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Registration number
ACTRN12625000176460
Ethics application status
Approved
Date submitted
30/01/2025
Date registered
14/02/2025
Date last updated
14/02/2025
Date data sharing statement initially provided
14/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the QuikFix Good Night Out (GNO) College Program on alcohol and other drug (AOD) use and related harm in residential college students.
Scientific title
A two-arm cluster randomised controlled trial of the social network targeted QuikFix Good Night Out Program on alcohol and other drug (AOD) use and related harm in young residential college students.
Secondary ID [1] 313845 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This record is extending on two pilot studies ACTRN12618001010280 and ACTRN12621000494831.

Health condition
Health condition(s) or problem(s) studied:
alcohol use 336492 0
drug use 336493 0
Condition category
Condition code
Mental Health 333005 333005 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study has two arms:
Colleges in the Arm 1 intervention group receive the QuikFix GNO Program which targets alcohol and other drug (AOD) use in student social networks in two ways:
a. An AOD trivia workshop, delivered by peer student leaders to all first-year students during Orientation-week. Student leaders are provided with a two hour training workshop on the delivery the AOD trivia workshop approximately one week before the workshop..
b. QuikFix a brief telehealth harm reduction intervention targeting the most socially influential heavy drinking students, incorporating assessment feedback, motivational interviewing, goal setting, and personality-targeted coping skills training.. The clinicians (counsellors, psychologists) delivering QuikFix have attended a 2-day training workshop and are receive clinical supervision.

Colleges in the Arm 2 control group receive AOD education as usual

Arm 1 Intervention Group
AOD trivia workshop: An interactive, 2-hour workshop will be delivered during orientation-week to first-year students at participating colleges to increase their knowledge of and intention to use harm reduction strategies and reduce their risk of AOD-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 with college student leaders in a series of participatory design workshops and refined based on feedback. The workshop includes information about:
- How alcohol and different types of drugs affect individuals physically, mentally, socially and emotionally.
- How to drink alcohol but not get too drunk (learning limits).
- Harm reduction strategies for safer AOD use to reduce risk of harm.

The workshop will be scheduled into the Colleges' formal orientation-week program, which all students are encouraged to attend.

QuikFix Brief Telehealth Intervention: First-year students from Intervention Group colleges who report risky drinking and are identified as socially influential by their peers at the 6-week survey will be offered the QuikFix Brief Telehealth Intervention. The social network 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. It is expected that targeting AOD use among the socially influential risky drinking students with the telehealth intervention will indirectly influence AOD use among the rest of the college social network.

The one-session QuikFix Brief Telehealth Intervention is delivered over a maximum of 30 minutes by clinicians (counsellors, psychologists) who have attended a 2-day training workshop. All clinicians will receive at least three supervision sessions. The QuikFix Brief Telehealth Intervention uses a harm reduction approach to assist students with developing a good night out plan. It incorporates personalised assessment feedback, psychoeducation, motivational interviewing and personality-targeted coping skills training. A comprehensive range of materials (e.g., fact and harm-minimisation sheets) are used to support program delivery.

During the phone call students receive assessment feedback on their AOD use and related consequences, including comparisons with normative data from general population and college student samples. Motivational interviewing techniques are then used to build the students readiness and commitment to develop a harm reduction focused AOD use plan for having a good night out. They are offered relevant information on the physical, psychological and social effects of AOD use, as well as harm reduction strategies for reducing their risk of harm. Students are also provided with feedback on their dominant personality style and how this may affect their AOD use, and will be offered personality-specific training in one coping skill. The session concludes with the young person developing a good night plan for future AOD-related situations, which incorporates their selected harm reduction strategies and personality-specific coping skill. All telephone treatment sessions are audio-recorded and a random 20% will be independently rated for treatment fidelity purposes. The telephone session will last up to 30 minutes. Students will be offered a follow-up phone call if they are unable to complete the QuikFix brief intervention in one session or need further support/referral. Participants will receive an emailed copy of relevant QuikFix AOD Factsheets and Harm Minimisation Factsheets as part of the intervention.
Intervention code [1] 330427 0
Treatment: Other
Intervention code [2] 330428 0
Behaviour
Comparator / control treatment
Arm 2 Control Group
Colleges in the Control Group will deliver AOD education as usual. This typically includes a 1-2 hour AOD education session delivered to all first year student during O’Week by an external provider. Detailed information on the specific programs delivered at the colleges will be collected by the research team.
Control group
Active

