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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]

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

Condition category

Condition code

Public Health

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]

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]

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]

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]

Illicit drug use. This will be measured by the Communities That Care youth survey.

Timepoint [1]

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]

Tobacco use, as measured by the Communities That Care youth survey.

Timepoint [2]