ANZCTR - Registration

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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]

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

Condition category

Condition code

Mental Health

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]

Treatment: Other

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in client retention as assessed by monitoring of length of time each participant remains in programme

Timepoint [1]

Outcome will be assessed on the date that the client leaves the programme.

Secondary outcome [1]

Measurement of motivation for change by using The Change Questionnaire

Timepoint [1]

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]

Measure change in readiness for change and treatment by using the SOCRATES questionnaire

Timepoint [2]

Pre- and Post- each MI session

Secondary outcome [3]

Measure therapeutic alliance by using WAI-SR

Timepoint [3]

Pre- and post- each MI session

Secondary outcome [4]

Measure readiness for treatment using the Readiness Ruler

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Canterbury

Address [1]

Clyde Road
Ilam, Christchurch, 8041

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington  6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

31/08/2016

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Retention rates in substance use disorder (SUD) treatment facilities in the early stages of treatment are typically less than optimum.  Therapeutic communities (TC) are one type of SUD treatment facility, and are an important part of many countries’ substance abuse reduction programmes.  The duration of the TC treatment differs across programmes, with 12-18 month programmes common.  However, there are also some modified TC’s with reduced durations of three, six or twelve months.  Dropout rates of approximately 45% in the first few weeks of treatment have been reported in Australian TC’s, and at Odyssey House, a TC in Christchurch, the dropout rate during the six-month period 1st September 2015 – 31st January 2016 was 56% in the first 90 days of treatment.

The reasons for the high dropout rates during the early stages of treatment are many and varied, and include both voluntary and enforced discharge due to programme rule violations by the client.  Some areas frequently identified as important factors in early dropout are low motivation or readiness for treatment, and a lack of engagement in the programme, along with low motivation for change, and an absence of therapeutic alliance.  

Motivational Interviewing (MI) has been shown to increase engagement in treatment for individuals with SUD who are low in motivation for change.  Motivational Interviewing may be particularly well suited for those mandated to receive treatment for SUD, but who may not yet be committed to make changes to their current lifestyle. In addition, MI may also assist in maintaining treatment engagement and abstinence for those who are further into their treatment programme.  Research on MI as a preparation for SUD treatment has reported mixed results.  

The first aim of study is to determine specific time points of vulnerability where a client is at higher risk of discharge, by gathering client data and analysing retention during a 12-month period.  The second aim is to evaluate the effectiveness of MI for engagement or MI for continuing engagement and abstinence on retention at Odyssey House, a therapeutic community in Christchurch.  Two MI sessions will be conducted by current key working staff, and will take place at a time determined by the initial analysis of client retention.  The MI sessions will be offered to all relevant clients: either new admissions or those further into the programme at the predetermined risk point.  Multiple baseline measures and pre- and post- measures of readiness to change and readiness for treatment, as well as therapeutic alliance will allow all clients to participate without the requirement of a separate treatment-as-usual control group.  This is in line with the TC model where all clients have equal access to treatments.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Jo Willcocks

Address

Psychology Masters Student
University of Canterbury
Clyde Road
Ilam, Christchurch, 8041

Country

New Zealand

Phone

+64 21 1322611

Fax

jo.willcocks@pg.canterbury.ac.nz

Contact person for public queries

Name

Eileen Britt

Address

Department of Psychology
University of Canterbury
Clyde Road
Ilam, Christchurch, 8041

Country

New Zealand

Phone

+64 3 364 2987

Fax

eileen.britt@canterbury.ac.nz

Contact person for scientific queries

Name

Eileen Britt

Address

Department of Psychology
University of Canterbury
Clyde Road
Ilam, Christchurch, 8041

Country

New Zealand

Phone

+64 3 364 2987

Fax

eileen.britt@canterbury.ac.nz

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

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Documents added automatically

No additional documents have been identified.

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