Condition category
Mental and Behavioural Disorders
Date applied
23/06/2014
Date assigned
02/07/2014
Last edited
02/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Binge drinking is a common behaviour among university students that can result in both social and health problems is associated (e.g., physical violence, accidents, unsafe sex). Significant life changes, such as going to university, are “teachable moments” when people are more open to making changes to their behaviour. This study will test the effectiveness of three health behaviour change techniques in reducing binge drinking at university:
1. Encouraging people to reflect on their personal values to increase their openness to health messages
2. Targeting the key beliefs associated with binge drinking
3. Helping people to form specific plans to avoid binge drinking.
The intervention(s) will be assessed online (as young people are the main users of the internet) two weeks before students start at university. Students will complete measures immediately after receiving the intervention(s) and will also be followed-up one week, one month and six months after starting university to examine the impact of the intervention(s) on binge drinking beliefs and behaviour.

Who can participate?
All incoming undergraduate students (in 2014) to the University of Sheffield.

What does the study involve?
Students who decide to take part will be asked to complete an initial online questionnaire on their typical drinking behaviour approximately two weeks before starting university. They will then be randomly assigned to one of three experimental groups after which they will complete measures of their beliefs about binge drinking. All participants will be asked to complete further questionnaires one week, one month and six months after starting university to assess their binge drinking behaviour and beliefs. In order to encourage participation, participants will have the opportunity to be entered into draws to win £100 after completing each questionnaire. Participants completing all of the questionnaires will also be entered into an additional prize draw to win an iPad-mini.

What are the possible benefits and risks of participating?
No major risks or discomfort are anticipated. Avoiding binge drinking can reduce the risk of both short-term and long-term negative social and health outcomes. We hope that the intervention will help students to reduce their levels of alcohol consumption at university.

Where is the study conducted?
University of Sheffield (UK)

When is study starting and how long is it expected to run for?
September 2014 to March 2015

Who is funding the study?
National Prevention Research Initiative (UK)

Who is the main contact?
Professor Paul Norman
p.norman@sheffield.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paul Norman

ORCID ID

Contact details

Department of Psychology
University of Sheffield
Sheffield
S10 2TP
United Kingdom
+44 (0)114 222 6505
p.norman@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V1

Study information

Scientific title

A brief theory-based online intervention to reduce binge drinking in new university students: Targeting reception, motivation, and volition at a teachable moment

Acronym

Study hypothesis

The project will assess the effect of different combinations of three health behaviour change techniques (i.e., self-affirmation, theory-based messages, implementation intentions), delivered in an online intervention to young people shortly before they start university, on their binge drinking beliefs and behaviour over the first six months at university.

Ethics approval

University of Sheffield, Department of Psychology Research Ethics Committee; 22/03/2013; ref. 2013-628

Study design

2 x 2 x 2 between-participants factorial design. Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format. Please use the contact details below to request patient information material.

Condition

Alcohol consumption

Intervention

Participants will be randomised to condition in a 2 (self-affirmation: yes, no) × 2 (theory-based messages: yes, no) × 2 (implementation intention: yes, no) between-participants factorial design.

Participants allocated to the self-affirmation condition will complete an attributes questionnaire (Napper et al., 2009) that comprises items adapted from the Values in Action Strength Scale (Peterson & Seligman, 2004). Participants will be asked to rate the extent to which 32 positive values or characteristics (e.g., “I always try to keep my word”) apply to themselves.

Participants allocated to the theory-based messages condition will be presented with messages (i.e., text and videos) based on the theory of planned behaviour that target the key beliefs underlying binge drinking at university. The messages have been developed on the basis of formative work that identified the key beliefs associated with new students’ binge drinking intentions and behaviour at university (Epton et al., 2014).

Participants allocated to the implementation intention condition will be asked to form if-then plans to avoid binge drinking at university (Gollwitzer, 1999). Participants will be provided with examples of appropriate implementation intentions (Hagger et al., 2012) and then instructed to generate their own if-then plans.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The experimental groups will be compared on the following primary outcome measures at six-month follow-up (controlling for baseline measures):

1. Number of units of alcohol consumed in a typical week assessed using a retrospective seven-day alcohol diary (Gmel & Rehm, 2004).
2. Number of binge drinking sessions in a typical week.

The experimental groups will also be compared on these measures at one-week, one-month and six-month follow-ups.

Secondary outcome measures

The experimental groups will also be compared on the following secondary outcome
measures:

1. AUDIT (Babor et al., 2001) scores (six-month follow-up).
2. Direct measures of the Theory of Planned Behaviour (Ajzen, 1988) constructs – attitude, subjective norms, descriptive norms, self-efficacy, perceived control and intention (post-intervention, one month and six months).
3. Belief strength (Ajzen, 1988) – beliefs targeted in the messages (post-intervention, one month and six months).

Overall trial start date

08/09/2014

Overall trial end date

30/03/2015

Reason abandoned

Eligibility

Participant inclusion criteria

All incoming undergraduate students (in 2014) to the University of Sheffield.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

At least 2000 students at baseline and 1320 at six-month follow-up.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

08/09/2014

Recruitment end date

30/03/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychology
Sheffield
S10 2TP
United Kingdom

Sponsor information

Organisation

University of Sheffield (UK)

Sponsor details

Research & Innovation Services
New Spring House
231 Glossop Road
Sheffield
S10 2GW
United Kingdom

Sponsor type

University/education

Website

http://www.shef.ac.uk/ris/index

Funders

Funder type

Research organisation

Funder name

Formative research to develop the intervention materials was, in part, funded by the National Prevention Research Initiative - Phase 4 (UK) ref: MR/J000450/1

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes