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Trial registered on ANZCTR


Registration number
ACTRN12622000239763
Ethics application status
Approved
Date submitted
7/02/2022
Date registered
10/02/2022
Date last updated
27/01/2023
Date data sharing statement initially provided
10/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the QuikFix Alcohol and Other Drug (AOD) Harm Minimisation Program for residential college students.
Scientific title
A three-arm cluster randomised controlled trial of the QuikFix Alcohol and Other Drug (AOD) harm minimisation workshop and targeted brief intervention on alcohol and other drug use among residential college students.
Secondary ID [1] 306366 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a second phase-study linked to three previous existing records ACTRN12618001010280, ACTRN12621000495820 and ACTRN12621000494831.

Health condition
Health condition(s) or problem(s) studied:
Alcohol Use 325166 0
Drug Use 325167 0
Condition category
Condition code
Mental Health 322574 322574 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are three groups in this study: Group 1) the comparison group – who receive the workshop only; Group 2) intervention group – who receive the Full QuikFix College Program (i.e., workshop + brief intervention), and Group 3) the control group – who receive the usual Alcohol and Other Drug (AOD) messaging from their respective colleges.

AOD Harm Minimisation Workshop (Group 1 and 2).

An interactive, 1-hour workshop will be delivered during orientation-week (O-Week) to first year students at participating UQ colleges assigned to Groups 1 and 2, to increase their knowledge of and intention to use harm minimisation strategies and reduce their risk of risky AOD use and related harm. A quiz show trivia format will be used, in which the first year cohort at each college will be split into teams (based on existing college structures). The workshop will be facilitated by trained student leaders from each college, with the support of the research team. The trivia content was co-developed and with college staff and leaders using focus groups/participatory design workshops, and refined based on feedback. The workshop includes information about: how alcohol and other drugs is likely to affect individuals physically, mentally, socially and emotionally; how to drink alcohol but not get too drunk; and harm minimisation strategies for safer alcohol and other drug use to reduce risk of harm. Colleges assigned to Groups 1 and 2 will receive access to QuikFix AOD use and harm minimisation factsheets throughout the year. Students in Group 1 and 2 will be sent four interactive emails containing booster material (5 trivia questions) from the workshop on alcohol, cannabis, MDMA, smoking/vaping (the drugs most commonly used drugs at baseline will be targeted) 3-4 weeks apart in Semester 2 to remind them of the workshop content. Colleges assigned to Group 3 will receive the harm minimisation factsheets at the end of the trial.

The workshop will be scheduled into the Colleges' O-Week formal orientation program, which all students are encouraged to attend. Attendance numbers will be monitored using the Colleges' enrolment lists.

Intervention – Socially-targeted QuikFix Brief AOD Telehealth Intervention (Group 2 only).

A survey will be conducted at 6-weeks with all first year students. The results from this survey will be used to identify students in Group 2 who are nominated as socially influential by their peers. This data is collected at 6-weeks post-baseline to allow sufficient time for social bonds to be established among first year students. This approach is based on recommendations made in previous research (Heckathorn et al., 2012; Paluck & Shepherd, 2012). In addition, only those socially influential students who also reported risky drinking in the baseline online survey (completed prior to the workshop) are offered the chance to participate in the targeted QuikFix brief intervention. This is because it is expected that targeting AOD use, among the socially influential students with the QuikFix brief intervention, will indirectly influence AOD use among the remainder of the network (i.e., Group 2 - intervention group).

The modified QuikFix intervention is delivered via phone over a maximum of 4 weeks by AOD workers, who have attended a 2-day training workshop, which has previously been delivered by Professor Hides to over 50 mental health, AOD and primary care workers.

QuikFix incorporates assessment feedback (AF), motivational interviewing (MI) and personality targeted coping skills training. In Session 1 (expected completion time 20 - 30 minutes), personalised AF on the student’s AOD use and related consequences, and information on the physical, psychological and social effects of AOD use with the QuikFix factsheets. MI is then used to build readiness and commitment to make a change and develop goals for their alcohol use. Participants are provided with information on alcohol harm minimisation strategies and are encouraged to develop a implementation intention for how they can use these strategies in future AOD use situations to reduce their risk of harm. At the end of this session participants are asked if they would also like to be emailed a copy of their AOD use harm minimisation plan; and are offered a second brief call to provide some brief coping skills training for one of the individual risk factors which may underlie their AOD use.