Outcomes
Primary outcome [1] 340544 0
Alcohol involvement score (alcohol use and associated problems) in past 3 months
Timepoint [1] 340544 0
Measured at baseline, then compared to 12, 26, 38 and 52 weeks post baseline.
Primary outcome [2] 340634 0
Frequency of alcohol use in the past month
Timepoint [2] 340634 0
Measured at baseline, then compared to 6, 12, 26, 38 and 52 weeks post baseline
Primary outcome [3] 340748 0
Typical quantity of alcohol use in the past month
Timepoint [3] 340748 0
Measured at baseline, then compared to 6, 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [1] 444406 0
Tobacco involvement (tobacco use and associated problems) in past 3 months
Timepoint [1] 444406 0
Measured at baseline, then compared to 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [2] 444407 0
Frequency of tobacco use in past month.
Timepoint [2] 444407 0
Measured at baseline, then compared to 6, 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [3] 444408 0
Problematic alcohol use
Timepoint [3] 444408 0
Measured at baseline, then compared to 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [4] 444409 0
Alcohol-related consequences
Timepoint [4] 444409 0
Measured at baseline, then compared to 12 weeks, 26, 38, and 52 weeks post baseline.
Secondary outcome [5] 444410 0
Depression symptom severity
Timepoint [5] 444410 0
Measured at baseline, then compared to 6, 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [6] 444411 0
Anxiety symptom severity
Timepoint [6] 444411 0
Measured at baseline, then compared to 6, 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [7] 444412 0
Presence of PTSD symptoms
Timepoint [7] 444412 0
Measured at baseline, then compared to 38 and 52 weeks post baseline.
Secondary outcome [8] 444413 0
Mental well-being
Timepoint [8] 444413 0
Measured at baseline, then compared to 6, 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [9] 444664 0
Health-related quality of life
Timepoint [9] 444664 0
Measured at baseline then, compared to 26 and 52 weeks post baseline.
Secondary outcome [10] 444665 0
Cannabis involvement (cannabis use and associated problems) in past 3 months
Timepoint [10] 444665 0
Measured at baseline, then compared to 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [11] 444666 0
Ecstasy involvement (ecstasy use and associated problems) in past 3 months
Timepoint [11] 444666 0
Measured at baseline, then compared to 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [12] 444671 0
Amphetamine-type stimulant involvement (use and associated problems) in past 3 months
Timepoint [12] 444671 0
Measured at baseline, then compared to 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [13] 444672 0
Cocaine involvement (cocaine use and associated problems) in past 3 months
Timepoint [13] 444672 0
Measured at baseline, then compared to 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [14] 444673 0
Frequency of cannabis use in the past month.
Timepoint [14] 444673 0
Measured at baseline, then compared to 6, 12, 26, 38 and 52 weeks post baseline
Secondary outcome [15] 444674 0
Frequency of cocaine use in the past month.
Timepoint [15] 444674 0
Measured at baseline, then compared to 6, 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [16] 444675 0
Frequency of ecstasy use in the past month
Timepoint [16] 444675 0
Measured at baseline, then compared to 6, 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [17] 444982 0
Typical quantity of tobacco use in the past month
Timepoint [17] 444982 0
Measured at baseline, then compared to 6, 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [18] 444983 0
Typical quantity of cannabis in the past month
Timepoint [18] 444983 0
Measured at baseline, then compared to 6, 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [19] 444985 0
Typical quantity of ecstasy use in the past month
Timepoint [19] 444985 0
Measured at baseline, then compared to 6, 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [20] 444986 0
Typical quantity of cocaine use in the past month
Timepoint [20] 444986 0
Measured at baseline, then compared to 6, 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [21] 444987 0
Frequency of amphetamine-type stimulant use in the past month
Timepoint [21] 444987 0
Measured at baseline, then compared to 6, 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [22] 444988 0
Typical quantity of amphetamine-type stimulant use in the past month
Timepoint [22] 444988 0
Measured at baseline, then compared to 6, 12, 26, 38 and 52 weeks post baseline.
Secondary outcome [23] 444989 0
Health Service Utilisation in past 52 weeks
Timepoint [23] 444989 0
52 weeks followup only

Eligibility
Key inclusion criteria
First-year college students
All first-year university students aged 17-25 years, living in a participating college; (ii) fluent in English; (iii) who provide informed consent and complete the baseline survey will be eligible to participate.

All first-years at colleges allocated to the Intervention Group will be able to attend the workshop regardless of whether they consent to participate in the research.

All consenting participants will be invited to complete follow up surveys at 6-, 12-, 26-, 38- and 52- weeks post baseline.

