Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001276448
Ethics application status
Approved
Date submitted
9/11/2015
Date registered
12/09/2016
Date last updated
12/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Estimating the contribution of adolescent alcohol misuse prevention to the reduction of alcohol-related harm in Australia.
Scientific title
A Clustered, Randomised, Longitudinal Type 2 Translational Research trial estimating the contribution of adolescent alcohol misuse prevention to the reduction of alcohol-related harm in Australia
Secondary ID [1] 286489 0
Nil
Universal Trial Number (UTN)
U1111-1169-1098
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent alcohol misuse 296722 0
Condition category
Condition code
Public Health 296956 296956 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The overall objective of this project is to complete a Type 2 translation research trial to demonstrate the long-term population-level health, social and economic benefits of a community delivered adolescent alcohol use prevention intervention.

The current study will build and extend the 2010-2014 trial (see Rowland, 2012 ACTRN12612000384853). The previous trial used a repeat cross-sectional parallel group clustered RCT. The current study will extend this intervention by offering the intervention communities assistance through the remaining 5 Phases of the Communities That
Care process:

I. Getting started; Communities get ready to introduce CTC. This involves assessing community readiness to implement a public health prevention framework, linking with champions to auspice the process

II. Getting organised; Communities form a new coalition or work with an existing coalition to develop a governance structure, comprising of Key Leaders and a Community Board, representing all stakeholders in the community.

III. Developing a profile: The community conducts an assessment of longitudinal risk and protective factors, together with health and behaviour outcomes, using the CTC youth survey. An assessment of community resources, services and programs is also undertaken to identify gaps and strengths.

IV. creating a plan; The Community Board creates a plan for prevention work in their community. he Community Board creates a plan for prevention work in their community. The Board: (a) prioritises behaviours it wants to reduce and risk and protective factors it will target to help bring about the behaviour change; (b) develops an action plan that documents tested and effective programs and policies to be implemented for the targeted risk and protective factors;

V. implementation and evaluation. Communities implement, monitor and evaluate the selected programs and policies in their action plan, assisted by the research team.

see:
http://www.communitiesthatcare.org.au/
http://www.communitiesthatcare.org.au/5-phases-ctc

For the intervention communities for each phase, standardized training sessions on how to implement and progress through the phases will be delivered.. A dedicated community relations officer (CRO) trained in the CTC process will be appointed to work with each community. This person will offer technical assistance and offer support through regular phone calls and emails. Coordinators will be appointed in each of the communities to work under the CRO facilitation to implement the local CTC effort. This appointment will be recommended at a minimum of 0.6 of a full-time position. Training for the coordinator and his/her line manager will be provided prior to the person commencing his/her role. A minimum of fortnightly contact will be maintained by the CRO with the coordinator.

Depending on the speed in which communities work through the CTC phases, and the ease in which ethics is approved in the relevant school jurisdictions, and thus when the subsequent collection of survey data can occur, we expect communities to have completed phase 3 and .first wave of longitudinal data collection during 2016/2017. The delivery of the intervention components will occur during 2018/2019. Intervention components will be delivered throughout the year. Wave 2 of data collection will occur after the intervention is delivered (2018/2019). Wave 3 data collection will occur, before the funding period has ended (2020).

The intervention will be delivered to either with a cohort of of two year levels; either a cohort of year 8 and year 10 students, or a cohort of year 9 and year 11 students. The cohort years will depend on when schools can be engaged to do the baseline survey, and thus fitting into the timeline of the funded study, which should be completed in 2020. We will ensure that for one year level in the last wave of data is post year 12 (i.e year post secondary school level). Thus, the last wave of data will comprise of participants from year 11 and 1 year post-secondary school.

The intervention will have multiple components, and all components will be delivered by the community.

Strategies/components will be selected by each community from the Communities That Care Prevention Strategies guide (attached to the ANZCTR record), including but not limited to, reducing the supply of alcohol , social marketing/community mobilisaton, and audit and implementation of evidence-based resiliency programs..

Supply monitoring – see page 36-40 of Communities That Care Prevention Strategies Guide. This activity will be coordinated and delivered by the local community, with support of the research team. The research team will delivery training to the community as to how to deliver this intervention component..

Social marketing to reduce adolescent demand and parent supply of alcohol: – see page 41-42 of Communities That Care Prevention Strategies Guide. Brochures designed based on behaviour change theory targeting students and their parents. One brochure is designed for students, another for parents. The purpose of this component is to promote three key messages:
1. Based on Australia’s National Health and Medical Research Council’s (NHMRC) alcohol guidelines for children adolescents should avoid drinking alcohol before the age of 18 years.
2. Based on secondary supply legislation and liquor sales laws), adults are breaking the law if they supply alcohol to a person under 18 years.
3. Parents should set a rule that their children will not be permitted to drink before 18.

Children's brochures will be delivered to children via a minimum of 2 school lessons; lessons have been developed with teachers and are designed to be integrated into the health curriculum, Teachers will be provided with a manual for the lessons and how to use brochures.. Brochures will also be sent home to parents. Before the 2nd lesson children will be encouraged to discuss with parents content of brochures, in particular parent's setting a rule,

Resiliency curricula – An audit of school resiliency curricula (including social and emotional health curricula) within all participating schools involved in the trial will be undertaken via a “School Administrator Survey”, by the research team. The aim of the audit is to identify the alignment of school social and emotional health and drug education curricula with evidence-based practice During “Phase 3” of the CTC process, results from the school audit will form the basis of technical assistance recommendations to the intervention communities for strengthening school-based resiliency and drug education training. Communities would be encouraged to implement these recommendations during “Phase 5” of the CTC process.

Implementers will attend training on implementation fidelity. Fidelity will be monitored with checklists, observations, quality delivery, participant involvement, and reach. Fidelity data will be sent to the research team.
Intervention code [1] 293231 0
Prevention
Comparator / control treatment
The control group will not receive any intervention activities. The control group will participate in the longitudinal youth surveying.
Control group
Active

Outcomes
Primary outcome [1] 296568 0
Adolescent alcohol use. This will be measured through the Communities That Care youth survey. The Communities That Care Youth Survey is designed to provide information on rates of health and social problems experienced by young people and in addition to provide information on the risk and protective factors that predict these problems. These include factors within community, school, family and peer group environments that can be modified to reduce or prevent health and behavioural problems, and improve health outcomes.
Timepoint [1] 296568 0
There will be three time points for data collection. Baseline data is likely to occur to occur in 2017 and two subsequent time points approximately 2 and 3 years post baseline.
.
Secondary outcome [1] 318768 0
Illicit drug use. This will be measured by the Communities That Care youth survey.
Timepoint [1] 318768 0
There will be three time points for data collection. Baseline data is likely to occur to occur in 2017 and two subsequent time points approximately 2 and 3 years post baseline..
Secondary outcome [2] 326872 0
Tobacco use, as measured by the Communities That Care youth survey.
Timepoint [2] 326872 0
There will be three time points for data collection. Baseline data is likely to occur to occur in 2017 and two subsequent time points approximately 2 and 3 years post baseline.
Secondary outcome [3] 326873 0
Antisocial behavior/violent offending, assesesed through the Communities That Care youth survey and.community accesible data.
Timepoint [3] 326873 0
There will be three time points for data collection. Baseline data is likely to occur to occur in 2017 and two subsequent time points approximately 2 and 3 years post baseline.
Secondary outcome [4] 326874 0
Depression as measured by the Short moods and feelings questionnaire.
Timepoint [4] 326874 0
There will be three time points for data collection. Baseline data is likely to occur to occur in 2017 and two subsequent time points approximately 2 and 3 years post baseline.
Secondary outcome [5] 326875 0
Secondary school engagement as measured by the Communities That Care youth survey.
Timepoint [5] 326875 0
There will be three time points for data collection. Baseline data is likely to occur to occur in 2017 and two subsequent time points approximately 2 and 3 years post baseline.
Secondary outcome [6] 326878 0
Community level alcohol-related hospital admissions, with community accessible archival data
Timepoint [6] 326878 0
There will be three time points for data collection. Baseline data is likely to occur to occur in 2017 and two subsequent time points approximately 2 and 3 years post baseline.
Secondary outcome [7] 326879 0
Medical visits, as measured with community accessible archival data
Timepoint [7] 326879 0
There will be three time points for data collection. Baseline data is likely to occur to occur in 2017 and two subsequent time points approximately 2 and 3 years post baseline.
Secondary outcome [8] 326880 0
Police arrests for assault and related offences, including criminal court apperances, withcommunity accessible archival data
Timepoint [8] 326880 0
There will be three time points for data collection. Baseline data is likely to occur to occur in 2017 and two subsequent time points approximately 2 and 3 years post baseline.
Secondary outcome [9] 326881 0
Completion of secondary school, measured through public available data : My School website (https://www.myschool.edu.au/)
Timepoint [9] 326881 0
There will be three time points for data collection. Baseline data is likely to occur to occur in 2017 and two subsequent time points approximately 2 and 3 years post baseline.

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
13 Years
Maximum age
18 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)
Allocation was concealed. It was centrally generated by a computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software program
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A community randomised control trial, where intervention group will receive core elements of the intervention, but intervention communities may also include other evidence-based components.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Students participating in the longitudinal part of the study will be surveyed on three occasions between 2016-2020, these students will be sampled from both the intervention and control communities.

Main and secondary outcome analysis will be based on all randomised participants (intention-to-treat analysis). Generalised linear model with binary outcome and logit link will be initially conducted to allow for covariates and testing of attrition bias. We will implement a repeated measures split-plot in time design through logistic regression. Model parameters will be estimated using generalised estimating equations (GEEs) accounting for correlation within participants with an exchangeable working correlation matrix.

To assess the impact of the intervention on primary and secondary outcomes, time by treatment interactions will be examined in a model that included the fixed categorical effects of assessment time, group indicator and treatment by group interaction. To evaluate any potential trend effect due to a staggered rollout of intervention additional models with a fix effect categorical factor for year of treatment implementation will be implemented.

Clustering effect of schools and communities will be evaluated by calculating intraclass correlation coefficients and if necessary a series of model adjusting for clustering effect as a fix factor will be reported.

Using structural equation models, analysis of the effects intervention processes on multiple outcomes (e.g. alcohol and drug use; violence; school completion) are mediated by changes in patterns of adolescent alcohol use, after adjusting for other risk factors, will be undertaken.


Sample size calculations:
Cross-sectional sample:
We will be working with 2 schools in each of the 14 intervention communities. Cross-sectional surveys will done with these communities/schools to inform their community profile (phase 3 of the CTC process). Cross-sectional surveys will be done with year two year levels in each intervention community. Another cross-sectional survey will occur after at Phase 5 of the CTC process with the same year levels. Over the life of the project, intervention communities will do 2 cross-sectional surveys.

An average class size in most schools is about 25 students, and most schools have about 2-3 classes per year level (i.e. between 50-75 students per year level). Thus, for the cross-sectional survey we will survey approximately 65 year students per year levels in each of the 2 schools where interventions are being delivered. Approximately 3640 students will participate in the cross-sectional surveys.

Longitudinal sample:
We will approach 5,400 parents for informed consent anticipating recruiting 3,500 Year 8 and 10 students in 2016 into the longitudinal survey (n=1750 intervention and n=1750 control).

We will assume an 80% retention rate, thus we will have a total of 2,800 students. Based on power calculations, the longitudinal sample size of 2,800 is sufficient to complete each of the planned analyses. We calculated the required sample with power 0.8, probability 0.05 and a design effect based on classroom clustering of 0.05. Recent Australian secondary school survey data (White & Bariola, 2012) indicate rates of alcohol use in the past month were 22% in Year 8 (average age 14) and 48% in Year 10 (age 16) (combined average 35%). With a sample of 2,800 and the above assumptions we can measure the hypothesised 15% reduction in monthly alcohol in the intervention group across the two year level cohorts.

The total expected number participants is 7140.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
31/07/2019
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
7140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 292355 0
Government body
Name [1] 292355 0
National Health and Medical Research Council
Country [1] 292355 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
Locked Bag 20001
Geelong VIC 3220
Country
Australia
Secondary sponsor category [1] 291034 0
University
Name [1] 291034 0
The University of Queensland
Address [1] 291034 0
The University of Queensland
Centre for Youth Substance Abuse
Brisbane St
Lucia QLD 4072
Country [1] 291034 0
Australia
Secondary sponsor category [2] 291035 0
University
Name [2] 291035 0
University of Exeter
Address [2] 291035 0
University of Exeter
College House
University of Exeter Medical School
St Luke’s Campus
Exeter EX1 2LU
United Kingdom
Country [2] 291035 0
United Kingdom
Secondary sponsor category [3] 291036 0
Hospital
Name [3] 291036 0
Centre for Adolescent Health, Royal Children's Hospital
Address [3] 291036 0
The Royal Children’s Hospital
Flemington Road
Parkville VIC 3052
Country [3] 291036 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293829 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 293829 0
Locked Bag 20001
Geelong VIC 3220
Ethics committee country [1] 293829 0
Australia
Date submitted for ethics approval [1] 293829 0
14/10/2015
Approval date [1] 293829 0
14/12/2015
Ethics approval number [1] 293829 0
2015-261

Summary
Brief summary
Preventing alcohol misuse was listed amongst the top three Australian preventative health priorities in a national review. Despite evidence that community rates of alcohol related harm are rising, to date, the evidence-based recommendations for the federal government to implement price controls and for state government regulatory controls have not been implemented.
In this context, it is important to investigate whether there are feasible and effective intervention alternatives to reduce alcohol-related harm. Evidence from other developed countries and preliminary work in Australia (Rowland et al, 2012) suggests that evidence-based strategies that are coordinated and delivered by communities can be feasible and effective for implementation in Australia. However, in order to be supported for wider dissemination these community delivered alcohol-related harm prevention strategies require comprehensive evaluations of longer-term outcomes and economic benefits.
Our team is the major Australian research group working to develop and evaluate effective community delivered strategies that can reduce adolescent alcohol use. In recent years, with support from Australian Research Council (ARC) Linkage funding (ACTRN 12612000384853), we have mounted a randomised community trial that utilised evidence-based supply and demand reduction strategies that have reduced population rates of early adolescent (age 13/14) alcohol use by 26%. Although our 2010-14 trial reveals community intervention is feasible, and our trial has reduced population rates of early adolescent alcohol use, in order for the intervention approach we are using to be recommended in evidence-based health economic reviews , longer-term follow-up and economic evaluation are required.
The current proposal is a “Type 2 translation research trial” that the Society for Prevention Research have recently advocated for priority research funding to increase understanding as to how evidence-based interventions can be sustained and expanded into large scale implementations that demonstrate population impacts.

Rowland, B., Toumbourou, J.W., Osborn, A., Smith, R., Hall, J., Kremer, P., Kelly, A., Williams, J., Leslie, E.
(2012) 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.
24;3(1) doi:10.1136/bmjopen-2012-002423
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 628 628 0 0
/AnzctrAttachments/368326-CTC Prevention Strategies Guide.pdf
Attachments [2] 629 629 0 0
/AnzctrAttachments/368326-2013_Rowland_Study protocol.pdf

Contacts
Principal investigator
Name 56362 0
Prof John Toumbourou
Address 56362 0
Deakin University
Locked Bag 20001
Geelong VIC 3220
Country 56362 0
Australia
Phone 56362 0
+61352278278
Fax 56362 0
Email 56362 0
[email protected]
Contact person for public queries
Name 56363 0
Dr Bosco Rowland
Address 56363 0
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country 56363 0
Australia
Phone 56363 0
+61392443002
Fax 56363 0
Email 56363 0
[email protected]
Contact person for scientific queries
Name 56364 0
Dr Bosco Rowland
Address 56364 0
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country 56364 0
Australia
Phone 56364 0
+61392443002
Fax 56364 0
Email 56364 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
Dimensions AITrial protocol: a clustered, randomised, longitudinal, type 2 translational trial of alcohol consumption and alcohol-related harm among adolescents in Australia2018https://doi.org/10.1186/s12889-018-5452-3
N.B. These documents automatically identified may not have been verified by the study sponsor.