| Source of record | UK Trials |
| ISRCTN | ISRCTN30784467 |
| Date ISRCTN assigned | 07/02/2008 |
| Local reference number(s) | N/A |
| Public title | Is brief personalised feedback effective in reducing alcohol-related problems amongst University students in different European countries? |
| Scientific title | The effectiveness of brief personalised feedback in reducing alcohol-related problems amongst University students in UK and Portugal: a randomised controlled trial |
| Acronym | N/A |
| Disease/condition/study domain | Alcohol misuse and associated problems |
| Study hypothesis | Null Hypothesis:
Brief personalised feedback will not significantly reduce alcohol related problems in University students compared with:
1. A measurement only control, and
2. A no measurement or intervention control |
| Design/methodology | Solomon Three Group Randomised Controlled Trial (RCT) |
| Research ethics review | Ethics approval received from the Oxford Brookes University Research Ethics Committee on the 16th March 2007 (ref: 2006/28). |
| Countries of trial | United Kingdom, Portugal |
| Participants - inclusion criteria | First and Second Year undergraduate University students. |
| Participants - exclusion criteria | Does not comply with the inclusion criteria. |
| Patient information material | Patient information can be found at http://www.student-survey.net/consent_en.htm |
| Anticipated start date | 05/11/2007 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Ongoing |
| Target number of participants | 4000 |
| Interventions | Study design:
"The solomon three group design is designed to deal with a potential testing threat. Recall that a testing threat occurs when the act of taking a test affects how people score on a retest or post-test. Two of the groups receive a pre-test and one does not. This design also allows an examination of external validity by determining whether the effect of the intervention is different in participants who did or did not receive a pretest" (Campbell & Stanley, 1963).
Interventions:
Participants will be randomly assigned, with concealed allocation, to one of three groups. There is one intervention group and two control groups, controlling separately for measurement and for intervention effects.
Baseline alcohol use and misuse will be measured in two of the groups, but not the third group. Demographic questions will be answered by all three groups before randomisation. The intervention group will receive the brief personalised normative feedback via email within 3 weeks of completing the assessment and will be followed up at 6 months, along with the first control group. All three groups will be followed up at 12 months. |
| Primary outcome measure(s) | 1. Alcohol use disorders identification test (AUDIT) score
2. Weekly consumption
3. Perceived social norms
4. Alcohol related problems
Outcomes measured at baseline, 6 and 12 months. |
| Secondary outcome measure(s) | 1. Alcohol expectancies
2. Social desirability
Outcomes measured at baseline, 6 and 12 months. |
| Sources of funding | 1. Alcohol Education and Research Council (AERC) (UK)
2. European Research Advisory Board (ERAB) (Belgium)
3. Foundation for Science and Technology (Fundação para a Ciência e a Tecnologia [FCT]) (Portugal) |
| Sponsor name | Oxford Brookes University (UK) |
| Sponsor details | Marston Road
Oxford
United Kingdom
OX3 0FL |
| Sponsor website | http://www.brookes.ac.uk/ |
| Contact name | Prof David Foxcroft |
| Contact details | Marston Campus
Oxford Brookes University
Oxford
United Kingdom
OX3 0FL |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN30784467 |
| Date last extracted from ISRCTN register | 17/04/2008 |
