Study protocol for a cluster randomised controlled trial testing the effectiveness of the ‘High schools High on life’ intervention on reducing excessive drinking in Danish high schools

Abstract

IntroductionThis paper describes the evaluation design of the ‘High schools High on life’ intervention; a school-based intervention to reduce excessive drinking among high school students in Denmark. The intervention includes a school environmental component to limit access to alcohol at school, a school-educational component to change social norms around alcohol among first year students and a parental component addressing parents’ knowledge and attitudes towards alcohol.Methods and designThe study will employ a cluster randomised controlled study design and will include a random sample of 16 high schools randomly allocated 1:1 to either intervention or control group. Target group: first year high school students. Timeline: baseline survey: January to March 2019, collected as part of the Danish National Youth Study 2019. Delivery of intervention: April 2019 to March 2020. Follow-up survey: April to May 2020. Primary outcome measure: 30% reduction in mean number of binge-drinking episodes (five or more alcoholic drinks on one occasion) within the last 30 days. Secondary outcome measures: proportion of students who drink alcohol, mean weekly alcohol consumption, alcohol intake at last school party, alcohol intake at the school during last school party, proportion of students who agree to be able to have fun at a party without drinking and the proportion of students who think alcohol plays a too dominant part at the school. Implementation will be monitored through process evaluation.Ethics and disseminationThe Scientific Ethics Committees for the Capital Region of Denmark has declared that the trial is not subject to notification (jnr. 19021957). The study is registered at the Research an Innovation Office at University of Southern Denmark (ref: 10.314) allowing collection of personal data. Results will be published in peer-reviewed journals.Trial registration numberNCT03906500.