Design of a school-based randomized trial to reduce smoking among 13 to 15-year olds, the X:IT study

BMC Public Health

Pernille Due¹  Peter Dalum²  Maria Svendsen¹  Poul Dengsøe Jensen²  Louise Wohllebe²  Lene Winther Ringgaard²  Lotus Sofie Bast¹  Anette Andersen¹ 

[1] National Institute of Public Health, University of Southern Denmark, Øster Farimagsgade 5A, 1353 Copenhagen, Denmark;Department for Prevention and Documentation, The Danish Cancer Society, Strandboulevarden 49, 2100 Copenhagen, Denmark

关键词: Intervention;    Design;    Randomized trial;    Parental involvement;    School-based;    Adolescence;    Smoking prevention;   

Others  :  1130206
DOI  :  10.1186/1471-2458-14-518

 received in 2013-02-01, accepted in 2014-05-19,  发布年份 2014

【 摘 要 】

Background

Adolescent smoking is still highly prevalent in Denmark. One in four 13-year olds indicates that they have tried to smoke, and one in four 15-year olds answer that they smoke regularly. Smoking is more prevalent in socioeconomically disadvantaged populations in Denmark as well as in most Western countries. Previous school-based programs to prevent smoking have shown contrasting results internationally. In Denmark, previous programs have shown limited or no effect. This indicates a need for developing a well-designed, comprehensive, and multi-component intervention aimed at Danish schools with careful implementation and thorough evaluation.

This paper describes X:IT, a study including 1) the development of a 3-year school-based multi-component intervention and 2) the randomized trial investigating the effect of the intervention. The study aims at reducing the prevalence of smoking among 13 to 15-year olds by 25%.

Methods/Design

The X:IT study is based on the Theory of Triadic Influences. The theory organizes factors influencing adolescent smoking into three streams: cultural environment, social situation, and personal factors. We added a fourth stream, the community aspects. The X:IT program comprises three main components: 1) smoke-free school premises, 2) parental involvement including smoke-free dialogues and smoke-free contracts between students and parents, and 3) a curricular component. The study encompasses process- and effect-evaluations as well as health economic analyses. Ninety-four schools in 17 municipalities were randomly allocated to the intervention (51 schools) or control (43 schools) group. At baseline in September 2010, 4,468 year 7 students were eligible of which 4,167 answered the baseline questionnaire (response rate = 93.3%).

Discussion

The X:IT study is a large, randomized controlled trial evaluating the effect of an intervention, based on components proven to be efficient in other Nordic settings. The X:IT study directs students, their parents, and smoking prevention policies at the schools. These elements have proven to be effective tools in preventing smoking among adolescents. Program implementation is thoroughly evaluated to be able to add to the current knowledge of the importance of implementation. X:IT creates the basis for thorough effect and process evaluation, focusing on various social groups.

Trial registration

Current Controlled Trials ISRCTN77415416.