If the participant agrees to receive a second call (expected completion time 20 - 30 minutes), AF on the students dominant personality risk style (highest score on the S-UPPS at baseline), and how this may affect their AOD use is provided. They then receive personality-specific training in two cognitive behavioural coping skills. For example, a participant with a 'Positive Urgency' style of coping personality might be provided with 'Urge Surfing' skills; on the other hand, a participant with an 'Impulsivity' style of coping personality might be provided with a 'Stop-Think-Do' skills technique. Step 2 concludes with the young person developing an implementation intention for future AOD-related situations, which incorporates their personality-specific coping skills. As with Session 1, upon completion of Session 2, participants are asked if they would like a copy of any of the purpose-built individually tailored coping skills emailed to them for future reference.

All telephone treatment sessions are audio-recorded and a random 20% will be independently rated for treatment fidelity purposes.
Intervention code [1] 322794 0
Treatment: Other
Intervention code [2] 322795 0
Behaviour
Comparator / control treatment
The outcomes of Group 3 (control) students at colleges who receive their usual college AOD messaging will be compared to two active treatments: Group 1 students who receive the QuikFix AOD harm minimisation workshop only and Group 2 students at colleges that receive the workshop plus access to a modified brief telehealth intervention for socially influential students who engage in risky drinking.
Control group
Active

Outcomes
Primary outcome [1] 330377 0
Alcohol involvement score (alcohol use and associated problems) assessed with the World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) (WHO ASSIST Working Group, 2002).
Timepoint [1] 330377 0
Baseline compared to 12 (primary timepoint), 26 and 52 weeks post baseline.
Secondary outcome [1] 405999 0
Other drug involvement (use and associated problems) assessed with the composite score of the World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) (WHO ASSIST Working Group, 2002), adapted to include common substances of concern among residential college students.
Timepoint [1] 405999 0
Baseline compared to 12, 26 and 52 weeks post baseline.
Secondary outcome [2] 406000 0
Past 4-week frequency and typical quantity of AOD use will be assessed with the adapted version of the Australian Treatment Outcome Profile (ATOP) (Ryan et al., 2014).
Timepoint [2] 406000 0
Baseline compared to 6, 12, 26 and 52 weeks post baseline.
Secondary outcome [3] 406001 0
Alcohol use assessed using the 8-item World Health Organisation (WHO) Alcohol Use Disorders Identification Test (WHO AUDIT, 2001).
Timepoint [3] 406001 0
Baseline compared to 12, 26 and 52 weeks post baseline.
Secondary outcome [4] 406002 0
Single item measures of alcohol use from Barnett et al (2019).
Timepoint [4] 406002 0
Baseline compared to 6, 12, 26 and 52 weeks post baseline.
Secondary outcome [5] 406003 0
Depression symptom severity, measured using the Patient Health Questionnaire (PHQ-9).
Timepoint [5] 406003 0
Baseline compared to 6, 12, 26 and 52 weeks post baseline.
Secondary outcome [6] 406004 0
Anxiety severity, measured using the Generalized Anxiety Disorder scale (GAD-7).
Timepoint [6] 406004 0
Baseline compared to 6, 12, 26 and 52 weeks post baseline.
Secondary outcome [7] 406005 0
Alcohol-related consequences are assessed using the Brief Young Adult Alcohol Consequences Questionnaire – Revised (24 items; Kahler et al., 2008) and an additional three items measuring alcohol-related sexual experiences (Jaffe, et al., 2021; Kaysen et al., 2006; Nguyen et al., 2010).
Timepoint [7] 406005 0
Baseline compared to 12, 26 and 52 weeks post baseline.
Secondary outcome [8] 406006 0
Alcohol and other drug (i.e. Tobacco/Nicotine, Cannabis, MDMA) related knowledge is assess using trivia items adapted from previous trials with young people (Hides et al., 2020; Teesson et al., 2014; Teesson et al., 2020). These items assess knowledge of national guidelines and laws, social norms, and common myths (targeted within the workshop) on a true/false/don’t know response scale.
Timepoint [8] 406006 0
Baseline compared to 6 weeks post baseline.
Secondary outcome [9] 406007 0
College drinking norms will be measured with several scales from the recent VicHealth report into alcohol cultures in residential colleges (Corney, Cronin, Leontini, Lim & Wright, 2020), including standardised measures of: alcohol consumption at college social events, harm prevention and alcohol awareness and social drinking patterns in college. Social identification with college will be measured using an adapted version of the Social Identification Scale (4-items; Doosje, Ellemers, and Spears, 1995). Frequency of personal and perceived peer drinking to intoxication (drinking to get drunk) in the past month is measured via two items used previously with young people (Hides et al., 2018).
Timepoint [9] 406007 0
Baseline compared to 6, 12, 26 and 52 weeks post baseline.

