A brief online psychosocial intervention to reduce binge drinking in new university students

ISRCTN	ISRCTN84252967
DOI	https://doi.org/10.1186/ISRCTN84252967
Secondary identifying numbers	V1

Submission date: 23/06/2014
Registration date: 02/07/2014
Last edited: 26/01/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

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?
Prof. Paul Norman
p.norman@sheffield.ac.uk

Contact information

Prof Paul Norman
Scientific

Department of Psychology
University of Sheffield
Sheffield
S10 2TP
United Kingdom

ORCID ID	0000-0002-5892-0470
Phone	+44 (0)114 222 6505
Email	p.norman@sheffield.ac.uk

Study information

Study design	2 x 2 x 2 between-participants factorial design. Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study objectives	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(s)	University of Sheffield, Department of Psychology Research Ethics Committee, 22/03/2013, ref: 2013-628
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	08/09/2014
Completion date	30/03/2015

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	At least 2000 students at baseline and 1320 at six-month follow-up.
Key inclusion criteria	All incoming undergraduate students (in 2014) to the University of Sheffield
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	08/09/2014
Date of final enrolment	30/03/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Sheffield

Sheffield
S10 2TP
United Kingdom

Sponsor information

University of Sheffield (UK)
University/education

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

Website	http://www.shef.ac.uk/ris/index
"ROR"	https://ror.org/05krs5044

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Paul Norman (p.norman@sheffield.ac.uk).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2018		Yes	No

Editorial Notes

26/01/2018: IPD sharing statement and publication reference added.