Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001210561p
Ethics application status
Not yet submitted
Date submitted
4/11/2015
Date registered
6/11/2015
Date last updated
6/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Motivational interviewing to increase attendance at a stopping violence group
Scientific title
Does Motivational interviewing enhance engagement for men mandated to attend a stopping violence group?
Secondary ID [1] 287747 0
Nil known
Universal Trial Number (UTN)
U1111-1175-9149
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
violence 296616 0
Condition category
Condition code
Mental Health 296899 296899 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Motivational interviewing, comprising two 30-50min individual sessions, as a prelude to attendance at a stopping violence group programme. The first session will occur after the initial assessment session, and the second session will occur within 2-4 weeks, before the participant is due to start the group. The sessions will be provided by a registered clinical psychologist, registered nurse, and a social worker.
Intervention code [1] 293179 0
Treatment: Other
Intervention code [2] 293180 0
Behaviour
Comparator / control treatment
The control condition will be assessment only (standard care) as a prelude to attendance at the stopping violence programme.
Control group
Active

Outcomes
Primary outcome [1] 296512 0
Number of sessions of the stopping violence group attended - this will be assessed via an attendance log maintained by the group facilitators.
Timepoint [1] 296512 0
At completion of the stopping violence group - this will either be when the participant withdraws from the group or at the end of the group (16 week programme).
Secondary outcome [1] 318631 0
Self-ratings on the Change Questions (Miller & Johnson, 2008)
Timepoint [1] 318631 0
Pre-assessment, pre-attendance at the stopping violence group, and on completion of the stopping violence group (either when the participant withdraws from the group or at the end of the 16 week group programme).
Secondary outcome [2] 318632 0
Self-rating on the Readiness for treatment scale
Timepoint [2] 318632 0
Pre-assessment, pre-attendance at the stopping violence group, and on completion of the stopping violence group (either when the participant withdraws from the group or at the end of the 16 week group programme). .
Secondary outcome [3] 318633 0
Self-rating of help-seeking. Participants will be asked to indicate which of 5 services they have sought advice/help from in the previous 2 months, and the frequency of this of a 6 point scale ranging from once only to 2-3 times per week. The scale is a modification of a scale used in similar research reported in Murphy and Maiuro (2009). The services listed a services commonly accessed
Timepoint [3] 318633 0
Pre-assessment, pre-attendance at the stopping violence group, and on completion of the stopping violence group (either when the participant withdraws from the group or at the end of the 16 week group programme).
Secondary outcome [4] 318634 0
Group facilitator rating on the Homework Compliance Scale (Primakoff, Epstein & Covi, 1986).
Timepoint [4] 318634 0
On completion of the stopping violence group - either when the participant withdraws from the group or at the end of the 16 week group programme.

Eligibility
Key inclusion criteria
Men mandated by the Courts or Community Probation Service to attend a stopping violence programme at He Waka Tapu.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to explore the data. Although this is a small pilot study inferential analysis is appropriate given the power and effect size calculations. A power calculation suggests that this study has 80.0% power to detect an effect size of 0.221. An independent groups t-test will be used to detect the treatment difference between groups. Results from hypothesis testing will be treated as preliminary and interpreted with caution.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/01/2016
Actual
Date of last participant enrolment
Anticipated
29/04/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 7292 0
New Zealand
State/province [1] 7292 0
Canterbury

Funding & Sponsors
Funding source category [1] 292320 0
University
Name [1] 292320 0
University of Canterbury
Country [1] 292320 0
New Zealand
Primary sponsor type
Other
Name
He Waka Tapu
Address
161 Pages Rd
Wainoni
Christchurch 8061
Country
New Zealand
Secondary sponsor category [1] 290999 0
None
Name [1] 290999 0
Address [1] 290999 0
Country [1] 290999 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 293791 0
Health and Disability Ethics Committees NZ
Ethics committee address [1] 293791 0
Ethics committee country [1] 293791 0
New Zealand
Date submitted for ethics approval [1] 293791 0
12/11/2015
Approval date [1] 293791 0
Ethics approval number [1] 293791 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 623 623 0 0
/AnzctrAttachments/369537-Protocoloutline.docx

Contacts
Principal investigator
Name 61206 0
Dr Eileen Britt
Address 61206 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 61206 0
Australia
Phone 61206 0
+6433642987 ext7195
Fax 61206 0
+6433642181
Email 61206 0
[email protected]
Contact person for public queries
Name 61207 0
Eileen Britt
Address 61207 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 61207 0
New Zealand
Phone 61207 0
+6433642987 ext7195
Fax 61207 0
+6433642181
Email 61207 0
[email protected]
Contact person for scientific queries
Name 61208 0
Eileen Britt
Address 61208 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 61208 0
New Zealand
Phone 61208 0
+6433642987 ext7195
Fax 61208 0
+6433642181
Email 61208 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.