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Trial registered on ANZCTR


Registration number
ACTRN12616001231437
Ethics application status
Approved
Date submitted
29/03/2016
Date registered
5/09/2016
Date last updated
13/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Drinking Intervention for Young Adults Delivered via a Smartphone Application: Preliminary Effectiveness and Usability
Scientific title
A pilot evaluation of a smartphone-based program to reduce harm associated with risky drinking in young adults aged 18-35
Secondary ID [1] 288853 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol misuse 298147 0
Condition category
Condition code
Public Health 298311 298311 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To examine the preliminary effectiveness of Minimise a randomised controlled trial design was employed.

The eligibility criteria for participants to engage in the study included; (a) being aged 18-35 years; (b) having access to a smartphone device with iOS functionality; (c) motivated to reduce alcohol use and (d) drinking alcohol at least once a week. If the individual met this eligibility they were randomised to receive either the intervention, Minimise smartphone app or the control, InstantSurvey smartphone app for 28 days.
At randomisation participants will be fully blinded to whether they have received the control or the intervention. Once participants have completed the follow up assessment they will be informed as to which group they were in and those in the control group will be offered the Minimise application. Using an online survey, assessments will be completed at baseline and immediately following the intervention.
To assess the usability of Minimise six participants from the intervention arm who completed baseline and follow up will be interviewed regarding their experience of the Minimise app.

*Please note - participants will be randomly assigned (through qualtrics) to either a baseline questionnaire that details the download of 'Instant Survey' or alternatively to 'Minimise'.

1. Control: these participants use a restricted version of the app, 'Instant Survey', to self-monitor - which involves participants reporting their affect, social context, plans and drinking behaviour in the mobile phone application. The self monitoring element of the application should take no more than one minute to complete. These participants will be prompted twice a day (morning and afternoon) to complete their assessment for 28 days.

2. Intervention: Participants in the intervention group will receive Minimise and will self monitor and receive harm minimisation strategies during episodes of drinking (e.g., substitute a glass of water for each alcoholic beverage) tailored to their goals (i.e., reduce alcohol quantity) and situational factors (i.e., affect, social context and plans for the evening). These participants will be prompted twice a day (morning and afternoon) to complete their assessment.




Intervention code [1] 294318 0
Prevention
Comparator / control treatment
For participants in the control group, they will self-monitor using InstantSurvey, a smartphone app, twice a day for 28 days
Control group
Active

Outcomes
Primary outcome [1] 297788 0
1. Change in alcohol consumption - This will be examined by comparing the participants' in all three groups score on the AUDIT sub-scales (total, depend, consumption and problems) in the baseline questionnaire compared to their scores on the AUDIT sub-scales in the post-study questionnaire.
Timepoint [1] 297788 0
The post-study questionnaire will be disseminated to all individuals immediately after the study is complete (i.e., after the 30 days of completing the mobile phone application). Participants will recieve via their email address, a link that takes them to the post-study questionnaire. The post-study questionnaire which will include the same items as the baseline questionnaire which will enable comparison within and between participants.
Employing post-questionnaires immediately after the study has been supported in a number of studies;
Gajecki, M., Berman, A. H., Sinadinovic, K., Rosendahl, I., & Andersson, C. (2014). Mobile phone brief intervention applications for risky alcohol use among university students: a randomized controlled study. Addiction science & clinical practice, 9(1), 1.
AND
Kypri, K., Saunders, J. B., Williams, S. M., McGee, R. O., Langley, J. D., Cashell-Smith, M. L., & Gallagher, S. J. (2004). Web-based screening and brief intervention for hazardous drinking: a double-blind randomized controlled trial. Addiction, 99(11), 1410-1417.


Primary outcome [2] 307218 0

Consumption of four or more standard drinks in a single occasion in the prior two weeks

A study specific item was used to measure this outcome
Timepoint [2] 307218 0
Baseline and immediately following the intervention
A study specific item was used to measure this outcome
Primary outcome [3] 307219 0
Difficulties with work and/or study due to drinking in the prior two weeks
A study specific item was used to measure this outcome
Timepoint [3] 307219 0
Baseline and immediately following the intervention
Secondary outcome [1] 322243 0
The following secondary outcomes will be assessed (at follow up) to identify the effect of the Secondary outcome: The number of times you have used a protective behavioural strategy to control the amount of alcohol you drank
A study specific item was used to measure this outcome

Timepoint [1] 322243 0
The post-study questionnaire will be conducted immediately after the conclusion of the study.
Secondary outcome [2] 351154 0
Primary outcome: Interpersonal difficulties due to drinking in the prior two weeks
A study specific item was used to measure this outcome
Timepoint [2] 351154 0
Baseline and immediately following the intervention
Secondary outcome [3] 351155 0
Primary outcome: Felt physically unwell due to your drinking in the prior two weeks
A study specific item was used to measure this outcome
Timepoint [3] 351155 0
Baseline and immediately following the intervention
Secondary outcome [4] 351156 0
Secondary outcome: The number of times you have used a protective behavioural strategy to reduce harm when drinking.

