Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000790842
Ethics application status
Approved
Date submitted
16/07/2012
Date registered
25/07/2012
Date last updated
25/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a web-based intervention to reduce young adults alcohol use and injury
Scientific title
The evaluation of the SayWhen web-based intervention tool to reduce young adults (18-35 year olds) alcohol use and injury: impact on self-reported injury, including alcohol-related injuries, and on alcohol use.
Secondary ID [1] 280708 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
injury associated with alcohol use 286750 0
Condition category
Condition code
Public Health 287048 287048 0 0
Health promotion/education
Injuries and Accidents 287049 287049 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SayWhen is a source of information, advice, brief intervention and referral options. The aim of the intervention is to reduce risky drinking. The site is self-guided with no interaction or assistance. Cognitive behavioural strategies are promoted to encourage healthy decisions around drinking. The site provides an opportunity to track drinking and encourages users to record and monitor their alcohol use. We recommend that participants access the site once per week with access to the website available for 3 months
Intervention code [1] 285130 0
Behaviour
Intervention code [2] 285342 0
Prevention
Comparator / control treatment
Internet-based alcohol information providing brief overview of 'what is low risk drinking', 'what is a standard drink' and links for further information. This is a separate website from the intervention condition. Participants are able to read through the information for a length time at their discretion. They are able to access the information with as much or as little frequency as they choose and we recommend that the access the site on the first occasion.
Control group
Active

Outcomes
Primary outcome [1] 287386 0
injury measured by self-report with the Extended Adolescent Injury Checklist
Timepoint [1] 287386 0
baseline, 1 month, 3 months
Secondary outcome [1] 298044 0
alcohol related harms measured by self-report with the AUDIT
Timepoint [1] 298044 0
baseline, 1 month, 3 months

Eligibility
Key inclusion criteria
participant reports they drink alcohol on more than 4 occasions of 4 or more standard drinks in a session, not engaged in other concurrent treatment for alcohol use, Australian resident, English fluency
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
children and young people, people who are highly dependent on medical care

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification by age (two groups: equal to and under 25 years and over 25 years) and sex (two groups: male and female). Computer sequence generation to randomise after stratification and to create random permutations. Undertaken by a researcher not connected to the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285478 0
University
Name [1] 285478 0
Queensland University of Technology - Institute for Health & Biomedical Innovation
Country [1] 285478 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology - Institute for Health & Biomedical Innovation
Address
130 Victoria Park Road, Kelvin Grove, Queensland, 4059
Country
Australia
Secondary sponsor category [1] 284330 0
None
Name [1] 284330 0
Address [1] 284330 0
Country [1] 284330 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287495 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 287495 0
Research Ethics Unit, Office of Research, Level 4, 88 Musk Avenue, Kelvin Grove, Qld, 4059
Ethics committee country [1] 287495 0
Australia
Date submitted for ethics approval [1] 287495 0
Approval date [1] 287495 0
12/06/2012
Ethics approval number [1] 287495 0
EC00171

Summary
Brief summary
Identifying alcohol misuse early and delivering simple advice can be effective in moderating people’s drinking patterns and related harms such as injury. The evidence indicates that for every eight people who receive advice, one will reduce their drinking to low risk levels. The internet is becoming an increasingly recognised tool for delivering self-help materials. The project seeks to evaluate change in alcohol use and injury (self-reported) after participation in an internet delivered program compared with an information only control condition.
Trial website
Trial related presentations / publications
nil to date
Public notes

Contacts
Principal investigator
Name 34343 0
Address 34343 0
Country 34343 0
Phone 34343 0
Fax 34343 0
Email 34343 0
Contact person for public queries
Name 17590 0
Lisa Buckley
Address 17590 0
CARRS-Q, QUT, 130 Victoria Park Road, Kelvin Grove, Queensland, 4059
Country 17590 0
Australia
Phone 17590 0
+61 7 3138 4638
Fax 17590 0
+61 7 3138 0111
Email 17590 0
ld.buckley@qut.edu.au
Contact person for scientific queries
Name 8518 0
Lisa Buckley
Address 8518 0
CARRS-Q, QUT, 130 Victoria Park Road, Kelvin Grove, Queensland, 4059
Country 8518 0
Australia
Phone 8518 0
+61 7 3138 4638
Fax 8518 0
+61 7 3138 0111
Email 8518 0
ld.buckley@qut.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
No additional documents have been identified.