Trial document




drksid header

  DRKS00007857

Trial Description

start of 1:1-Block title

Title

Primary Prevention of Smoking and Drinking in Young People: Nine year follow-up of two cluster-randomized school based drug prevention trials

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

PSD

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

For many years school-based programs aimed at preventing substance use and misuse have been implemented and evaluated. While there is evidence that some of these programs have positive short-term and mid-term effects, little is known about their long-term effectiveness.
Aim of the current study is to investigate the long-term effects of two German universal school-based prevention programs, „Be Smart - Don't Start” and „Aktion Glasklar”. Starting in 2006, two studies have been conducted in which students who took part in one of the programs were compared with students who received education as usual. The classes were randomly assigned to the groups. Taken together, a total of 5,176 7th graders from 289 classes and 114 schools could be surveyed at baseline in both studies. The results indicate that participation in „Be Smart - Don't Start” and „Aktion Glasklar” might affect smoking and alcohol use positively in the short term.
Nine years after the baseline assessment, the samples of the two original studies shall be contacted and surveyed again. Findings of the current study will help to fill the research gap regarding the potential of school-based programs to sustainably influence cigarette and alcohol use up to early adulthood.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Background and study aims:
For many years school-based programs aimed at preventing substance use and misuse have been implemented and evaluated. Current evidence suggests that certain generic psychosocial and developmental prevention programs might be particularly effective (Cochrane Database Syst Rev. 2013;4:CD001293; Cochrane Database Syst Rev. 2011:CD009113). However, empirical evidence on the long-term effects is not yet uniquely convincing (Tob Induc Dis. 2009;5:7). This study aims to examine the long-term effects of two German universal school-based prevention programs nine years after their implementation.

Interventions:
The prevention programs are „Be Smart - Don't Start” and „Aktion Glasklar”.
„Be Smart - Don't Start” is conceptualized for implementation in schools with a focus on targeting students aged 11–14. Participating classes commit themselves by contract management to stay smokefree for up to six months. Students in these classes report regularly on whether or not they have smoked. At the end of the competition period successful classes can win attractive prizes in a lottery.
„Aktion Glasklar” is an information and awareness-raising campaign on alcohol which targets adolescents. It consists of booklets for students and parents, teaching materials and a quiz. The teaching materials cover topics such as statutory regulations, marketing, peer pressure and social norms with regard to alcohol.

Methods:
For each of the programs, „Be Smart - Don't Start” and „Aktion Glasklar”, a two-arm cluster-randomized trial („intervention” vs. „education as usual”) with schools as the unit of randomization was conducted between 2006 and 2008. Students of the respective intervention group participated either in „Be Smart - Don't Start” (November 2006 – April 2007) or in „Aktion Glasklar“ (March – May 2006). The students of the respective control group received education as usual. Taken together, a total of 5,176 7th graders from 289 classes and 114 schools could be surveyed at baseline in both studies. Data suggested short term effects of the prevention programs on smoking (J Epidemiol Community Health 2012;66:334-41) and binge drinking (Addiction 2009;104:402-12).

Nine years after the baseline assessment, the samples of the two original studies shall be contacted and surveyed again. The former participants are now young adults aged between 20 and 22. They will be contacted via their former schools. In Germany, schools have to hold class lists with personal data including names and addresses of students for a number of years. Schools that agree to participate in the follow-up trial will be asked to send a postal package containing all relevant study materials to the parents of the former students. In addition to filling in a paper-pencil version of the questionnaire the participants also have the opportunity to use an online platform. In both cases, the survey will be conducted anonymously. To permit a linking between the baseline and long-term surveys a seven-digit individual code generated by the students in the original studies will be used. The code does not allow drawing any conclusions on the personal data of the participants.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007857
  •   2015/03/03
  •   [---]*
  •   yes
  •   Approved
  •   RH_122014, Ethikkommission der Deutschen Gesellschaft für Psychologie e.V.
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F10 -  Mental and behavioural disorders due to use of alcohol
  •   F17 -  Mental and behavioural disorders due to use of tobacco
  •   Tobacco and alcohol use
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Participation in one of the school-based prevention programs, „Be Smart – Don’t Start” and „Aktion Glasklar” in 2006 and 2007 within the original studies; within the current study, no intervention takes place
  •   No participation in one of the two school-based substance use prevention programs (i. e. education as usual) within the original studies; within the current study, no intervention takes place
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Frequency and quantity of past and current cigarette and alcohol use at long-term follow-up 9 years after baseline

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Current cannabis use, (emotional and physical) health (reference: Individual questionnaire 2014 of the German Socio-Economic Panel Study; SOEP)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/04/01
  •   1000
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Participation in one of the original studies in 2006

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

No participation in one of the original studies in 2006

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Therapie- und Gesundheitsforschung,IFT-Nord gGmbH
    • Mr.  Prof. Dr.  Reiner  Hanewinkel 
    • Harmsstraße 2
    • 24114  Kiel
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Universität Hamburg,Fakultät für Betriebswirtschaftslehre,Institut für Recht der Wirtschaft
    • Mr.  Dr.  Tobias  Effertz 
    • Max-Brauer-Allee 60
    • 22765  Hamburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Institut für Therapie- und Gesundheitsforschung,IFT-Nord gGmbH
    • Mr.  Prof. Dr.  Reiner  Hanewinkel 
    • Harmsstraße 2
    • 24114  Kiel
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Institut für Therapie- und Gesundheitsforschung,IFT-Nord gGmbH
    • Ms.  Dr.  Karin  Maruska 
    • Harmsstraße 2
    • 24114  Kiel
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • DAK-Gesundheit
    • Nagelsweg 27-31
    • 20097  Hamburg
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2016/04/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Isensee B, Morgenstern M, Stoolmiller M, Maruska K, Sargent JD, Hanewinkel R. Effects of Smokefree Class Competition 1 year after the end of intervention: a cluster randomised controlled trial. J Epidemiol Community Health. 2012;66:334-341.
  •   Morgenstern M, Wiborg G, Isensee B, Hanewinkel R. School-based alcohol education: results of a cluster-randomized controlled trial. Addiction. 2009;104:402-412.
  •   Hanewinkel R, Isensee B, Morgenstern M. „Be Smart – Don’t Start“: Untersuchung langfristiger Effekte eines schulbasierten Präventionsprogramms. SUCHT. 2018;64:29-40.
  •   Morgenstern M, Isensee B, Hanewinkel R. Vorhersage des Rauschtrinkens im jungen Erwachsenenalter: Eine Kohortenstudie über 9 Jahre. Zeitschrift für Kinder- und Jugendpsychiatrie und Psychotherapie. 2018. https://doi.org/10.1024/1422-4917/a000590
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.