Study protocol of the Our Futures Vaping Trial: a cluster randomised controlled trial of a school-based eHealth intervention to prevent e-cigarette use among adolescents.

Humans Adolescent Electronic Nicotine Delivery Systems Vaping / prevention & control Australia Quality of Life Schools Randomized Controlled Trials as Topic
Adolescence E-cigarettes Prevention School-based intervention Tobacco Vaping eHealth

Journal

BMC public health
ISSN: 1471-2458
Titre abrégé: BMC Public Health
Pays: England
ID NLM: 100968562

Informations de publication

Date de publication:
12 04 2023
Historique:
received: 20 03 2023
accepted: 05 04 2023
medline: 14 4 2023
entrez: 12 4 2023
pubmed: 13 4 2023
Statut: epublish

Résumé

Effective and scalable prevention approaches are urgently needed to address the rapidly increasing rates of e-cigarette use among adolescents. School-based eHealth interventions can be an efficient, effective, and economical approach, yet there are none targeting e-cigarettes within Australia. This paper describes the protocol of the OurFutures Vaping Trial which aims to evaluate the efficacy and cost-effectiveness of the first school-based eHealth intervention targeting e-cigarettes in Australia. A two-arm cluster randomised controlled trial will be conducted among Year 7 and 8 students (aged 12-14 years) in 42 secondary schools across New South Wales, Western Australia and Queensland, Australia. Using stratified block randomisation, schools will be assigned to either the OurFutures Vaping Program intervention group or an active control group (health education as usual). The intervention consists of four web-based cartoon lessons and accompanying activities delivered during health education over a four-week period. Whilst primarily focused on e-cigarette use, the program simultaneously addresses tobacco cigarette use. Students will complete online self-report surveys at baseline, post-intervention, 6-, 12-, 24-, and 36-months after baseline. The primary outcome is the uptake of e-cigarette use at 12-month follow-up. Secondary outcomes include the uptake of tobacco smoking, frequency/quantity of e-cigarettes use and tobacco smoking, intentions to use e-cigarettes/tobacco cigarettes, knowledge about e-cigarettes/tobacco cigarettes, motives and attitudes relating to e-cigarettes, self-efficacy to resist peer pressure and refuse e-cigarettes, mental health, quality of life, and resource utilisation. Generalized mixed effects regression will investigate whether receiving the intervention reduces the likelihood of primary and secondary outcomes. Cost-effectiveness and the effect on primary and secondary outcomes will also be examined over the longer-term. If effective, the intervention will be readily accessible to schools via the OurFutures platform and has the potential to make substantial health and economic impact. Without such intervention, young Australians will be the first generation to use nicotine at higher rates than previous generations, thereby undoing decades of effective tobacco control. The trial has been prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12623000022662; date registered: 10/01/2023).

Sections du résumé

BACKGROUND
Effective and scalable prevention approaches are urgently needed to address the rapidly increasing rates of e-cigarette use among adolescents. School-based eHealth interventions can be an efficient, effective, and economical approach, yet there are none targeting e-cigarettes within Australia. This paper describes the protocol of the OurFutures Vaping Trial which aims to evaluate the efficacy and cost-effectiveness of the first school-based eHealth intervention targeting e-cigarettes in Australia.
METHODS
A two-arm cluster randomised controlled trial will be conducted among Year 7 and 8 students (aged 12-14 years) in 42 secondary schools across New South Wales, Western Australia and Queensland, Australia. Using stratified block randomisation, schools will be assigned to either the OurFutures Vaping Program intervention group or an active control group (health education as usual). The intervention consists of four web-based cartoon lessons and accompanying activities delivered during health education over a four-week period. Whilst primarily focused on e-cigarette use, the program simultaneously addresses tobacco cigarette use. Students will complete online self-report surveys at baseline, post-intervention, 6-, 12-, 24-, and 36-months after baseline. The primary outcome is the uptake of e-cigarette use at 12-month follow-up. Secondary outcomes include the uptake of tobacco smoking, frequency/quantity of e-cigarettes use and tobacco smoking, intentions to use e-cigarettes/tobacco cigarettes, knowledge about e-cigarettes/tobacco cigarettes, motives and attitudes relating to e-cigarettes, self-efficacy to resist peer pressure and refuse e-cigarettes, mental health, quality of life, and resource utilisation. Generalized mixed effects regression will investigate whether receiving the intervention reduces the likelihood of primary and secondary outcomes. Cost-effectiveness and the effect on primary and secondary outcomes will also be examined over the longer-term.
DISCUSSION
If effective, the intervention will be readily accessible to schools via the OurFutures platform and has the potential to make substantial health and economic impact. Without such intervention, young Australians will be the first generation to use nicotine at higher rates than previous generations, thereby undoing decades of effective tobacco control.
TRIAL REGISTRATION
The trial has been prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12623000022662; date registered: 10/01/2023).

Identifiants

DOI: 10.1186/s12889-023-15609-8 PMID: 37046211 PMC: PMC10090743
pubmed: 37046211
doi: 10.1186/s12889-023-15609-8
pii: 10.1186/s12889-023-15609-8
pmc: PMC10090743
doi:

Banques de données

ANZCTR
['ACTRN12623000022662']

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

683

Informations de copyright

© 2023. The Author(s).

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Auteurs

Lauren A Gardner (LA)

The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia. lauren.gardner@sydney.edu.au.

Amy-Leigh Rowe (AL)

The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.

Emily Stockings (E)

The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.

Katrina E Champion (KE)

The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.

Leanne Hides (L)

School of Psychology, The University of Queensland, Brisbane, QLD, Australia.

Nyanda McBride (N)

National Drug and Research Institute, EnAble Institute, Curtin University, Perth, WA, Australia.

Steve Allsop (S)

National Drug and Research Institute, EnAble Institute, Curtin University, Perth, WA, Australia.

Siobhan O'Dean (S)

The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.

Matthew Sunderland (M)

The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.

Yong Yi Lee (YY)

Health Economics Group, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
School of Public Health, The University of Queensland, Brisbane, QLD, Australia.
Queensland Centre for Mental Health Research, Brisbane, QLD, Australia.

Cathy Mihalopoulos (C)

Health Economics Group, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.

Becky Freeman (B)

School of Public Health, The University of Sydney, Sydney, NSW, Australia.

Janni Leung (J)

School of Psychology, The University of Queensland, Brisbane, QLD, Australia.
National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, QLD, Australia.

Hayden McRobbie (H)

National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.

Lexine Stapinski (L)

The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.

Nicole Lee (N)

National Drug and Research Institute, Curtin University, Perth, WA, Australia.

Louise Thornton (L)

The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.

Jennifer Debenham (J)

The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.

Maree Teesson (M)

The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.

Nicola C Newton (NC)

The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.

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