Prevention of risky drinking among university students. A study of the effectiveness of a mail-based computerized screening and personalised feedback in three universities in Sweden the AMADEUS 2 study
| ISRCTN | ISRCTN02335307 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02335307 |
| Secondary identifying numbers | AMADEUS 2 version 1 |
- Submission date
- 04/03/2013
- Registration date
- 25/04/2013
- Last edited
- 18/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Going to university is associated with increased levels of heavy drinking. Alcohol is often used to promote social integration despite the potential negative consequences of excessive drinking among students. Therefore, in most countries around the world the number of students with risky drinking is high - often above 50 % of the total student population. College and university students constitute a large and important proportion of the future labour force. Already at an early stage of a professional career it is fundamentally important to have sensible alcohol habits in order to prevent future negative alcohol-related consequences. This calls for value for money treatments in order to reach the maximum number of students starting university each year. The objective of the study is to assess how well a fully automated email-based internet alcohol intervention works.
Who can participate?
Eligible participants are all term 2,4 and 6 students whose drinking habits are hazardous or harmful in nine colleges and universities in Sweden identified by a single screening question.
What does the study involve?
The students get an invitation to participate in the study via an e-mail with a single question screening for risky drinking. Risky drinkers are then randomly allocated to an Intervention group which will have access to the internet alcohol intervention or a control group that will have access to the intervention after 2 months (at the time of a follow-up of the intervention group).
What are the possible benefits and risks of participating?
The possible benefits from participating for the individuals are a personalized feedback on their alcohol consumption with recommendations about sensible drinking. There are no known side effects.
Where is the study run from?
The study is carried out by researchers at Linköping University, Sweden, using students from nine universities in Sweden.
When is the study starting and how long is it expected to run for?
The study started in February 2013 and will end in June 2013. The recruitment period will be for 3 weeks. A follow-up of all participants will be done after 2 months.
Who is funding the study?
The study is funded by The Swedish Council For Working Life and Social Research (FAS, in Swedish).
Who is the main contact?
Professor Preben Bendtsen
preben.bendtsen@liu.se
Contact information
Scientific
Linköpings Universitet
IMH/SAM
Hälsans Hus
Linköping
581 83
Sweden
| Phone | +46 (0)70 232 4615 |
|---|---|
| preben.bendtsen@liu.se |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Prevention of risky drinking among university students. A RCT study of the effectiveness of a mail-based computerized screening and personalised feedback in three universities in Sweden the AMADEUS 2 study |
| Study acronym | AMADEUS 2 study |
| Study objectives | The study aims to evaluate the effectiveness of a mail-based Internet alcohol intervention (eSBI) offered to non treatment seekers among university students, The study will randomise risky drinkers to an intervention group or a waiting list group that first will have access to the Intervention after 2 months. Current hypothesis as of 02/07/2013: The hypothesis is that the intervention group will have a lower total weekly alcohol consumption than the waiting list group at the time of follow-up. Previous hypothesis: The hypothesis is that the Intervention group will have a 5-10% lower total weekly alcohol consumption than the waiting list group at the time of follow-up. Added 02/07/2013: 55,000 students to be invited. It is desirable that this study is as large as possible. For indicative purposes to detect an effect size of 0.1 standard deviations between the two groups with 5% significance level and 80% power, we required 1,600 individuals analysed per group. Assuming a follow-up rate of 50%, we should aim to recruit 3,200 individuals per group i.e. 6,400 in total. We had no data on the number of screen positives who may be willing to participate in this trial and assumed approximately 70% would do so, meaning that we would need to identify approximately 8,000 hazardous and harmful drinkers. |
| Ethics approval(s) | Ethics Committee in Linköping Sweden, 20/02/2013, ref: Dnr 2013/46-31 |
| Health condition(s) or problem(s) studied | Prevention of risky drinking |
| Intervention | Intervention group and a waiting list group. The study is based on a mail-based computerized alcohol intervention (eSBI) that has been developed by the Lifestyle Intervention Research group (LIR group) at Linköping University. In short, the students receives a mail from the student health care service with a short welcome greeting followed by an invitation to perform a computerized alcohol test by clicking on a hyperlink. Two reminders are sent with a week apart to those who have not answered and thereafter the link is closed. The link can only be used once in order to ensure that each student only performs the test once. The test includes questions about average consumption day by day in a typical week during the last 2 months, frequency of binge drinking, highest blood alcohol concentration (BAC) the last two months (calculated by the computer based upon the students input), experienced negative consequences related to alcohol, views upon how much other students and peers drink, and questions about motivation to change. The student then gets immediate feedback by computer consisting of three statements summarizing their weekly consumption, their frequency of heavy episodic drinking and their highest blood alcohol concentration during the last three months, comparing the respondents' drinking patterns against the safe drinking limits established by the Swedish Institute for Public Health. After this follows a comprehensive normative feedback with information describing participants' alcohol use compared to peers at the university, and, if applicable, personalized advice concerning the need for reducing any unhealthy levels or pattern of consumption. The feedback can be printed out by the student. |
| Intervention type | Behavioural |
| Primary outcome measure | Total weekly alcohol consumption. |
| Secondary outcome measures | Current secondary outcome measures as of 02/07/2012: 1. Proportion drinking above official safe drinking limits 2. Frequency of drinking (number of days per week) 3. Quantity of drinks per drinking day 4. Frequency of heavy episodic drinking as defined in the screening question 5. Highest estimated blood alcohol concentration (eBAC) 6. Stage of change Previous secondary outcome measures: 1. The frequency of drinking (number of days per week) 2. Quantity of drinks per 3. Drinking day 4. Frequency of heavy episodic drinking 5. Highest estimated blood alcohol concentration (eBAC) |
| Overall study start date | 27/02/2013 |
| Completion date | 15/06/2013 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 55,000 students |
| Total final enrolment | 1605 |
| Key inclusion criteria | All term 2, 4 and 6 students (both sexes and between 18 and 30 years of age) at nine colleges and universities in Sweden were invited to participate by an email. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 27/02/2013 |
| Date of final enrolment | 15/06/2013 |
Locations
Countries of recruitment
- Sweden
Study participating centre
581 83
Sweden
Sponsor information
Government
Box 894
Stockholm
10137
Sweden
| Phone | +46 (0)87 754 070 |
|---|---|
| fas@fas.se | |
| Website | http://www.fas.se |
"ROR" |
https://ror.org/02d290r06 |
Funders
Funder type
Government
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Swedish Council for Working Life and Social Research, FAS
- Location
- Sweden
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/10/2013 | Yes | No | |
| Results article | results | 09/07/2015 | Yes | No | |
| Other publications | re-analysis using a Bayesian framework | 17/12/2019 | 18/12/2019 | Yes | No |
Editorial Notes
18/12/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the 2015 reference.
