title: The 'Eigenstandig werden' prevention trial: a cluster randomised controlled study on a school-based life skills programme to prevent substance use onset.
abstract: Objective To implement and evaluate 'Eigenständig werden 5+6' ('Becoming Independent 5+6'), a school-based curriculum for grades 5 and 6 developed on the basis of evidence-based criteria for effective drug prevention curricula in schools. Evaluation of the programme includes efficacy, feasibility and practicability in daily school routine.  Methods and results The intervention 'Eigenständig werden 5+6' consists of 14 teaching units evenly distributed over grades 5 and 6 which are interactively delivered, and a parent component. Programme effects are studied in a four wave cluster randomised controlled trial with two arms, an intervention and a control group. Self-completed questionnaires from students and teachers are collected by trained research staff. 45 schools, 172 classes and 3444 students with a mean age of 10.37 years (SD=0.59) and 47.9% girls from four federal states in Germany were assessed at baseline. 1685 students in 81 classes were assigned to intervention classes, 1759 students in 91 classes to the control arm. No differences between conditions were found for age, gender, immigration background, socioeconomic status, substance use or life skills at baseline. Exceptions were higher self-efficacy (t(3438)=2.34, p=0.02, d=0.08) and empathy (t(3302)=2.4, p=0.02, d=0.09) in the control group, whereas class climate seemed better in the intervention group (t(3037)=2.01, p=0.05, d=0.07), but effect sizes state marginal differences.  Conclusion Baseline data suggest that the initial conditions are favourable for testing programme efficacy since distribution of baseline levels of the outcomes did not differ in the intervention and control groups, except for negligible differences between self-efficacy and empathy, which were higher in the control group, and class climate, which was higher in the intervention group.  Trial registration number Current Controlled Trials ISRCTN99442407.
authors.affiliation: Institute for Therapy and Health Research, IFT-Nord, Kiel, Germany.
authors.forename: Julia
authors.initials: J
authors.lastname: Hansen
authors.forename: Reiner
authors.initials: R
authors.lastname: Hanewinkel
authors.forename: Karin
authors.initials: K
authors.lastname: Maruska
authors.forename: Barbara
authors.initials: B
authors.lastname: Isensee
references.citation: Health Educ Behav. 1998 Jun;25(3):319-37
references.pmid: 9615242
references.citation: Health Psychol. 1995 Jul;14(4):291-300
references.pmid: 7556032
references.citation: Health Educ Res. 2008 Aug;23(4):621-32
references.pmid: 17897931
references.citation: Pediatrics. 2009 Feb;123(2):e274-81
references.pmid: 19171580
references.citation: Health Psychol. 1990;9(6):701-16
references.pmid: 2286181
references.citation: Health Educ Res. 2007 Jun;22(3):351-60
references.pmid: 16963725
references.citation: J Natl Cancer Inst. 2000 Dec 20;92(24):1979-91
references.pmid: 11121460
references.citation: Tob Induc Dis. 2009 Mar 26;5(1):6
references.pmid: 19323826
references.citation: Soc Sci Med. 2008 Mar;66(6):1429-36
references.pmid: 18179852
references.citation: Comput Biol Med. 2004 Mar;34(2):113-25
references.pmid: 14972631
references.citation: MMWR Surveill Summ. 2006 Jun 9;55(5):1-108
references.pmid: 16760893
references.citation: J Consult Clin Psychol. 1990 Aug;58(4):458-68
references.pmid: 2212183
references.citation: Addict Behav. 2002 Nov-Dec;27(6):1009-23
references.pmid: 12369469
references.citation: Prev Sci. 2003 Mar;4(1):27-38
references.pmid: 12611417
references.citation: Cochrane Database Syst Rev. 2011 May 11;(5):CD009113
references.pmid: 21563171
references.citation: Am J Public Health. 2004 Mar;94(3):423-32
references.pmid: 14998806
references.citation: Prev Med. 2000 Feb;30(2):115-25
references.pmid: 10656839
references.citation: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2007 May-Jun;50(5-6):600-8
references.pmid: 17514444
references.citation: J Behav Med. 1987 Apr;10(2):159-71
references.pmid: 3612776
references.citation: Prev Med. 2007 Feb;44(2):170-3
references.pmid: 17084887
references.citation: Stat Med. 2007 Jan 15;26(1):2-19
references.pmid: 17136746
references.citation: Dtsch Med Wochenschr. 2009 Jul;134(31-32):1573-7
references.pmid: 19629920
references.citation: Psychol Bull. 1992 Jan;111(1):23-41
references.pmid: 1539088
references.citation: Arch Pediatr Adolesc Med. 2001 May;155(5):554-9
references.pmid: 11343497
references.citation: Addiction. 2005 Oct;100(10):1464-76
references.pmid: 16185208
references.citation: Lancet. 2006 Mar 4;367(9512):749-53
references.pmid: 16517275
references.citation: Addict Behav. 2008 Apr;33(4):528-37
references.pmid: 18164827
references.citation: Addict Behav. 2000 Nov-Dec;25(6):861-85
references.pmid: 11125776
references.citation: Tob Induc Dis. 2009 Mar 26;5(1):7
references.pmid: 19323827
references.citation: Drug Alcohol Depend. 2003 Dec 11;72(3):279-86
references.pmid: 14643945
references.citation: Prev Med. 2008 May;46(5):385-96
references.pmid: 18258289
references.citation: Drug Alcohol Depend. 2002 Nov;68 Suppl 1:S69-83
references.pmid: 12324176
references.citation: Prev Med. 2007 Feb;44(2):174-7
references.pmid: 16979751
references.citation: Health Psychol. 1996 Sep;15(5):355-61
references.pmid: 8891714
references.citation: J Adolesc Health. 2005 Mar;36(3):162-9
references.pmid: 15737770