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A randomised controlled trial to investigate the effects of two personalised digital interventions on alcohol risky drinking and alcohol related harms in young people
Last registered on March 14, 2017

Pre-Trial

Trial Information
General Information
Title
A randomised controlled trial to investigate the effects of two personalised digital interventions on alcohol risky drinking and alcohol related harms in young people
RCT ID
AEARCTR-0001082
Initial registration date
March 10, 2016
Last updated
March 14, 2017 5:21 AM EDT
Location(s)
Primary Investigator
Affiliation
Oxford Brookes University
Other Primary Investigator(s)
PI Affiliation
Oxford Brookes University
PI Affiliation
Oxford Brookes University
Additional Trial Information
Status
Completed
Start date
2015-10-12
End date
2016-05-31
Secondary IDs
Abstract
Alcohol misuse is associated with a number of harmful short and long term consequences for young people. Health campaigns that aim to educate people about these risks are often ineffective, possibly because consequences may be felt too far in the future, or they fail to account for the determinants of drinking for young people. However, social image and reputation may be important concerns for young people (Gerrard et al, 2008). Therefore, a focus on short term social consequences, rather than long term harms may be more appropriate in this population. This study aims to explore the potential of two online interventions to reduce risky drinking and alcohol related harms in young people compared to controls. Participants will be young people aged 18-30 who identify as drinking alcohol. They will complete baseline measures about their drinking behaviours and psychological factors including measures of public and private self-consciousness and prototype perceptions. They will then be randomised to one of four groups, two interventions and two control groups. Four weeks later they will complete follow up measures. Furthermore we will interview approximately 25 people to explore their views about the online interventions.
External Link(s)
Registration Citation
Citation
Davies, Emma, David Foxcroft and Adam Lonsdale. 2017. "A randomised controlled trial to investigate the effects of two personalised digital interventions on alcohol risky drinking and alcohol related harms in young people ." AEA RCT Registry. March 14. https://doi.org/10.1257/rct.1082-3.0.
Former Citation
Davies, Emma et al. 2017. "A randomised controlled trial to investigate the effects of two personalised digital interventions on alcohol risky drinking and alcohol related harms in young people ." AEA RCT Registry. March 14. http://www.socialscienceregistry.org/trials/1082/history/14946.
Experimental Details
Interventions
Intervention(s)
Arm 1) ‘One too many’
The ‘One Too Many’ online intervention focuses on social embarrassment that young people may encounter when drinking to excess. This novel intervention asks participants about 20 potentially embarrassing situations that they may have experienced while drinking. The questions were developed following focus group discussions with students and refined by piloting in a number of stages. For example the questions ask about posting something embarrassing on social media, being sick in public and getting into fights with friends. On completion, the participant is presented with a social embarrassment score (0-20?).
Arm 2) Drinks meter
Web-based interventions such as ‘One Too Many’ are advantageous because of their potential to reach large numbers of people, and since intervention fidelity can be maintained. There is some evidence to suggest that brief interventions delivered using the internet might be effective in targeting alcohol consumption (Bewick et al., 2008). An appropriate comparison to ‘One Too Many’ therefore is ‘Drinks Meter’ developed by the Global Drug Survey. Drinks meter uses a traditional ‘identification and brief advice (IBA) approach in which receive personalised feedback about their own drinking, and they also get information about how it compares with other people.
Intervention Start Date
2015-10-12
Intervention End Date
2016-05-31
Primary Outcomes
Primary Outcomes (end points)
Primary outcome measures:
• Audit C
• Last four week harms (major / minor)
• Last four weeks pre-loading

Sub group analyses:

• Risky drinking at baseline

Secondary outcome measures:
• Prototype perceptions
• Public and private self-consciousness
Primary Outcomes (explanation)
Alcohol consumption will be measured using AUDIT C as this has been found to be an appropriate measure to identify risky drinking in young people (Foxcroft et al, 2014). Drinking related harms will offer a proxy measure for heavy consumption, with a focus on preventable consequences of drinking. Pre-loading, or consuming alcohol at home before a night out, is associated with high subsequent levels of consumption, intoxication and harms (Foster & Ferguson, 2013).
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
Simple RCT with four conditions
Experimental Design Details
Randomization Method
Random allocation via Qualtrics Survey Software
Randomization Unit
Individual
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
800 individuals
Sample size: planned number of observations
800 individuals at baseline and four week follow up
Sample size (or number of clusters) by treatment arms
800
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Oxford Brookes University
IRB Approval Date
2015-08-06
IRB Approval Number
150944
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
Yes
Intervention Completion Date
May 31, 2016, 12:00 AM +00:00
Is data collection complete?
Yes
Data Collection Completion Date
May 31, 2016, 12:00 AM +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
Was attrition correlated with treatment status?
Final Sample Size: Total Number of Observations
Final Sample Size (or Number of Clusters) by Treatment Arms
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports, Papers & Other Materials
Relevant Paper(s)
REPORTS & OTHER MATERIALS