Plain English Summary
Background and study aims
Several studies have assessed various forms of screening and interventions to change students’ drinking behaviour. This can be done online, asking people to complete a few questions and giving brief feedback and advice where it may be needed. Electronic screening and brief intervention (e-SBI) is as an efficient approach to reach large numbers of adolescents as a result of high levels of internet use among young people. This study aims to find out whether e-SBI works, and whether it is necessary to receive feedback or whether simply answering questions helps people to think about their drinking and to change it.
Who can participate?
All freshmen at Linköping University, Sweden
What does the study involve?
Participants are randomly allocated into three groups. The first group receive an e-mail asking them to participate in a short 9-question survey about alcohol habits. After completing the questionnaire they immediately receive feedback about their alcohol consumption. The second group are not contacted at all until the end of the study. The third group complete the questionnaire without getting feedback. After 3 months all three groups receive an email asking them to participate in a seemingly unrelated survey about students’ alcohol habits with no reference to the previous survey. All students at this time have an opportunity to receive personalised feedback.
What are the possible benefits and risks of participating?
The benefit could be that participants consider their alcohol habits and might change these to be more healthy. No risks are anticipated for the participants.
Where is the study run from?
Linköping University (Sweden)
When is the study starting and how long is it expected to run for?
September to December 2010
Who is funding the study?
Swedish Council for Working Life and Social Research (Sweden)
Who is the main contact?
Prof. Preben Bendtsen,
preben.bendtsen@liu.se
Trial website
Contact information
Type
Scientific
Primary contact
Prof Preben Bendtsen
ORCID ID
Contact details
Department of Medicine and Health
Linköping University
Linköping
5581 83
Sweden
+46 (0)70 232 4615
preben.bendtsen@liu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Randomised controlled trial of the effectiveness of electronic mail based alcohol intervention with university students: dismantling the assessment and feedback components
Acronym
Study hypothesis
The overall aim of the study is to evaluate the effectiveness of electronic screening and brief intervention (e-SBI), employing an randomised controlled trial (RCT) design that takes account of baseline assessment reactivity (and other possible effects of the research process) due to the similarity between the intervention and assessment content. The hypothesis is that assessment per se have an impact on drinking behaviour however to a lesser extent that the intervention.
Ethics approval
Regional Ethics Committee in Linköping, Sweden, 12/10/2010, ref: 2010/291-31
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Alcohol risk/drinking behaviour
Intervention
The present study is designed in such a manner that the control group is as non contaminated as possible from the possible effects of research participation. Two kind of control groups will therefore be included in the study
1. A delayed intervention group that do not know they will get an intervention after 3 month
2. A screening only group without intervention at baseline who also do not know they will get an intervention after 3 months, when they will be offered an e-SBI following outcome assessment.
Students in the screening group (S) will receive a mail from the local student health care asking them to participate in a short 9 question survey concerning alcohol habits among students in Linköping. They will be informed that the survey is part of the university´s work with alcohol in general.
Students in the control group (C) will not be aware that they have been selected for a study before 3 months when students in all three groups (e-SBI, S and C) will receive a mail from the research group asking them to participate in a survey about students alcohol habits with no reference to the previous survey 3 month earlier with the research procedures otherwise identical to those used in Luleå.
After 3 month all students in both the intervention and control groups will receive a mail from the research group asking them to participate in a survey about students alcohol habits with no reference to the previous survey 3 month earlier. This is done in order minimise a Hawthorne effect in the intervention group i.e. being aware that the results will be compared with the first survey. The appearance of the two surveys, as well as their source, will be different from each other to protect against this possibility. All students will at this time receive a normative personalised feedback opportunity directly on the screen of their computer and have the possibility to print it out. The students will also automatically receive a mail with their feedback so they can read the feedback at a later stage.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Average alcohol consumption
2. Frequency of heavy episodic drinking
3. Maximal drinking at one occasion
Measured at baseline before they get a written feedback and after 3 months before another written feedback
Secondary outcome measures
Proportion of students with risky drinking, measured at baseline before they get a written feedback and after 3 months before another written feedback.
Overall trial start date
01/09/2010
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
All freshmen at Linköping University, Sweden
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
5000
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/09/2010
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Sweden
Trial participating centre
Linköping University
Linköping
5581 83
Sweden
Sponsor information
Organisation
Swedish Council for Working Life and Social Research (Sweden)
Sponsor details
FAS
Box 2220
Stockholm
10315
Sweden
+46 (0)87 754 070
fas@fas.se
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Swedish Council for Working Life and Social Research (Sweden) (Grant number: 2010-0024)
Alternative name(s)
Swedish Council for Working Life and Social Research, FAS
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Sweden
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 results in: http://www.ncbi.nlm.nih.gov/pubmed/23113955
Publication citations
-
Results
Bendtsen P, McCambridge J, Bendtsen M, Karlsson N, Nilsen P, Effectiveness of a proactive mail-based alcohol Internet intervention for university students: dismantling the assessment and feedback components in a randomized controlled trial., J. Med. Internet Res., 2012, 14, 5, e142, doi: 10.2196/jmir.2062.