Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001291774
Ethics application status
Approved
Date submitted
11/06/2013
Date registered
21/11/2013
Date last updated
10/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Young and Well Collaborative Research Centre (YAWCRC) Youth Wellbeing Etool Evaluation
Scientific title
Evaluation of "Ray's night out": a new iPhone app targeting alcohol use in young people
Secondary ID [1] 282401 0
Nil
Universal Trial Number (UTN)
U1111-1142-3573
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Excessive drinking in young people 288982 0
Condition category
Condition code
Mental Health 289324 289324 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Young people who drink regularly will be invited to use a new mobile phone game application, 'Ray's Night Out', over a one month period, to increase their knowledge of harm minimisation strategies for alcohol consumption. Participants' knowledge of harm reduction strategies will be measured before and after
Intervention code [1] 287034 0
Treatment: Other
Comparator / control treatment
A waitlist control will be used whereby 50% of the sample will be provided the mobile phone application one month later than the experimental cohort.
Control group
Active

Outcomes
Primary outcome [1] 289434 0
Participants are able to identify a greater number of harm minimisation strategies and have improved knowledge of alcohol based on free recall.
Timepoint [1] 289434 0
Baseline, 1 month post, 2 month post, 3 months post, 6 months post
Primary outcome [2] 289435 0
Participants have used more harm minimisation strategies, based on reports of their drinking experiences.
Timepoint [2] 289435 0
Baseline, 1 month post, 2 month post, 3 months post, 6 months post
Secondary outcome [1] 303230 0
nil
Timepoint [1] 303230 0
nil

Eligibility
Key inclusion criteria
1. Aged 16-25 years
2. Drink alcohol at least once a month
3. Have access to an iPhone4 or higher
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
nil

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Half of the sample will be randomly allocated to a waitlist control group. These participants will act as a control for themselves (one month without the intervention vs one month with the intervention) and for the immediate-access group (effect of intervention vs. no intervention over a one-month period).
Phase
Type of endpoint/s
Statistical methods / analysis
Earlier, similarly-structured research conducted by the same team has used a sample of this size to observe outcomes in similar variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/03/2014
Actual
27/03/2014
Date of last participant enrolment
Anticipated
Actual
10/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
197
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 287430 0
Charities/Societies/Foundations
Name [1] 287430 0
Young and Well Cooperative Research Centre
Country [1] 287430 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Young and Well Collaborative Research Centre
Address
Unit 17, 71 Victoria Crescent
Abbotsford VIC 3067
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 286177 0
None
Name [1] 286177 0
Address [1] 286177 0
Country [1] 286177 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289410 0
QUT Human Research Ethics Committee
Ethics committee address [1] 289410 0
Ethics committee country [1] 289410 0
Australia
Date submitted for ethics approval [1] 289410 0
12/06/2013
Approval date [1] 289410 0
03/07/2013
Ethics approval number [1] 289410 0
EC00171

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

Contacts
Principal investigator
Name 39586 0
Dr Leanne Hides
Address 39586 0
QUT IHBI 60 Musk Ave Kelvin Grove QLD 4059
Country 39586 0
Australia
Phone 39586 0
+617 3138 6144
Fax 39586 0
Email 39586 0
[email protected]
Contact person for public queries
Name 39587 0
Leanne Hides
Address 39587 0
QUT IHBI 60 Musk Ave Kelvin Grove QLD 4059
Country 39587 0
Australia
Phone 39587 0
+617 3138 6144
Fax 39587 0
Email 39587 0
[email protected]
Contact person for scientific queries
Name 39588 0
Leanne Hides
Address 39588 0
QUT IHBI 60 Musk Ave Kelvin Grove QLD 4059
Country 39588 0
Australia
Phone 39588 0
+617 3138 6144
Fax 39588 0
Email 39588 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
No additional documents have been identified.