Condition category
Mental and Behavioural Disorders
Date applied
28/11/2007
Date assigned
07/02/2008
Last edited
15/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Foxcroft

ORCID ID

Contact details

Marston Campus
Oxford Brookes University
Oxford
OX3 0FL
United Kingdom

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

http://www.brookes.ac.uk/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes