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Trial registered on ANZCTR


Registration number
ACTRN12617000929303
Ethics application status
Approved
Date submitted
9/06/2017
Date registered
27/06/2017
Date last updated
6/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Motivational Interviewing for Enhancing Engagement in Intimate Partner Violence (IPV) Treatment for Men at High Risk of IPV Behaviour
Scientific title
Effects of Motivational Interviewing for Enhancing Engagement in Intimate Partner Violence (IPV) Treatment for Men at High Risk of IPV Behaviour
Secondary ID [1] 292165 0
None
Universal Trial Number (UTN)
U1111-1196-6248
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intimate Partner Violence Treatment 303606 0
Condition category
Condition code
Public Health 303016 303016 0 0
Health service research
Public Health 303017 303017 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research conducted at Aviva and SVS. Aviva is a not-for-profit agency dedicated to supporting New Zealand families to become their best, free from violence. SVS provides non-violence programs for men and women since 1983 and for youth since 2008.
Primary Objectives

The primary objective of the research project was to assess the effects of MI for treatment engagement, as a brief (two sessions) pre-treatment intervention, to enhance treatment engagement in an IPV treatment for men who have been referred to Aviva and SVS to attend the IPV treatment programmes.
The research comprised three main studies: a control phase, a training study in which staff at Aviva and SVS were trained in MI in preparation for the third study, which was an evaluation of the implementation of MI for engagement as part of the standard intake procedures occurring at Aviva and SVS.
Phase one: Control Group

Participants: The study comprised men who have been referred to Aviva and SVS via the different sources of referrals including self-referral, ISR, Police, and referrals from other agencies like the Department of Corrections and Family Court, to attend an IPV Treatment Program at Aviva and SVS. If a client had received MI or IPV treatment previously, they were excluded from the study. This was asked by staff on a client referral before their allocation to MI or Control group. No participant was paid for his involvement with the study.
Procedure: The standard engagement procedure was conducted by staff at Aviva and SVS. The recruitment started in July 2017 at Aviva and Oct 2017 at SVS. The control phase was ended in November at both agencies and lasted for 5 months in total for Aviva and 2 months for SVS. The current treatment process at Aviva and SVS is that social workers receive referrals and then they engage with the client for the first time over the phone. Afterward, they have a session called assessment session to engage with the client in more detail and get to know them. After the assessment sessions (usually two assessment sessions or sometimes more depending on the needs of the clients) they will initiate the IPV treatment program.
Measure: The mean number of IPV treatment sessions attended were the primary outcome measures. The number of the sessions attended was recorded and reported by staff at Aviva and SVS. Secondary measures include: self-ratings: on the Change Questionnaire, in which participants have been asked to rate the importance, commitment, and ability to change their violent behaviour on a scale of 0-10 (0=definitely not,10=definitely); the Readiness Ruler which determined the participants’ readiness to change on a scale of 0 to 10 in which the lower numbers indicate less readiness, and the higher numbers indicate greater readiness for change.
These questionnaires administrated before and after the assessment session, before initiating the IPV treatment program. The outcome was reported as within group changes. The validity and reliability of these questionnaires are confirmed.
Recruitment and randomization: Participants were recruited between July 2017 and July 2018 through family violence services centres (Aviva and SVS) in the Canterbury, Christchurch. Recruitment occurred from several sources including self-referrals, ministry of justice, department of correction, ISR pilot study, and police.
Phase two: Staff Training
Participants: Clinicians at Aviva and SVS who provide the initial contact with men referred via the ISR pilot or other sources of referrals for IPV treatment were recruited into the study.
Measures: Pre and post-training the Aviva and SVS staff were administered the Video Assessment of Simulated Encounters Revised New Zealand version (VASE-R NZ), a test of MI skill attainment. Studies indicate that VASE-R can be useful in assessing respondent skills and providing a preliminary, but data-based method to evaluate their scores. The findings also show that subscales could help researchers to discriminate between areas of skill and areas in need of further work. Furthermore, VASE-R can be employed in group, while there is no need for complex technology, and as a result it could be administrated easily. Finally, the VASE-R is helpful for researchers to determine individual skill levels and to ascertain if a priori skill targets are met before permitting a MI clinician to begin a trial.
Additionally, the MI sessions were audio-recorded and coded using the Motivational Interviewing Treatment Integrity (MITI 4.2.1) scale by the MINT members as a measure of treatment integrity. The VASE-R NZ and MI integrity served as the primary outcome measures for this part of the study. Also, a focus group with Aviva and SVS staff will be conducted in July to explore their experiences of MI after they have been trained in MI and had the opportunity to utilize it with clients.
Phase three: MI Implementation for Engagement

Procedure: Men referred to for IPV treatment at Aviva and SVS received two MI for engagement sessions. There was one session of MI for engagement, followed by the assessment session, and then the second session of MI for engagement. The duration of each MI session was 20-40 minute. None of the participants were formally engaged in MI intervention at the time of their consent in the study. No participant was paid for his or her involvement with the study.
Measures: The mean number of IPV treatment sessions attended were the primary outcome measures. Treatment attendance data for these men who received MI was compared with attendance data of matched clients who received the standard treatment (group 1). Also, the attendance data was compared with another matched group of clients that had been referred to Aviva and SVS (group 3) 12 months earlier. Secondary measures were same as in phase1 and they were administrated before the first MI session and after the second MI session.
Intervention code [1] 298313 0
Lifestyle
Intervention code [2] 298314 0
Behaviour
Intervention code [3] 298341 0
Prevention
Comparator / control treatment
Phase 1: Control group
Participants: The study will comprise men who have referred to Aviva for IPV Treatment as there is a concern of potential serious family violence harm.
Procedure: The current standard engagement procedure (Reach Out program ) will be conducted by staff at Aviva. Recruiting will occur for 4 months.
Measure: The mean number of IPV treatment sessions attended is the primary outcome measures.
Control group
Active

Outcomes
Primary outcome [1] 302390 0
The mean number of IPV treatment sessions attended as recorded and reported by staff at Aviva
Timepoint [1] 302390 0
After completion of the 10 sessions of IPV treatment or dropping out from the treatment
Secondary outcome [1] 335814 0
self-ratings: on the Change Questionnaire in which participants in the control and MI groups will be asked to rate the importance, commitment, and ability to change their violent behaviour on a scale of 0-10 (0=definitely not,10=definitely).
Timepoint [1] 335814 0
At the beginning of the first engagement session and at the of the end of last engagement session
Secondary outcome [2] 335815 0
self-ratings: on the Readiness Ruler which determines the participants’ readiness to change on a scale of 0 to 10 in which the lower numbers indicate less readiness, and the higher numbers indicate greater readiness for change.
Timepoint [2] 335815 0
At the beginning of the first engagement session and at the end of the last engagement session

Eligibility
Key inclusion criteria
The study will comprise men who have been referred to Aviva and SVS for IPV treatment.
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusion criteria so that the study sample is as much like the population who attend IPV treatment as possible.

Study design
Purpose of the study
Prevention
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
Other
Other design features
At first, 4 months of recruitment will occur for the control group, followed by 4 months of recruitment into the intervention group.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample calculation was done using R package. Descriptive statistics and multiple linear regression will be used to analyse the data.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
3/07/2017
Actual
3/07/2017
Date of last participant enrolment
Anticipated
Actual
30/05/2018
Date of last data collection
Anticipated
1/10/2018
Actual
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 8960 0
New Zealand
State/province [1] 8960 0
Canterbury

Funding & Sponsors
Funding source category [1] 296698 0
University
Name [1] 296698 0
Sir Don Beaven Scholarship, University of Canterbury
Country [1] 296698 0
New Zealand
Primary sponsor type
Individual
Name
Sara Soleymani
Address
School of Health Sciences, University of Canterbury, Christchurch,
2/41 Naseby Street, Merivale, Christchurch, 8014
Country
New Zealand
Secondary sponsor category [1] 295659 0
None
Name [1] 295659 0
None
Address [1] 295659 0
None
Country [1] 295659 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297928 0
Health and Disability Ethics Committees
Ethics committee address [1] 297928 0
Health and Disability Ethics Committees, Ministry of Health, 133 Molesworth Street, PO Box 5013, Wellington 6011
Ethics committee country [1] 297928 0
New Zealand
Date submitted for ethics approval [1] 297928 0
25/05/2017
Approval date [1] 297928 0
08/06/2017
Ethics approval number [1] 297928 0

Summary
Brief summary
The current study aims to evaluate the effectiveness of MI as a brief (two sessions) pre-treatment intervention to enhance treatment engagement in IPV treatment for men who have been identified as high risk of future IPV. It is hypothesised that MI for engagement will be effective as a pre-treatment intervention leading to enhanced engagement in the IPV treatment.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1785 1785 0 0
/AnzctrAttachments/373107-Ethics Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 75486 0
Mrs Sara Soleymani
Address 75486 0
School of Health Science, University of Canterbury, Christchurch, Private Bag 4800, postcode:8041
Country 75486 0
New Zealand
Phone 75486 0
+64210308361
Fax 75486 0
Email 75486 0
sara.soleymani@pg.canterbury.ac.nz
Contact person for public queries
Name 75487 0
Sara Soleymani
Address 75487 0
School of Health Sciences, Universtiy of Canterbury, Christchurch, Private Bag 4800, postcode:8041
Country 75487 0
New Zealand
Phone 75487 0
+64210308361
Fax 75487 0
Email 75487 0
sara.soleymani@pg.canterbury.ac.nz
Contact person for scientific queries
Name 75488 0
Sara Soleymani
Address 75488 0
School of Health Sciences, University of Canterbury, Christchurch, Private Bag 4800, postcode:8041
Country 75488 0
New Zealand
Phone 75488 0
+64210308361
Fax 75488 0
Email 75488 0
sara.soleymani@pg.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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