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.

A multicomponent psychosocial intervention among people with early-stage dementia involving physical exercise, cognitive stimulation therapy, psychoeducation and counselling: Results from a mixed-methods study.

BACKGROUND: There is increasing awareness of the benefits of both physical and psychosocial interventions to empower and benefit people with dementia and their caregivers. However, the potential additional benefits of combining physical and psychosocial interventions have only been sparsely explored. The aim of this pilot study was to investigate the acceptability and potential impact of a multicomponent intervention comprising physical exercise, cognitive stimulation therapy (CST), psychoeducation and counselling for people with early-stage dementia. DESIGN: A 15-week multicomponent group-based intervention was offered to people with early-stage dementia in Denmark (N = 44). A mixed-methods design combining interviews, observations, tests of cognitive and physical functioning and an interviewer-assisted questionnaire on quality of life was applied to (1) investigate acceptability of the intervention, including whether people with dementia and their caregivers found the intervention meaningful and (2) to explore and assess changes in participants' physical and cognitive functioning and quality of life. The study was conducted between June 2018 and August 2019. RESULTS: The pilot study demonstrated that the multicomponent intervention was acceptable for people with early-stage dementia and their caregivers. Test results did not show significant changes in measures of participants' physical and cognitive functioning or quality of life. However, qualitative data revealed that participants perceived the intervention as meaningful and found that it had a positive influence on their physical and social well-being. In addition, interaction and support from peers and staff members was considered important and rewarding. CONCLUSION: This multicomponent intervention constitutes a meaningful and beneficial activity for people with early-stage dementia and their caregivers. It provides an opportunity to engage in social interactions with peers and experience professional support. The study also underlines the importance of providing prolonged and sustainable interventions for people with dementia to maintain personal and social benefits.

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.

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.