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Trial registered on ANZCTR

Registration number

ACTRN12618000015246

Ethics application status

Approved

Date submitted

3/12/2017

Date registered

11/01/2018

Date last updated

17/01/2022

Date data sharing statement initially provided

11/12/2018

Date results provided

25/11/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Effectiveness of a Combined Web-Based and Ecological Momentary Intervention for Incoming First Year University Students

Scientific title

Effectiveness of a Combined Web-Based and Ecological Momentary Intervention for Incoming First Year University Students: A three-armed Randomised Controlled Trial

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1206-1464

Trial acronym

Linked study record

Health condition

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

Alcohol use

Condition category

Condition code

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will be randomised into one of three conditions after completing the initial survey before Orientation Week: 1. an active control group, 2. A Web-Based feedback Intervention (WBI) only condition, 3. A WBI and Ecological Momentary Intervention (EMI) condition.

The WBI only and the WBI + EMI condition will receive the WBI at baseline. The WBI will combine aspects of social norms, provide information on Alcohol Use Disorder Identification Test (AUDIT) score, Blood Alcohol Content, risk of alcohol-related consequences, long-term consequences, and protective behavioural strategies. The intervention will be automatically generated by the system and delivered after participants' initial survey and include sections of text with feedback about their drinking. The online intervention will take approximately 5-10 minutes to complete and is to be completed by participants prior to Orientation Week.

The WBI and EMI condition will be sent intervention text messages twice a day (at 1pm and 7pm) on the Tuesday, Thursday, Friday, and Saturday of Orientation Week. The 1pm messages will remind participants of a protective behavioural strategy presented in the online intervention. The 7pm messages will contain a social consequence of alcohol use. These participants will also receive fortnightly EMI messages during the first semester. These messages will be sent on a Wednesday reminding participants of the drinking norms (tailored to gender).

All conditions will be asked to respond to 2 Orientation Week messages and 14 fortnightly text messages during the academic year asking them to report their drinking from the past 3 days (e.g., 'How many standard drinks did you consume Thurs, Fri, Sat? Please Text Back (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, 9 months, 15 months, and 21 months) asking them to report the number of alcohol related consequences they experienced over the past 3 months (Brief Young Adult Alcohol Consequences Questionnaire [B-YAACQ]), drinks consumed during a typical week in the past month, and the AUDIT.

Intervention code [1]

Prevention

Intervention code [2]

Lifestyle

Comparator / control treatment

No-intervention control.

Control group

Active

Outcomes

Primary outcome [1]

Alcohol use

Timepoint [1]

Measured at baseline, 3 months (primary timepoint), 9 months, 15 months, 21 month. Assessment will use a modified version of timeline followback asking participants to report their drinking during a typical week.
During Orientation Week and fortnightly during their first academic year, participants will be sent messages asking them to report their drinking from the past 3 days.

Secondary outcome [1]

Alcohol related consequences as measured by the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ).

Timepoint [1]

The B-YAACQ will be measured at baseline, 3 months, 9 months, 15 months, 21 months.

Eligibility

Key inclusion criteria

Must be a full time first year student residing at a residential college.

Minimum age

17 Years

Maximum age

25 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

We will also exclude participants who do not finish the first survey.

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 concealed (randomized by computer software).

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

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

We intend to use Multi-Level Modelling to test for differences between conditions over time.

The total sample size [n = 800] should have sufficient power, even when taking potential drop-out into account. The design is well powered for detecting group differences of 3.5 standard drinks during O’Week and 2 standard drinks/week during the academic year.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2018

Actual

2/02/2018

Date of last participant enrolment

Anticipated

17/02/2019

Actual

18/02/2019

Date of last data collection

Anticipated

1/11/2021

Actual

1/11/2021

Sample size

Target

800

Accrual to date

Final

746

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of New Zealand

Address [1]

Level 3, 110 Stanley St, Grafton, Auckland 1010, New Zealand

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Otago, Department of Psychology

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 using a combination of web-based intervention (WBI) and EMI. We hypothesize that a brief WBI and EMI will reduce the amount of alcohol use throughout both Orientation Week and throughout the year (relative to a control group or a WBI only condition).
Participants will be randomly assigned at baseline to either a control condition, WBI only condition, or a WBI + EMI condition. The WBI only and the WBI + EMI condition will receive the WBI at baseline. The WBI will combine aspects of social norms, provide information on Alcohol Use Disorder Identification Test (AUDIT) score, Blood Alcohol Content, risk of alcohol-related consequences, long-term consequences, and protective behavioural strategies. The intervention will be automatically generated by the system and delivered after participants' initial survey and include sections of text with feedback about their drinking. The online intervention will take approximately 5-10 minutes to complete and is to be completed by participants prior to Orientation Week.

The WBI and EMI condition will also be sent intervention text messages twice a day (at 1pm and 7pm) on the Tuesday, Thursday, Friday, and Saturday of Orientation Week. The 1pm messages will remind participants of a protective behavioural strategy presented in the online intervention. The 7pm messages will contain a social consequence of alcohol use. These participants will also receive fortnightly EMI messages during the first semester. These messages will be sent on a Wednesday reminding participants of the drinking norms (tailored to gender). 

All conditions will be asked to respond to 2 Orientation Week messages and 14 fortnightly text messages during the academic year asking them to report their drinking from the past 3 days (e.g., 'How many standard drinks did you consume Thurs, Fri, Sat? Please Text Back (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, 9 months, 15 months, and 21 months) asking them to report their drinking and alcohol-related consequences.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Benjamin Riordan

Address

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

Country

New Zealand

Phone

+64 273540840

Fax

riobe135@student.otago.ac.nz

Contact person for public queries

Name

Damian Scarf

Address

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

Country

New Zealand

Phone

+64 3 479 7636

Fax

damian@psy.otago.ac.nz

Contact person for scientific queries

Name

Damian Scarf

Address

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

Country

New Zealand

Phone

+64 3 479 7636

Fax

damian@psy.otago.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
687	Study protocol				https://www.researchprotocols.org/2018/5/e10164/

Results publications and other study-related documents

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