The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000388516
Ethics application status
Approved
Date submitted
9/04/2015
Date registered
28/04/2015
Date last updated
28/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A brief Ecological Momentary Intervention to reduce alcohol use and alcohol related harm in new college students.
Scientific title
A brief Ecological Momentary Intervention to reduce alcohol use and alcohol related harm in new college students.
Secondary ID [1] 286496 0
Nil
Universal Trial Number (UTN)
U1111-1169-1378
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol use 294705 0
Alcohol Related Consequences 294706 0
Condition category
Condition code
Other 294997 294997 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will be assigned to one of 2 conditions outlined below:

Ecological momentary intervention and ecological momentary assessment (EMI-EMA): Participants in the EMI-EMA condition will be sent intervention text messages twice a day (at 7:30pm and 9pm) on the Tuesday, Thursday, Friday, and Saturday of Orientation Week. These messages will contain a social consequence of alcohol use. EMI-EMA participants will also receive messages asking them to report their weekend alcohol use fortnightly throughout the year (e.g., 'How many standard drinks did you consume Thurs, Fri, Sat? Please TB like this 5, 0, 1).

EMA only: Participants in the EMA condition will only receive messages asking them to report their alcohol use fortnightly throughout the year (e.g., 'How many standard drinks did you consume Thurs, Fri, Sat? Please TB like this 5, 0, 1).

All participants will also fill out a questionnaire at the start and end of the semester (baseline, 3 months, 6 months) asking them to report the number of alcohol related consequences they experienced over the past 3 months (B-YAACQ) as well as alcohol use over the last week and the AUDIT-C.
Intervention code [1] 291590 0
Prevention
Intervention code [2] 291630 0
Behaviour
Comparator / control treatment
No-intervention control (EMA only condition).
Control group
Active

Outcomes
Primary outcome [1] 294746 0
Alcohol use (number of drinks in the last week measured by timeline follow back).
Timepoint [1] 294746 0
Timeline follow back measured at baseline, 3 months, and 9 months. E.g., the Sunday before Orientation Week (baseline), and at the end of the academic semesters (3 months and 9 months).
Primary outcome [2] 294871 0
AUDIT-C questionnaire

Timepoint [2] 294871 0
AUDIT-C measured at baseline, 3 months, and 9 months. E.g., the Sunday before Orientation Week (baseline), and at the end of the academic semesters (3 months and 9 months).
Primary outcome [3] 294872 0
EMA message - the number of weekend and Orientation Week drinks measured by text messages asking students to report their drinking from the past 3 days).
Timepoint [3] 294872 0
Academic year weekend alcohol use, measured by an EMA message asking participants to report their last 3 nights drinking. Messages sent fortnightly; weeks 3, 5, 7, 9, 11, and 13 of the first semester and second semester).
Secondary outcome [1] 313988 0
Alcohol related consequences as measured by the Brief Young Adult Alcohol Consequences Questionnaire.
Timepoint [1] 313988 0
Baseline and after each semester (approximately 3 months and 9 months after baseline).

Eligibility
Key inclusion criteria
Must be a full time first year student residing at a residential college.
Minimum age
16 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students who do not live at a residential college. Returning students.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
NA
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Hierarchical Linear Modelling will be used to analyse all data. The model will examine drinking behaviour over time for
the EMA and EMA-EMI groups. The model will examine drinking behaviour as a repeated measure over time for the EMA and EMA-EMI groups and directly compare these groups.

The total sample size [n = 350] should have sufficient power, even when taking potential drop-out into account. The design is well powered for detecting group differences of 6.5 standard drinks during O’Week and 2 standard drinks/week during the academic year.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6793 0
New Zealand
State/province [1] 6793 0
Otago

Funding & Sponsors
Funding source category [1] 291058 0
University
Name [1] 291058 0
University of Otago
Address [1] 291058 0
University of Otago
362 Leith Street
Dunedin. 9016
New Zealand
Country [1] 291058 0
New Zealand
Primary sponsor type
University
Name
University of Otago Psychology Department
Address
University of Otago
362 Leith Street
Dunedin. 9016
New Zealand
Country
New Zealand
Secondary sponsor category [1] 289741 0
None
Name [1] 289741 0
Address [1] 289741 0
Country [1] 289741 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292645 0
University of Otago Ethics Committee
Ethics committee address [1] 292645 0
University of Otago
362 Leith Street
Dunedin. 9016
New Zealand
Ethics committee country [1] 292645 0
New Zealand
Date submitted for ethics approval [1] 292645 0
25/11/2013
Approval date [1] 292645 0
09/01/2014
Ethics approval number [1] 292645 0
13/267

Summary
Brief summary
Young adults have the highest alcohol consumption of any age group. Within this high risk age group, university students stand out, consuming more alcohol than their non-university attending peers. As a result, university students not only have a higher incidence of alcohol use disorders, but also report a higher incidence of harm resulting from alcohol. A number of factors have been implicated in this increase in alcohol use at university, however, new research suggests that drinking during certain events (e.g., Orientation Week) may have a flow on effect and influence the number of drinks students consume throughout the year.
The primary aim of the research project is to reduce overall alcohol consumption by university students (i.e., alcohol consumed during the academic year) by reducing the heavy drinking that characterises students drinking behaviour during O’Week. We hypothesize that an ecological momentary intervention (EMI) aimed at Orientation Week will reduce the amount of alcohol use throughout both Orientation Week and throughout the year.

Participants will be randomly assigned to either an Ecological Momentary Intervention (EMA) or EMA-EMI condition. Participants in the EMA condition will receive assessment text messages during O’Week to report their
alcohol consumption from the previous 3 days. Outside of these intensive periods, participants will receive a text message every second Sunday asking them to report their alcohol consumption for the previous 3 days. Participants in the EMA-EMI condition [i.e., assessment + intervention] will receive EMA text
messages and EMI text messages on four days during O’Week. The content of the EMI text messages will focus on the potential social implications of drinking too much.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56382 0
Dr Tamlin Conner
Address 56382 0
Department of Psychology, University of Otago, 275 Leith Walk, Dunedin, 9016 NZ
Country 56382 0
New Zealand
Phone 56382 0
+64 (03) 479-7624
Fax 56382 0
Email 56382 0
tconner@psy.otago.ac.nz
Contact person for public queries
Name 56383 0
Dr Tamlin Conner
Address 56383 0
Department of Psychology, University of Otago, 275 Leith Walk, Dunedin 9016 NZ
Country 56383 0
New Zealand
Phone 56383 0
+64 (03) 479-7624
Fax 56383 0
Email 56383 0
tconner@psy.otago.ac.nz
Contact person for scientific queries
Name 56384 0
Dr Tamlin Conner
Address 56384 0
Department of Psychology, University of Otago, 275 Leith Walk, Dunedin 9016 NZ
Country 56384 0
New Zealand
Phone 56384 0
+64 (03) 479-7624
Fax 56384 0
Email 56384 0
tconner@psy.otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary