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Trial registered on ANZCTR


Registration number
ACTRN12610000279022
Ethics application status
Approved
Date submitted
31/03/2010
Date registered
7/04/2010
Date last updated
11/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial to estimate the effect of web-based screening and brief intervention on alcohol consumption in students aged 17-25 years at New Zealand universities
Scientific title
A randomised controlled trial to estimate the effect of web-based screening and brief intervention on alcohol consumption in New
Zealand university students aged 17-25 years identified as being hazardous drinkers or as having active alcohol use disorders
Secondary ID [1] 1577 0
nil
Universal Trial Number (UTN)
U1111-1113-5555
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hazardous drinking 256739 0
Condition category
Condition code
Public Health 256894 256894 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group complete the Alcohol Use Disorders Identification Test, Items 1 -3 (AUDIT-C items) and the AUDIT items 4-10, they will also complete questions concerning the largest number of standard drinks consumed on one occasion in the last four weeks, the duration of the drinking episode in hours, and their body weight for the purpose of estimating their blood alcohol concentration. They then complete the Leeds Dependence Questionnaire (LDQ; 10 items). The approximate duration of the screening part of the intervention will be 10 minutes. The mode of intervention of the screening is a web-based questionnaire. The intervention group will then receive personalised feedback (web-based information, provided immediately following screening, duration approximately 10 minutes, provided via computer generated information taking the participants answers into account so that the feedback is personalised) consisting of: their AUDIT score, an LDQ score, with an explanation of the associated health risk and information about how to reduce that risk; an estimated blood alcohol concentration (BAC) for the respondent’s heaviest episode in the previous four weeks, with information on the behavioural and physiological sequelae of various BACs, and traffic crash relative risk; estimates of monetary expenditure per month and year (estimates are for alcohol purchased); bar graphs comparing episodic and weekly consumption with that of other students of the same age and gender; and hyperlinks for help with drinking problems. Further web pages will be presented as options, offering facts about alcohol, tips for reducing the risk of alcohol-related harm, and where medical help and counselling support could be found. Participants will be contacted for follow up 5 months later (12 months follow up is intended but subject to funding)
Intervention code [1] 255958 0
Behaviour
Intervention code [2] 256248 0
Lifestyle
Intervention code [3] 256267 0
Prevention
Comparator / control treatment
Control group only completes AUDIT-C (items 1-3 of AUDIT, web-based questionnaire, approximate duration of the screening 5 minutes) and will then be send to a 'Thanks' page. Subjects in the control group will not receive personalised feedback.

Participants in the control group will be contacted for follow up 6 months later (12 months follow up is intended but subject to funding).
Control group
Active

Outcomes
Primary outcome [1] 257763 0
volume of alcohol consumed per week

will be computed from the responses to the frequency and quantity questions as (frequency*quantity)/4
Timepoint [1] 257763 0
5 months after randomisation
Primary outcome [2] 258117 0
frequency of drinking

participants will select a value from a
drop-down menu reflecting their frequency (range: 0-28) in the last 4 weeks
Timepoint [2] 258117 0
6 months after randomisation
Primary outcome [3] 258118 0
amount consumed per typical drinking occasion

participants will select a value from a
drop-down menu reflecting their typical
quantity of drinking (in whole standard drinks) in the last 4 weeks
Timepoint [3] 258118 0
5 months after randomisation
Secondary outcome [1] 263769 0
respondents' subjective impressions of the intervention: whether as a consequence of viewing the web pages they had sought help for their drinking

- participants will be invited to complete the following questions:
I have sought support to reduce my drinking as a consequence of
completing the survey in April/May .
Drop Down menu:
No
Yes
Timepoint [1] 263769 0
5 months after randomisation
Secondary outcome [2] 263800 0
proportion who exceed New Zealand (NZ) recommended upper limits for acute harm (no more than 4 drinks per occasion for women; no more than 6 drinks per occasion for men)

- values which the participants report will be compared against the recommended limit
Timepoint [2] 263800 0
5 months after randomisation
Secondary outcome [3] 263801 0
proportion who exceed NZ recommended upper limits for chronic harm (no more than 14 drinks per week for women, no more than 21 drinks per week for men)

