Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001102662
Ethics application status
Approved
Date submitted
29/09/2014
Date registered
16/10/2014
Date last updated
9/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing pre-drinking alcohol consumption and alcohol-related harm in university undergraduates: A randomized controlled trial of a psychological theory-based intervention
Scientific title
A randomized controlled trial of a psychological theory-based intervention to reduce pre-drinking alcohol consumption and alcohol-related harm in university undergraduates
Secondary ID [1] 285195 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol consumption 292802 0
Alcohol-related harm 292803 0
Condition category
Condition code
Mental Health 293098 293098 0 0
Addiction
Public Health 293508 293508 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to one of four conditions: (1) autonomy support, (2) implementation intention, (3) combined autonomy support and implementation intention, and (4) a control. Intervention components have been developed and written by the researchers, and will be automatically presented to participants as they progress through an online survey tool (Qualtrics). The one-time intervention will be of approximately 30-minute duration, depending on participants' progression through questions and content.

All conditions will receive National Health and Medical Research Council guidelines on alcohol consumption to reduce the risk of harm.

Participants receiving the autonomy support component will be asked to generate their own reasons for pursuing reduced pre-drinking alcohol consumption that are consistent with their needs and perceived as beneficial.

Participants receiving the implementation intention component will formulate their own if-then plans to be enacted in certain pre-drinking contexts, to help attain the goal of reduced pre-drinking alcohol consumption.

Participants in the combined condition will receive the autonomy support component to facilitate autonomous motivation to reduce pre-drinking alcohol consumption, then the implementation intention component to help translate this motivation into action by generating if-then statements to be enacted in response to certain contextual cues.

Participants' responses to the intervention components (i.e., prompts) will be content analyzed for monitoring adherence to the intervention. Participants will be emailed their respective intervention components following the completion of the intervention, and will complete a brief follow-up, four weeks later, to ascertain the effects of the intervention on reducing pre-drinking alcohol consumption and alcohol-related harm. Participants will be send a weekly text message (SMS) reflecting the content they received in the intervention (e.g., participants in the implementation intention condition will receive an SMS each week reminding them of their if-then plans to reduce pre-drinking alchol consumption).
Intervention code [1] 290063 0
Behaviour
Intervention code [2] 290064 0
Lifestyle
Intervention code [3] 290395 0
Prevention
Comparator / control treatment
Participants will receive two of the National Health and Medical Research Council's guidelines to reduce alcohol-related harm. Specifically, these guidelines state:

(1) For healthy men and women, drinking no more than two standard drinks on any day reduces the lifetime risk of harm from alcohol-related disease or injury

(2) For healthy men and women, drinking no more than four standard drinks on a single occasion reduces the risk of alcohol-related injury arising from that occasion.

These statements will be delivered to all participants within the online survey tool (Qualtrics) and emailed upon completion of the intervention.
Control group
Active

Outcomes
Primary outcome [1] 292966 0
Pre-drinking alcohol consumption (in standard drink equivalents) over the past four weeks from baseline, as measured by self-report with aid of a pictorial guide from the National Health and Medical Research Council's standard drink equivalent guide to assist in accurate self-reporting.
Timepoint [1] 292966 0
Baseline and follow-up (four weeks after receiving the intervention).
Secondary outcome [1] 310033 0
Alcohol-related harm experienced over the previous four weeks, as measured by a psychometric scale of alcohol-related harm; the Brief Young Adult Alcohol Consequences Scale (B-YAACQ). The B-YAACQ allows participants to respond with a 'yes' or 'no' answer to a series of statements reflecting experienced alcohol-related harm (e.g., "I have taken foolish risks when I have been drinking"). 'Yes' answers are summed to create an index of alcohol-related harm. The measure has been modified to reflect experience of alcohol-related harm in the previous four weeks, as opposed to the previous 12 months, to better ascertain the potential changes in alcohol-related harm as a result of the intervention.
Timepoint [1] 310033 0
Baseline and follow-up (four weeks' after receiving the intervention).

Eligibility
Key inclusion criteria
Current university undergraduate 'pre-drinkers' (i.e., those who report pre-drinking within the previous 12 months). Pre-drinking will be defined consistent with previous uses throughout empirical studies, as follows:

"The practice of consuming alcohol prior to attending a subsequent social event, where alcohol consumption often continues."
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-drinkers

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)
Participants access the intervention online. An online survey tool block randomises participants to one of the four conditions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation concealment, involved central randomization by computer (Qualtrics random allocation tool).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A MANCOVA will be used to ascertain the effect of the intervention components (i.e., autonomy support (present/absent); implementation intention (present/absent) on outcomes (self-reported pre-drinking alcohol consumption and alcohol-related harm [B-YAACQ]). Power analysis indicates a conservative sample size estimate of 341 participants to detect a significant small-to-medium effect as found in a meta-analysis of online health behavioral interventions targeting alcohol consumption (i.e., d+ = .14) and a previous implementation intention intervention (eta-squared .02 to .07) of the intervention on outcome variables.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/03/2015
Actual
27/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
341
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 289810 0
Self funded/Unfunded
Name [1] 289810 0
Country [1] 289810 0
Primary sponsor type
Individual
Name
Professor Martin Hagger
Address
Health Psychology and Behavioral Medicine Research Group
School of Psychology and Speech Pathology
Curtin University
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 288503 0
Individual
Name [1] 288503 0
A/Prof Barbara Mullan
Address [1] 288503 0
Health Psychology and Behavioral Medicine Research Group
School of Psychology and Speech Pathology
Curtin University
Kent St, Bentley WA 6102
Country [1] 288503 0
Australia
Other collaborator category [1] 278113 0
Individual
Name [1] 278113 0
Mr Kim Caudwell
Address [1] 278113 0
Health Psychology and Behavioral Medicine Research Group
School of Psychology and Speech Pathology
Curtin University
Kent St, Bentley WA 6102
Country [1] 278113 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291543 0
Human Research Ethics Committee
Ethics committee address [1] 291543 0
Ethics committee country [1] 291543 0
Australia
Date submitted for ethics approval [1] 291543 0
20/08/2014
Approval date [1] 291543 0
24/09/2014
Ethics approval number [1] 291543 0
HR185/2014

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50802 0
Prof Martin Hagger
Address 50802 0
Health Psychology and Behavioral Medicine Research Group
School of Psychology and Speech Pathology
Curtin University
Kent St, Bentley WA 6102
Country 50802 0
Australia
Phone 50802 0
+61 8 9266 9266
Fax 50802 0
Email 50802 0
[email protected]
Contact person for public queries
Name 50803 0
Kim M Caudwell
Address 50803 0
Health Psychology and Behavioral Medicine Research Group
School of Psychology and Speech Pathology
Curtin University
Kent St, Bentley WA 6102
Country 50803 0
Australia
Phone 50803 0
+61 402 740 310
Fax 50803 0
Email 50803 0
[email protected]
Contact person for scientific queries
Name 50804 0
Barbara Mullan
Address 50804 0
Health Psychology and Behavioral Medicine Research Group
School of Psychology and Speech Pathology
Curtin University
Kent St, Bentley WA 6102
Country 50804 0
Australia
Phone 50804 0
+61 8 9266 9266
Fax 50804 0
Email 50804 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCombining motivational and volitional approaches to reducing excessive alcohol consumption in pre-drinkers: a theory-based intervention protocol.2016https://dx.doi.org/10.1186/s12889-015-2648-7
N.B. These documents automatically identified may not have been verified by the study sponsor.