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Trial registered on ANZCTR


Registration number
ACTRN12621000467831
Ethics application status
Approved
Date submitted
12/02/2021
Date registered
20/04/2021
Date last updated
17/06/2024
Date data sharing statement initially provided
20/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the 'First Step' in treatment for individuals seeking substance use interventions
Scientific title
A pilot single arm uncontrolled trial to determine the feasibility of a brief intervention ('First Step') for substance use in adults
Secondary ID [1] 302009 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Substance Use 318568 0
Alcohol use 318569 0
Condition category
Condition code
Mental Health 316584 316584 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
First Step is a co-designed alcohol and drug brief intervention, tailored to meet the specific needs of Lives Lived Well (LLW) clients, based upon motivational interviewing and cognitive behavioural techniques. This was achieved through active consultation with UQ staff and nine LLW counselling staff across multiple LLW programs and regions (including staff from QLD and NSW), managers and upper managers. Components of First Step were adapted from other evidence-based brief interventions, namely the Quikfix intervention (Hides et al., 2020). Program content has been developed so that it can be delivered both face-to-face and over-the-phone.
The First Step brief intervention includes comprehensive materials (e.g., manual, information sheets and worksheets) that have been designed specifically for this study, that can be used by all counsellors; and that have the flexibility that they can be applied to a wide range of presenting client concerns. It is designed to be the first step in a stepped care model of treatment. Therefore, while all clients will have the opportunity to complete the brief intervention, they will also have access to further treatment as needed.
The First Step brief intervention is comprised of three modules delivered over two treatment sessions.
Module 1 - Assessment Feedback/Information: focuses on providing comprehensive personalised feedback to the client based on the LLW outcome measures they were required to complete upon enrolling with LLW for treatment. The areas feedback can be provided for are: 1) Substance use (frequency and amount, and severity and risks for up to three drug types); 2) Mental health (including depression and anxiety, suicide risk, trauma, psychotic symptoms, and gambling); 3) Social and life factors; and 4) Additional factors (including domestic and family violence, violence to others, child safety/protection, justice issues, homelessness, and chronic pain). Substance use, depression and anxiety, and social and life factors are discussed with every client. The remaining areas are only discussed if the outcome measures indicate this is an area of concern for the client. Psychoeducation is then offered to the client using relevant substance-related fact sheets and information sheets on common comorbid conditions. This information will be discussed with the client in session and/or emailed to the client after the session.
Module 2 – Motivational Interviewing: focuses on motivational enhancement and goal setting. Motivational interviewing techniques are used to build motivation and commitment to change. The client’s patterns of substance use are first explored, and, the pros and cons of making a change/not making a change in their substance use are discussed. Options for change (reduce substance use or the potential harm associated with use) are then explored. These MI techniques are supported by information sheets and worksheets, to be completed during the session. The module ends with the client setting a substance-related goal using an implementation intention framework, a technique based on the Theory of Planned Behaviour. The intent is for the goal to be very simple and specific, and able to be achieved in the next week, to build the client’s self-efficacy. The goal comprises of three core elements: 1) When the goal will be executed (it is important this is a specific day/time, and if appropriate within a specific location); 2) How the goal can be accomplished – the client is provided with one or two simple strategies to help them achieve their goal; and 3) what the goal is. The client is asked to rate their level of confidence (1-10) in achieving their goal and they identify and address any potential impediments. The goal and additional resources are emailed to the client at the end of the session.

Module 1 and 2 are usually delivered in one session.

Module 3 – Targeted Coping Skills Training: explores risk profiles, based on client’s scores on the S-UPPS which is completed with the LLW outcome measures, which may underlie the client’s substance use behaviours. The risk profile is discussed with the client and then training is provided in 2-3 coping strategies to target the profile. If the risk profile identified is negative urgency – anxiety prone, the coping strategies include belly breathing; mind chill – based on the thought diffusion techniques from Acceptance and Commitment Therapy; and urge surfing from unpleasant emotions, which encourages clients to notice their unpleasant emotions and accept their urge or impulse, recognising that it will pass. For the risk profile negative urgency – depression prone, the coping strategies include good vibes, which focuses on evidence-based behavioural activation strategies; three good things, which encourages clients to identify three good things that happened during the day; mind change, based on CBT techniques to reframe negative thoughts; and urge surfing from unpleasant emotions. The coping skills for the impulsivity profile include Stop-Think-Do, to help them slow down their decision making processes; urge surfing, which focuses on noticing and accepting their urge or impulse rather than emotion; and Breathe-Ground-Centre-Focus to encourage staying in the present moment. Those high in sensation seeking 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). Those with the positive urgency risk profile are also trained in savouring techniques and urge surfing, and they work through the coping strategy fun finder, which encourages them to identify and schedule substance-free activities which bring them positive reinforcement. For clients with the final profile of lack of perseverance, they are taken through an activity to help them identify their values or purpose, and then goal setting activities to help them live in line with their identified values. The session ends with the client setting a second substance use goal which incorporates coping, using an implementation intention framework. There are accompanying worksheets to assist clients to complete and practice their relevant coping strategies. These are designed to be completed in session, which the client can then take home to use as a reference.

The intervention is designed to be delivered in 2 50-60 minute sessions. Ideally these sessions would occur in consecutive weeks after the completion of baseline measures. However, due to counsellor caseloads and allowing for non-attendance and rescheduled sessions, it is likely the intervention will be delivered over 4-6 weeks after baseline completion.

The intervention will be delivered by all LLW counsellors at the implementation site. The counsellors will receive training in the First Step intervention and are also supported by an intervention manual. They will receive one full day of training as a whole group, followed by ongoing, fortnightly training in smaller groups before the trial commences, which will then become ongoing, individual supervision for the duration of the trial.

