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Trial registered on ANZCTR


Registration number
ACTRN12618001010280
Ethics application status
Approved
Date submitted
13/06/2018
Date registered
15/06/2018
Date last updated
15/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation and effectiveness of an early intervention program (QuikFix) for young people experiencing alcohol and other drug-related harm
Scientific title
A randomised controlled trial of a risk-targeted early intervention program (QuikFix) for reducing alcohol and other drug use and related harm in young people
Secondary ID [1] 293121 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol use 305076 0
Cannabis use 305078 0
Methamphetamine use 308350 0
Condition category
Condition code
Mental Health 304394 304394 0 0
Addiction
Injuries and Accidents 304395 304395 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Approximately 50% of the alcohol and drug clinicians (n = 10) across seven sites will be trained in the risk-targeted QuikFix intervention. The 1-day training (8 hours) will involve a face to face group workshop facilitated by 1 experienced clinical psychologist and 2 psychologists. It will be delivered twice, with smaller groups of clinicians (approximately 5 clinicians). The training will cover (1) a refresher of motivational interviewing, assessment feedback, and psychoeducation, (2) developing a QuikFix plan targeted to personality styles, (3) effectively using the telehealth model of QuikFix (phone intervention and 'Clinical Companion' website), and (4) integrating QuikFix into clinical practice.

Participants randomly assigned to clinician will receive either personalised assessment and feedback via email and usual care, or 2-3 sessions of the telephone-delivered QuikFix intervention using the e-QuikFix 'Clinical Companion' website.

(i) Brief Risk-Targeted QuikFix Intervention: The Brief Risk-Targeted QuikFix intervention involves a psychological risk-targeted assessment and feedback, motivational interviewing, and cognitive-behavioural coping skills training components. These are delivered over the phone and using a e-QuikFix ‘Clinician Companion’ website. The intervention is designed to target how individuals with specific psychological risk factors cope with their vulnerability to alcohol and other drug (AOD) use. It is not intended to change these risk factors, but to alter specific alcohol and other drug-related behaviours.

In Session 1, participants are given personalised assessment and feedback via email, which not only includes a focus on alcohol or drug use, but also includes psychoeducation about their dominant psychological risk factor (anxiety proneness, depression proneness, impulsivity, or sensation seeking), associated problematic coping behaviors (e.g. avoidance, aggression, risky behaviors), and how this may affect their alcohol and other drug use. Using an motivational interviewing style and the e-QuikFix ‘Clinician Companion’ website, therapists guide individual exploration of the personal relevance of these issues using the e-companion tool. Participants are given information on alcohol or other drug harm minimisation 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 them accessing support care services. 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 AOD 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 are emailed a session summary and a brief SMS message as a reminder. The plan and additional resources are emailed to young people at the end of the session.

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. They then receive risk-targeted training in two cognitive behavioural coping skills guided by the e-QuikFix ‘Clinician Companion’ website. Those predominantly with anxiety proneness are given training in mindful breathing and thought awareness and acceptance training for anxious thoughts. Individuals high in depression proneness receive behavioural activation and thought awareness and acceptance training for depressive thoughts. Sensation seekers receive training in savouring techniques to increase their awareness and ability to focus on and experience positive feelings from everyday activity (e.g. mindful eating) and 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 mindfulness training to increase awareness of their thoughts and are encouraged to apply the Stop-Think-Do rubric to help them slow down their decision-making processes sufficiently to consider likely outcomes of behavioural alternatives. Session 2 concludes with participants developing an implementation intention for future alcohol or other drug-related situations, which incorporates their specific coping skills. They are encouraged to rehearse this plan in session, and identify and address potential impediments. A session summary of their QuikFix plan is subsequently sent via email as well as the coping tools. Finally, the clinician then makes 2 brief phone calls (maximum 30 minutes) at 2 months post-baseline to check in with the young person and remind them of session content. The 2 sessions are designed to be delivered over a period of 2 weeks, however, the sessions can be delivered over a maximum of 4 weeks as flexibility in the implementation of these sessions is considered important as the intervention is being delivered in a clinical setting.
Intervention code [1] 299363 0
Treatment: Other
Comparator / control treatment
(ii) Assessment Feedback and Information (AF) and usual care: Participants receive personalised assessment feedback on their alcohol and other drug use and related physical, psychological and social consequences sent to them via email. The participants will also receive usual care as delivered by the clinicians which includes case management strategies and individualised strategies to reduce harm associated with alcohol and drug use.
Control group
Active