Student leaders
Student leaders must be at a participating college allocated to the Intervention group; over the age of 17; provide consent to participate in the research and complete a brief baseline survey. Student leaders will not be invited to complete follow up surveys.

QuikFix Brief Telehealth Intervention:
Only socially influential first-year students identified as risky drinkers at the colleges assigned to the Intervention Group 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.

Risky drinking is defined as consumption of 4 (if female) or 5 (if male, other) standard drinks on 2 or more occasions in the past month (30 days). 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). First-years at colleges assigned to the Intervention Group who are not identified as ‘socially influential’ or ‘risky drinkers’, and students allocated to the Control Group will not be offered the QuikFix Brief Telehealth Intervention.
Minimum age
17 Years
Maximum age
25 Years
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 into either the Intervention or Control Group which was generated centrally by a computer.
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 state.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis was conducted using the crt2arm function from R WebPower. Based on our previous work, we assumed a moderate difference between the intervention and control (f=.25), with alpha set at 0.05 for a two-tailed test. We anticipated an intracluster correlation coefficient of 0.02 (generally reported for health-related behaviours and used in past alcohol reduction studies and an average cluster size of 160). Given these parameters, we would require 18 clusters to achieve a power of 0.87: a total of 2,880 students or 1,440 per the two treatment arms. To account for student attrition (15% over 12 months), we need to recruit 18-20 colleges to achieve a sample size of 3,312 students or 1,656 per treatment arm.

Data analyses will be conducted on an intention-to-treat basis. Generalised mixed effects regression will investigate whether the (i) QuikFix GNO College Program (intervention) or (ii) AOD education as usual (control) has superior outcomes on the primary and secondary outcomes (e.g., linear regression for continuous outcomes, logistic regression for dichotomous outcomes, Poisson regression for count outcomes).

To account for within-person and within-college dependency in the data, models will include the participant and college as nested random intercepts, and participant and time as random slopes. We will also test different specifications of time (linear, quadratic & categorical) to determine the best fitting model for the data. Model fit will be compared using likelihood ratio tests, AIC, and BIC statistics.

The effect of greatest interest will be the time x group interaction for the primary outcome (WHO ASSIST alcohol total score) at 6- and 12-months, adjusting for baseline differences. Mixed-effects models use maximum likelihood estimation (MLE), producing unbiased estimates when data is assumed to be not missing completely at random. Missing data will be explored by examining baseline differences on the outcome and other potential confounding variables between those retained and those lost to follow-up. Sensitivity analysis will examine the impact of potential covariates related to missingness and examine the impact of including/excluding same-sex colleges, strategic players who received QuikFix Brief Telehealth Intervention and different states in the analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/02/2025
Actual
Date of last participant enrolment
Anticipated
28/02/2026
Actual
Date of last data collection
Anticipated
28/03/2027
Actual
Sample size
Target
3312
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 318313 0
Government body
Name [1] 318313 0
Department of Health and Aged Care: Medical Research Future Fund, 2023 Maternal Health and Healthy Lifestyles Grant
Country [1] 318313 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 320701 0
None
Name [1] 320701 0
Address [1] 320701 0
Country [1] 320701 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316947 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 316947 0
Ethics committee country [1] 316947 0
Australia
Date submitted for ethics approval [1] 316947 0
14/01/2024
Approval date [1] 316947 0
21/01/2025
Ethics approval number [1] 316947 0
2020/HE002817

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

Contacts
Principal investigator
Name 139526 0
Prof Leanne Hides
Address 139526 0
School of Psychology McElwain Building The University of Queensland St Lucia QLD 4072
Country 139526 0
Australia
Phone 139526 0
+61 7 336 56398
Fax 139526 0
Email 139526 0
l.hides@uq.edu.au
Contact person for public queries
Name 139527 0
Leanne Hides
Address 139527 0
School of Psychology McElwain Building The University of Queensland St Lucia QLD 4072
Country 139527 0
Australia
Phone 139527 0
+61 7 336 56398
Fax 139527 0
Email 139527 0
l.hides@uq.edu.au
Contact person for scientific queries
Name 139528 0
Leanne Hides
Address 139528 0
School of Psychology McElwain Building The University of Queensland St Lucia QLD 4072
Country 139528 0
Australia
Phone 139528 0
+61 7 336 56398
Fax 139528 0
Email 139528 0
l.hides@uq.edu.au

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 2028
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?
All analyses considered on a case-by-case basis at the discretion of Primary Sponsor.
How or where can data be obtained?
On request to the primary sponsor (l.hides@uq.edu.au)


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
No additional documents have been identified.