Effectiveness of the multi-component intervention 'Focus' on reducing smoking among students in the vocational education setting: a cluster randomized controlled trial.

BACKGROUND: Social inequality in smoking remains an important public health issue. Upper secondary schools offering vocational education and training (VET) comprise more students from lower socioeconomic backgrounds and have higher smoking prevalence than general high schools. This study examined the effects of a school-based multi-component intervention on students' smoking. METHODS: A cluster randomized controlled trial. Eligible participants were schools offering VET basic courses or preparatory basic education in Denmark, and their students. Schools were stratified by subject area and eight schools were randomly allocated to intervention (1,160 invited students; 844 analyzed) and six schools to control (1,093 invited students; 815 analyzed). The intervention program comprised smoke-free school hours, class-based activities, and access to smoking cessation support. The control group was encouraged to continue with normal practice. Primary outcomes were daily cigarette consumption and daily smoking status at student level. Secondary outcomes were determinants expected to impact smoking behavior. Outcomes were assessed in students at five-month follow-up. Analyses were by intention-to-treat and per protocol (i.e., whether the intervention was delivered as intended), adjusted for covariates measured at baseline. Moreover, subgroup analyses defined by school type, gender, age, and smoking status at baseline were performed. Multilevel regression models were used to account for the cluster design. Missing data were imputed using multiple imputations. Participants and the research team were not blinded to allocation. RESULTS: Intention-to-treat analyses showed no intervention effect on daily cigarette consumption and daily smoking. Pre-planned subgroup analyses showed statistically significant reduction in daily smoking among girls compared with their counterparts in the control group (OR = 0.39, 95% CI: 0.16, 0.98). Per-protocol analysis suggested that schools with full intervention had higher benefits compared with the control group (daily smoking: OR = 0.44, 95% CI: 0.19, 1.02), while no marked differences were seen among schools with partial intervention. CONCLUSION: This study was among the first to test whether a complex, multicomponent intervention could reduce smoking in schools with high smoking risk. Results showed no overall effects. There is a great need to develop programs for this target group and it is important that they are fully implemented if an effect is to be achieved. TRIAL REGISTRATION: https://www.isrctn.com/ISRCTN16455577 , date of registration 14/06/2018.

Implementation of initiatives to prevent student stress: process evaluation findings from the Healthy High School study.

Process evaluation of public health interventions is important for understanding intervention results and can help explain why interventions succeed or fail. This study evaluated implementation of a school-based intervention combining educational and environmental strategies to prevent stress among Danish high school students. We investigated dose delivered, dose received, fidelity, appreciation, barriers and facilitators at the 15 intervention schools using mixed methods and multiple data sources: questionnaires among students, teachers and school coordinators; semi-structured interviews with school coordinators; telephone interviews with student counsellors; and focus group interviews with students and teachers. Implementation varied by schools and classes. Half of the intervention schools delivered the environmental strategies. For the educational strategies, dose delivered differed according to intervention provider. Students reported a lower dose received compared with dose delivered reported by school staff. Overall, student counsellors, school coordinators and students-especially those with low perceived stress-were satisfied with the stress preventive initiatives while teacher satisfaction varied. Five main barriers and three facilitators for implementation were identified. The use of multiple data sources and data methods created new knowledge of the implementation process which is important for the interpretation of effect evaluation and development of future interventions.

Do school-based smoking preventive interventions have unintended effects? Post hoc analysis of the Focus cluster randomised controlled trial.

OBJECTIVES: Public health interventions are designed to improve specific health-related outcomes; however, they may also produce negative side effects, such as substitution use, psychological or social harms. Knowledge about the unintended effects of school-based smoking preventive interventions is sparse. Hence, this study examined these potential unintended effects of the smoking-reducing intervention, Focus, among students in the vocational education and training setting. DESIGN: Cluster randomised controlled trial stratified by school type with 5 months follow-up. SETTING AND PARTICIPANTS: Across Denmark, eight schools were randomised to the intervention group (n=844 students, response proportion 76%) and six schools to the control group (n=815 students, response proportion 75%). This study focused solely on students who smoked at baseline (N=491). INTERVENTIONS: The intervention was developed systematically based on theory and a thoroughly mixed-methods needs assessment. Intervention components included a comprehensive school tobacco policy (smoke-free school hours) supported by a 3-day course for school staff and launched by an edutainment session for students; class-based lessons and a quit-and-win competition; and individual telephone smoking cessation support. OUTCOMES: Alternative tobacco and nicotine products (regular use of smokeless tobacco, hookah and e-cigarettes), regular cannabis use, boredom and loneliness at school, stress and perceived stigmatisation among smokers. RESULTS: We found no statistically significant unintended effects of the intervention. Nonetheless, insignificant findings indicated that students in the intervention group were less likely to be bored during school hours (OR 0.59, 95% CI 0.32 to 1.10) and experience stress (OR 0.62, 95% CI 0.35 to 1.10), but more likely to report feeling stigmatised compared with the control group (OR 1.55, 95% CI 0.71 to 3.40). CONCLUSIONS: Overall, findings suggested no unintended effects of the Focus trial with respect to substitution use, psychological, nor group or social harms. Future research is encouraged to report potential harmful outcomes of smoking preventive interventions, and interventions should be aware of the possible stigmatisation of smokers. TRIAL REGISTRATION NUMBER: ISRCTN16455577.

Reducing smoking in youth by a smoke-free school environment: A stratified cluster randomized controlled trial of Focus, a multicomponent program for alternative high schools.

Youth smoking remains a major challenge for public health. Socioeconomic position influences the initiation and maintenance of smoking, and alternative high school students are at particularly high risk. The school environment is an important setting to promote health, however there is a lack of evidence-based school intervention programs. This article presents the Focus study, which aims to test the implementation and effectiveness of a school-based intervention integrating1 a comprehensive school smoking policy [i.e. smoke-free school hours (SFSH)]2, a course for school staff in short motivational conversations3, school class-based teaching material4, an edutainment session5, a class-based competition, and6 access to smoking cessation support. Together these intervention components address students' acceptability of smoking, social influences, attitudes, motivation, and opportunities for smoking. The setting is alternative high schools across Denmark, and the evaluation design is based on a stratified cluster randomized controlled trial comparing the intervention group to a control group. Outcome data is collected at baseline, midway, and at the end of the intervention period. Moreover, a detailed process evaluation, using qualitative and quantitative methods, is conducted among students, teachers, and school principals. The results from this trial will provide important knowledge on the effectiveness of a smoke-free school environment. The findings will lead to a better understanding of which policies, environments, and cognitions, contribute to preventing and reducing cigarette use among young people in a diverse and high-risk school setting, and illuminate which complementary factors are significant to achieve success when implementing SFSH.