At the end of each session, counsellors complete a checklist to indicate which components of the intervention they delivered. Treatment sessions will also be audio-recorded and a random selection will be reviewed to check treatment fidelity.
Intervention code [1] 318302 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324834 0
Level of substance use and related problems through a composite score on the Alcohol, Smoking and Substances Involvement Screening Test (WHO ASSIST)
Timepoint [1] 324834 0
Baseline, and 1, 3, and 6 months post-baseline
Primary outcome [2] 324835 0
Past 4 week frequency and typical quantity of substance use as measured by the Australian Treatment Outcome Profile (ATOP)
Timepoint [2] 324835 0
Baseline and 1, 3, and 6 month post-baseline
Secondary outcome [1] 385884 0
Depression symptom severity, measured using the Patient Health Questionnaire (PHQ-9)
Timepoint [1] 385884 0
Baseline, and 1, 3, and 6 months post-baseline
Secondary outcome [2] 385885 0
Anxiety severity, measured using the Generalized Anxiety Disorder scale (GAD-7)
Timepoint [2] 385885 0
Baseline, and 1, 3, and 6 months post-baseline
Secondary outcome [3] 385886 0
Quality of life/functioning will be explored using the LLW quality of life measures (which are based on the ATOP and the BTOM).
Timepoint [3] 385886 0
Baseline, and 1, 3 and 6 months post-baseline

Eligibility
Key inclusion criteria
- Aged over 18 years
- Participants seeking help for their AOD use from participating Lives Lived Well Services;
- Completion of LLW baseline Outcome Measures suite.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
To ensure maximum representativeness of the sample, besides age, there is no other exclusion criteria.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: We will be aiming to recruit 400 participants in the feasibility study. Sample size calculations were conducted using G*Power, using an a error level of 0.01. With this sample size we will have 95% power to detect small to medium effects (0.25), accounting for multiple analyses and a retention rate of 60% at the 6-month follow-up (based on existing trials).

Statistical Methods:
Preliminary logistic regressions will be undertaken to check for baseline differences on demographic, primary and secondary outcomes. A similar analysis will be conducted to detect differences between those with missing data, and those without, on key baseline demographic and outcome variables. Any significant differences will be reported and controlled for wherever possible, to control for sampling bias and completion bias. To determine whether there are time effect improvements in primary and secondary outcomes post treatment (1 month), 3 and 6 months follow up will be compared to baseline, using a series of repeated measures analyses of variance. This technique can also control for potential confounds (e.g. demographic characteristics, baseline factors). Intent to treat analyses will be performed, with all participants included in analyses, regardless of whether they withdraw from the treatment program, or did not complete all follow-up assessments.
Outcome success will be determined by examining the significant difference in scores from baseline to each of the follow-up points, as well as whether the effect size is small (0.2), moderate (0.5) and strong (0.8) depending on the value of cohen’s d.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/11/2020
Date of last participant enrolment
Anticipated
30/06/2021
Actual
30/11/2021
Date of last data collection
Anticipated
31/12/2021
Actual
22/12/2022
Sample size
Target
418
Accrual to date
Final
418
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 31000 0
4506 - Morayfield
Recruitment postcode(s) [2] 31001 0
4020 - Redcliffe
Recruitment postcode(s) [3] 31002 0
4500 - Strathpine

Funding & Sponsors
Funding source category [1] 306430 0
Government body
Name [1] 306430 0
Australian Government Department of Health
Country [1] 306430 0
Australia
Funding source category [2] 307860 0
Charities/Societies/Foundations
Name [2] 307860 0
Lives Lived Well
Country [2] 307860 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] 306945 0
None
Name [1] 306945 0
Address [1] 306945 0
Country [1] 306945 0
Other collaborator category [1] 281433 0
Charities/Societies/Foundations
Name [1] 281433 0
Lives Lived Well
Address [1] 281433 0
Level 1/Boundary Court,
55 Little Edward Street,
Spring Hill, Brisbane.
Queensland 4000
Country [1] 281433 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306638 0
University of Queensland HREC
Ethics committee address [1] 306638 0
Ethics committee country [1] 306638 0
Australia
Date submitted for ethics approval [1] 306638 0
23/06/2020
Approval date [1] 306638 0
10/09/2020
Ethics approval number [1] 306638 0
2020001448

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

Contacts
Principal investigator
Name 104514 0
Prof Leanne Hides
Address 104514 0
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Country 104514 0
Australia
Phone 104514 0
+61 7 336 56398
Fax 104514 0
Email 104514 0
l.hides@uq.edu.au
Contact person for public queries
Name 104515 0
Leanne Hides
Address 104515 0
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Country 104515 0
Australia
Phone 104515 0
+61 7 336 56398
Fax 104515 0
Email 104515 0
l.hides@uq.edu.au
Contact person for scientific queries
Name 104516 0
Leanne Hides
Address 104516 0
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Country 104516 0
Australia
Phone 104516 0
+61 7 336 56398
Fax 104516 0
Email 104516 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 of the de-identified baseline and follow up data collected
When will data be available (start and end dates)?
Anticipated start date: Jan 2023
End date: ongoing
Available to whom?
Individual researchers with the approval of the chief investigators
Available for what types of analyses?
Replication; moderation/mediation, cost effectiveness analysis
How or where can data be obtained?
via University of Queensland Research Data Management System website
https://rdm.uq.edu.au/


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8877Study protocol  l.hides@uq.edu.au 380364-(Uploaded-12-02-2021-12-15-04)-Study-related document.docx
8878Informed consent form  l.hides@uq.edu.au 380364-(Uploaded-12-02-2021-12-20-37)-Study-related document.docx
8879Ethical approval  l.hides@uq.edu.au 380364-(Uploaded-12-02-2021-12-21-32)-Study-related document.pdf



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.