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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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Address [1] 1755 0
GPO Box 1421
Canberra ACT 2601
Country [1] 1755 0
Australia
Funding source category [2] 1756 0
Government body
Name [2] 1756 0
Victorian Community Support Grant Fund
Address [2] 1756 0
Department for Victorian Communities
GPO Box 2392V, Melbourne 2001
Country [2] 1756 0
Australia
Funding source category [3] 4535 0
Charities/Societies/Foundations
Name [3] 4535 0
Victorian Health Promotion Foundation.
Address [3] 4535 0
PO Box 154, Carlton South 3053
Country [3] 4535 0
Australia
Funding source category [4] 4536 0
Charities/Societies/Foundations
Name [4] 4536 0
beyondblue, the national depression initiative.
Address [4] 4536 0
PO Box 6100, Hawthorn West, VIC 3122
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
MOSAIC is a community randomised trial which examines whether mentor mothers can reduce partner abuse and depression, and strengthen health, wellbeing and mother-child bonds in women who are pregnant or have children under 5, attending upskilled and supported Maternal and Child Health (MCH) nurses or GPs. Mentor mothers (MMs) are para-professional trusted community women with additional training in domestic violence and parenting skills, who provide home-visiting, empowerment, advocacy and support to women pregnant or with children under 5, identified as abused or symptomatic of abuse by their GP or nurse.
AIMS: The study’s primary aims are:
• to reduce partner abuse or depression by 16% among women pregnant or with children under 5 whom GPs or MCH nurses identify as abused or at risk
Its secondary aims are:
• to strengthen infrastructure support for GP and nurse management of partner abuse, by enhancing effective inter-sectoral collaboration between general practice, MCH nurse teams and community-based family violence networks
• to enhance health professional case management of family members living with partner abuse
Trial website
Trial related presentations / publications
Taft A, Small R, Hoang K. Intimate partner/family violence in Vietnam and among Vietnamese diaspora communities in western societies : a comprehensive review. J Family Studies (2008) 14: 167-182


Hegarty K, Taft A, Feder G. Working with the whole family when domestic violence is present: what do generalists need to know? Brit Med J 2008: 337(a839 doi:10.1136/bmj.a839).

Taft A, Hegarty KL, Feder GS. Tackling partner violence in families: new guidelines extend opportunities to respond. Med J Aust 2006:185 (10): 535-536.)

Taft A, Hegarty K, Feder G. Management of the whole family when intimate partner violence is present: guidelines for primary care physicians. Brochure 4pp. Victorian Community Council Against Violence 2006

Taft A. Promoting women’s mental health: the challenge of intimate partner/domestic violence. Issues Paper 8. Australian Domestic and Family Violence Clearinghouse, University of New South Wales. 2003: 24pp (also www.austdvclearinghouse.unsw.edu.au)

Taft A. Violence in pregnancy and after childbirth. Issues Paper No. 6. Australian Domestic and Family Violence Clearinghouse, University of New South Wales, 2002: 24pp.

Taft A, Lumley J, Small R, Hegarty K. Report on the Development Phase of the Mentor Mothers’ Project to Maternity Services’ Effectiveness Unit, Victorian Department of Human Services. Centre for the Study of Mothers’ and Children’s Health, June 2002.
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
a.taft@latrobe.edu.au
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
a.taft@latrobe.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary