Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000494831
Ethics application status
Approved
Date submitted
12/02/2021
Date registered
28/04/2021
Date last updated
12/04/2023
Date data sharing statement initially provided
28/04/2021
Date results provided
28/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Implementation of the QuikFix College Alcohol and Other Drug (AOD)-related Harm Minimisation Project among residential college students.
Scientific title
Effect of the QuikFix Alcohol and Other Drug (AOD) harm reduction workshop and brief intervention on levels of alcohol and other drug use among residential college students.
Secondary ID [1] 303428 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a sub-study linked to existing record ACTRN12618001010280

Health condition
Health condition(s) or problem(s) studied:
Alcohol Use 320729 0
Drug Use 321078 0
Condition category
Condition code
Mental Health 318571 318571 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two groups in this study a) intervention group – who receive the Full QuikFix College Program (i.e., workshop + QuikFix), and b) the comparison group – who receive the workshop only.

Pre-intervention Baseline education - QuikFix Alcohol and other Drug (AOD) Harm Reduction Workshop:
An interactive, 2-hour workshop will be delivered to all first year students at participating UQ colleges during Orientation-Week, 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 third-year student peer leaders from each college, with the support of the research team. The trivia content was co-developed with college peer leaders using focus groups/participatory design workshops, and provided feedback in an ongoing manner. 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. Participants are not provided with any additional hardcopy materials.

The workshop will be scheduled into the Colleges' O-Week formal orientation, which all students are encouraged to attend. Attendance numbers will be monitored using the Colleges' enrolment lists. These numbers will then be compared with records of baseline survey completion (which includes consent to workshop participation), which are done just prior to workshop delivery. All participants who complete a baseline survey are therefore present for engagement in workshop delivery.

Intervention - QuikFix Brief AOD Telehealth Intervention:
An additional survey will be conducted at 4-weeks with the students in the Intervention College for the expressed purposed of identifying students who are nominated as socially influential by their peers. The rationale for waiting until 4-weeks post-baseline to identify these socially influential students, is to ensure that there has been sufficient time for social bonds to have been established and more accurate identification of students who are considered central within the social network. 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 QuikFix brief intervention. This is because it is expected that by targeting these centrally positioned socially influential students to receive the QuikFix intervention directly, the remainder of the network (i.e., intervention group) will indirectly experience the effect of the QuikFix intervention via the targeted central players. Students identified as risky drinkers and centrally positioned in the college social network that provide additional consent will receive the QuikFix brief intervention.

All peer leaders at the intervention college will also be offered the QuikFix brief intervention. The two-session 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. QuikFix includes comprehensive materials (e.g., fact and harm minimisation sheets) that can be used by all research therapists. These materials have been purpose-built for the QuikFix intervention.

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 alcohol is provided. 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 plan for how they can use these strategies in future alcohol use situations to reduce their risk of harm. These harm minimisation strategies are purpose-built for the QuikFix intervention and are initially provided verbally to the participants during the session. The strategies are tailored to suit the particular substance of concern for the participant. At the end of Session 1 participants are asked if they would also like to have a soft copy of these individually tailored purpose-built strategies emailed to them for future reference.

In Session 2 (expected completion time 20 - 30 minutes), AF on the students dominant personality style 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. Session 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 soft-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] 319733 0
Treatment: Other
Intervention code [2] 319734 0
Behaviour
Comparator / control treatment
The outcomes of students at colleges who receive the QuikFix AOD harm minimisation workshop only will be compared to a college that receives the workshop plus access to a brief telehealth intervention for socially influential students who engage in risky drinking.
Control group
Active

Outcomes
Primary outcome [1] 326526 0
Level of alcohol and other Drug use and associated problems assessed through a composite score of the World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) (WHO ASSIST Working Group, 2002).
Timepoint [1] 326526 0
Baseline compared to primary time-point of 12 weeks post-baseline, and at 26 and 52 weeks post baseline (secondary time-points).
Secondary outcome [1] 391787 0
Past 4 week frequency and typical quantity of substance use will be assessed with the Australian Treatment Outcome Profile (ATOP) (Ryan et al., 2014)
Timepoint [1] 391787 0
Baseline compared to 26 and 52 weeks post baseline (secondary time-points).
Secondary outcome [2] 391788 0
Alcohol use assessed using the 8-item World Health Organisation (WHO) Alcohol Use Disorders Identification Test (WHO AUDIT, 2001)
Timepoint [2] 391788 0
Baseline compared to 26 and 52 weeks post baseline (secondary time-points)
Secondary outcome [3] 391789 0
Single item measures of alcohol use from Barnett et al (2019)
Timepoint [3] 391789 0
Baseline compared to 26 and 52 weeks post baseline (secondary time-points).
Secondary outcome [4] 391790 0
Depression symptom severity, measured using the Patient Health Questionnaire (PHQ-9)
Timepoint [4] 391790 0
Baseline compared to 26 and 52 weeks post baseline (secondary time-points).
Secondary outcome [5] 391791 0
Anxiety severity, measured using the Generalized Anxiety Disorder scale (GAD-7)
Timepoint [5] 391791 0
Baseline compared to 26 and 52 weeks post baseline (secondary time-points).
Secondary outcome [6] 391792 0
Alcohol-related consequences are assessed using the Brief Young Adult Alcohol Consequences Questionnaire – Revised (24 items; Kahler et al., 2008).
Timepoint [6] 391792 0
Baseline compared to 26 and 52 weeks post baseline (secondary time-points).

