Effectiveness of the universal prevention program 'Healthy School and Drugs': study protocol of a randomized clustered trial.
BACKGROUND
Substance use is highly prevalent among Dutch adolescents. The Healthy School and Drugs program is a nationally implemented school-based prevention program aimed at reducing early and excessive substance use among adolescents. Although the program's effectiveness was tested in a quasi-experimental design before, many program changes were made afterwards. The present study, therefore, aims to test the effects of this widely used, renewed universal prevention program.


METHODS
A randomized clustered trial will be conducted among 3,784 adolescents of 23 secondary schools in The Netherlands. The trial has three conditions; two intervention conditions (i.e., e-learning and integral) and a control condition. The e-learning condition consists of three digital learning modules (i.e., about alcohol, tobacco, and marijuana) that are sequentially offered over the course of three school years (i.e., grade 1, grade 2, and grade 3). The integral condition consists of parental participation in a parental meeting on substance use, regulation of substance use, and monitoring and counseling of students' substance use at school, over and above the three digital modules. The control condition is characterized as business as usual. Participating schools were randomly assigned to either an intervention or control condition.Participants filled out a digital questionnaire at baseline and will fill out the same questionnaire three more times at follow-up measurements (8, 20, and 32 months after baseline). Outcome variables included in the questionnaire are the percentage of binge drinking (more than five drinks per occasion), the average weekly number of drinks, and the percentage of adolescents who ever drunk a glass of alcohol and the percentage of adolescents who ever smoked a cigarette or a joint respectively for tobacco and marijuana.


CONCLUSIONS
This study protocol describes the design of a randomized clustered trial that evaluates the effectiveness of a school-based prevention program. We expect that significantly fewer adolescents will engage in early or excessive substance use behaviors in the intervention conditions compared to the control condition as a direct result of the intervention. We expect that the integral condition will yield most positive results, compared with the e-learning condition and control condition.


BACKGROUND
The protocol for this study is registered with the Nederlands Trial Register NTR1516.
Malmberg
Monique
M
Behavioural Science Institute, Radboud University Nijmegen, The Netherlands. m.malmberg@pwo.ru.nl
Overbeek
Geertjan
G
Kleinjan
Marloes
M
Vermulst
Ad
A
Monshouwer
Karin
K
Lammers
Jeroen
J
Vollebergh
Wilma Am
WA
Engels
Rutger Cme
RC
D000293:Adolescent; D016000:Cluster Analysis; D005260:Female; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008297:Male; D009426:Netherlands; D015397:Program Evaluation; D040242:Risk Reduction Behavior; D012574:Schools; D019966:Substance-Related Disorders / Q000517:prevention & control*; D011795:Surveys and Questionnaires
Addiction. 2005 Jul;100(7):963-70
15955012
J Int Neuropsychol Soc. 2002 Nov;8(7):873-83
12405538
Psychol Addict Behav. 2003 Sep;17(3):211-8
14498815
J Behav Med. 2007 Oct;30(5):435-45
17605099
Addiction. 2002 Jan;97(1):67-73
11895272
Health Educ Res. 2004 Jun;19(3):227-38
15140843
Addiction. 2005 Oct;100(10):1464-76
16185208
J Child Psychol Psychiatry. 2007 Feb;48(2):202-9
17300559
Prev Med. 2008 May;46(5):385-96
18258289
Prev Sci. 2009 Mar;10(1):41-53
18985451
J Youth Adolesc. 1988 Apr;17(2):117-33
24277579
Nicotine Tob Res. 2007 Nov;9(11):1109-18
17978984
Eur J Public Health. 2003 Mar;13(1):67-74
12678317
Addict Behav. 1997 Sep-Oct;22(5):613-23
9347063
J Drug Educ. 2002;32(4):363-86
12556138
Addiction. 2003 Nov;98(11):1505-11
14616176
Prev Med. 2003 Nov;37(5):451-74
14572430
Addict Behav. 2002 Nov-Dec;27(6):1009-23
12369469
Prev Sci. 2003 Mar;4(1):27-38
12611417
Am Psychol. 2003 Jun-Jul;58(6-7):449-56
12971191
BMJ. 2001 Aug 11;323(7308):334-6
11498496
Addict Behav. 2009 Dec;34(12):1042-55
19683400
Health Educ Res. 1999 Dec;14(6):791-802
10585386
Psychol Bull. 1992 Jul;112(1):155-9
19565683
Prev Med. 2001 Nov;33(5):392-401
11676579
Addiction. 2009 Oct;104(10):1669-78
21265908
J Adolesc Health. 2003 Dec;33(6):436-57
14642706
Prev Med. 2004 Nov;39(5):951-61
15475029