Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000010493
Ethics application status
Approved
Date submitted
21/11/2006
Date registered
8/01/2007
Date last updated
18/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
MOSAIC (Mothers’ Advocates In the Community)
Scientific title
MOSAIC: a cluster randomised trial of mentor mother support to reduce partner violence and depression among pregnant women and women with children under five at risk of or experiencing intimate partner violence
Universal Trial Number (UTN)
Trial acronym
MOSAIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Partner violence and associated depression among pregnant women and women with children under five years old 1513 0
Condition category
Condition code
Reproductive Health and Childbirth 1611 1611 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All referring health care professionals (GPs and maternal and child health (MCH)nurses) are trained for 6 hours to identify and refer pregnant and recent mothers at risk of partner violence. They are subsequently randomised by cluster (GP clinic or MCH nurse team).
Women in the intervention arm are offered the weekly visit, outing or phone call support of a mentor mother for up to twelve months. We aim for 1-2 hour contact.
MOSAIC mentors are community mothers trained initially for five days in domestic violence advocacy, support for depressed mothers, parenting support and other empowerment strategies. This supportive friendship is regularly supervised in groups and individually by MOSAIC coordination staff. Mentors are offered regular upskilling opportunities. Research staff give all referred women a handout which includes family violence services.
Intervention code [1] 1458 0
Other interventions
Comparator / control treatment
Women in the comparison arm are offered the standard care - identification and referral by upskilled GPs or nurses.
Control group
Active

Outcomes
Primary outcome [1] 2221 0
Partner violence (Composite Abuse Scale) Hegarty et al, 2005
Timepoint [1] 2221 0
Baseline; twelve months post intervention
Primary outcome [2] 2222 0
Depression (Edinburgh Postnatal Depression Scale) Murray and Carothers, 1990
Timepoint [2] 2222 0
Baseline; twelve months post intervention
Secondary outcome [1] 3874 0
Strengthened general health and wellbeing (Short Form (SF) 36) Thorpe, 1993
Timepoint [1] 3874 0
Baseline; twelve months post intervention
Secondary outcome [2] 3875 0
Enhanced mother-child bonding of abused or at-risk women to their children (Parenting Stress Index Short form) Abidin, 1995
Timepoint [2] 3875 0
Baseline; twelve months post intervention
Secondary outcome [3] 3876 0
Social Support (Medical Outcomes Scale) Short Form (Sarason et al, 1983)
Timepoint [3] 3876 0
Baseline; twelve months post intervention

