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

Veronica Sofie Clara Pisinger, Sofie Hoffmann, Johanne Aviaja Rosing, Morten Grønbæk, Janne Schurmann Tolstrup, Lau Thygesen, Rikke Krølner, Veronica Sofie Clara Pisinger, Sofie Hoffmann, Johanne Aviaja Rosing, Morten Grønbæk, Janne Schurmann Tolstrup, Lau Thygesen, Rikke Krølner

Abstract

Introduction: This 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 design: The 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 dissemination: The 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 number: NCT03906500.

Keywords: epidemiology; preventive medicine; public health.

Conflict of interest statement

Competing interests: The Danish Cancer Society developed intervention materials based on an ongoing campaign. The Danish Cancer Society had no influence on the study design, data analysis or interpretation of data.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Programme theory of ‘High schools High on life’.
Figure 2
Figure 2
Timeline of the evaluation process.
Figure 3
Figure 3
Flow chart of expected number of participating schools and students.

References

    1. Rehm J, Baliunas D, Borges GLG, et al. . The relation between different dimensions of alcohol consumption and burden of disease: an overview. Addiction 2010;105:817–43. 10.1111/j.1360-0443.2010.02899.x
    1. Mokdad AH, Forouzanfar MH, Daoud F, et al. . Global burden of diseases, injuries, and risk factors for young people's health during 1990-2013: a systematic analysis for the global burden of disease study 2013. Lancet 10.1016/S0140-6736(16)00648-6
    1. Kraus L, Guttormsson U, Leifman H, et al. . Results from the European school survey project on alcohol and other drugs 2016. publications office of the European Union, 2015.
    1. Rasmussn M, Pedersen TP, Due P. Skolebørnsundersøgelsen 2015. Statens Institut for Folkesundhed, 2014.
    1. Inchley J, Currie D. Growing up unequal: gender and socioeconomic differences in young people’s health and well-being. Health Behaviour in School-aged Children (HBSC) study: international report from the. 2013, 2014.
    1. Brink AS A. Unges livsstil OG dagligdag 2008, MULD rapport NR. 7. Sundhedstyrrelsen & Kræftens Bekæmpelse, 2008.
    1. Nielsen JC, Sørensen NU, Ozmec MN. Når det ER svært at være Ung I DK: unges trivsel OG mistrivsel I TAL, 2010.
    1. Bendtsen P, Mikkelsen SS, Tolstrup JS. Ungdomsprofilen 2014. Statens Institut for Folkesundhed, SDU, 2015..
    1. Rehm J, Mathers C, Popova S, et al. . Global burden of disease and injury and economic cost attributable to alcohol use and alcohol-use disorders. The Lancet 2009;373:2223–33. 10.1016/S0140-6736(09)60746-7
    1. Andersen A, Due P, Holstein BE, et al. . Tracking drinking behaviour from age 15-19 years. Addiction 2003;98:1505–11. 10.1046/j.1360-0443.2003.00496.x
    1. Eliasen M, Kaer SK, Munk C, et al. . The relationship between age at drinking onset and subsequent binge drinking among women. Eur J Public Health 2009;19:378–82. 10.1093/eurpub/ckp023
    1. Jefferis BJMH, Power C, Manor O. Adolescent drinking level and adult binge drinking in a national birth cohort. Addiction 2005;100:543–9. 10.1111/j.1360-0443.2005.01034.x
    1. Pitkänen T, Lyyra A-L, Pulkkinen L. Age of onset of drinking and the use of alcohol in adulthood: a follow-up study from age 8-42 for females and males. Addiction 2005;100:652–61. 10.1111/j.1360-0443.2005.01053.x
    1. Hingson RW, Heeren T, Winter MR. Age at drinking onset and alcohol dependence: age at onset, duration, and severity. Arch Pediatr Adolesc Med 2006;160:739–46. 10.1001/archpedi.160.7.739
    1. Griffin KW, Botvin GJ. Evidence-Based interventions for preventing substance use disorders in adolescents. Child Adolesc Psychiatr Clin N Am 2010;19:505–26. 10.1016/j.chc.2010.03.005
    1. Foxcroft DR, Tsertsvadze A. Cochrane review: universal school-based prevention programs for alcohol misuse in young people. Evidence-Based Child Health: A Cochrane Review Journal 2012;7:450–575. 10.1002/ebch.1829
    1. Foxcroft DR, Tsertsvadze A. Universal multi‐component prevention programs for alcohol misuse in young people. The Cochrane Library, 2011.
    1. Das JK, Salam RA, Arshad A, et al. . Interventions for adolescent substance abuse: an overview of systematic reviews. J Adolesc Health 2016;59:S61–75. 10.1016/j.jadohealth.2016.06.021
    1. Cuijpers P. Effective ingredients of school-based drug prevention programs. A systematic review. Addict Behav 2002;27:1009–23. 10.1016/s0306-4603(02)00295-2
    1. Carey KB, Scott-Sheldon LAJ, Elliott JC, et al. . Face-To-Face versus computer-delivered alcohol interventions for College drinkers: a meta-analytic review, 1998 to 2010. Clin Psychol Rev 2012;32:690–703. 10.1016/j.cpr.2012.08.001
    1. Barnett NP, Read JP, JPJJoSAT R. Mandatory alcohol intervention for alcohol-abusing college students: a systematic review. J Subst Abuse Treat 2005;29:147–58. 10.1016/j.jsat.2005.05.007
    1. Fachini A, Aliane PP, Martinez EZ, et al. . Efficacy of brief alcohol screening intervention for college students (basics): a meta-analysis of randomized controlled trials. Subst Abuse Treat Prev Policy 2012;7:1. 10.1186/1747-597X-7-40
    1. Seigers DKL, Carey KB. Screening and brief interventions for alcohol use in college health centers: a review. J Am Coll Health 2010;59:151–8. 10.1080/07448481.2010.502199
    1. Bhochhibhoya A, Hayes L, Branscum P, et al. . The use of the Internet for prevention of binge drinking among the College population: a systematic review of evidence. Alcohol Alcohol 2015;50:526–35. 10.1093/alcalc/agv047
    1. Braitman AL, Lau-Barraco C. Personalized boosters after a computerized intervention targeting College drinking: a randomized controlled trial. Alcohol Clin Exp Res 2018;42:1735–47. 10.1111/acer.13815
    1. Eliasen M, Rod MH, Flensborg-Madsen T, et al. . The association between blood alcohol content and cheerfulness, focus distraction, and sluggishness among young adults attending high school parties. Alcohol Clin Exp Res 2014;38:826–33. 10.1111/acer.12268
    1. Beck S, Reesen S. Festkultur OG rusmidler I gymnasieskolen. Dansk Institut for Gymnasiepaedagogik, Syddansk Universitet, 2004.
    1. Dahlgren G, Whitehead M. Policies and strategies to promote social equity in health. Stockholm: Institute for future studies, 1991.
    1. Eldredge LKB, Markham CM, Ruiter RA, et al. . Planning health promotion programs: an intervention mapping approach. John Wiley & Sons, 2016.
    1. Michie S, Richardson M, Johnston M, et al. . The behavior change technique taxonomy (V1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med 2013;46:81–95. 10.1007/s12160-013-9486-6
    1. Craig P, Dieppe P, Macintyre S, et al. . Developing and evaluating complex interventions: the new medical Research Council guidance. BMJ 2008;337:a1655. 10.1136/bmj.a1655
    1. Michie S, van Stralen MM, West R, RJIs W. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implementation Sci 2011;6 10.1186/1748-5908-6-42
    1. Moreira MT, Smith LA, Foxcroft D. Social norms interventions to reduce alcohol misuse in University or college students. Cochrane Database Syst Rev. 2009;3.
    1. Perkins H. The social norms approach to preventing school and College age substance abuse: a Handbook for educators, counselors, and clinicians. Jossey-Bass, 2003.
    1. Natvig H, Aarø LE. Effects of induced compliance on alcohol use: evaluation of a school-based intervention among Norwegian 8th graders. Nord Psychol 2014;66:2–19. 10.1080/19012276.2014.885763
    1. Ivers NM, Halperin IJ, Barnsley J, et al. . Allocation techniques for balance at baseline in cluster randomized trials: a methodological review. Trials 2012;13 10.1186/1745-6215-13-120
    1. Greene EJ. A SAS macro for Covariate-Constrained randomization of general cluster-randomized and Unstratified designs. J Stat Softw 2017;77:jss.v077.c01. 10.18637/jss.v077.c01
    1. Currie C, Zanotti C, Morgan A. Social determinants of health and well-being among young people. health behaviour in school-aged children (HBSC) study: international report from the 2009/2010 survey. Copenhagen: WHO Regional Office for Europe, 2012.
    1. Pisinger V, Mikkelsen SS, Bendtsen P, et al. . The Danish national youth study 2014: study design, population characteristics and non-response analysis. Scand J Public Health 2020;48:1403494817729283. 10.1177/1403494817729283
    1. Kuntsche E, Kuntsche S, Thrul J, et al. . Binge drinking: health impact, prevalence, correlates and interventions. Psychol Health 2017;32:976–1017. 10.1080/08870446.2017.1325889
    1. Bramming M, Møller SP, Pisinger V. Alkohol blandt gymnasie-og erhvervsskoleelever: Alkoholvaner alkoholkultur OG trivsel, 2018.
    1. Moore GF, Littlecott HJ, Turley R, et al. . Socioeconomic gradients in the effects of universal school-based health behaviour interventions: a systematic review of intervention studies. BMC Public Health 2015;15:907. 10.1186/s12889-015-2244-x
    1. Caria MP, Faggiano F, Bellocco R, et al. . The influence of socioeconomic environment on the effectiveness of alcohol prevention among European students: a cluster randomized controlled trial. BMC Public Health 2011;11:312. 10.1186/1471-2458-11-312
    1. Lange T, Hansen KW, Sørensen R, et al. . Applied mediation analyses: a review and tutorial. Epidemiol Health 10.4178/epih.e2017035
    1. Faggiano F, Galanti MR, Bohrn K, et al. . The effectiveness of a school-based substance abuse prevention program: EU-Dap cluster randomised controlled trial. Prev Med 2008;47:537–43. 10.1016/j.ypmed.2008.06.018
    1. Aarestrup AK, Jørgensen TS, Due P, et al. . A six-step protocol to systematic process evaluation of multicomponent cluster-randomised health promoting interventions illustrated by the boost study. Eval Program Plann 2014;46:58–71. 10.1016/j.evalprogplan.2014.05.004
    1. Grant A, Treweek S, Dreischulte T, et al. . Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting. Trials 2013;14:15. 10.1186/1745-6215-14-15
    1. Durlak JA, DuPre EP. Implementation matters: a review of research on the influence of implementation on program outcomes and the factors affecting implementation. Am J Community Psychol 2008;41:327–50. 10.1007/s10464-008-9165-0
    1. NVK Scientific ethics Commitees, 2019. Available:
    1. Subbaraman MS. Substitution and complementarity of alcohol and cannabis: a review of the literature. Subst Use Misuse 10.3109/10826084.2016.1170145
    1. Kane R, Wellings K, Free C, et al. . Uses of routine data sets in the evaluation of health promotion interventions: opportunities and limitations. Health Educ 2000;100:33–41. 10.1108/09654280010309030

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