Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000022662
Ethics application status
Approved
Date submitted
22/12/2022
Date registered
10/01/2023
Date last updated
7/04/2024
Date data sharing statement initially provided
10/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The OurFutures Vaping Program: A cluster randomised controlled trial to evaluate the efficacy of a school-based eHealth intervention to prevent e-cigarette use among adolescents
Scientific title
The OurFutures Vaping Program: A cluster randomised controlled trial to evaluate the efficacy of a school-based eHealth intervention to prevent e-cigarette use among adolescents
Secondary ID [1] 308661 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
E-cigarette use 328584 0
Tobacco cigarette use 328585 0
Condition category
Condition code
Public Health 325601 325601 0 0
Health promotion/education
Mental Health 325602 325602 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 (designed specifically for this study) 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.

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] 325130 0
Prevention
Intervention code [2] 325131 0
Lifestyle
Intervention code [3] 325132 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] 333437 0
Uptake of e-cigarette use. Assessed using a single item: “Have you ever used a vape, even one or two puffs?” (Yes/No). 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.
Timepoint [1] 333437 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up. The primary timepoint in 12-months.
Secondary outcome [1] 417104 0
Uptake of tobacco cigarette use. 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).
Timepoint [1] 417104 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [2] 417105 0
Frequency of e-cigarette use. 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.
Timepoint [2] 417105 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [3] 417106 0
Frequency of tobacco cigarette use. 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.
Timepoint [3] 417106 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [4] 417107 0
Quantity of e-cigarette use. 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).
Timepoint [4] 417107 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [5] 417108 0
Quantity of tobacco cigarette use. 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).
Timepoint [5] 417108 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [6] 417109 0
Knowledge about e-cigarettes and tobacco cigarettes (assessed as a composite outcome). Measured using a 15-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.
Timepoint [6] 417109 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [7] 417110 0
Motives to use e-cigarettes. 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”.
Timepoint [7] 417110 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [8] 417111 0
Attitudes towards e-cigarettes. Assessed using the E-cigarette Expectancy Scale for Adolescents (Enlow et al., 2021).
Timepoint [8] 417111 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [9] 417112 0
Intentions to use e-cigarettes in the next year are 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”.
Timepoint [9] 417112 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [10] 417113 0
Intentions to use tobacco cigarettes in the next year are 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”.
Timepoint [10] 417113 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [11] 417114 0
Depressive symptoms. Assessed via the adolescent version (PHQ-A; Johnson et al., 2002) of the Patient Health Questionnaire-8 (PHQ-8; Kroenke et al., 2001).
Timepoint [11] 417114 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [12] 417115 0
Anxiety symptoms. Assessed via the PROMIS Anxiety Paediatric Item Bank (Irwin et al., 2010).
Timepoint [12] 417115 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [13] 417116 0
Psychological distress. Assessed using the Kessler 6 (K6; Kessler et al., 2002).
Timepoint [13] 417116 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [14] 417118 0
Wellbeing. Assessed using the Short Warwick–Edinburgh Mental Well-being Scale (Clarke et al., 2011).
Timepoint [14] 417118 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [15] 417119 0
Quality of life. The Child Health Utility (CHU9D; Stevens & Ratcliffe, 2012) will be used to assess health related quality of life and to obtain quality adjusted life years (QALYs) for the cost effectiveness analysis.
Timepoint [15] 417119 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [16] 417348 0
Internalising symptoms. Assessed using the Strengths and Difficulties Questionnaire by summing the emotional and peer problems subscales (SDQ; Goodman, 2001).
Timepoint [16] 417348 0
Measured at baseline, 12-, 24- and 36-month follow-up.
Secondary outcome [17] 417350 0
Externalising symptoms. Assessed using the Strengths and Difficulties Questionnaire by summing the conduct and hyperactivity subscales (SDQ; Goodman, 2001).
Timepoint [17] 417350 0
Measured at baseline, 12-, 24- and 36-month follow-up.
Secondary outcome [18] 417746 0
E-cigarette refusal skill techniques. Assessed using items adapted from a measure developed to assess drug refusal skill techniques (Epstein et al., 1997). Participants will report their level of confidence using five refusal skills in a scenario where someone has asked them to vape.
Timepoint [18] 417746 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [19] 417747 0
Self-efficacy to resist peer pressure. 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.
Timepoint [19] 417747 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [20] 417748 0
Resource utilisation. The utilisation of healthcare and other related services will be measured using a self-report resource use questionnaire (RUQ) that has been developed for use in previous studies (e.g., Lee et al., 2022; Chatterton et al., 2020). Participants will be asked to provide self-report data on healthcare resource use, such as: the number of contacts with primary care and specialist healthcare professionals; use of prescription medications; hospital admissions; emergency department presentations; and engagement with headspace services. Additional questions will be asked in relation to educational impacts, including school absence days. Healthcare resource use will be valued using unit prices obtained from publicly available cost schedules, such as the Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Schedule (PBS) and National Hospital Cost Data Collection (NHCDC). Hourly wages will also be based on data provided by schools, where applicable, or the Australian Bureau of Statistics.
Timepoint [20] 417748 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.
Secondary outcome [21] 420048 0
Perceptions of Stress which will be measured by the Perceived Stress Scale (PSS), a 10-item self-report scale validated for use with adolescents (Kechter et al., 2019; Liu et al., 2020; Sood et al., 2013). It is designed to measure the degree to which a person appraises situations over the past month as stressful (see appendix J). The PSS asks the respondent to rate their feelings and thoughts from the last month on a 5-point Likert scale from 0 (never) to 4 (very often). Total scores range from 0 to 40 with higher scores indicating greater overall perceptions of stress.
Timepoint [21] 420048 0
Measured at baseline, post-test (post-completion of 4-week intervention), 6-, 12-, 24- and 36-month follow-up.

