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ISRCTN
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ISRCTN95538913
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DOI
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10.1186/ISRCTN95538913
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Web-based screening and brief Intervention for SubstancE using teens
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Scientific title
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Web-based screening and brief Intervention for SubstancE using teens: a randomised controlled trial
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Acronym
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WISEteens
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Serial number at source
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JUST/2010/DPIP/AG/0914-30-CE-0379823/00-48
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Study hypothesis
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We hypothesize that adolescents with risky substance use who participated in the WISEteens intervention show lower levels of substance consumption and higher levels of substance reduction and abstinence related cognitions as opposed to those who received an assessment only.
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Lay summary
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Lay summary under review 3
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Ethics approval
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1. Hamburg, Chamber of Physicians,Germany, 10 April 2012 ref: PV4087
2. Ethics Committee of Prague Psychiatric Centre, Czech Republic, 18 April 2012, ref: 49/12
3. The Regional Ethical Review Board Karolinska Institutet, Sweden, ref: nr 2012/462-31/3
4. Committee for Medical Ethics, University of Antwerp, Belgium (Comité voor medische ethiek Universiteit Antwerpen), ref: B300201214283
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Study design
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Two-arm randomized controlled trial study
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Countries of recruitment
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Belgium, Czech Republic, Germany, Sweden
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Disease/condition/study domain
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Prevention of continued risky substance consumption among young persons
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Participants - inclusion criteria
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1. Participants' age between 16 and 18 years
2. A positive screen on the CRAFFT for risky substance use
3. Informed consent of the participants
4. Access to the internet
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Participants - exclusion criteria
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Does not meet inclusion criteria.
Particpants are informed that they can withdraw from particpation at any time.
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Anticipated start date
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25/06/2012
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Anticipated end date
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25/01/2013
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Status of trial
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Completed |
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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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n = 800
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Interventions
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The overarching goal of the intervention is to encourage reduced alcohol consumption and abstinence of any illicit drugs. The intervention relies on a single session, is fully electronically delivered (automatic) yet interactive. It works with presenting tailored feedback to the participants’ responses in the earlier assessment (i.e., consumption levels) and provides choice options to react to this feedback. This interactivity simulates a face-to face “dialogue”, which aims for an empathic style, avoids argumentation, rolls with resistance and aims at creating a dissonance between actual and desired behavior and raising self-efficacy. In these goals, our intervention basically comprises of three components. First, participants will receive personalized feedback on their substance consumption patterns including the associated risks (related to health and other consequences) and comparisons to a normative reference group. Second, participants engage in interactive MI-based exercises that have been proven effective in prompting readiness to change by encouraging the participant to consider the costs and benefits of their current substance use and actual change. Finally, the intervention will include practical advice concerning alternative behavior in tempting situations, with a focus on peer resistance skills to raise self-efficacy beliefs and implementation intentions. All components will be described in more detail below. Time to complete the intervention is supposed to take 10 to 15 minutes approximately.
The control group will get no intervention. Participants are invited to visit again and participate after the evaluation period of the intervention of 3 months.
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Primary outcome measure(s)
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Reductions in frequency and quantity of use of alcohol and drugs other than alcohol over a 30 day period, as well as consumption per typical occasion.
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Secondary outcome measure(s)
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1. Additional behavioral outcomes including peak drinking quantity
2. Frequency of drinking to intoxication and typical weekend-drinking
3. Possible changes in substance use related cognitions including attitudes, subjective norms, control/self-efficacy beliefs, implementation intentions, and stages of change
4. Moreover the study addresses a number of moderator variables, such as general psychopathology and quality of parent-child relationship
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Sources of funding
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1. European Commission (EU) ref: JUST/2010/DPIP/AG/0914-30-CE-0379823/00-48
2. German Centre for Addiction Research in Children and Adolescents, University Medical centre Hamburg-Eppendorf (Germany)
3. Laboratory of Social Psychiatry at Prague Psychiatric Center (Czech Republic)
4. Stockholm Centre for Psychiatric Research and Education, Stockholm County Council Health Care Provision and Karolinska Institute (Sweden)
5. Vereniging voor Alcohol en andere Drugproblemen vzw (VAD) (Belgium)
6. Universität Lund, Clinical Alcohol Research, Skane University Hospital (Sweden)
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Trial website
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Publications
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1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23013141
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Contact name
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Prof
Rainer
Thomasius
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Address
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Deutsches Zentrum für Suchtfragen des Kindes und Jugendalters
University Hospital Hamburg-Eppendorf
Center for Psychosocial Medicine
Martinistrasse 52
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City/town
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Hamburg
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Zip/Postcode
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20246
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Country
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Germany
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Email
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thomasius@uke.uni-hamburg.de
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Sponsor
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German Center for Addiction Research of Child and Adolescent (Germany)
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Address
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Deutsches Zentrum für Suchtfragen des Kindes und Jugendalters (DZSKJ)
University Hospital Hamburg-Eppendorf
Center for Psychosocial Medicine
Martinistrasse 52
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City/town
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Hamburg
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Zip/Postcode
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D-20246
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Country
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Germany
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Email
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Sponsor website:
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http://www.uke.de/zentren/suchtfragen-kinder-jugend/index.php
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Date applied
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12/06/2012
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Last edited
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01/10/2012
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Date ISRCTN assigned
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16/07/2012
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