A study specific item was used to measure this outcome
Timepoint [4] 351156 0
Baseline and immediately following the intervention

Eligibility
Key inclusion criteria
1. Access to a iOs mobile phone device
2. Consume alcohol at least once a week
3. Aged 18-35
4. Wanting to reduce drinking
Minimum age
18 Years
Maximum age
35 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals who are clinical-type drinkers

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)

Allocation was concealed as the randomisation was controlled by the Qualtrics server for the baseline questionnaire (i.e., which either allocated participants to the Control or intervention group)
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 receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Sample size calculations were conducted using G*Power (Faul, Erdfelder, Lang, & Buchner, 2007). Comparable interventions (e.g., Arnaud et al., 2017; Haug et al., 2017) have found moderate effects for post-intervention drinking outcomes and harms (Cohen’s d = .25). Moreover, this calculation assumes a correlation between baseline and follow up of .60 (Napper, Kenney, Lac, Lewis, & LaBrie, 2014; Wiers, Van De Luitgaarden, Van Den Wildenberg, & Smulders, 2005). With the alpha set at .05 and power at .80, a total sample of 28 individuals was needed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 8145 0
United States of America
State/province [1] 8145 0

Funding & Sponsors
Funding source category [1] 293213 0
University
Name [1] 293213 0
Deakin University
Address [1] 293213 0
221 Burwood Highway
Burwood, 3125
Vic
Country [1] 293213 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway
Burwood, 3125
Vic
Country
Australia
Secondary sponsor category [1] 292011 0
None
Name [1] 292011 0
Nill
Address [1] 292011 0
Nil
Country [1] 292011 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294694 0
Deakin Research Ethics
Ethics committee address [1] 294694 0
221 Burwood Highway
Burwood, 3125
Vic
Ethics committee country [1] 294694 0
Australia
Date submitted for ethics approval [1] 294694 0
29/02/2016
Approval date [1] 294694 0
23/08/2016
Ethics approval number [1] 294694 0
2016-059

Summary
Brief summary
Proposed Research Design:

We intend to pilot the app to establish its usability and possible effectiveness using an
experimental design where 28 young adults are randomly assigned to one of two conditions.

1. Control: these participants use a restricted version of the app to self-monitor their drinking
behaviour and related variables (e.g., mood, behaviour of others, etc.).
2. Intervention: in addition to self monitoring, these participants will receive harm
minimisation strategies tailored to their goals and behaviours


The intervention is delivered through participants’ mobile-phone devices. Kypri and colleagues (2003) found young adults as more receptive to engage with mobile phone interventions in comparison to web-based or one-on-one counselling sessions, as such, this design should minimise attrition rates.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1074 1074 0 0
/AnzctrAttachments/370408-2016059-160823-Mi-o.pdf (Ethics approval)
Attachments [2] 1075 1075 0 0
/AnzctrAttachments/370408-PLS_V.2_STUDY 28_02-1 copy.docx (Participant information/consent)

Contacts
Principal investigator
Name 64690 0
Miss Renee O'Donnell
Address 64690 0
Deakin Univeristy - School of Psychology
221 Burwood Highway
Burwood, 3125
Vic
Country 64690 0
Australia
Phone 64690 0
+61 422 984 527
Fax 64690 0
Email 64690 0
renee.odonnell@deakin.edu.au
Contact person for public queries
Name 64691 0
Miss Renee O'Donnell
Address 64691 0
Deakin Univeristy - School of Psychology
221 Burwood Highway
Burwood, 3125,
Vic
Country 64691 0
Australia
Phone 64691 0
+61 422 984 527
Fax 64691 0
Email 64691 0
renee.odonnell@deakin.edu.au
Contact person for scientific queries
Name 64692 0
Miss Renee O'Donnell
Address 64692 0
Deakin Univeristy - School of Psychology
221 Burwood Highway
Burwood, 3125
Vic
Country 64692 0
Australia
Phone 64692 0
+61 422 984 527
Fax 64692 0
Email 64692 0
renee.odonnell@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary