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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 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]

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

Condition category

Condition code

Public Health

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]

Prevention

Intervention code [2]

Behaviour

Intervention code [3]

Lifestyle

Comparator / control treatment

Control communities will not receive any of the project activities.

Control group

Active

Outcomes

Primary outcome [1]

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]

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]

A reduction in the self-report of adolescents receiving alcohol from parents.

This information will be gathered by a questionnaire.

Timepoint [1]

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]

A reduction in the intention to consume alcohol before the age of 18.

This information will be gathered by a questionnaire.

Timepoint [2]

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]

3550

Recruitment postcode(s) [2]

3978

Recruitment postcode(s) [3]

3810

Recruitment postcode(s) [4]

3152

Recruitment postcode(s) [5]

3220

Recruitment postcode(s) [6]

3280

Recruitment postcode(s) [7]

3364

Recruitment postcode(s) [8]

4226

Recruitment postcode(s) [9]

6430

Recruitment postcode(s) [10]

6210

Recruitment postcode(s) [11]

3630

Recruitment postcode(s) [12]

3631

Recruitment postcode(s) [13]

7307

Recruitment postcode(s) [14]

4670

Recruitment postcode(s) [15]

4350

Recruitment postcode(s) [16]

4157

Recruitment postcode(s) [17]

4161

Recruitment postcode(s) [18]

4285

Recruitment postcode(s) [19]

4558

Recruitment postcode(s) [20]

4556

Recruitment postcode(s) [21]

6065

Recruitment postcode(s) [22]

4114

Recruitment postcode(s) [23]

4020

Recruitment postcode(s) [24]

3047

Recruitment postcode(s) [25]

6021

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Research Council

Address [1]

lst Floor, B Brindabella Circuit, Brindabella Business Park, CANBERRA AIRPORT ACT 2609

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Centre for Adolescent Health at the Murdoch Childrens Research Institute (MCRI), Royal Childrens Hospital

Address [2]

Flemington Road, Parkville, 3052

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

Communities That Care Ltd.

Address [3]

50 Flemington Rd, Parkville, Victoria, 3052.

Country [3]

Australia

Primary sponsor type

University

Name

Deakin University

Address

Waterfront Campus, Locked Bag 20000 Geelong, Victoria 3220

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Centre for Adolescent Health at the Murdoch Childrens Research Institute (MCRI), Royal Childrens Hospital

Address [1]

Flemington Road, Parkville, 3052

Country [1]

Australia

Secondary sponsor category [2]

Charities/Societies/Foundations

Name [2]

Communities That Care Ltd.

Address [2]

50 Flemington Rd, Parkville, Victoria, 3052.

Country [2]

Australia

Other collaborator category [1]

Charities/Societies/Foundations

Name [1]

Keep em Safe Inc

Address [1]

474 Ryrie St, East Geelong, Victoria, 3219

Country [1]

Australia

Other collaborator category [2]

Charities/Societies/Foundations

Name [2]

Australian Drug Foundation

Address [2]

PO Box 818 North Melbourne 3051, Victoria.

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Deakin University Human Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Office, Deakin Research Integrity, Deakin University, 221 Burwood Hwy, Burwood, Victoria 3125

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/06/2011

Ethics approval number [1]

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

Prof John Toumbourou

Address

1 Gheringhap Street, Geelong VIC 3220, Deakin University

Country

Australia

Phone

+61 352278278

Fax

[email protected]

Contact person for public queries

Name

Prof John Toumbourou

Address

1 Gheringhap Street, Geelong VIC 3220, Deakin University

Country

Australia

Phone

+61 352278278

Fax

not provided.

[email protected]

Contact person for scientific queries

Name

Mr Bosco Rowland

Address

221 Burwood Highway, Burwood Victoria 3125, Deakin University

Country

Australia

Phone

+61 3 924 43002

Fax

not provided.

[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.	Type	Citation	Link	Email	Other Details	Attachment
18152	Study protocol	Rowland, 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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Social marketing and community mobilisation to reduce underage alcohol consumption in Australia: A cluster randomised community trial.	2018	https://dx.doi.org/10.1016/j.ypmed.2018.02.032
Embase	A Component Evaluation of a Randomised Control Community Intervention to Reduce Adolescent Alcohol Use in Australia.	2022	https://dx.doi.org/10.1007/s11121-021-01310-y

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically