email 33895 0
[email protected]
Contact person for public queries
Name 17142 0
Prof Prof John Toumbourou
Address 17142 0
1 Gheringhap Street, Geelong VIC 3220, Deakin University
Country 17142 0
Australia
Phone 17142 0
+61 352278278
Fax 17142 0
not provided.
Email 17142 0
[email protected]
Contact person for scientific queries
Name 8070 0
Dr Mr Bosco Rowland
Address 8070 0
221 Burwood Highway, Burwood Victoria 3125, Deakin University
Country 8070 0
Australia
Phone 8070 0
+61 3 924 43002
Fax 8070 0
not provided.
Email 8070 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?
Only individual participant data underlying published results will be made available. However, researchers can apply to analyse participant data that has not yet been published.
When will data be available (start and end dates)?
Participant data is expected to be made available beginning 3 months and ending 5 years following the publication of results.
Available to whom?
Suitably qualified researchers will be required to provide a methodologically sound research proposal.
Available for what types of analyses?
Applications will be evaluated by the Investigator Team for scientific merit and congruence with the team policies and project aims of the approved proposal.
How or where can data be obtained?
Researchers applying to analyse data can email the Principal Investigator Professor John Toumbourou [[email protected]].


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18152Study protocolRowland, B., Toumbourou, J.W., Osborn, A., Smith, R., Hall, J., Kremer, P., Kelly, A., Williams, J., Leslie, E. (2013) A clustered randomised trial examining the effect of social marketing and community mobilisation on the age of uptake and levels of alcohol consumption by Australian adolescents: Study protocol. BMJ Open. vol. 3, no. 1, pp. 1-8. e002423. http://dx.doi.org/10.1136/bmjopen-2012-002423 



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSocial marketing and community mobilisation to reduce underage alcohol consumption in Australia: A cluster randomised community trial.2018https://dx.doi.org/10.1016/j.ypmed.2018.02.032
EmbaseA Component Evaluation of a Randomised Control Community Intervention to Reduce Adolescent Alcohol Use in Australia.2022https://dx.doi.org/10.1007/s11121-021-01310-y
N.B. These documents automatically identified may not have been verified by the study sponsor.