Eligibility
Key inclusion criteria
Pre-intervention baseline - QuikFix Alcohol and Other Drug (AOD) harm reduction workshop:
Those aged 17 + years who provide consent to participate in the research and complete the baseline survey will be eligible to participate in the evaluation. All first years at colleges allocated to Groups 1 and 2 will be able to attend the workshop regardless of their consent to participate in the research.

QuikFix Brief AOD Intervention:
Only socially influential first year students identified as risky drinkers at the colleges assigned to Group 2 (i.e., workshop + QuikFix) will be eligible to receive the QuikFix Brief Telehealth Intervention. Socially Influential first years will be identified using the first year cohorts’ responses to an adapted version of the Important People Instrument administered at 6-weeks post baseline (Clifford & Longabaugh, 1991).

Risky drinking is defined as consumption of 4 (if female) or 5 (if male) standard drinks on greater than or equal to 2 occasions in the past month (30 days; Barnett, 2019). Users of illicit drugs including cannabis will be eligible to receive QuikFix, as long as alcohol is the most frequently used drug (other than tobacco).
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Each college will be allocated to a pre-determined randomisation sequence based on the order that they confirmed participation in response to a recruitment email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using a computer-generated, random allocation sequence. Randomisation sequence will be created using statistical software and stratified by college type (both genders, female only), using block sequences.
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
First year students at colleges allocated to Groups 1 and 2 receive the QuikFix Alcohol and Other Drug (AOD) harm reduction workshop during O-Week, and have access to the AOD fact and harm minimisation sheets throughout the study.

Participants in the first year cohort at the colleges allocated to Group 2 will be offered the modified QuikFix Brief AOD Intervention if they are identified as a strategic player using the strategic player package developed by Miles Ott (Ott, 2016). As was done in a similar study by Miles Ott, Nancy Barnett and colleagues (Barnett, 2019), the strategic player package will be used to identify ‘targets’ (strategic players) who are located centrally in the network, particularly amongst other students who drink heavily. See 'Statistical Methods' section for sample size calculation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: Sample allocation will be determined by the size of the college first year cohorts. The research will recruit from 6 colleges, with an estimated total first year cohort size of approximately 600 (across all colleges).

A power analysis was conducted for a mixed effect model of repeated measures (Guo, Logan, Gluek, & Muller, 2013), to achieve a power of .9 with a Type I error rate of .05, for the primary hypothesis of time trend by treatment interaction on the primary outcome (ASSIST-Alcohol involvement score). Means and standard deviation estimates for ASSIST score from previously collected data were used in the analysis (N = 349, from trial ACTRN12621000494831). According to this analysis, 189 participants are required. Although there were no significant differences across colleges in baseline ASSIST alcohol scores in our 2021 study, to account for clustering effects, we will increase this sample size by 20%, requiring 237 participants, with 79 participants in each condition. A 20% attrition rate is predicted at 12 months therefore we will require a minimum of 297 participants to achieve high power (90%). However, recruitment will be open to all the first year students attending the colleges sampled.

For social network analyses performed as part of this research, it will be ideal to obtain participation rates greater than 65% at relevant measurement points; a figure consistent with recommendations for minimum participation in peer nomination studies (Cillessen, 2009; cited in Kiuru, Net al., 2010). Based on the work of Barnett et al (2019) we require 27% of the target colleges (Group 2) first-year peer social network to receive the QuikFix brief intervention (plus additional participants to account for attrition over time). The 27% will be those individuals who are heavy drinking students who are centrally located, as identified by the peer nomination data.

We expect up to 20% attrition over the follow up period (based on prior studies of the QuikFix Brief Telehealth Intervention; Hides et al., 2021), which requires us to recruit an additional 20% of participants at each college to receive the QuikFix brief intervention.

Main Analyses
Mixed effects model repeated measures analyses of variance will be used to determine if there are i) changes over time in primary and secondary outcomes across Workshop only (Group 1), Workshop + Brief Intervention (Group 2: Full QuikFix program) and control group (Group 3), and ii) group differences on relevant primary and secondary outcomes among students at 6-. 12-, 26- and 52-weeks follow up. The within-groups factor will be time (baseline, 6, 12, 26, 52 weeks) and the between-subjects factor will be group (Full QuikFix Program vs Workshop only vs Control). Analyses will be adjusted for covariates and be conducted on an intention-to-treat basis.

Additional Analyses
Additional analyses are planned to analyse the association between the college network characteristics and substance-use outcomes. These are not primary or secondary analyses. Additional analyses will also be conducted to examine the association between network variables (prestige/centrality; expansiveness/outdegree; relationship agreement) and alcohol use involvement of hazardous drinkers and their peer network, and whether this varies by QuikFix status. These models control for covariates and network autocorrelation.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
14/02/2022
Actual
14/02/2022
Date of last participant enrolment
Anticipated
30/03/2022
Actual
30/03/2022
Date of last data collection
Anticipated
2/02/2023
Actual
Sample size
Target
237
Accrual to date
Final
556
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 36708 0
4072 - University Of Queensland

Funding & Sponsors
Funding source category [1] 310721 0
Government body
Name [1] 310721 0
Australian Government Department of Health
Country [1] 310721 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 311941 0
None
Name [1] 311941 0
Address [1] 311941 0
Country [1] 311941 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310298 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 310298 0
Level 3, Brian Wilson Chancellery, The University of Queensland St Lucia QLD 4072
Ethics committee country [1] 310298 0
Australia
Date submitted for ethics approval [1] 310298 0
24/11/2020
Approval date [1] 310298 0
20/02/2021
Ethics approval number [1] 310298 0
2020002817

Summary
Brief summary
Binge drinking is common in residential colleges in Australia and abroad. The objective of this study is to determine what type of AOD harm minimisation intervention is most effective for reducing risky AOD use and related harms among first year residential college students. Six colleges will be randomised to one of three different types AOD interventions: 1) trivia style AOD harm-minimisation workshop; 2) the AOD harm-minimisation workshop + QuikFix brief intervention; and 3) usual AOD / harm minimisation messaging. We expect students at colleges who receive the AOD harm-minimisation workshop + QuikFix brief intervention will have better outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117166 0
Prof Leanne Hides
Address 117166 0
School of Psychology McElwain Building The University of Queensland St Lucia QLD 4072
Country 117166 0
Australia
Phone 117166 0
+61 7 336 56398
Fax 117166 0
Email 117166 0
[email protected]
Contact person for public queries
Name 117167 0
Leanne Hides
Address 117167 0
School of Psychology McElwain Building The University of Queensland St Lucia QLD 4072
Country 117167 0
Australia
Phone 117167 0
+61 7 336 56398
Fax 117167 0
Email 117167 0
[email protected]
Contact person for scientific queries
Name 117168 0
Leanne Hides
Address 117168 0
School of Psychology McElwain Building The University of Queensland St Lucia QLD 4072
Country 117168 0
Australia
Phone 117168 0
+61 7 336 56398
Fax 117168 0
Email 117168 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual participant data collected at baseline and follow-up will be available upon request.
When will data be available (start and end dates)?
Anticipated start date: May 2023
End date: ongoing
Available to whom?
Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Only to achieve the aims of the approved proposal.
How or where can data be obtained?
On request to the primary sponsor ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14969Study protocol  [email protected] Available upon request, post publication.
14970Statistical analysis plan  [email protected] Available upon request, post publication.
14971Informed consent form  [email protected] Available upon request
14972Ethical approval  [email protected] Available upon request
14973Analytic code  [email protected] Available upon request, post publication.



Results publications and other study-related documents

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