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Trial registered on ANZCTR


Registration number
ACTRN12621000495820
Ethics application status
Approved
Date submitted
26/03/2021
Date registered
29/04/2021
Date last updated
29/04/2021
Date data sharing statement initially provided
29/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness and real-world applicability of the QuikFix risk-targeted intervention for reducing alcohol and other drug use and related harm in young people.
Scientific title
QuikFix: A randomised controlled trial of clinical setting implementation and efficacy of the QuikFix risk-targeted intervention for reducing alcohol and other drug use and related harm in young people.
Secondary ID [1] 303759 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Alcohol Use 321247 0
Tobacco Use 321254 0
Drug Use 321259 0
Condition category
Condition code
Mental Health 319030 319030 0 0
Addiction
Injuries and Accidents 319031 319031 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Risk-Targeted QuikFix Intervention: The Brief Risk-Targeted QuikFix Interventions incorporates psychological risk-targeted assessment and feedback, motivational interviewing, and cognitive-behavioural coping skills training components. The intervention is designed to target how individuals with specific psychological risk factors cope with their vulnerability to AOD misuse. It is not intended to change these risk factors, but to alter specific substance-related behaviours. The QuikFix intervention is delivered via a purpose-built QuikFix clinician companion online portal, which is accessible to clinicians and researchers but not the participants.

In Session 1, the participant is given personalised Assessment Feedback (AF), which includes a focus on alcohol or drug use, and also includes psychoeducation about a) their dominant psychological risk factor, i.e., negative urgency (anxiety/depression subtypes), impulsivity, sensation seeking, lack of perseverance; b) associated problematic coping behaviors (e.g. avoidance, aggression, risky behaviors); and c) how their dominant psychological risk factor and problematic coping behaviours may affect their alcohol and other substance use. Using a motivational interviewing style, therapists guide individual exploration of the personal relevance of these issues. Participants are given information on alcohol or other drug harm minimization strategies and are encouraged to think about how they could have used some of these strategies to prevent the recent alcohol or drug-related injury or illness which resulted in crisis support care. The intervention encourages them to develop implementation intentions, a technique based on the Theory of Planned Behavior. Implementation intentions are specific hypothetical or actual plans for change, which take the form “if situation Y is encountered, I could use Z coping behaviour, in order to achieve my alcohol use goal”. Young people are guided to develop an implementation intention for future alcohol use situations. They are asked to identify an alcohol or other drug use situation in which they could test this plan in the next week and are asked to rate their level of confidence (1-10) in implementing the plan. They recall past successes in behaviour control to build their self-efficacy, and they identify and address any potential impediments. For homework, they are encouraged to implement their alcohol or drug use plan, and they are emailed a session summary and a brief SMS message as a reminder.

In Session 2, the young person’s success in implementing their alcohol or drug use plan is reviewed and if necessary, the plan is revised. The young person then is provided with coping strategies, which specifically target one of five personality styles that may be contributing to maintaining or reinforcing their substance use - namely: negative urgency, including anxiety and depression subtypes; positive urgency; sensation seeking; impulsivity; and lack of perseverance.

The young person then receives risk-targeted training in relevant cognitive behavioural coping skills:
•Participants presenting predominantly with negative urgency, anxiety subtype are given training in mindful breathing as well as thought awareness and acceptance training for anxious thoughts.
•Individuals with negative urgency, depression subtype receive behavioural activation, thought awareness, and thought challenging training for depressive thoughts.
•All individuals with negative urgency are also provided the opportunity to complete an exercise for surfing negative emotions to delay, distract and then decide upon an action, when experiencing negative emotions.
•Individuals experiencing positive urgency are taught savouring techniques to increase their awareness of, and ability to focus upon and experience, positive feelings from everyday activity (e.g. mindful eating). They are also taught urge-surfing to delay, distract and then decide upon an action when experiencing substance-related or other urges. They are encouraged to identify the role of substance use in their fun activity engagement and to schedule fun activities that do not involve substance use.
•Sensation seekers also receive training in savouring techniques to increase their awareness and ability to focus upon and experience positive feelings from everyday activity (e.g. mindful eating) and they are encouraged to identify and schedule natural highs from functional activities (e.g. exercise, skateboarding, rock climbing) and daily experiences (food, sex, music).
•Participants with high levels of impulsivity receive urge-surfing training to delay, distract and then decide upon an action when experiencing substance-related or other urges. They are encouraged to apply the Stop-Think-Do rubric to help them slow down their decision-making processes to a sufficient level that allows then to consider likely outcomes of behavioural alternatives.
•Participants with high levels of lack of perseverance receive training in orientating themselves to future goals and why they are important. A follow-up exercise focuses on strategies to achieve those future goals.

