Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
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
Ethics approval
Ethics approval received from the Oxford Brookes University Research Ethics Committee on the 16th March 2007 (ref: 2006/28).
Study design
Solomon Three Group Randomised Controlled Trial (RCT)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Patient information can be found at http://www.student-survey.net/consent_en.htm
Condition
Alcohol misuse and associated problems
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
1. Alcohol expectancies
2. Social desirability
Outcomes measured at baseline, 6 and 12 months.
Overall trial start date
05/11/2007
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
First and Second Year undergraduate University students.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
4000
Participant exclusion criteria
Does not comply with the inclusion criteria.
Recruitment start date
05/11/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Portugal, United Kingdom
Trial participating centre
Marston Campus
Oxford
OX3 0FL
United Kingdom
Sponsor information
Organisation
Oxford Brookes University (UK)
Sponsor details
Marston Road
Oxford
OX3 0FL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Alcohol Education and Research Council (AERC) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
European Research Advisory Board (ERAB) (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Foundation for Science and Technology (Fundação para a Ciência e a Tecnologia [FCT]) (Portugal)
Alternative name(s)
Portuguese Science and Technology Foundation, Foundation for Science and Technology, FCT
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Portugal
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
1. 2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18402657
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22984466
Publication citations
-
Protocol
Moreira T, Foxcroft DR, The effectiveness of brief personalized normative feedback in reducing alcohol-related problems amongst university students: protocol for a randomized controlled trial., BMC Public Health, 2008, 8, 113, doi: 10.1186/1471-2458-8-113.
-
Results
Moreira MT, Oskrochi R, Foxcroft DR, Personalised normative feedback for preventing alcohol misuse in university students: Solomon three-group randomised controlled trial., PLoS ONE, 2012, 7, 9, e44120, doi: 10.1371/journal.pone.0044120.