Outcomes
Primary outcome [1] 303633 0
Alcohol specific involvement score from the Alcohol and other drug use (WHO Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Timepoint [1] 303633 0
6 weeks, and 3 [primary timepoint], 6, and 12 months post-baseline
Primary outcome [2] 303634 0
Amphetamine specific involvement score from the Alcohol and other drug use (WHO Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Timepoint [2] 303634 0
6 weeks, and 3 [primary timepoint], 6, and 12 months post-baseline
Primary outcome [3] 306311 0
Cannabis specific involvement score from the Alcohol and other drug use (WHO Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Timepoint [3] 306311 0
6 weeks, and 3 [primary timepoint], 6, 12 months post-baseline
Secondary outcome [1] 339715 0
Psychological risk: (Patient Health Questionnaire (PHQ-9), Reinforcement Sensitivity Theory of Personality Questionnaire (RST-PQ), Generalised Anxiety Disorder 7-item (GAD-7) scale, the 6-item physical subscale of the Anxiety Sensitivity Index, and Behavioral Inhibition and Behavioral Activation Survey (BIS-BAS), SHORT UPPS-P (Cyders et al., Addictive Behaviors, 2014).
Timepoint [1] 339715 0
6 weeks, and 3, 6 and 12 months post baseline
Secondary outcome [2] 339716 0
Self Efficacy and Confidence: Drug Taking Confidence Questionnaire (DTCQ-8)
Timepoint [2] 339716 0
6 weeks, and 3, 6 and 12 months post baseline
Secondary outcome [3] 339721 0
Drug Use Motives Questionnaire modified from the Drinking Motives Questionnaire (excluding social conformity sub scale)
Timepoint [3] 339721 0
6 weeks, and 3, 6 and 12 months post baseline
Secondary outcome [4] 339723 0
Difficulties in Emotion Regulation Scale-Short Form
Timepoint [4] 339723 0
6 weeks, and 3, 6 and 12 months post baseline
Secondary outcome [5] 339724 0
Client Service Receipt Inventory (CSRI; Beecham & Knapp, 2001)
Timepoint [5] 339724 0
6 weeks, and 3, 6 and 12 months post baseline
Secondary outcome [6] 347974 0
Pain & Injury: Pain NRS and pain items based on the IASP recommendations and the RAPI
Timepoint [6] 347974 0
6 weeks, and 3, 6, 12 months post-baseline
Secondary outcome [7] 347979 0
Implementation Survey (adapted from Skoien, Page, Parsonage, Ashover, Milburn, & Cullen, 2016)
Timepoint [7] 347979 0
2 and 6 months post-baseline
Secondary outcome [8] 348149 0
Coping Inventory for Stressful Situations (CISS)
Timepoint [8] 348149 0
6 weeks, 3, 6, 12 months post-baseline
Secondary outcome [9] 348151 0
Confidence in MI and CBT survey (adapted from Petrova et al., 2015)
Timepoint [9] 348151 0
2 and 6 months post-baseline
Secondary outcome [10] 348153 0
uMARS to assess the e-QuikFix ‘Clinician Companion’ program,
Timepoint [10] 348153 0
2 and 6 months post-baseline
Secondary outcome [11] 348154 0
Technology Acceptance Model Perceived Usefulness and Ease of Use survey (Davis, Bagozzi, & Warshaw, 1989)
Timepoint [11] 348154 0
2 and 6 months post-baseline
Secondary outcome [12] 348155 0
Computer Self-efficacy and Anxiety survey (Richardson & Tan, 2005)
Timepoint [12] 348155 0
2 and 6 months post-baseline
Secondary outcome [13] 348156 0
7 subscales of the Work Practices Questionnaire
Timepoint [13] 348156 0
2 and 6 months post-baseline
Secondary outcome [14] 348157 0
Assessment of Quality of Life-6D (AQoL-6D)
Timepoint [14] 348157 0
6 weeks, 3, 6, 12 months post-baseline

Eligibility
Key inclusion criteria
Inclusion criteria are young people aged 16 to 25 years who have either 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 have presented to one of the seven participating AOD treatment services. 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).

Inclusion criteria for clinicians are clinicians working as health professionals at a Lives Lived Well Service that is a participating site in the study.
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

There are no exclusion criteria for the clinicians involved in this study.