【 授权许可】

   
2014 Andersen et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

【 参考文献 】

• [1]Juel K, Sørensen J, Brønnum-Hansen H: Risikofaktorer og Folkesundhed i Danmark (Risk Factors and Public Health in Denmark). Copenhagen, Denmark: National Institute of Public Health; 2006.
• [2]Nielsen GA, Ringgaard LW, Jensen PD, Møller TP, Nissen SB, Sindballe A, Falk J, Broholm K: Unges livsstil og dagligdag (Adolescent life style and daily living). Copenhagen: The Danish Cancer Society, Danish National Board of Health; 2006.
• [3]Nielsen LS, Andersen A, Rasmussen M: Tobaksrygning (Tobacco Smoking). In Skolebørnsundersøgelsen 2010 (Health Behaviour in School-Aged Children, Denmark 2010). Edited by Rasmussen M, Due P. Copenhagen: National Institute of Public Health, University of Southern Denmark; 2011:32-35.
• [4]Rasmussen M, Due P (Eds): Skolebørnsundersøgelsen 2010 (Health Behaviour in School-Aged Children Denmark 2010). Copenhagen; 2011.
• [5]Rasmussen M, Due P, Damsgaard MT, Holstein BE: Social inequality in adolescent daily smoking: has it changed over time? Scand J Public Health 2009, 37(3):287-294.
• [6]Krolner R, Damsgaard MT, Andersen A, Holstein BE, Due P: Social inequality in living conditions, health, well-being, and health behaviours. In Skolebørnsundersøgelsen 2010 (Health Behaviours in School-aged Children, Denmark 2010). Edited by Rasmussen M, Due P. Copenhagen: National Institute of Public Health, University of Southern Denmark; 2011:84-91.
• [7]Currie C, Molcho M, Boyce W, Holstein B, Torsheim T, Richter M: Researching health inequalities in adolescents: the development of the Health Behaviour in School-Aged Children (HBSC) family affluence scale. Soc Sci Med 2008, 66(6):1429-1436.
• [8]Rasmussen M, Due P, Andersen A, Krolner R, Holstein BE: Smoking trends in 11-15-year-olds from 1988 to 2006. Ugeskr Laeger 2008, 170(9):736-739.
• [9]School-based programmes for preventing smoking Cochrane Database Syst Rev 2006., 19(3) CD001293
• [10]Bruvold WH: A meta-analysis of adolescent smoking prevention programs. Am J Public Health 1993, 83(6):872-880.
• [11]Backinger CL, Fagan P, Matthews E, Grana R: Adolescent and young adult tobacco prevention and cessation: current status and future directions. Tob Control 2003, 12(Suppl 4):IV46-IV53.
• [12]Sowden A, Arblaster L, Stead L: Community interventions for preventing smoking in young people. Cochrane Database Syst Rev 2003., 1CD001291
• [13]de Vries H, Dijk F, Wetzels J, Mudde A, Kremers S, Ariza C, Vitoria PD, Fielder A, Holm K, Janssen K, Lehtovuori R, Candel M: The European Smoking prevention Framework Approach (ESFA): effects after 24 and 30 months. Health Educ Res 2006, 21(1):116-132.
• [14]Vinther-Larsen M, Bendtsen P, Jørgensen MH, Grønbæk M: Evaluering af Undervisningsmaterialet Tackling (Evaluation of Tackling). Copenhagen: National Board of Health, Center for Prevention; 2008.
• [15]Flay BR, Petraitis J, Hu FB: The Theory of Triadic Influence; Preliminary Evidence Related to Alcohol and Tobacco use. In Alcohol and Tobacco: From Basic Science to Policy. Edited by Fertig JB, Allen JP. Bethesda, MD: National Institute on Alcohol Abuse and Alcoholism; 1995:37-57.
• [16]Johnston V, Westphal DW, Earnshzaw C, Thomas DP: Starting to smoke: a qualitative study of the experiences of Australian indigenous youth. BMC Public Health 2012, 12(1):963. BioMed Central Full Text
• [17]Lippke S, Nigg CR, Maddock JE: Health-promoting and health-risk behaviors: theory-driven analyses of multiple health behavior change in three international samples. Int J Behav Med 2012, 19(1):1-13.
• [18]Schofield PE, Pattison PE, Hill DJ, Borland R: Youth culture and smoking: integrating social group processes and individual cognitive processes in a model of health-related behaviours. J Health Psychol 2003, 8(3):291-306.
• [19]Klepp KI, Perez-Rodrigo C, De Bourdeaudhuij I, Due PP, Elmadfa I, Haraldsdottir J, Konig J, Sjostrom M, Thorsdottir I, de Almeida MD V, Yngve A, Brug J: Promoting fruit and vegetable consumption among European schoolchildren: rationale, conceptualization and design of the pro children project. Ann Nutr Metab 2005, 49(4):212-220.
• [20]Emmons KM: Health Behaviors in a Social Context. In Social Epidemiology. Edited by Berkman LF, Kawachi I. New York: Oxford University Press; 2000:242-266.
• [21]Bartholomew LK, Parcel GS, Kok G, Gottlieb NH: Planning health promotion programs. An intervention mapping approach. San Francisco: Jossey-Bass; 2006.
• [22]Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG: CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010, 340:c869. doi: 10.1136/bmj.c869.: p. c869
• [23]Campbell MK, Piaggio G, Elbourne DR, Altman DG: Consort 2010 statement: extension to cluster randomised trials. BMJ 2012, 345:e5661.
• [24]Nilsson M, Stenlund H, Bergstrom E, Weinehall L, Janlert U: It takes two: reducing adolescent smoking uptake through sustainable adolescent-adult partnership. J Adolesc Health 2006, 39(6):880-886.
• [25]Josendal O, Aaro LE, Torsheim T, Rasbash J: Evaluation of the school-based smoking-prevention program "BE smokeFREE". Scand J Psychol 2005, 46(2):189-199.
• [26]Poulsen LH, Osler M, Roberts C, Due P, Damsgaard MT, Holstein BE: Exposure to teachers smoking and adolescent smoking behaviour: analysis of cross sectional data from Denmark. Tob Control 2002, 11(3):246-251.
• [27]Lipperman-Kreda S, Paschall MJ, Grube JW: Perceived enforcement of school tobacco policy and adolescents’ cigarette smoking. Prev Med 2009, 48(6):562-566.
• [28]Adams ML, Jason LA, Pokorny S, Hunt Y: The relationship between school policies and youth tobacco use. J Sch Health 2009, 79(1):17-23. quiz 41-3
• [29]Jackson C, Henriksen L: Do as I say: parent smoking, antismoking socialization, and smoking onset among children. Addict Behav 1997, 22(1):107-114.
• [30]Donaldson SI, Sussman S, MacKinnon DP, Severson HH, Glynn T, Murray DM, Stone EJ: Drug abuse prevention programming; do we know what works? Am Behav Sci 1996, 39:868-883.
• [31]Wold B, Currie C, Lund M: Control of Adolescent Smoking (the CAS Study) 1997/1998. Technical Report on Surveys of 15 Year-Olds in Nine European Countries. Bergen; Norway: Bergen University; 2000.
• [32]Wold B, Torsheim T, Currie C, Roberts C: National and school policies on restrictions of teacher smoking: a multilevel analysis of student exposure to teacher smoking in seven European countries. Health Educ Res 2004, 19(3):217-226.
• [33]de Vries H, Mudde A, Kremers S, Wetzels J, Uiters E, Ariza C, Vitoria PD, Fielder A, Holm K, Janssen K, Lehtovuori R, Candel M: The European Smoking Prevention Framework Approach (ESFA): short-term effects. Health Educ Res 2003, 18(6):649-663.
• [34]De Vries H, Mudde AN: Predicting stage transitions for smoking cessation applying the attitude-social influence-efficacy model. Psychol Health 1998, 13:17.
• [35]Griebler R, Molcho M, Samdal O, Inchley J, Dür W, Currie C (Eds): Health Behaviour in School-Aged Children: a World Health Organization Cross-National Study. Research Protocol for the 2009/2010 Survey. Vienna: LBIHPR & Edinburgh: CAHRU; 2010. Available from http://www.hbsc.org webcite
• [36]Kremers SP, Mudde AN, De Vries H: Subtypes within the precontemplation stage of adolescent smoking acquisition. Addict Behav 2001, 26(2):237-251.
• [37]Nordahl H, Krolner R, Pall G, Currie C, Andersen A: Measurement of ethnic background in cross-national school surveys: agreement between students’ and parents’ responses. J Adolesc Health 2011, 49(3):272-277.
• [38]Schwarzer R: Measurement of Perceived Self-Efficacy. Psychometric Scales for Cross-Cultural Research. Berlin, Germany: Freie Universität Berlin; 1993.
