Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000768392
Ethics application status
Approved
Date submitted
23/05/2017
Date registered
25/05/2017
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving Alcohol and Well-Being Outcomes for Same-Sex Attracted Women
Scientific title
Randomised-controlled trial of a tailored SMS intervention for same-sex attracted women to support alcohol reduction and improve well-being
Secondary ID [1] 291847 0
None
Universal Trial Number (UTN)
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Hazardous alcohol use 303107 0
Addiction 303109 0
Condition category
Condition code
Mental Health 302567 302567 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a short message service (SMS) alcohol intervention tailored to same-sex attracted women (SSAW). The messages in the intervention were developed by Rachel Bush and approved by SSAW and an expert panel. The intervention has three performance objectives: (1) alcohol reduction, (2) Improve well-being, (3) increase help-seeking. These will be achieved by addressing four behavioural determinants which were selected after conducting a comprehensive needs assessment: (1) social support, (2) motivation to change, (3) mental health, (4) resilience.
The intervention consists of 37 messages which will be delivered over four weeks. One message will be sent in the afternoon on Sundays, Mondays, Tuesdays and Wednesdays, and two messages will be sent in the afternoon and evening on Thursdays, Fridays and Saturdays. Every Sunday, the message will ask participants to respond with the number of standard drinks they have consumed in the last seven days.
The messages will be sent using an Australian SMS platform, MessageMedia, and delivered by Rachel Bush who is a PhD candidate.
Each message delivered Mondays to Saturdays will be different. On Sundays the message will ask participants, "Text back the number of standard drinks you’ve had in the last 7 days. Use the drink chart in the welcome email or the SayWhen online calculator: goo.gl/0xJxbi". Messages delivered Mondays, Tuesdays, and Wednesdays are factual and/or provide links to resources. Example messages are "A professional psychologist can help you learn new ways to cope with problems in your life rather than using alcohol: www.psychology.org.au/FindaPsychologist" and "Seeking support can help you identify or relearn healthy coping strategies. Visit or call QLife for support and referrals: qlife.org.au/support/ or 1800184527". Messages delivered Thursdays, Fridays, and Saturdays provide suggestions for limiting alcohol use and prompt the recipient to reflect on ways to reduce their alcohol use. Example messages are, "It may be difficult to control the amount you drink when you’re out with your partner or friends. Set a limit before you go out" and "Decide how many drinks you want tonight and put that number of coins in your pocket. Move one across to the other pocket with each drink to help keep track."
Intervention code [1] 297964 0
Behaviour
Intervention code [2] 297965 0
Lifestyle
Comparator / control treatment
Participants who are randomised into the control condition will receive one message on Sundays for four weeks which will thank them for participating and direct them to a website (http://touchbase.org.au/) with lesbian, gay, bisexual, and transgender specific information on drug/alcohol use, mental health and sexual health.
Control group
Active

Outcomes
Primary outcome [1] 301994 0
Change in severity of alcohol use
Alcohol Use Disorders Identification Test (AUDIT) World Health Organisation (WHO) (Saunders et al. 1993).
Asking participants to report the number of standard drinks consumed in the last 30 days.
Timepoint [1] 301994 0
Baseline, Post-intervention, 12 week follow-up.
Primary outcome [2] 301995 0
Well-being
The Personal Wellbeing Index – Adult (Cummins et al., 2003).
Timepoint [2] 301995 0
Baseline, Post-intervention, 12 week follow-up.
Primary outcome [3] 302002 0
Service access and engagement
Measured using an adapted list of services from the Alcohol and lesbian/bisexual women – insights into culture and emotions (ALICE) study.
Timepoint [3] 302002 0
Baseline, Post-intervention, 12 week follow-up
Secondary outcome [1] 334475 0
Quality of Life
The World Health Organization Quality of Life (WHOQOL)-BREF (World Health Organization. Division of Mental Health, 1996).
Timepoint [1] 334475 0
Baseline. Post-intervention. 12 week follow-up.

Eligibility
Key inclusion criteria
A woman (including lesbian, bisexual, queer, and gender diverse women).
Identify as a same-sex attracted woman.
Aged 18 years or over.
Score 8 or above on the Alcohol Use Disorders Identification Test.
Own a mobile phone.
Have access to the internet.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Failure to confirm email address and mobile phone number by responding to welcome email and SMS message.

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)
Allocation is concealed using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 50 participants per group will be recruited as this will be a pilot study but it is anticipated that 20% will be lost to attrition. Thus it is expected that there will be 40 participants in each group for analysis. Sample size was calculated using data from the Australian ALICE study at a power of 84% for detecting a mean change of 4 points in the AUDIT score, when the standard deviation is assumed as 6 for two independent groups, two-tailed sample, and significance level of 0.05.

