Condition category
Mental and Behavioural Disorders
Date applied
12/06/2012
Date assigned
16/07/2012
Last edited
26/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

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
-
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

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.

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 below 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

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.

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. 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

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

Deutsches Zentrum für Suchtfragen des Kindes und Jugendalters
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

Belgium

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

  1. 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.

  2. 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.

Additional files

Editorial Notes

26/05/2016: Publication reference added.