Eligibility
Key inclusion criteria
Pre-intervention baseline: QuikFix 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 workshop.

QuikFix Brief AOD Intervention:
Only socially influential first year students identified as risky drinkers at Emmanuel college 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 (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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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
All first year student participants receive the QuikFix AOD harm reduction workshop throughout the study.

Participants in the first year cohort at the intervention college will be offered the 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. We intend to recruit 60 strategic players for the QuikFix intervention (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 5 colleges, with an estimated total first year cohort size of approximately 500 (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. Medium-large effect sizes were estimated, based on the findings of the QuikFix RCT (Hides et al., 2020) and previously published mean and standard deviation estimates for ASSIST scores (Humeniuk et al., 2008) were used in the analysis. According to this analysis, 80 participants are required, with 40 participants in each condition. A 20% attrition rate is predicted at 12 months, therefore we will require 100 participants. Given that approximately 40% of students screen positively for hazardous drinking we will need to recruit 250 students, approximately 125 per college. Although this is the ideal number to achieve high power (90%), recruitment will be restricted by what is feasible with the number of 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). We anticipate 50-60 students will receive the QuikFix brief intervention based on our participation rates from previous QuikFix studies (40% of eligible young people agreed to participate). Based on the work of Barnett et al (2019) we require 27% of the heavy drinking students who are centrally located in the target college first-year peer social network (identified using peer nomination data) to receive the QuikFix brief intervention (plus additional participants to account for attrition over time) to determine whether the delivery of the QuikFix to this subset of students, benefits the entire first year cohort (e.g. reduced drinking outcomes).

In the current study, 27% of the brief intervention cohort (n = 150) is approximately 41 students. We expect up to 20% attrition over the follow up period (based on prior studies of the QuikFix Brief Telehealth Intervention; Hides et al., 2020), which requires us to recruit an 9 additional participants. Based on these calculations, the team aims to recruit 50-60 students from the intervention cohort (target College, first year cohort) 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 and Full QuikFix program and ii) group differences in primary and secondary outcomes. among students at 12-, 26- and 52-weeks follow up. The within-groups factor will be time (baseline, 12, 26, 52 weeks) and group (Full QuikFix Program vs Workshop only) will be the between-subjects factor. 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
Completed
Date of first participant enrolment
Anticipated
Actual
14/02/2021
Date of last participant enrolment
Anticipated
Actual
22/02/2021
Date of last data collection
Anticipated
22/04/2022
Actual
2/05/2022
Sample size
Target
250
Accrual to date
Final
497
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 33153 0
4072 - University Of Queensland

Funding & Sponsors
Funding source category [1] 307849 0
Government body
Name [1] 307849 0
Australian Government Department of Health
Country [1] 307849 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] 308558 0
None
Name [1] 308558 0
NA
Address [1] 308558 0
NA
Country [1] 308558 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307853 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 307853 0
Ethics committee country [1] 307853 0
Australia
Date submitted for ethics approval [1] 307853 0
24/11/2020
Approval date [1] 307853 0
20/01/2021
Ethics approval number [1] 307853 0
2020002817

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

Contacts
Principal investigator
Name 108710 0
Prof Leanne Hides
Address 108710 0
School of Psychology McElwain Building The University of Queensland St Lucia QLD 4072
Country 108710 0
Australia
Phone 108710 0
+61 7 336 56398
Fax 108710 0
Email 108710 0
[email protected]
Contact person for public queries
Name 108711 0
Carol Keane
Address 108711 0
School of Psychology McElwain Building The University of Queensland St Lucia QLD 4072
Country 108711 0
Australia
Phone 108711 0
+61 7 3366 9643
Fax 108711 0
Email 108711 0
[email protected]
Contact person for scientific queries
Name 108712 0
Carol Keane
Address 108712 0
School of Psychology McElwain Building The University of Queensland St Lucia QLD 4072
Country 108712 0
Australia
Phone 108712 0
+61 7 3366 9643
Fax 108712 0
Email 108712 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
When will data be available (start and end dates)?
Anticipated start date: May 2022
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
10633Study protocol  [email protected] Available upon request, post publication.
10634Statistical analysis plan  [email protected] Available upon request, post publication.
10635Informed consent form  [email protected] Available upon request
10636Ethical approval  [email protected] Available upon request
10637Analytic code  [email protected] Available upon request, post publication.



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA two-stage social network intervention for reducing alcohol and other drug use in residential colleges: Protocol for a feasibility trial.2022https://dx.doi.org/10.1016/j.cct.2022.106779
N.B. These documents automatically identified may not have been verified by the study sponsor.