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Trial registered on ANZCTR


Registration number
ACTRN12624001460594p
Ethics application status
Submitted, not yet approved
Date submitted
26/11/2024
Date registered
16/12/2024
Date last updated
16/12/2024
Date data sharing statement initially provided
16/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Can peer-workers help those leaving residential addiction treatment improve their recovery by planning and setting goals based on recovery strengths and weaknesses?
Scientific title
The effectiveness of a recovery capital (REC-CAP) facilitated, continuing care intervention, led by peer workers on improving recovery capital after discharge from residential Alcohol and Other Drug treatment: A pilot study
Secondary ID [1] 313128 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Addiction 335390 0
Condition category
Condition code
Mental Health 331962 331962 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of intervention
Intervention title: Peer Facilitated REC-CAP Continuing Care

Overview
The intervention is a model of continuing care for people discharged from inpatient addiction treatment. The intervention uses a validated assessment tool to assess recovery capital called REC-CAP (short for RECovery CAPital), which highlights participants' recovery strengths and weaknesses. The REC-CAP output will be used by Lived Experience Workers (LEWs) to plan goals that aim to build recovery capital. Goals follow the SMART goal format.

Materials

REC-CAP: This tool is a battery of questionnaires. It includes;
1. Assessment of Recovery Capital (ARC; Groshkova et al., 2013)
2. Quality of Life: World Health Organisation’s quality of life assessment (WHOQL-BREF; Skevington, Lofty, O’Connell, 2004)
3. Barriers to recovery: Five ‘Barriers to recovery’ adapted from the TOP (Delgadillo et al., 2013): (1) Accommodation risk, assessed by a composite of perceived risk of eviction and acute housing problems in the last three months; (2) any substance use in the past 90 days; (3) any risk taking i.e. drug injecting; (4) any involvement with the criminal justice system (offending); (5) lack of meaningful activities (training or employment)
4. Meaningful activities: Meaningful activities, adapted from the Treatment Outcome Profile (TOP; Delgadillo et al., 2013): 1) Are you currently working?, 2) Are you currently volunteering?
5. Recovery Group Participation Scale (RGPS; Groshkova et al., 2011)
6. Commitment to Sobriety Scale (CSS; Kelly and Green 2014)
7. Social Support Scale (Jetten et al., 2011)
8. Service involvement needs: Developed for the REC-CAP that asks “Do you need help or additional help with:”
1) AOD treatment Yes/No
2) Mental health Yes/No
3) Housing support Yes/No
4) Employment Yes/No
5) Primary healthcare (GP, medical services) Yes/No
6) Family relationships Yes/No
7) Other specialist help/support (please specify) Yes/No

Training/support materials to aid LEWs in delivering the intervention: a) Information handout on what to do with each barrier, b) information on the intervention process, c) information on SMART goals, d) information on available services for referral, e) training day slide pack.

Procedures
Training and support – LEWs attended a 5 hour workshop prior to beginning the intervention, covering several topics (background in recovery capital, introduction to REC-CAP including questions and interpretation of output, goal setting, what to do with different REC-CAP profiles, role play, the role of peers, follow-up sessions, and the intervention process). Take home materials are provided (see materials). In addition to initial training, LEWs attend fortnightly check-ins (between 10 to 30 minutes) with the research team that aim to ensure the LEWs are completing the intervention properly. LEWs also complete a spreadsheet with details of client interactions (attendance, session length, cancelations) that can be checked by the research team before team check-in calls to ensure LEWs are adhering to the intervention process. During the LEW check-in calls, the facilitator will ask LEWs about various aspects of the intervention including translating REC-CAP output to SMART goals. LEWs will be reminded of the take home materials especially : a) What to do with each barrier, and b) intervention process.

Intervention
Baseline (between 45 and 90 minutes) - LEWs meet with participants in person to conduct the baseline session. This involves 1) building rapport, 2) completing the REC-CAP, 3) goal setting, 4) arranging the follow-up sessions.
Participant fortnightly check-in calls (between 5 and 30 minutes) – This involves short calls to the participants made by LEWs. The call is aimed at 1) reminding participants of their goals, 2) seeing how participants are going with recovery and their goals.
Follow-up (between 30 to 60 minutes) – A 4-week follow up session is conducted in-person by an LEW. This involves 1) maintaining rapport, 2) completing the REC-CAP, 3) reflecting on REC-CAP scores now compared to baseline, 4) reflecting on goal progress, 5) updating goals.
Fortnightly calls continue aimed at 1) reminding participants of their goals, 2) seeing how participants are going with recovery and their goals, 3) updating goals where necessary.
The final fortnightly call (at 12-weeks - 10 to 60 minutes) will be focused on 1) reflect and review, 2) celebrate achievements, 3) closure.

A 12-week follow-up session is completed by a researcher to collect REC-CAP only (approx. 30 min). Six month and 12-month follow-ups are also completed by a researcher. (approx. 30 min) These follow-ups are not part of the intervention.
Goal setting will often include linkage to services, groups, or activities that are identified as a barrier during the REC-CAP assessment and/or issues that the participant wishes to address. For example, linkage to Alcoholics Anonymous, financial support services, or employment services. The process of linking participants to services involves identifying the service, providing details (e.g. phone number/address), and creating SMART goals (e.g. attending a particular alcoholics anonymous meeting a particular number of times).