• [39]Steckler A, Linnan L (Eds): Process Evaluation for Public Health Interventions and Research. San Francisco: Jossey-Bass; 2002.
• [40]Flay BR, Biglan A, Boruch RF, Castro FG, Gottfredson D, Kellam S, Moscicki EK, Schinke S, Valentine JC, Ji P: Standards of evidence: criteria for efficacy, effectiveness and dissemination. Prev Sci 2005, 6(3):151-175.
• [41]Coast J: Is economic evaluation in touch with society’s health values? BMJ 2004, 329(7476):1233-1236.
• [42]Rasmussen M, Due P: Skolebørnsundersøgelsen 2006 (Health Behaviour in School-Aged Children 2006). Copenhagen: Institute of Public Health, University of Copenhagen; 2007.
• [43]Donner A, Klar N: Statistical considerations in the design and analysis of community intervention trials. J Clin Epidemiol 1996, 49(4):435-439.
• [44]Christensen AI, Ekholm O, Davidsen M, Juel K: Sundhed og Sygelighed i Danmark 2010 & Udviklingen Siden 1987 (Health and Sickness in Denmark 2010 & Development Since 1987). Copenhagen, Denmark: National Institute of Public Health, University of Southern Denmark; 2012.
• [45]Cuijpers P: Effective ingredients of school-based drug prevention programs. A systematic review. Addict Behav 2002, 27(6):1009-1023.
• [46]Flay BR: The promise of long-term effectiveness of school-based smoking prevention programs: a critical review of reviews. Tob Induc Dis 2009, 5(1):7. BioMed Central Full Text
• [47]Crone MR, Reijneveld SA, Willemsen MC, van Leerdam FJ, Spruijt RD, Sing RA: Prevention of smoking in adolescents with lower education: a school based intervention study. J Epidemiol Community Health 2003, 57(9):675-680.
• [48]De Vries H: Socio-economic differences in smoking: Dutch adolescents’ beliefs and behaviour. Soc Sci Med 1995, 41(3):419-424.
• [49]Senn SJ: Covariate imbalance and random allocation in clinical trials. Stat Med 1989, 8(4):467-475.
• [50]Kentala J, Utriainen P, Pahkala K, Mattila K: Verification of adolescent self-reported smoking. Addict Behav 2004, 29(2):405-411.
• [51]Post A, Gilljam H, Rosendahl I, Meurling L, Bremberg S, Galanti MR: Validity of self reports in a cohort of Swedish adolescent smokers and smokeless tobacco (snus) users. Tob Control 2005, 14(2):114-117.
• [52]Dolcini MM, Adler NE, Lee P, Bauman KE: An assessment of the validity of adolescent self-reported smoking using three biological indicators. Nicotine Tob Res 2003, 5(4):473-483.
• [53]Caraballo RS, Giovino GA, Pechacek TF: Self-reported cigarette smoking vs. serum cotinine among U.S. adolescents. Nicotine Tob Res 2004, 6(1):19-25.
• [54]Roberts C, Freeman J, Samdal O, Schnohr CW, de Looze ME, Nic Gabhainn S, Iannotti R, Rasmussen M: The Health Behaviour in School-aged Children (HBSC) study: methodological developments and current tensions. Int J Public Health 2009, 54(Suppl 2):140-150.
• [55]Andersen A, Krolner R, Currie C, Dallago L, Due P, Richter M, Orkenyi A, Holstein BE: High agreement on family affluence between children’s and parents’ reports: international study of 11-year-old children. J Epidemiol Community Health 2008, 62(12):1092-1094.
• [56]Dane AV, Schneider BH: Program integrity in primary and early secondary prevention: are implementation effects out of control? Clin Psychol Rev 1998, 18(1):23-45.
• [57]Dusenbury L, Brannigan R, Falco M, Hansen WB: A review of research on fidelity of implementation: implications for drug abuse prevention in school settings. Health Educ Res 2003, 18(2):237-256.
• [58]Thomas S, Fayter D, Misso K, Ogilvie D, Petticrew M, Sowden A, Whitehead M, Worthy G: Population tobacco control interventions and their effects on social inequalities in smoking: systematic review. Tob Control 2008, 17(4):230-237.
• [59]Niederdeppe J, Kuang X, Crock B, Skelton A: Media campaigns to promote smoking cessation among socioeconomically disadvantaged populations: what do we know, what do we need to learn, and what should we do now? Soc Sci Med 2008, 67(9):1343-1355.