Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001150437p
Ethics application status
Not yet submitted
Date submitted
18/08/2016
Date registered
24/08/2016
Date last updated
24/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Increasing retention in an alcohol and other drug therapeutic community: The potential role of Motivational Interviewing.
Scientific title
Increasing retention in an alcohol and other drug therapeutic community: The potential role of Motivational Interviewing.
Secondary ID [1] 289948 0
Nil known
Universal Trial Number (UTN)
U1111-1185-2754
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment retention for Substance Use Disorder 299932 0
Condition category
Condition code
Mental Health 299831 299831 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study 1

Design:
This study will be a retrospective analysis of patterns of attrition, derived from data gathered from client records.

Procedure:
Study one will entail gathering data from the Odyssey House client database for admissions to the programme during the twelve months 1st August, 2014 to 31st July, 2015. Variables gathered will be: date of admission; date of discharge; whether the client was mandated to attend Odyssey, or attended on a voluntary basis; which level in the programme the client had attained on discharge, including how long they had been in that level. In addition, various demographic data such as age, ethnicity, comorbid mental health diagnoses, primary substance/s of abuse, and whether or not the client had undergone prior treatment for SUD will be collected for descriptive purposes.

Study 2

Design:
This study will use a single case experimental design, using non-concurrent multiple baseline, and repeated measures.

Participants:
Participants will be clients at Odyssey House (either newly admitted, or at a later stage of the programme dependant on the timing of the MI intervention as informed by the results of Study 1 over a 4-5-week period. A maximum of 10 participants will be required; however, a minimum of 5 participants will be acceptable to get robust results. As the research will be utilising a single case experimental design with multiple baseline and repeated measures, each participant will serve as their own control. Participants will be given a supermarket voucher to the value of $10 at completion of both the pre- and post- MI psychometrics.

Procedure:
For Study 2, participants will be drawn from clients at Odyssey House. The clients will be either newly admitted to Odyssey House, or will be at a stage in treatment congruent with the findings from Study 1. All participants, regardless of the timing of the MI, will receive two MI for engagement, or MI for continuing engagement and adherence sessions, delivered by Odyssey House client keyworkers who will be trained in MI. Each MI session will be approximately 40-60 minutes duration. To ensure competence and MI integrity, MI sessions will be audio recorded. An experienced member of the Motivational Interviewing Network of Trainers will use the Motivational Interviewing Treatment Integrity (MITI) 4.2.1 scale to code the first MI session from each keyworker, then each week one recorded session will be randomly chosen for further coding. This will mean that approximately 50% of all recorded sessions will be coded for competence and integrity.

Should the results of Study 1 indicate that MI for engagement may be more beneficial for retention during the initial involvement with the programme, the first session will be delivered at the end of the first week of residence, and the second session at the end of the second week of residence. However, should the results of Study 1 indicate that MI for continuing engagement and abstinence may be more beneficial later in the programme, the sessions will be timed accordingly to target the period of most potential impact. Thus, the timing of the MI for continuing engagement and abstinence will only be determined once the results of Study 1 are known and will be informed by these results.
Intervention code [1] 295633 0
Treatment: Other
Intervention code [2] 295634 0
Lifestyle
Intervention code [3] 295635 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299309 0
Change in client retention as assessed by monitoring of length of time each participant remains in programme
Timepoint [1] 299309 0
Outcome will be assessed on the date that the client leaves the programme.
Secondary outcome [1] 326814 0
Measurement of motivation for change by using The Change Questionnaire
Timepoint [1] 326814 0
Daily for three weeks, used as baseline. First week will be prior to first MI session, second week will be between first and second MI session, third week will be immediately after second MI session.
Secondary outcome [2] 326945 0
Measure change in readiness for change and treatment by using the SOCRATES questionnaire
Timepoint [2] 326945 0
Pre- and Post- each MI session
Secondary outcome [3] 326946 0
Measure therapeutic alliance by using WAI-SR
Timepoint [3] 326946 0
Pre- and post- each MI session
Secondary outcome [4] 326989 0
Measure readiness for treatment using the Readiness Ruler
Timepoint [4] 326989 0
Daily for three weeks. First week is immediately prior to first MI session, second week is between first and second MI session, third week is immediately post second MI session.

Eligibility
Key inclusion criteria
Participants will be clients at Odyssey House, Christchurch. Inclusion criteria will be in accordance with the results of study one, and will include either all new admissions to the programme, or all clients that reach the time point of vulnerability further on in the programme.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 8107 0
New Zealand
State/province [1] 8107 0
Canterbury

Funding & Sponsors
Funding source category [1] 294328 0
University
Name [1] 294328 0
University of Canterbury
Country [1] 294328 0
New Zealand
Primary sponsor type
Individual
Name
Jo Willcocks
Address
Psychology Masters Student
c/- Department of Psychology
University of Canterbury
Clyde Road
Ilam, Christchurch, 8041
Country
New Zealand
Secondary sponsor category [1] 293167 0
None
Name [1] 293167 0
Address [1] 293167 0
Country [1] 293167 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 295751 0
Health and Disability Ethics Committee
Ethics committee address [1] 295751 0
Ethics committee country [1] 295751 0
New Zealand
Date submitted for ethics approval [1] 295751 0
31/08/2016
Approval date [1] 295751 0
Ethics approval number [1] 295751 0

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

Contacts
Principal investigator
Name 68310 0
Mrs Jo Willcocks
Address 68310 0
Psychology Masters Student
University of Canterbury
Clyde Road
Ilam, Christchurch, 8041
Country 68310 0
New Zealand
Phone 68310 0
+64 21 1322611
Fax 68310 0
Email 68310 0
[email protected]
Contact person for public queries
Name 68311 0
Eileen Britt
Address 68311 0
Department of Psychology
University of Canterbury
Clyde Road
Ilam, Christchurch, 8041
Country 68311 0
New Zealand
Phone 68311 0
+64 3 364 2987
Fax 68311 0
Email 68311 0
[email protected]
Contact person for scientific queries
Name 68312 0
Eileen Britt
Address 68312 0
Department of Psychology
University of Canterbury
Clyde Road
Ilam, Christchurch, 8041
Country 68312 0
New Zealand
Phone 68312 0
+64 3 364 2987
Fax 68312 0
Email 68312 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.

Documents added automatically
No additional documents have been identified.