Who, when and how
The intervention will be delivered by Lived Experience Workers (LEWs), defined in this project as people who have personal experience of recovery from addiction, and training, and have been hired into formal “lived experience” roles. The intervention will begin with a baseline session (see intervention procedures) delivered to patients in residential addiction treatment during their stay, in-person (face-to-face), at the residential facility, after the participant has been in the program for at least 5 days. Fortnightly calls will be made to the participant by the LEWs over the phone between baseline and 12-week follow up. The 4-week follow-up is conducted by LEWs, in-person, in a building located near the residential treatment facility. The intervention finishes after 12-weeks and the 12 week follow up is not part of the intervention (this will be done by a researcher and only involves data collection – no goal setting ). Six and 12-month follow-ups are also completed by a researcher.


Intervention code [1] 329704 0
Behaviour
Comparator / control treatment
Participants will be randomised to the intervention group (Peer Facilitated REC-CAP Continuing Care) or REC-CAP Feedback (control) group.
Participants in the REC-CAP Feedback group complete the measures within REC-CAP with a researcher (30 to 60 minutes), and are provided with feedback only at baseline. Sessions with the researcher will not involve any recovery planning.
Feedback consists of a printout of participants' overall recovery capital score and colour coded sub-categories of recovery capital that indicate how well the participant is doing in each area of recovery.

The control group will complete the same follow-up outcome measures as the intervention group with a researcher at 12 weeks, 6 months, and 12 months (approximately 30 to 60 minutes).
Control group
Active

Outcomes
Primary outcome [1] 339572 0
Overall Recovery Capital (RCI)
Timepoint [1] 339572 0
Baseline, 12-week follow up (post intervention), 6-month, 12-month
Secondary outcome [1] 440471 0
Simple Recovery Capital (ARC)
Timepoint [1] 440471 0
baseline, 12-week follow up, 6 month follow-up, and 12 month follow-up
Secondary outcome [2] 440473 0
Return to residential AOD treatment
Timepoint [2] 440473 0
12-week follow up, 6 month follow-up, and 12 month follow-up
Secondary outcome [3] 440478 0
Acceptability of the intervention to participants
Timepoint [3] 440478 0
After they have completed a full 12 week intervention
Secondary outcome [4] 440479 0
Acceptability of the intervention to LEWs
Timepoint [4] 440479 0
After they have delivered a full 12 week intervention

Eligibility
Key inclusion criteria
Inclusion criteria:
-Currently receiving residential inpatient AOD treatment
-Completed at least five days at inpatient facility
-Able to provide consent to contact details to research team
-Age 18+ years
-Sufficient English literacy
-Plan to be discharged to independent living in the community only
-Be interested in trialling a peer-supported intervention to assist with recovery planning
-Be able to attend in-person follow-ups
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Plan to be discharged to longer-term residential inpatient treatment

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)
Eligibility is determined before allocation. Thus, the person assessing eligibility is unaware of allocation at the time of conducting the eligibility assessment.
Allocation is done by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification will be done for gender (male/female), with non-binary participants randomly allocated without stratification. Stratification will also be done for the primary drug of concern (alcohol/other drugs). Randomisation will employ a computer-generated random sequence to allocate participants to either the control or intervention group within each stratum. This ensures that each group will have relatively even numbers of males and females, as well as even numbers of participants who select alcohol as their primary drug of concern and those who select other drugs.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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
Statistical methods (primary outcome)
A linear mixed model with a group and time interaction will be used to compare changes in recovery capital score from baseline to 12-week follow-up (primary outcome).

Power analysis
A required sample of 80 participants was calculated using power analysis and allowing for attrition. A total sample of 54 participants is required to detect an effect size of .25, at an alpha of .05, and a power of .95.

Statistical analysis (secondary outcomes)
A linear mixed model with a group and time interaction will be used to compare changes in secondary outcome scores (e.g. ARC) from baseline to 12-week follow-up. Additionally, the same will be done to test the primary outcome measure and secondary measures at different time points (6 month and 12 month).


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/01/2025
Actual
Date of last participant enrolment
Anticipated
24/11/2025
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317575 0
Commercial sector/Industry
Name [1] 317575 0
HCF Research Foundation
Country [1] 317575 0
Australia
Primary sponsor type
Individual
Name
Dan Lubman (Eastern Health)
Address
Country
Australia
Secondary sponsor category [1] 319880 0
None
Name [1] 319880 0
Address [1] 319880 0
Country [1] 319880 0
Other collaborator category [1] 283250 0
Hospital
Name [1] 283250 0
Eastern Health
Address [1] 283250 0
Country [1] 283250 0
Australia
Other collaborator category [2] 283251 0
University
Name [2] 283251 0
Monash University
Address [2] 283251 0
Country [2] 283251 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316281 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 316281 0
Ethics committee country [1] 316281 0
Australia
Date submitted for ethics approval [1] 316281 0
18/07/2024
Approval date [1] 316281 0
Ethics approval number [1] 316281 0

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

Contacts
Principal investigator
Name 137382 0
Dr Ariel Dart Roxburgh
Address 137382 0
Turning Point, 110 Church St. Richmond, Victoria, 3121
Country 137382 0
Australia
Phone 137382 0
+61 384138666
Fax 137382 0
Email 137382 0
ari.roxburgh@monash.edu
Contact person for public queries
Name 137383 0
Ariel Dart Roxburgh
Address 137383 0
Turning Point. 110 Church St. Richmond, Victoria, 3121
Country 137383 0
Australia
Phone 137383 0
+61 384138666
Fax 137383 0
Email 137383 0
ari.roxburgh@monash.edu
Contact person for scientific queries
Name 137384 0
Ariel Dart Roxburgh
Address 137384 0
Turning Point. 110 Church St. Richmond, Victoria, 3121
Country 137384 0
Australia
Phone 137384 0
+61 384138666
Fax 137384 0
Email 137384 0
ari.roxburgh@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Non-aggregate data will not be released as it is believed that this may hinder recruitment. The idea that participant data will be published publicly, even if de-identified, may deter people from participating.


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.