ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

U1111-1169-1378

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Alcohol use

Alcohol Related Consequences

Condition category

Condition code

Other

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]

Prevention

Intervention code [2]

Behaviour

Comparator / control treatment

No-intervention control (EMA only condition).

Control group

Active

Outcomes

Primary outcome [1]

Alcohol use (number of drinks in the last week measured by timeline follow back).

Timepoint [1]

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]

AUDIT-C questionnaire

Timepoint [2]

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]

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]

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]

Alcohol related consequences as measured by the Brief Young Adult Alcohol Consequences Questionnaire.

Timepoint [1]

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

Sex

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

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

15/02/2015

Actual

15/02/2015

Date of last participant enrolment

Anticipated

15/02/2015

Actual

15/02/2015

Date of last data collection

Anticipated

Actual

Sample size

Target

350

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

University of Otago
362 Leith Street
Dunedin. 9016
New Zealand

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Ethics Committee

Ethics committee address [1]

University of Otago
362 Leith Street
Dunedin. 9016
New Zealand

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

25/11/2013

Approval date [1]

09/01/2014

Ethics approval number [1]

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

Dr Tamlin Conner

Address

Department of Psychology, University of Otago, 275 Leith Walk, Dunedin, 9016 NZ

Country

New Zealand

Phone

+64 (03) 479-7624

Fax

tconner@psy.otago.ac.nz

Contact person for public queries

Name

Tamlin Conner

Address

Department of Psychology, University of Otago, 275 Leith Walk, Dunedin 9016 NZ

Country

New Zealand

Phone

+64 (03) 479-7624

Fax

tconner@psy.otago.ac.nz

Contact person for scientific queries

Name

Tamlin Conner

Address

Department of Psychology, University of Otago, 275 Leith Walk, Dunedin 9016 NZ

Country

New Zealand

Phone

+64 (03) 479-7624

Fax

tconner@psy.otago.ac.nz

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Riordan, B. C., Conner, T. S., Flett, J. A., & Sca... [More Details]	368331-(Uploaded-21-11-2019-11-58-37)-Journal results publication.pdf

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No additional documents have been identified.

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