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Trial registered on ANZCTR


Registration number
ACTRN12625000143426
Ethics application status
Approved
Date submitted
22/01/2025
Date registered
7/02/2025
Date last updated
7/02/2025
Date data sharing statement initially provided
7/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Replication trial of the OurFutures Vaping Program: Evaluation of a school-based eHealth program to prevent e-cigarette use among adolescents in NSW Public Schools
Scientific title
Replication trial of the OurFutures Vaping Program: A cluster randomised controlled trial of a school-based eHealth intervention to prevent e-cigarette use among adolescents in NSW Public Schools.
Secondary ID [1] 313779 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a replication study of ACTRN12623000022662, which was conducted in 40 Australian Independent and Catholic schools. This replication study aims to evaluate the efficacy of the intervention in 12 NSW Government schools.

Health condition
Health condition(s) or problem(s) studied:
E-cigarette use 336400 0
Tobacco cigarette use 336401 0
Condition category
Condition code
Public Health 332923 332923 0 0
Health promotion/education
Mental Health 332924 332924 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The OurFutures Vaping Program is a universal school-based eHealth prevention program that aims to prevent the uptake, and reduce the use, of e-cigarettes among adolescents. The program is built on the effective “OurFutures” (formerly “Climate Schools”) prevention model which is based on social influence and social competence principles.

Participating secondary schools will be randomly allocated to one of two groups: i) an active control group (usual health education) or ii) an intervention group (the OurFutures Vaping Program).

The OurFutures Vaping Program aligns with the Australian and state-based Health & Physical Education Curriculums and is designed to be delivered during Year 7/8 health education classes. The program consists of 4x40-minute lessons (delivered one week apart over 4 weeks) consisting of a web-based cartoon component completed individually by students (approx. 20mins), followed by optional teacher-facilitated activities (e.g., quizzes, class discussions, role plays). There are quizzes and reflective activities embedded in the cartoons to ensure student engagement, comprehension, and critical thinking. Factsheets are provided after each lesson to summarise and reinforce key content.

The intervention aims to provide students with evidence-based information about e-cigarettes and tobacco cigarettes (e.g., what they are made of, short- and long-term harms, the influence of media and marketing, signs of nicotine addiction, coping and help-seeking information and the benefits of avoiding e-cigarettes and tobacco cigarettes), to modify existing norms, and improve resistance skills (via practicing assertive communication and other refusal skills).

Students and teachers access the intervention materials online via the OurFutures Vaping Program website. Teachers are provided with links to curriculum outlines, lesson summaries and implementation guides. No formal teacher training is required to deliver the intervention; however, researchers are available for a one-off meeting with teachers (approx. 30 minutes) to demonstrate how to navigate the study website and answer any questions from teachers.

Program Fidelity: Teachers will be asked to complete logbooks to document their implementation of the OurFutures Vaping Program (i.e. timing, activities delivered, technical problems, other implementation details). Website analytics will provide objective data on the dose and timing of intervention delivery.



Intervention code [1] 330364 0
Prevention
Intervention code [2] 330365 0
Lifestyle
Intervention code [3] 330366 0
Behaviour
Comparator / control treatment
Schools allocated to the control condition will implement health education as usual in their Health and Physical Education lessons. As drug education is mandatory within the Australian health education curriculum, these schools serve as an ‘active control’. A logbook will be completed by teachers at control schools to understand the amount and format of e-cigarette or tobacco cigarette education delivered to their Year 7/8 students. Control schools will be offered access to the intervention at the end of the study.
Control group
Active

Outcomes
Primary outcome [1] 340457 0
Uptake of e-cigarette use.

Timepoint [1] 340457 0
Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up. The primary timepoint in 12-months.
Secondary outcome [1] 444134 0
Uptake of tobacco cigarette use.
Timepoint [1] 444134 0
Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
Secondary outcome [2] 444135 0
Frequency of e-cigarette use.
Timepoint [2] 444135 0
Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
Secondary outcome [3] 444136 0
Frequency of tobacco cigarette use.
Timepoint [3] 444136 0
Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
Secondary outcome [4] 444137 0
Quantity of e-cigarette use.
Timepoint [4] 444137 0
Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
Secondary outcome [5] 444138 0
Quantity of tobacco cigarette use.
Timepoint [5] 444138 0
Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
Secondary outcome [6] 444139 0
Motives to use e-cigarettes.
Timepoint [6] 444139 0
Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
Secondary outcome [7] 444140 0
Attitudes towards e-cigarettes.
Timepoint [7] 444140 0
Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
Secondary outcome [8] 444141 0
Intentions to use e-cigarettes in the next year.
Timepoint [8] 444141 0
Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
Secondary outcome [9] 444142 0
Knowledge related to e-cigarettes, tobacco cigarettes and related harms.
Timepoint [9] 444142 0
Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
Secondary outcome [10] 444143 0
Intentions to use tobacco cigarettes in the next year.
Timepoint [10] 444143 0
Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
Secondary outcome [11] 444144 0
Psychological distress.
Timepoint [11] 444144 0
Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
Secondary outcome [12] 444145 0
Self-efficacy to resist peer pressure.
Timepoint [12] 444145 0
Measured at baseline, post-test (post-completion of 4-week intervention), and 12-month follow-up.
Secondary outcome [13] 444147 0
Internalising symptoms.
Timepoint [13] 444147 0
Measured at baseline, post-test (post-completion of 4-week intervention), and 12-month follow-up.

Eligibility
Key inclusion criteria
Eligible participants will be Year 7 and/or Year 8 students attending participating NSW Public schools in 2025. Students will be required to be fluent in English, provide informed active consent, and only students who receive parental consent will be eligible to participate.
Minimum age
11 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Schools with fewer than 70 enrolled Year 7/8 students in 2025.
-Schools based outside NSW.
-Schools that are not public/government schools.

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 will be concealed. Schools will be randomly allocated to groups by an independent statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The blockrand package in R will be used to generate an unpredictable, concealed random allocation sequence. After schools’ consent and enrolment in the study, a biostatistician with no role in school recruitment will use the package to block randomise schools to study groups, with stratification by state and school gender mix (coeducational, predominately male [>60%], or predominately female [>60%]). Automatic randomisation removes any researcher involvement, and the allocation will be concealed from the investigators and all research personnel (blinded), except those with direct school involvement where blinding is not possible (e.g., Research Assistants who will need to discuss intervention delivery with teachers). Six schools will be randomly allocated to the OurFutures Vaping Program intervention group and six schools to an active control group (health education as usual).
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
Sample size calculations:
The sample size calculations are based on a method to detect intervention by time interactions in longitudinal cluster RCTs (Heo & Leon, 2009). To detect differences between groups by the final timepoint (12-month follow up), five schools and 550 students will need to be randomly allocated to each of the control and intervention groups. This will achieve 95% power to detect an Odds Ratio (OR) of 0.7 in the primary outcome, which is in line with effect sizes from similar school-based prevention trials targeting tobacco smoking. To account for school dropout (approx. 15%) and student attrition (approx. 15%), we aim to recruit a minimum of 12 schools and 1265 students at baseline to test intervention effects. Based on rates in our previous school-based universal substance use prevention trials (M. Teesson et al., 2017), we anticipate most, if not all, students will participate.

Statistical analysis:
Data analysis will be conducted on an intention-to-treat basis, whereby all randomised students will be analysed in the groups that they were originally assigned. Generalized mixed effects regression will investigate whether receiving the intervention reduces the likelihood of primary and secondary outcomes (e.g., logistic regression for dichotomous outcomes, poisson regression for count outcomes, linear regression for continuous outcomes). Analyses will be conducted in R, using the lme4 package (Bates, Mächler, Bolker, & Walker, 2015). To account for within-person and within-school dependency in the data, models will include participant and school as nested random intercepts; and participant and time as random slopes. We will also test different specifications of time (linear, quadradic & categorical) to determine the best fitting model for the data. Model fit will be compared using likelihood ratio tests, AIC and BIC statistics. The effect of greatest interest will be the time × group interaction for the primary outcome, which reflects the relative average 12-month change in the log odds of the outcome for the intervention group compared to control, adjusting for baseline differences. Due to loss to follow-up, we reasonably expect some outcome data to be missing. Mixed-effects models use maximum likelihood estimation (MLE), producing unbiased estimates when data is assumed to be not missing completely at random. Missing data will be explored by examining baseline differences on the outcome and other potential confounding variables between those retained and those lost to follow-up. Sensitivity analysis will examine the impact of potential covariates related to missingness by including those predictors in the imputation model during multiple imputation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318244 0
Government body
Name [1] 318244 0
National Health and Medical Research Council
Country [1] 318244 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 320628 0
None
Name [1] 320628 0
Address [1] 320628 0
Country [1] 320628 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316883 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 316883 0
https://www.sydney.edu.au/research/research-integrity-and-ethics.html
Ethics committee country [1] 316883 0
Australia
Date submitted for ethics approval [1] 316883 0
01/11/2024
Approval date [1] 316883 0
28/11/2024
Ethics approval number [1] 316883 0
2022/HE000818

Summary
Brief summary
Adolescent e-cigarette use has drastically increased in recent years, posing several acute and chronic harms, including poisonings, burns, serious lung injury, and - where nicotine e-liquid is used - the potential to impact brain development and lead to dependence. Effective and scalable preventive interventions are urgently needed, and school-based eHealth interventions are an efficient, effective and economical approach.

To address this need, we developed the OurFutures Vaping Program. Built on the successful ‘OurFutures’ (formerly ‘Climate Schools’) prevention model, the OurFutures Vaping Program involves 4x40 minute online cartoon-based lessons that are delivered during Year 7/8 health education classes.

An initial trial of the intervention began in 2023 among 40 Independent and Catholic schools across NSW, QLD and WA. Due to time constraints for ethical approvals, public schools were unable to be included. To address this limitation, this replication study aims to evaluate the OurFutures Vaping Program among 12 NSW public schools via a cluster randomised controlled trial. It is hypothesized that:
• H1 (primary outcome): Students who receive the OurFutures Vaping Program will be less likely to commence e-cigarette use at the 12-month follow-up, compared to students in an active control condition.
• H2: The OurFutures Vaping Program will achieve superior outcomes to the control condition on secondary outcomes including: uptake of tobacco smoking, frequency/quantity of e-cigarettes use and tobacco smoking, intentions to use e-cigarettes/tobacco cigarettes, knowledge about e-cigarettes and tobacco smoking,

Trial website
https://ourfuturesvaping.org.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139314 0
Dr Lauren Gardner
Address 139314 0
Level 6, Jane Foss Russell Building, The University of Sydney, Darlington, NSW 2008.
Country 139314 0
Australia
Phone 139314 0
+61 02 8627 9012
Fax 139314 0
Email 139314 0
Contact person for public queries
Name 139315 0
Lauren Gardner
Address 139315 0
Level 6, Jane Foss Russell Building, The University of Sydney, Darlington, NSW 2008.
Country 139315 0
Australia
Phone 139315 0
+61 02 8627 9012
Fax 139315 0
Email 139315 0
Contact person for scientific queries
Name 139316 0
Lauren Gardner
Address 139316 0
Level 6, Jane Foss Russell Building, The University of Sydney, Darlington, NSW 2008.
Country 139316 0
Australia
Phone 139316 0
+61 02 8627 9012
Fax 139316 0
Email 139316 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data
When will data be available (start and end dates)?
After trial close-out until at least 20 years post-study closure
Available to whom?
Researchers whom make a request with appropriate reason and provide a study protocol and analysis plan
Available for what types of analyses?
Meta-analyses and other research questions
How or where can data be obtained?
By emailing Dr Lauren Gardner at [email protected]


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
No additional documents have been identified.