Session 2 concludes with participants developing an implementation intention for future alcohol or other drug-related situations, which incorporates their specific coping skills. Participants are encouraged to rehearse this plan in session and identify and address potential impediments. A session summary, alcohol or drug use plan, and summary of the coping strategies learned in session, are subsequently sent to the participant via email. This information is also accessible on the QuikFix clinician companion online portal - only accessible by clinicians and researchers. The two sessions are designed to be delivered over a period of two weeks; however, the sessions can be delivered over a maximum of six weeks. Flexibility in the implementation of these sessions is considered important because the intervention is being delivered in a clinical setting.

The QuikFix clinician companion online portal has been purpose-built to monitor treatment adherence and also intervention fidelity. This is done via 'end of module' checklists that clinicians complete in order to generate the sessions summaries for participants and to progress the participants through to the next stage of the intervention or for treatment completion. In addition to these in-built checks, clinicians undertake weekly clinical supervision sessions, which includes clinical notes review. Clinicians also do audio recordings of sessions (with participant consent), which are reviewed by the clinical supervisor. Collectively these processes contribute further to fidelity and treatment adherence monitoring.
Intervention code [1] 320089 0
Treatment: Other
Comparator / control treatment
Assessment Feedback (AF) and Information: Participants receive online personalised assessment feedback on their alcohol and/or substance use and information on the physical, psychological and social effects of their use. Those who are randomised to the AF condition are also provided the opportunity for a follow-up phone call with a Lives Lived Well (LLW)/Adis counsellor to discuss this feedback. This is facilitated by providing the participants with an email that contains an embedded link they can select, which will immediately trigger an email alert to the research team that this request has been made. The research team will advise the LLW/Adis counsellors of this request, who will then conduct the follow up phone call with the participant.
Control group
Active

Outcomes
Primary outcome [1] 326939 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] 326939 0
Baseline and 1-, 3- [primary timepoint], 6-, and 12- months post-baseline
Primary outcome [2] 326949 0
Substance-related problems (e.g., social, medical, legal, family, vocational) will be assessed using the Brief Young Adult Alcohol and other Drugs Consequences Questionnaire adapted from ( B-YAADCQ; Kahler et al., 2005).
Timepoint [2] 326949 0
Baseline and 1-, 3- [primary timepoint], 6-, and 12- months post-baseline
Primary outcome [3] 326950 0
The Australian Treatment Outcome Profile (ATOP) will provide a validated measure of treatment outcomes including substance use and self-reported health and wellbeing (Ryan et al., 2014).
Timepoint [3] 326950 0
Baseline and 1-, 3- [primary timepoint], 6-, and 12- months post-baseline
Secondary outcome [1] 393231 0
Psychological risk will be assessed using the Patient Health Questionnaire (PHQ-9; Kroenke et al., 2014);
Timepoint [1] 393231 0
Baseline and 1-, 6-, and 12- months post-baseline [secondary time-points]
Secondary outcome [2] 393232 0
Psychological risk will be assessed using the Generalised Anxiety Disorder 7-item (GAD-7) scale (Spitzer et al., 2006),
Timepoint [2] 393232 0
Baseline and 1-, 6-, and 12- months post-baseline [secondary time-points]
Secondary outcome [3] 393233 0
Young people's protective behavioural strategies relevant to drinking and other drug use will be assessed using the 20-item Protective Drinking Practices Scale (PDPS; Martin et al., 2020), which has been adapted to suit AOD population.
Timepoint [3] 393233 0
Baseline and 1-, 6-, and 12- months post-baseline [secondary time-points]
Secondary outcome [4] 393302 0
Social support will be measured using the 10-item version of the Social Provisions Scale (Gottlieb & Bergen, 2010; Steigen & Bergh, 2018)
Timepoint [4] 393302 0
Baseline and 1-, 6-, and 12- months post-baseline [secondary time-points]
Secondary outcome [5] 393375 0
Substance use motives will be measured with a modified version of the 20-item Drinking Motives Questionnaire (Cooper et al.,1994), which was adapted to measure four different types of motives related to alcohol or drug use (social, coping, enhancement, and social pressure and conformity).
Timepoint [5] 393375 0
Baseline and 1-, 6-, and 12- months post-baseline [secondary time-points]
Secondary outcome [6] 393376 0
Drinking and substance use self-efficacy will be assessed using the Controlled Drinking Self-Efficacy Scale (CDSE; Sitharthan et al., 2003)
Timepoint [6] 393376 0
Baseline and 1-, 6-, and 12- months post-baseline [secondary time-points]
Secondary outcome [7] 393377 0
Emotion and task oriented coping will be assessed using the 21-item Coping Inventory for Stressful Situations (CISS-SF; Cohen et al., 2006)
Timepoint [7] 393377 0
Baseline and 1-, 6-, and 12- months post-baseline [secondary time-points]
Secondary outcome [8] 393378 0
The brief 14-item version of the Mental Health Continuum – Short Form (MHC-SF; Keyes 2005), will assess participants' emotional, psychological and social well-being in the past month.
Timepoint [8] 393378 0
Baseline and 1-, 6-, and 12- months post-baseline [secondary time-points]
Secondary outcome [9] 393379 0
The EUROQoL-5D-5L will measure of quality of life across 5 dimensions – mobility, self-care, usual activities, pain/discomfort and anxiety/depression (Brazier et al., 2019).
Timepoint [9] 393379 0
Baseline and 1-, 6-, and 12- months post-baseline [secondary time-points]
Secondary outcome [10] 393380 0
The 5-item Patient Experiences Questionnaire (PEQ) will be used to collect feedback from the participants about their level of satisfaction with their treatment and to better inform treatment procedures.
Timepoint [10] 393380 0
Baseline and 1-, 6-, and 12- months post-baseline [secondary time-points]