Eligibility
Key inclusion criteria
Pregnant women or those who have a child under five years of age aged 18 and over who are psychosocially distressed (depressed and at risk of, or experiencing, partner abuse).
Minimum age
16 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Childless women or those with older children or women with active psychotic illness. We are conducting a Vietnamese sub-study (bilingual staff and translated materials/resources) so except for Vietnamese women, exclude women whose English is insufficient to give informed consent.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation. MCH nurse teams were randomised according to numbers of births in the LGA. GP clinics were stratified according to whether one or two GPs per clinic were participating.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
182
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1755 0
Government body
Name [1] 1755 0
National Health and Medical Research Council
Country [1] 1755 0
Australia
Funding source category [2] 1756 0
Government body
Name [2] 1756 0
Victorian Community Support Grant Fund
Country [2] 1756 0
Australia
Funding source category [3] 4535 0
Charities/Societies/Foundations
Name [3] 4535 0
Victorian Health Promotion Foundation.
Country [3] 4535 0
Australia
Funding source category [4] 4536 0
Charities/Societies/Foundations
Name [4] 4536 0
beyondblue, the national depression initiative.
Country [4] 4536 0
Australia
Primary sponsor type
University
Name
Mother and Child Health Research, La Trobe University
Address
324-328 Little Lonsdale Street, Melbourne, VIC 3000
Country
Australia
Secondary sponsor category [1] 1556 0
University
Name [1] 1556 0
Department of General Practice, University of Melbourne
Address [1] 1556 0
200 Berkeley Street, Carlton, VIC 3053
Country [1] 1556 0
Australia
Other collaborator category [1] 572 0
Individual
Name [1] 572 0
Assoc. Prof. Rhonda Small
Address [1] 572 0
Mother and Child Health Research,
324-328 Little Lonsdale St, Melbourne, Vic 3000
Country [1] 572 0
Australia
Other collaborator category [2] 573 0
Individual
Name [2] 573 0
Assoc. Prof. Kelsey Hegarty
Address [2] 573 0
Department of General Practice, University of Melbourne, 200 Berkeley St, Carlton, Vic 3053
Country [2] 573 0
Australia
Other collaborator category [3] 574 0
Individual
Name [3] 574 0
Prof. Judith Lumley
Address [3] 574 0
Mother and Child Health Research,
324-328 Little Lonsdale St, Melbourne, Vic 3000
Country [3] 574 0
Australia
Other collaborator category [4] 575 0
Individual
Name [4] 575 0
Dr Lyndsey Watson
Address [4] 575 0
Mother and Child Health Research,
324-328 Little Lonsdale St, Melbourne, Vic 3000
Country [4] 575 0
Australia
Other collaborator category [5] 576 0
Individual
Name [5] 576 0
Dr Lisa Gold
Address [5] 576 0
School of Health and Social Development
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country [5] 576 0
Australia
Other collaborator category [6] 577 0
Individual
Name [6] 577 0
Assoc. Prof. Rhonda Small
Address [6] 577 0
Mother and Child Health Research,
324-328 Little Lonsdale St, Melbourne, Vic 3000
Country [6] 577 0
Australia
Other collaborator category [7] 578 0
Individual
Name [7] 578 0
Assoc. Prof. Kelsey Hegarty
Address [7] 578 0
Department of General Practice, University of Melbourne, 200 Berkeley St, Carlton, Vic 3053
Country [7] 578 0
Australia
Other collaborator category [8] 579 0
Individual
Name [8] 579 0
Prof. Judith Lumley
Address [8] 579 0
Mother and Child Health Research,
324-328 Little Lonsdale St, Melbourne, Vic 3000
Country [8] 579 0
Australia
Other collaborator category [9] 580 0
Individual
Name [9] 580 0
Dr Lyndsey Watson
Address [9] 580 0
Mother and Child Health Research,
324-328 Little Lonsdale St, Melbourne, Vic 3000
Country [9] 580 0
Australia
Other collaborator category [10] 581 0
Individual
Name [10] 581 0
Dr Lisa Gold
Address [10] 581 0
School of Health and Social Development
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country [10] 581 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3280 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 3280 0
Ethics committee country [1] 3280 0
Australia
Date submitted for ethics approval [1] 3280 0
Approval date [1] 3280 0
Ethics approval number [1] 3280 0
03-76
Ethics committee name [2] 3281 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [2] 3281 0
Ethics committee country [2] 3281 0
Australia
Date submitted for ethics approval [2] 3281 0
Approval date [2] 3281 0
Ethics approval number [2] 3281 0
030441
Ethics committee name [3] 3282 0
Victorian Department of Human Services Ethics committee
Ethics committee address [3] 3282 0
Ethics committee country [3] 3282 0
Australia
Date submitted for ethics approval [3] 3282 0
Approval date [3] 3282 0
Ethics approval number [3] 3282 0

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

Contacts
Principal investigator
Name 27392 0
Address 27392 0
Country 27392 0
Phone 27392 0
Fax 27392 0
Email 27392 0
Contact person for public queries
Name 10647 0
Dr Angela Taft
Address 10647 0
251 Faraday St
Carlton VIC 3053
Country 10647 0
Australia
Phone 10647 0
+61 3 83418571
Fax 10647 0
+61 3 83418555
Email 10647 0
[email protected]
Contact person for scientific queries
Name 1575 0
Dr Angela Taft
Address 1575 0
251 Faraday St
Carlton VIC 3053
Country 1575 0
Australia
Phone 1575 0
+61 3 83418571
Fax 1575 0
+61 3 83418555
Email 1575 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23124Study protocol   
23125Informed consent form   
23126Clinical study report   
23127Ethical approval   
23128Other   
23811Other   

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.