Title: Development and evaluation of a novel intervention providing insight into the tobacco industry to prevent the uptake of smoking in school-aged children
Funder: Department of Health (England)

Abstract: Design: Iterative design piloting assessment and refinement of a multi-component intervention whose effectiveness will then be evaluated in a cluster-randomised controlled trial.Setting: Secondary schools in the East Midlands. Target population: Students aged 11-13 the age group where large numbers of young people begin to experiment with smoking.Intervention: This project will develop and test a new intervention comprising materials for schools and families to prevent the uptake of smoking in young people. We plan to pilot evaluate and refine a promising novel resource (Operation Smoke Storm) developed by the Hammersmith and Fulham Stop Smoking Service for teachers delivering Personal Social Health and Economic (PSHE) education in which young people assume the role of secret agents working undercover in the tobacco industry. Operation Smoke Storm is strongly evidence-based and draws heavily on the ideas of the US Truth Campaign. The package combines paper-based audiovisual and online interactive components delivered over three hour-long classroom-based sessions providing conventional information on the health impacts of active and passive smoking in association with content not previously widely used in youth smoking prevention in the UK (including insights into marketing tactics environmental impacts of the tobacco industry and exploitation of developing country populations). In a small-scale evaluation of acceptability and ease of use in two London schools it has been very positively evaluated and feedback has been used to inform initial refinements. We will pilot the use of Operation Smoke Storm with Year 7 students and in addition will develop a booster component for use in Year 8 to maintain and strengthen any positive effects of Operation Smoke Storm as well as a family-based component intended to promote communication about smoking between children and their parents in line with a promising developing body of literature. Qualitative work with students and teachers will inform the development of these materials; their exact nature will be finalised by the end of the first year of the study. In the design of both the booster and family components we will take as a starting point resources proven effective in earlier studies such as printed materials videos and online materials considering the acceptability and practicality of their use in the UK. Measurement of outcomes duration of follow-up and planned analyses: As our primary outcome in both the development phase and main trial we will measure the proportion of students who are current smokers or susceptible to smoking at the final follow-up point in Year 8 and compare this between those who have and have not received the intervention. In the development phase this comparison will be between the combined proportion of Year 8 students in our two schools reporting current smoking or susceptibility after receiving the intervention with the proportion of Year 8 students from the same two schools reporting these behaviours in a survey we carried out shortly before our research started. We will judge the intervention to be effective if the confidence interval for the difference in prevalence between the two groups excludes the possibility of no change. If this preliminary evidence proves encouraging (for example with a 7% absolute difference in current or susceptibility to smoking between Year 8 students who have and have not received the intervention in line with that seen in the ASSIST study and with schools willing to be involved in further work) we will carry out a cluster-randomised controlled trial over one year delivering the school and family-based components to students in Years 7 and 8. Our primary comparison here will be between intervention and control schools using a multilevel model to take into account the clustering of students within form groups and schools including as covariates baseline smoking behaviour school stratifying variables and other demographic variables that are predictors of the smoking outcome to adjust for any baseline differences and to improve power. The work needed to develop the intervention means it will not be possible to undertake a definitive evaluation with longer term follow-up at reasonable cost. Thus our cluster-randomised controlled trial will form the first stage of a longitudinal study; we intend to apply for funding at a later date to allow us to follow up students to the end of Year 11. The study will estimate the cost-effectiveness of the intervention in line with previous studies. The costs of the programme (materials and staff time) will be estimated using local costs. Potential health care cost savings will also be estimated from the reductions in current smoking and susceptibility to smoking. The reduction in current smoking and susceptibility will be used to model quality-adjusted life year (QALY) gains and combined with the costs to estimate cost per QALY. During the development phase focus groups and depth interviews with students and teachers will be used to map the key components of the intervention to explore its acceptability and feasibility and to provide feedback to inform refinements. Work will be carried out with boys and girls separately in each pilot school with the aim of reaching theme saturation; data will be analysed using the framework method. We will also undertake a process evaluation during the main trial to assess the delivery of the intervention using staff questionnaires and observations of delivery. Sample size: A cluster randomised trial with 20 schools in each arm (and 150 pupils in Year 7) will provide just over 80% power to detect a 7% absolute difference in combined current smoking and susceptibility to smoking in Year 8 between intervention and control schools (e.g. from 35% to 28%). Project timetable: Months 1-24: Ethics approval; recruit schools; exploratory trial of Operation Smoke Storm in Year 7 with pre-and post-survey evaluation of changes in current smoking and uptake susceptibility; qualitative work to develop resources for use in Year 8 and with families; deliver complete intervention; assess evidence for effectiveness. Months 25-27: ethics approval for main cluster randomised trial; school recruitment. Months 28-43: Cluster randomised trial. Analysis and publication of results.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: STROKE;RESPIRATORY;CANCER AND NEOPLASMS;CARDIOVASCULAR