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ISRCTN
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ISRCTN99442407
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ClinicalTrials.gov identifier
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Public title
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"Be Independent (Eigenständig werden)" prevention trial: a school-based substance use prevention programme based on the Social Influence Approach
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Scientific title
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A school-based substance use prevention programme based on the Social Influence Approach: a prospective cluster randomised controlled trial
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Acronym
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N/A
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Serial number at source
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108374
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Study hypothesis
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Participation in the prevention programme "Eigenständig werden" leads to higher social and personal competencies, lower rates of substance use and initiation, better knowledge on substance use, lower susceptibilitiy to smoking and alcohol and more negative attitudes towards substances.
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Lay summary
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Ethics approval
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Ethics Board of Medical Faculty of Christian Albrechts University Kiel, Germany, approved on the 23rd April 2010 (ref: D419/10)
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Study design
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Prospective cluster randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Tobacco and alcohol dependance
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Participants - inclusion criteria
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1. Students of public schools
2. Aged between 10 and 12 years (grade 5 to 6), either sex
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Participants - exclusion criteria
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1. Students of schools with special pedagogic needs
2. Missing consent of school
3. Missing parental consent
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Anticipated start date
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01/05/2010
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Anticipated end date
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15/01/2014
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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3160 students (in 158 classes)
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Interventions
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"Eigenständig werden" (Becoming independent) is a school-based life skill programme with substance specific units and information of parents. Trained teachers implement 9 units school year. In the contol group, classes receive treatment as usual (normal school lessons).
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Primary outcome measure(s)
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1. Life skills, social and interpersonal competencies
2. Smoking and alcohol use behaviour (lifetime, current) and intentions
These will be measured at baseline, post-test 1 (end of grade 5), post-test 2 (end of grade 6), 6 and 18 months follow-up.
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Secondary outcome measure(s)
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1. Knowledge on smoking and alcohol
2. Attitudes on smoking and alcohol
These will be measured at baseline, post-test 1 (end of grade 5), post-test 2 (end of grade 6), 6 and 18 months follow-up.
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Sources of funding
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German Cancer Aid (Deutsche Krebshilfe e.V.) (Germany) (ref: 108374)
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Trial website
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Publications
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Contact name
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Dr
Reiner
Hanewinkel
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Address
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IFT-Nord
Harmsstr. 2
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City/town
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Kiel
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Zip/Postcode
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24114
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Country
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Germany
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Tel
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+49 (0)431 570 2920
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Fax
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+49 (0)431 570 2929
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Email
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hanewinkel@ift-nord.de
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Sponsor
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German Cancer Aid (Deutsche Krebshilfe e.V.) (Germany)
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Address
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Buschstr. 32
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City/town
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Bonn
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Zip/Postcode
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53113
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Country
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Germany
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Sponsor website:
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http://www.krebshilfe.de
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Date applied
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06/05/2010
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Last edited
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22/07/2010
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Date ISRCTN assigned
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22/07/2010
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