Plain English Summary
Background and study aims
Adolescents aged 16 to 18 are at risk of problematic drinking and illegal drug use. While the short- and long-term effects are a major public health concern, current prevention programs targeting alcohol- and other drug-using adolescents are scarce. The aim of this study is to test the effectiveness of a web-based brief intervention aimed at reducing problematic alcohol use and abstaining from illegal drugs among adolescents aged 16 to 18 in Belgium, Germany, Czech Republic and Sweden.
Who can participate?
Adolescents aged 16 to 18 from Sweden, Czech Republic, Belgium and Germany who are tested for and found to be at risk of alcohol and drugs-related problems
What does the study involve?
Participants are randomly allocated to one of two groups. One group receives the web-based intervention, which takes about 10 to 15 minutes. The intervention provides feedback on participants’ alcohol and drug use, including the risks, and practical advice to encourage reduced drinking and abstinence from illegal drugs. The other group receives no intervention. Both groups’ use of alcohol and drugs is measured at the start of the study and at 3 months follow-up.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University Hospital Hamburg-Eppendorf (Germany)
When is the study starting and how long is it expected to run for?
June 2012 to January 2013
Who is funding the study?
1. European Commission (EU)
2. University Hospital 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)
Who is the main contact?
Prof Rainer Thomasius
thomasius@uke.uni-hamburg.de
Trial website
Contact information
Type
Scientific
Primary contact
Prof Rainer Thomasius
ORCID ID
Contact details
Deutsches Zentrum für Suchtfragen des Kindes und Jugendalters
University Hospital Hamburg-Eppendorf
Center for Psychosocial Medicine
Martinistrasse 52
Hamburg
20246
Germany
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thomasius@uke.uni-hamburg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
JUST/2010/DPIP/AG/0914-30-CE-0379823/00-48
Study information
Scientific title
Web-based screening and brief Intervention for SubstancE using teens: a randomised controlled trial
Acronym
WISEteens
Study hypothesis
Adolescents with risky substance use who participate 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 receive an assessment only.
Ethics approval
1. Hamburg, Chamber of Physicians,Germany, 10/04/2012 ref: PV4087
2. Ethics Committee of Prague Psychiatric Centre, Czech Republic, 18/04/2012, 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
Study design
Two-arm randomized controlled trial study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Prevention of continued risky substance consumption among young persons
Intervention
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.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Frequency and quantity of use of alcohol and drugs other than alcohol over a 30 day period, as well as consumption per typical occasion
Secondary outcome measures
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
Overall trial start date
25/06/2012
Overall trial end date
25/01/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
n = 800
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
25/06/2012
Recruitment end date
25/01/2013
Locations
Countries of recruitment
Belgium, Czech Republic, Germany, Sweden
Trial participating centre
University Hospital Hamburg-Eppendorf
Hamburg
20246
Germany
Sponsor information
Organisation
German Center for Addiction Research of Child and Adolescent (Germany)
Sponsor details
Deutsches Zentrum für Suchtfragen des Kindes und Jugendalters (DZSKJ)
University Hospital Hamburg-Eppendorf
Center for Psychosocial Medicine
Martinistrasse 52
Hamburg
D-20246
Germany
Sponsor type
Government
Website
http://www.uke.de/zentren/suchtfragen-kinder-jugend/index.php
Funders
Funder type
Government
Funder name
European Commission (EU) ref: JUST/2010/DPIP/AG/0914-30-CE-0379823/00-48
Alternative name(s)
EC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Funder name
German Centre for Addiction Research in Children and Adolescents, University Medical Centre Hamburg-Eppendorf (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Laboratory of Social Psychiatry at Prague Psychiatric Center (Czech Republic)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Stockholm Centre for Psychiatric Research and Education, Stockholm County Council Health Care Provision and Karolinska Institute (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Vereniging voor Alcohol en andere Drugproblemen vzw (VAD) (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Universität Lund, Clinical Alcohol Research, Skane University Hospital (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23013141
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27220276
Publication citations
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Protocol
Arnaud N, Bröning S, Drechsel M, Thomasius R, Baldus C, Web-based screening and brief intervention for poly-drug use among teenagers: study protocol of a multicentre two-arm randomized controlled trial., BMC Public Health, 2012, 12, 826, doi: 10.1186/1471-2458-12-826.
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Results
Arnaud N, Baldus C, Elgán TH, De Paepe N, Tønnesen H, Csémy L, Thomasius R, Effectiveness of a Web-Based Screening and Fully Automated Brief Motivational Intervention for Adolescent Substance Use: A Randomized Controlled Trial, J Med Internet Res, 2016 , 18, 5, e103, doi: 10.2196/jmir.4643.