Alcohol eMail Assessment & feedback study Dismantling Effectiveness for University Students: the AMADEUS-1 trial
| ISRCTN | ISRCTN28328154 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28328154 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/10/2011
- Registration date
- 04/11/2011
- Last edited
- 08/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Because alcohol causes huge health problems for society in order to prevent and reduce problems we need to help people think about their drinking. This can be done online, asking people to complete a few questions and giving brief feedback and advice where it may be needed. This study aims to find out whether a brief online intervention 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?
Students from two universities in 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, comparing their drinking patterns against the safe drinking limits established by the Swedish Institute for Public Health. After this follows feedback describing their alcohol use compared to their peers in Swedish universities and, if applicable, personalised advice concerning the importance of reducing unhealthy levels or patterns of drinking. The feedback can be printed out by the student. 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 general health survey about students’ lifestyle habits with no reference to the previous surveys. All students at this time have an opportunity to receive personalised feedback.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Two universities in Sweden.
When is the study starting and how long is it expected to run for?
September to December 2011.
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
Contact information
Scientific
Department of Medicine and Health
Linköping University
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) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Alcohol eMail Assessment & feedback study Dismantling Effectiveness for University Students: the AMADEUS-1 trial |
| Study acronym | AMADEUS-1 |
| Study hypothesis | 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 the assessment has an impact on drinking behaviour but to a lesser extent that the intervention. |
| Ethics approval(s) | Regional Ethical Committe in Linköping, Sweden, 12/10/2010, ref: 2010/291-31 |
| Condition | Risky alcohol consumption |
| Intervention | Intervention delivery begins with receipt of an e-mail with a hyperlink to a computerised alcohol intervention. The mail is send from the local student health care asking them to participate in a short 9 question survey concerning alcohol habits. They will be informed that the survey is part of the university´s work with alcohol in general. After having completed a 9 item questionnaire the intervention Group feedback immediately upon completion of the assessment consisting of three statements summarising their weekly consumption, their frequency of heavy episodic drinking and their highest blood alcohol concentration during the last four weeks, comparing drinking patterns against the safe drinking limits established by the Swedish Institute for Public Health. After this follows comprehensive normative feedback with information describing participants' alcohol use compared to their peers in Swedish universities, and, if applicable, personalised advice concerning the importance of reducing any unhealthy levels or pattern of consumption. The feedback can be printed out by the student. A demonstration version can be viewed of the assessment and feedback intervention can be viewed at demo.livsstilstest.nu. 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 no contact group that do not know they will be asked to complete a seemingly unrelated general health survey, including alcohol questions, after 3 months 2. An assessment only group that complete the baseline questionnaire without getting a feedback who also do not know they will be asked to complete a seemingly unrelated general health survey, including alcohol questions, after 3 month. After 3 month all students in all three groups will receive a mail from the research group asking them to participate in a seemingly unrelated general health survey about students lifestyle habits with no reference to the previous survey 3 month earlier. This is done in order minimise a Hawthorne effect in the assessment group and the assessment and feedback 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 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 | Behavioural |
| Primary outcome measure | 1. Reduced average alcohol consumption 2. Reduced frequency of heavy episodic drinking 3. Reduced 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 | Reduction in proportion of students with risky drinking. Measured at baseline before they get a written feedback and after 3 months before another written feedback. |
| Overall study start date | 01/09/2011 |
| Overall study end date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 15,000 |
| Participant inclusion criteria | All university students at term 1, 3 and 5 in two universities in Sweden |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/09/2011 |
| Recruitment end date | 31/12/2011 |
Locations
Countries of recruitment
- Sweden
Study participating centre
581 83
Sweden
Sponsor information
Government
FAS
Box 2220
Stockholm
10315
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 | 06/07/2012 | Yes | No | |
| Results article | results | 01/11/2013 | Yes | No | |
| Other publications | reanalysis | 07/11/2019 | 08/11/2019 | Yes | No |
Editorial Notes
08/11/2019: Publication reference added.