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)
Randomisation will occur at the clinician level. Young people are first referred to one of the seven treatment sites according to their home postcode. They are then randomised to clinician by the Team Leaders using one of seven site-specific pre-allocation sequence (stratified by the full time equivalent (FTE) status of each clinician in the respective site plus 0.05 FTE of research psychologists at each site). If the first clinician the young person is randomised to is not available, then they are randomised to a second clinician in the same site. The Team Leader is blind to the clinician allocation until they enter the young person’s ID number into an excel spreadsheet. The second clinician allocation is only revealed when the Team Leader indicates the first clinician is unavailable. The allocation is communicated to the clinician within 48 hours of randomisation. Allocation will also be communicated to the research psychologists who will be supporting the clinicians with implementation. The research assistant conducting the follow up assessments will remain blind to clinician allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Two computerised random number sequences were generated for each of the seven treatment sites. This enabled the young person to be randomised to a second clinician in the same site, if the first clinician they were randomised to is not available. Both random allocation sequences were stratified by the FTE status of the treating clinicians at each site.
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
Clinicians who are not initially trained in the QuikFix intervention will be offered training once data collection has been completed.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be conducted on an intention-to-treat basis. Primary analyses will compare the primary and secondary outcomes between the assessment feedback and usual care group and the QuikFix intervention group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/06/2018
Actual
Date of last participant enrolment
Anticipated
21/12/2018
Actual
Date of last data collection
Anticipated
21/12/2019
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 17822 0
4000 - Brisbane
Recruitment postcode(s) [2] 17823 0
4220 - Burleigh
Recruitment postcode(s) [3] 17824 0
4217 - Surfers Paradise
Recruitment postcode(s) [4] 17825 0
4006 - Fortitude Valley
Recruitment postcode(s) [5] 17826 0
4207 - Beenleigh
Recruitment postcode(s) [6] 17827 0
4510 - Caboolture
Recruitment postcode(s) [7] 17828 0
4020 - Redcliffe
Recruitment postcode(s) [8] 17829 0
4500 - Strathpine
Recruitment postcode(s) [9] 17830 0
4508 - Deception Bay
Recruitment postcode(s) [10] 17832 0
4133 - Chambers Flat
Recruitment postcode(s) [11] 17833 0
4211 - Nerang

Funding & Sponsors
Funding source category [1] 297747 0
Government body
Name [1] 297747 0
Department of Health
Country [1] 297747 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] 296785 0
None
Name [1] 296785 0
Address [1] 296785 0
Country [1] 296785 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298810 0
The University of Queensland Research Ethics Committee B [EC00457]
Ethics committee address [1] 298810 0
Level 3, Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072
Ethics committee country [1] 298810 0
Australia
Date submitted for ethics approval [1] 298810 0
10/10/2017
Approval date [1] 298810 0
13/11/2017
Ethics approval number [1] 298810 0
2017001525

Summary
Brief summary
The overall aim of this study is to determine the clinical utility, efficacy and cost-effectiveness of the QuikFix risk-targeted brief intervention for reducing Alcohol and Other Drug (AOD) use and related harm when delivered by AOD workers in real world settings. In Part 1, a RCT design will be used to randomise young people aged 16-25 years to clinicians who have been trained or not trained in the QuikFix intervention. Clinicians trained in QuikFix will deliver 2-4 telephone sessions of QuikFix using the 'Clinician Companion' website, with sessions including assessment feedback (AF), motivational interviewing and cognitive behavioural coping skills training, while clinicians who aren't trained will deliver assessment feedback (AF) and usual AOD care. Participants' AOD use and related harm, mental distress, and functional outcomes will be assessed at baseline, and at 6 weeks, 3, 6 and 12 month follow-ups. In Part 2, an evaluation of the implementation and supervision program as well as the e-QuikFix ‘Clinician Companion’ website which will support clinicians to implement the program will be conducted.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78298 0
Prof Leanne Hides
Address 78298 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072
Country 78298 0
Australia
Phone 78298 0
+61406185750
Fax 78298 0
Email 78298 0
[email protected]
Contact person for public queries
Name 78299 0
Leanne Hides
Address 78299 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072
Country 78299 0
Australia
Phone 78299 0
61406185750
Fax 78299 0
Email 78299 0
[email protected]
Contact person for scientific queries
Name 78300 0
Rachel Elphinston
Address 78300 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072
Country 78300 0
Australia
Phone 78300 0
+61412662084
Fax 78300 0
Email 78300 0
[email protected]

No information has been provided regarding IPD availability


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.

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