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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
13/04/2025
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
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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.
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Secondary ID [1]
313779
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None
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Universal Trial Number (UTN)
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Trial acronym
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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.
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Health condition
Health condition(s) or problem(s) studied:
E-cigarette use
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Tobacco cigarette use
336401
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Condition category
Condition code
Public Health
332923
332923
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0
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Health promotion/education
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Mental Health
332924
332924
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0
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Addiction
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330365
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Lifestyle
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Intervention code [2]
330364
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Prevention
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Intervention code [3]
330366
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Past 12-month e-cigarette use.
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Assessment method [1]
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Assessed using two items: i) “Have you ever used a vape, even one or two puffs?” (Yes/No); and, ii) “When did you last vape” (Within the past 30 days/More than 1 month ago, but within the past 6 months/More than 6 months ago, but within the past 12 months/More than 12 months ago). This item was created specifically for this trial and is based on items used in our previous OurFutures trials (Teesson, Newton et al., 2017; Teesson et al., 2014) and the National Drug Strategy Household Survey. Participants are provided with a description of e-cigarettes/vapes and alternate names that may have been used to describe them.
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Timepoint [1]
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Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up. The primary timepoint is 12-months.
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Secondary outcome [1]
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Frequency of e-cigarette use.
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Assessment method [1]
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Participants who report vaping within the past 30 days are asked “During the past 30 days, on how many days did you vape?” (adapted from Vogel et al., 2020). Participants who last vaped >30 days ago are asked “How often were you vaping?” with response options including: Daily/At least weekly (but not daily)/At least monthly (but not weekly)/Less than monthly/I only tried them once or twice/Never used. This item was based on the National Drug Strategy Household Survey.
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Timepoint [1]
444135
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Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
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Secondary outcome [2]
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Frequency of tobacco cigarette use.
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Assessment method [2]
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Participants who report smoking within the past 30 days are asked “During the past 30 days, on how many days did you smoke cigarettes?” (adapted from Vogel et al., 2020). Participants who last smoked >30 days ago are asked “How often were you smoking” with response options including: Daily/At least weekly (but not daily)/At least monthly (but not weekly)/Less than monthly/I only tried them once or twice/Never used. This item was based on the National Drug Strategy Household Survey.
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Timepoint [2]
444136
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Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
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Secondary outcome [3]
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Quantity of tobacco cigarette use.
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Assessment method [3]
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Participants who report smoking within the past 30 days are asked “Thinking about the past 30 days, in a typical week, how many cigarettes did you smoke each day?” (adapted from Heatherton et al., 1989; Vogel et al., 2020).
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Timepoint [3]
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Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
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Secondary outcome [4]
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Intentions to use e-cigarettes in the next year.
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Assessment method [4]
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Assessed using a single item based on those used in our previous school-based trials (e.g., Teesson et al., 2020). Response options are on a 5-point Likert scale ranging from “Certain not to try” to “Certain to try”.
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Timepoint [4]
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Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
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Secondary outcome [5]
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Knowledge related to e-cigarettes, tobacco cigarettes and related harms.
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Assessment method [5]
444142
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Measured using a 20-item scale specifically developed to reflect the intended content of the OurFutures Vaping intervention. The scale was derived from a larger pool of items that was piloted among adolescents to condense the scale to 20 items of varying degrees of difficulty. The items assess a range of topics such as what e-cigarettes and nicotine are, the short- and long-term effects/harms of e-cigarettes and tobacco cigarettes, common myths about e-cigarettes and tobacco cigarettes, the laws around e-cigarette and tobacco cigarette use among young people in Australia, and the prevalence of e-cigarette and tobacco cigarette use among young people in Australia. Response options include: True/False/Don’t know. Scores are summed to produce a total knowledge score.
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Timepoint [5]
444142
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Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
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Secondary outcome [6]
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Psychological distress.
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Assessment method [6]
444144
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Assessed using the Kessler 6 (K6; Kessler et al., 2002).
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Timepoint [6]
444144
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Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
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Secondary outcome [7]
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Attitudes towards e-cigarettes.
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Assessment method [7]
444140
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Assessed using the E-cigarette Expectancy Scale for Adolescents (Enlow et al., 2021).
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Timepoint [7]
444140
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Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
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Secondary outcome [8]
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Motives to use e-cigarettes.
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Assessment method [8]
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Assessed using an adapted version of the Tobacco Motives Inventory (Wills et al., 1999; Wills et al., 2002), with instances of “smoking” replaced with “vaping”. This scale will only be completed by participants who report having used e-cigarettes in the past.
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Timepoint [8]
444139
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Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
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Secondary outcome [9]
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Uptake of tobacco cigarette use.
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Assessment method [9]
444134
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Assessed using a single item: “Have you ever tried smoking a cigarette, even one or two puffs?” (Yes/No). This item was based on items used in our previous trials (e.g., Teesson et al., 2020) and the Standard High School Youth Risk Behaviour Survey (Centers for Disease Control and Prevention, 2019).
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Timepoint [9]
444134
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Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
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Secondary outcome [10]
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Internalising symptoms.
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Assessment method [10]
444147
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Assessed using the Strengths and Difficulties Questionnaire by summing the emotional and peer problems subscales (SDQ; Goodman, 2001).
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Timepoint [10]
444147
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Measured at baseline, post-test (post-completion of 4-week intervention), and 12-month follow-up.
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Secondary outcome [11]
444137
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Quantity of e-cigarette use.
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Assessment method [11]
444137
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Participants who report vaping within the past 30 days are asked “Thinking about the past 30 days, in a typical week, how many sessions did you vape each day. A ‘session’ is a period or block of time when you are vaping” (adapted from Vogel et al., 2020).
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Timepoint [11]
444137
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Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
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Secondary outcome [12]
444143
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Intentions to use tobacco cigarettes in the next year.
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Assessment method [12]
444143
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assessed using a single item based on those used in our previous school-based trials (e.g., Teesson et al., 2020). Response options are on a 5-point Likert scale ranging from “Certain not to try” to “Certain to try”.
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Timepoint [12]
444143
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Measured at baseline, post-test (post-completion of 4-week intervention) and 12-month follow-up.
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Secondary outcome [13]
444145
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Self-efficacy to resist peer pressure.
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Assessment method [13]
444145
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Assessed using an adapted version of the Resistive Self-Regulatory Efficacy Scale (Bandura et al., 2003). Items will be summed to generate a total score, with higher scores indicating greater self-efficacy to resist peer pressure.
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Timepoint [13]
444145
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Measured at baseline, post-test (post-completion of 4-week intervention), and 12-month follow-up.
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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.
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Minimum age
11
Years
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Maximum age
15
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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).
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
17/02/2025
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Actual
4/03/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
1265
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Accrual to date
500
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
320628
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Country [1]
320628
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The University of Sydney Human Research Ethics Committee
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Ethics committee address [1]
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https://www.sydney.edu.au/research/research-integrity-and-ethics.html
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Ethics committee country [1]
316883
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Australia
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Date submitted for ethics approval [1]
316883
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01/11/2024
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Approval date [1]
316883
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28/11/2024
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Ethics approval number [1]
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2022/HE000818
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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,
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Trial website
https://ourfuturesvaping.org.au/
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Lauren Gardner
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Address
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Level 6, Jane Foss Russell Building, The University of Sydney, Darlington, NSW 2008.
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Country
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Australia
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Phone
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+61 02 8627 9012
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Lauren Gardner
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Address
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Level 6, Jane Foss Russell Building, The University of Sydney, Darlington, NSW 2008.
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Country
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Australia
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Phone
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+61 02 8627 9012
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Lauren Gardner
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Address
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Level 6, Jane Foss Russell Building, The University of Sydney, Darlington, NSW 2008.
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Country
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Australia
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Phone
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+61 02 8627 9012
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers whom make a request with appropriate reason and provide a study protocol and analysis plan
Conditions for requesting access:
•
-
What individual participant data might be shared?
•
De-identified individual participant data
What types of analyses could be done with individual participant data?
•
Meta-analyses and other research questions
When can requests for individual participant data be made (start and end dates)?
From:
After trial close-out until at least 20 years post-study closure
To:
-
Where can requests to access individual participant data be made, or data be obtained directly?
•
By emailing Dr Lauren Gardner at
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
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.
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