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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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

N/A

Health condition

Health condition(s) or problem(s) studied:

Alcohol Use

Tobacco Use

Drug Use

Condition category

Condition code

Mental Health

Addiction

Injuries and Accidents

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]

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]

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]

Baseline and 1-, 3- [primary timepoint], 6-, and 12- months post-baseline

Primary outcome [2]

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]

Baseline and 1-, 3- [primary timepoint], 6-, and 12- months post-baseline

Primary outcome [3]

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]

Baseline and 1-, 3- [primary timepoint], 6-, and 12- months post-baseline

Secondary outcome [1]

Psychological risk will be assessed using the Patient Health Questionnaire (PHQ-9; Kroenke et al., 2014);

Timepoint [1]