Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000104358
Ethics application status
Approved
Date submitted
25/02/2008
Date registered
25/02/2008
Date last updated
13/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
THRIVE (Tertiary Health Research Intervention Via Email)
Scientific title
For undergraduate university students drinking at harmful and hazardous levels, how effective is 10 minutes of web-based motivational assessment and personalised feedback compared to screening alone in reducing frequency and quantity of alcohol consumption?
Universal Trial Number (UTN)
Trial acronym
THRIVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Consumption 2366 0
Alcohol-Related Harm 2367 0
Tobacco Use 2368 0
Condition category
Condition code
Public Health 2473 2473 0 0
Health promotion/education
Public Health 3002 3002 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10 minutes of web-based motivational assessment and personalised feedback on alcohol consumption versus screening only control followed up at one and six months.
Intervention code [1] 2087 0
Early detection / Screening
Intervention code [2] 2088 0
Prevention
Intervention code [3] 2089 0
Behaviour
Comparator / control treatment
Web-based assessment of drinking only
Control group
Active

Outcomes
Primary outcome [1] 3368 0
Frequency of drinking
Timepoint [1] 3368 0
At 1 and 6 months after randomization
Primary outcome [2] 3369 0
Drinks per typical occasion
Timepoint [2] 3369 0
At 1 and 6 months after randomization
Primary outcome [3] 3370 0
Overall volume of alcohol consumed
Timepoint [3] 3370 0
At 1 and 6 months after randomization
Secondary outcome [1] 5587 0
Frequency of heavy episodes
Timepoint [1] 5587 0
At 6 months after randomization
Secondary outcome [2] 5588 0
Number of personal problems
Timepoint [2] 5588 0
At 1 and 6 months after randomization
Secondary outcome [3] 5589 0
Number of academic problem behaviours
Timepoint [3] 5589 0
At 1 and 6 months after randomization
Secondary outcome [4] 5590 0
Subjective views of intervention effects
Timepoint [4] 5590 0
At 6 months after randomization
Secondary outcome [5] 5591 0
Intervention effect on health seeking behaviour
Timepoint [5] 5591 0
At 6 months after randomization

Eligibility
Key inclusion criteria
Inclusion criteria: full-time enrolment at Curtin University of Technololgy, internal study mode at Bentley campus, recent hazardous drinking: scoring 8+ on the Alcohol Use Disorders Identification Test (AUDIT) and drinking more than 4/6 (females/males) standard drinks on one or more occasions in previous 4 weeks. (Hazardous drinking status assessed via web-based screening questionnaire.)
Minimum age
17 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not recent hazardous drinking: scoring 7 or below on the AUDIT and/or not drinking more than 4/6 (females/males) standard drinks on one or more occasions in previous 4 weeks.

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 randomly selected from university enrolment database, sent postal and email invitations to complete baseline survey. Those screening positive for hazardous drinking via computer algorithms within the baseline survey were then automatically allocated to intervention or control group via computerised randomisation. Contacted by letter and email at 1 and 6 months to complete follow ups via web-based interface. In accordance with ethics approval, participants were not informed that the study was a RCT.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation conducted by programmer not involved in implementation of the trial on site (therefore not in contact with study participants) by using a randomisation table created by computer software. Sequence applied automatically by computer algorithms during completion of the baseline survey.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
13000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 431 0
6102

Funding & Sponsors
Funding source category [1] 2620 0
Government body
Name [1] 2620 0
Healthway (Western Australian Health Promotion Foundation)
Country [1] 2620 0
Australia
Primary sponsor type
University
Name
Western Australian Centre for Health Promotion Research, Curtin University of Technology
Address
Kent Street
Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 2369 0
None
Name [1] 2369 0
Address [1] 2369 0
Country [1] 2369 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4540 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 4540 0
Ethics committee country [1] 4540 0
Australia
Date submitted for ethics approval [1] 4540 0
28/11/2005
Approval date [1] 4540 0
26/01/2006
Ethics approval number [1] 4540 0
189/2005

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

Contacts
Principal investigator
Name 28050 0
Address 28050 0
Country 28050 0
Phone 28050 0
Fax 28050 0
Email 28050 0
Contact person for public queries
Name 11207 0
Professor Peter Howat
Address 11207 0
Centre for Behavioural Research in Cancer Control
Curtin University
GPO Box U1987
Perth WA 6845
Country 11207 0
Australia
Phone 11207 0
+61 8 92661719
Fax 11207 0
Email 11207 0
p.howat@curtin.edu.au
Contact person for scientific queries
Name 2135 0
Dr Kypros Kypri
Address 2135 0
School of Medicine and Public Health
Level 3
David Maddison Clinical Sciences Building
University of Newcastle
King & Watt Streets
Newcastle NSW 2300
Country 2135 0
Australia
Phone 2135 0
+61 2 4913 8231
Fax 2135 0
Email 2135 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
Dimensions AIUndergraduate student drinking and related harms at an Australian university: web-based survey of a large random sample2012https://doi.org/10.1186/1471-2458-12-37
N.B. These documents automatically identified may not have been verified by the study sponsor.