Eligibility
Key inclusion criteria
Inclusion criteria are: i) young people aged 16 to 25 years who have either a) presented to a support service in a Safe Night Precinct (SNP) in past 2 weeks and had >5 drinks or drug use on that night, or b) who have presented to one of the seven participating AOD treatment services; and ii) participants will also be included if they score either = 5 or higher for alcohol use or = 2 or higher on the ASSIST for cannabis or meth use on the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST).
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria are: (i) current high suicide risk (current intent and plan) (ii) current or past history of psychosis (iii) currently in acute alcohol or drug withdrawal, and (iv) have received psychological or pharmacological treatment for a drug or alcohol problem in the previous month.

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)
Centrally randomised by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using a purpose-built trial management website (Goji), which has the capability to grant blinded or unblinded access to the project team as required.
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
We plan to recruit 300 participants over a 12-month period for the randomised controlled trial. We expect a similar number of participants to enrol in the present study as were enrolled for the NHMRC Quikfix project (Hides et al., 2021). As such, we expect to enrol approximately 150 participants in the Assessment Feedback (AF) group and 150 participants in the QuikFix intervention group. According to the Lives Lived Well (LLW) services, more than 50% of their patients are seeking treatment for the first time, and they provide services to approximately 2100 individuals per year. In addition, figures reported for the NHMRC QuikFix trial indicated a total of 1091 patients were referred to that study. Collectively, these data ensure the feasibility of the trial.

All analyses will be conducted on an intention-to-treat basis. Primary analyses will compare the primary and secondary outcomes between the assessment feedback group and the QuikFix intervention group. Due to the small number of clusters, we will employ a fixed effects linear regression model to assess intervention effectiveness. We will include a fixed effect for site for 2 reasons: i) it will account for differences in the average outcome levels across sites; and ii) account for the association between before/after intervention and site specifically related to the design. A continuous time measure will be included to account for secular patterns. All of these analyses will be adjusted for covariates. Bootstrapping will be used to account for any violations in the assumption of normality of residuals.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/05/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 33541 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 308167 0
Government body
Name [1] 308167 0
Department of Health
Country [1] 308167 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] 308937 0
None
Name [1] 308937 0
Address [1] 308937 0
Country [1] 308937 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308152 0
The University of Queensland Research Ethics Committee B [EC00457]
Ethics committee address [1] 308152 0
Level 3
Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072
Ethics committee country [1] 308152 0
Australia
Date submitted for ethics approval [1] 308152 0
21/01/2020
Approval date [1] 308152 0
11/02/2020
Ethics approval number [1] 308152 0
2017001525

Summary
Brief summary
An RCT will be conducted across multiple community AOD services to examine clinical setting implementation and efficacy of the QuikFix risk-targeted intervention for reducing alcohol and other drug use and related harm in young people. The intervention is designed to address how individuals with specific psychological risk factors cope with their susceptibility to AOD misuse, with an intention to change specific AOD-related behaviours. While the efficacy of this risk-targeted intervention has been demonstrated for alcohol, its efficacy for reducing AOD use and related harm when delivered as part of real-world clinical practice is yet to be determined. Participants will be young people aged between 16-25 years, who have recently presented to a support service located at a SNP, festival or schoolies celebration with an AOD-related injury or illness, or to an AOD community service. Participants will be randomised to receive either (i) online assessment with feedback (AF) or (ii) the telephone-delivered risk-targeted QuikFix brief intervention which includes AF, motivational interviewing (MI) and cognitive-behavioural coping skills training.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109714 0
Prof Leanne Hides
Address 109714 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072
Country 109714 0
Australia
Phone 109714 0
+61406185750
Fax 109714 0
Email 109714 0
[email protected]
Contact person for public queries
Name 109715 0
Carol Keane
Address 109715 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072
Country 109715 0
Australia
Phone 109715 0
+61733669643
Fax 109715 0
Email 109715 0
[email protected]
Contact person for scientific queries
Name 109716 0
Carol Keane
Address 109716 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072
Country 109716 0
Australia
Phone 109716 0
+61733669643
Fax 109716 0
Email 109716 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
11152Study protocol  [email protected] Available upon request, post publication.
11153Statistical analysis plan  [email protected] Available upon request, post publication.
11154Informed consent form  [email protected] Available upon request, post publication.
11155Ethical approval  [email protected] Available upon request, post publication.
11156Analytic code  [email protected] Available upon request, post publication.



Results publications and other study-related documents

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