- values which the participants report will be compared against the recommended limit
Timepoint [3] 263801 0
5 months after randomisation
Secondary outcome [4] 264477 0
Alcohol Role Expectations and Alcohol Scale (McGee & Kypri 2004)
Timepoint [4] 264477 0
5 months after randomisation

Eligibility
Key inclusion criteria
- New Zealand university students aged 17-25 years
- AUDIT-C score of 4 or more
Minimum age
17 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
AUDIT-C score less than 4

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)
On 26 April 2010 random samples of students aged 17-25 years will be sent an e-mail message containing a hyperlink to a web questionnaire. Up to two reminder e-mails will be sent in the following weeks. Any student who indicates they do not wish to participate (by e-mail or phone) will not be sent a reminder e-mail.

Respondents will visit the study website and be presented with an introductory page followed by one page of three questions concerning (1) gender, (2) age, and (3) ethnicity, and a following page with a question concerning alcohol consumtpion in the last 12 months (yes/no) and the three items of the Alcohol Use Disorders Identification Test--Consumption (AUDIT-C) subscale; frequency of drinking; number of drinks consumed per typical drinking occasion; and frequency of having six or more drinks per occasion. Upon clicking the submit button on this page, AUDIT-C scores will be calculated. Those who score 4 or more on the AUDIT-C (the standard cut-off score) will be randomly allocated to either the intervention or control group.

method of allocation concealment: central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Those who score 4 or more on the AUDIT-C (the standard cut-off score) will be randomly allocated by the web server to either the intervention or control group. Randomisation will be effected by the computer server administering the electronic Screening and Brief Intervention (e-SBI) program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
There will be two trials run in parallel: one for students of Maori ethnicity and another for students of non-Maori ethnicity, determined on the basis of self report by students at the point of enrollment at university.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1094
Accrual to date
Final
Recruitment outside Australia
Country [1] 2463 0
New Zealand
State/province [1] 2463 0

Funding & Sponsors
Funding source category [1] 256456 0
Government body
Name [1] 256456 0
Alcohol Advisory Council of New Zealand (ALAC)
Country [1] 256456 0
New Zealand
Primary sponsor type
Individual
Name
Dr. Kypros Kypri
Address
Injury Prevention Research Unit
Dept of Preventive and Social Medicine
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 255764 0
Individual
Name [1] 255764 0
Hank Weiss
Address [1] 255764 0
Injury Prevention Research Unit
Dept of Preventive and Social Medicine
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin 9054
New Zealand
Country [1] 255764 0
New Zealand
Other collaborator category [1] 1111 0
Individual
Name [1] 1111 0
Tina Vater
Address [1] 1111 0
Injury Prevention Research Unit
Dept of Preventive and Social Medicine
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin 9054
New Zealand
Country [1] 1111 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258517 0
Health and Disability Multi-Region Ethics Committees
Ethics committee address [1] 258517 0
Ethics committee country [1] 258517 0
New Zealand
Date submitted for ethics approval [1] 258517 0
17/12/2009
Approval date [1] 258517 0
Ethics approval number [1] 258517 0
MEC/10/01/009

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

Contacts
Principal investigator
Name 30797 0
Address 30797 0
Country 30797 0
Phone 30797 0
Fax 30797 0
Email 30797 0
Contact person for public queries
Name 14044 0
Kypros Kypri
Address 14044 0
Injury Prevention Research Unit
Dept of Preventive and Social Medicine
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin 9054
New Zealand
Country 14044 0
New Zealand
Phone 14044 0
+61 2 4913 8231
Fax 14044 0
+61 2 4913 8148
Email 14044 0
Kypros.Kypri@newcastle.edu.au
Contact person for scientific queries
Name 4972 0
Kypros Kypri
Address 4972 0
Injury Prevention Research Unit
Dept of Preventive and Social Medicine
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin 9054
New Zealand
Country 4972 0
New Zealand
Phone 4972 0
+61 2 4913 8231
Fax 4972 0
+61 2 4913 8148
Email 4972 0
Kypros.Kypri@newcastle.edu.au

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
EmbaseWeb-based alcohol screening and brief intervention for Maori and non-Maori: the New Zealand e-SBINZ trials.2010https://dx.doi.org/10.1186/1471-2458-10-781
N.B. These documents automatically identified may not have been verified by the study sponsor.