Eligibility
Key inclusion criteria
Eligible participants will be all Year 7 and/or Year 8 students attending participating schools in 2023. 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 2023
-Schools based outside NSW, WA and QLD

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). Twenty-one schools will be randomly allocated to the OurFutures Vaping Program intervention group and 21 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 by state, and between groups across the six measurement occasions, six schools and 420 students will be randomly allocated to each of the control and intervention groups in each state (12 schools; 840 students per state). 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 (Teesson, Newton, & Barrett, 2012; Thomas, McLellan, & Perera, 2015). To account for school dropout (approx. 15%) and student attrition (approx. 25% over 36 months), we aim to recruit a minimum of 14 schools and 1,120 students per state at baseline to test intervention effects (N = 42 schools; 3,360 students). Based on rates in our previous school-based universal substance use prevention trials and successful recruitment strategies (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.

To evaluate cost-effectiveness, the base case analysis will be undertaken using a partial societal perspective, alongside an additional analysis from a health sector perspective. Area-under-the-curve methods will be applied to CHUD9D data to estimate the QALYs associated with the OurFutures Vaping Program and active control condition. The costs that accrue across each trial arm will be calculated as the sum of: all relevant intervention delivery costs; and the cost of utilising additional healthcare and other related services. The cost of delivering the OurFutures Vaping Program and health education as usual will be estimated based on a detailed accounting of resources required to deliver each respective program. This will consider all costs associated with intervention delivery and usual education, including staff and teacher time alongside program materials. Data from the RUQ will be used to estimate the cost of utilising additional healthcare and other related services. The cost-effectiveness of the OurFutures Vaping Program – when compared to health education as usual – will be evaluated using the incremental cost-effectiveness ratio (ICER) as the main measure of cost-effectiveness. That is, the difference in mean costs divided by the difference in mean QALYs between the intervention and control arms.
A cost-consequences analysis will also be done to produce a dashboard of all relevant costs and outcomes resulting in each trial arm. Additional cost-effectiveness ratios can then be estimated by adopting primary and secondary outcomes as the denominator (e.g., the cost per student not engaging in vaping behaviours and the cost per unit gained on the PHQ-8). Standardised economic evaluation techniques, such as Fieller’s theorem and non-parametric bootstrapping, will be used to estimate confidence intervals around each cost-effectiveness ratio. Economic modelling can also be undertaken, if applicable, to estimate the long-term costs and outcomes that may accrue beyond the timeframe of the cluster RCT and to estimate the cost-effectiveness and/or budget impact of scaling up the intervention across Australian schools.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
24/04/2023
Actual
24/03/2023
Date of last participant enrolment
Anticipated
Actual
27/07/2023
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
3360
Accrual to date
Final
5166
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA

Funding & Sponsors
Funding source category [1] 312894 0
Government body
Name [1] 312894 0
Medical Research Future Fund (MRFF)
Country [1] 312894 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, NSW, 2006, Australia
Country
Australia
Secondary sponsor category [1] 314573 0
None
Name [1] 314573 0
Address [1] 314573 0
Country [1] 314573 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312170 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 312170 0
Ethics committee country [1] 312170 0
Australia
Date submitted for ethics approval [1] 312170 0
30/09/2022
Approval date [1] 312170 0
13/01/2023
Ethics approval number [1] 312170 0
2022/818
Ethics committee name [2] 312684 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 312684 0
Ethics committee country [2] 312684 0
Australia
Date submitted for ethics approval [2] 312684 0
20/01/2023
Approval date [2] 312684 0
23/01/2023
Ethics approval number [2] 312684 0
2023/HE000082
Ethics committee name [3] 312685 0
Curtin University Human Research Ethics Committee
Ethics committee address [3] 312685 0
Ethics committee country [3] 312685 0
Australia
Date submitted for ethics approval [3] 312685 0
01/02/2023
Approval date [3] 312685 0
09/02/2023
Ethics approval number [3] 312685 0
HRE2023-0059

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123722 0
Prof Nicola Newton
Address 123722 0
Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006
Country 123722 0
Australia
Phone 123722 0
+61 2 8627 9030
Fax 123722 0
Email 123722 0
[email protected]
Contact person for public queries
Name 123723 0
Lauren Gardner
Address 123723 0
Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006
Country 123723 0
Australia
Phone 123723 0
+61 2 8627 9012
Fax 123723 0
Email 123723 0
[email protected]
Contact person for scientific queries
Name 123724 0
Lauren Gardner
Address 123724 0
Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006
Country 123724 0
Australia
Phone 123724 0
+61 2 8627 9012
Fax 123724 0
Email 123724 0
[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?
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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17920Study protocol    Will be made available upon publication.
17921Statistical analysis plan    Will be made available upon publication.
17922Informed consent form    Will be made available upon ethical approval.
17923Ethical approval    Will be made available upon ethical approval.



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInterventions to prevent or cease electronic cigarette use in children and adolescents.2023https://dx.doi.org/10.1002/14651858.CD015511.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.