Linear regression and logistic regression will be used to assess differences in post-intervention and 12 week outcomes between groups..

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/04/2017
Date of last participant enrolment
Anticipated
30/11/2017
Actual
Date of last data collection
Anticipated
30/04/2018
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296344 0
University
Name [1] 296344 0
Deakin University
Country [1] 296344 0
Australia
Primary sponsor type
Individual
Name
Dr Rhonda Brown
Address
School of Nursing and Midwifery
Faculty of Health
Deakin University
221 Burwood Highway
Burwood, VIC 3125
Country
Australia
Secondary sponsor category [1] 295276 0
Individual
Name [1] 295276 0
Associate Professor Petra Staiger
Address [1] 295276 0
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood, VIC 3125
Country [1] 295276 0
Australia
Secondary sponsor category [2] 295294 0
Individual
Name [2] 295294 0
Associate Professor Ruth McNair
Address [2] 295294 0
The Deparment of General Practice
University of Melbourne
200 Berkeley Street
Carlton VIC 3053
Country [2] 295294 0
Australia
Secondary sponsor category [3] 295295 0
Individual
Name [3] 295295 0
Professor Daniel Lubman
Address [3] 295295 0
Turning Point Alcohol and Drug Centre
5462 Gertrude Street
Fitzroy VIC 3065
Country [3] 295295 0
Australia
Secondary sponsor category [4] 295296 0
Individual
Name [4] 295296 0
Ms Rachel Bush
Address [4] 295296 0
School of Nursing and Midwifery
Faculty of Health
Deakin University
221 Burwood Highway
Burwood, VIC 3125
Country [4] 295296 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297577 0
Deakin University Human Research Ethics Committee (EC00213)
Ethics committee address [1] 297577 0
Ethics and Biosafety
Deakin University
221 Burwood Highway
Burwood Victoria 3125
Ethics committee country [1] 297577 0
Australia
Date submitted for ethics approval [1] 297577 0
06/03/2017
Approval date [1] 297577 0
20/04/2017
Ethics approval number [1] 297577 0
2017-077

Summary
Brief summary
Australian and international research has found that same-sex attracted women (SSAW) are more likely to drink at higher levels than heterosexual women. Yet despite this evidence, limited research has focused on interventions specifically for SSAW to facilitate alcohol reduction. The absence of evidence-based services for SSAW is problematic as the current mainstream services assume the needs of SSAW match those of heterosexual women. Consequently, many SSAW are not receiving appropriate treatment and are left feeling frustrated and invisible. Therefore, this project will explore the efficacy of a short message service (SMS) intervention tailored to SSAW to reduce alcohol use, improve well-being, and increase help-seeking.
To do this, two studies are proposed. The first study was approved by Deakin University Human Ethics Advisory Group, Faculty of Health (reference number HEAG-H 111_2016). It involved developing the content for the SMS alcohol intervention tailored to SSAW by designing and presenting SMS messages and the structure of the SMS intervention to two focus groups of SSAW, and using their feedback to inform the final SMS messages and intervention.
The second study will involve conducting a Randomised Controlled Trial to implement and evaluate the intervention. This trial registration pertains to the second study; that is, the implementation and evaluation of the SMS alcohol intervention tailored to SSAW. The intervention and control groups will receive messages for four weeks and will provide follow-up data relating to their alcohol two time points after they have completed the intervention - post-intervention and 12 week follow-up.
It is hypothesised that participants receiving the SMS alcohol intervention will report lower alcohol intake at intervention completion and 3 months post intervention than participants not receiving the SMS alcohol intervention.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1698 1698 0 0
http://www.anzctr.org.au/AnzctrAttachments/372859-Ethics Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 74494 0
Dr Rhonda Brown
Address 74494 0
School of Nursing and Midwifery
Faculty of Health
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country 74494 0
Australia
Phone 74494 0
+61 3 92517026
Fax 74494 0
Email 74494 0
rhonda.brown@deakin.edu.au
Contact person for public queries
Name 74495 0
Ms Rachel Bush
Address 74495 0
School of Nursing and Midwifery
Faculty of Health
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country 74495 0
Australia
Phone 74495 0
+61 415306989
Fax 74495 0
Email 74495 0
rbus@deakin.edu.au
Contact person for scientific queries
Name 74496 0
Ms Rachel Bush
Address 74496 0
School of Nursing and Midwifery
Faculty of Health
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country 74496 0
Australia
Phone 74496 0
+61 415306989
Fax 74496 0
Email 74496 0
rbus@deakin.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
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