Web-based screening and brief Intervention for substance using teens

ISRCTN ISRCTN95538913
DOI https://doi.org/10.1186/ISRCTN95538913
Secondary identifying numbers JUST/2010/DPIP/AG/0914-30-CE-0379823/00-48
Submission date
12/06/2012
Registration date
16/07/2012
Last edited
31/03/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Rainer Thomasius
Scientific

Deutsches Zentrum für Suchtfragen des Kindes und Jugendalters
University Hospital Hamburg-Eppendorf
Center for Psychosocial Medicine
Martinistrasse 52
Hamburg
20246
Germany

Email thomasius@uke.uni-hamburg.de

Study information

Study designTwo-arm randomized controlled trial study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleWeb-based screening and brief Intervention for SubstancE using teens: a randomised controlled trial
Study acronymWISEteens
Study objectivesAdolescents 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(s)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
Health condition(s) or problem(s) studiedPrevention of continued risky substance consumption among young persons
InterventionThe 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 typeBehavioural
Primary outcome measureFrequency 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 measures1. 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 study start date25/06/2012
Completion date25/01/2013

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit16 Years
Upper age limit18 Years
SexBoth
Target number of participantsn = 800
Key inclusion criteria1. 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
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment25/06/2012
Date of final enrolment25/01/2013

Locations

Countries of recruitment

  • Belgium
  • Czech Republic
  • Germany
  • Sweden

Study participating centre

University Hospital Hamburg-Eppendorf
Hamburg
20246
Germany

Sponsor information

German Center for Addiction Research of Child and Adolescent (Germany)
Government

Deutsches Zentrum für Suchtfragen des Kindes und Jugendalters (DZSKJ)
University Hospital Hamburg-Eppendorf
Center for Psychosocial Medicine
Martinistrasse 52
Hamburg
D-20246
Germany

Website http://www.uke.de/zentren/suchtfragen-kinder-jugend/index.php

Funders

Funder type

Government

European Commission (EU) ref: JUST/2010/DPIP/AG/0914-30-CE-0379823/00-48
Government organisation / National government
Alternative name(s)
European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
German Centre for Addiction Research in Children and Adolescents, University Medical Centre Hamburg-Eppendorf (Germany)

No information available

Laboratory of Social Psychiatry at Prague Psychiatric Center (Czech Republic)

No information available

Stockholm Centre for Psychiatric Research and Education, Stockholm County Council Health Care Provision and Karolinska Institute (Sweden)

No information available

Vereniging voor Alcohol en andere Drugproblemen vzw (VAD) (Belgium)

No information available

Universität Lund, Clinical Alcohol Research, Skane University Hospital (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 26/09/2012 Yes No
Results article results 24/05/2016 Yes No

Editorial Notes

31/03/2017: Plain English summary added.
26/05/2016: Publication reference added.