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First 2000 Days Care Connect (FDCC) – a holistic first 2000 days model of antenatal care for pregnant migrants or refugees

First 2000 Days Care Connect (FDCC) – effect of a holistic first 2000 days model of antenatal care on attendance and completeness of health checks for pregnant migrants or refugees

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001088831
Acronym
FDCC
Enrollment
241
Registered
2021-08-18
Start date
2021-11-29
Completion date
2022-12-02
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The overall aim of the FDCC study is to evaluate: 1) impact, of FDCC (an integrated Child and Family Health (CFH) hub with navigation support) on attendance at CFH services and completion of CFH checks, support of child growth and development, breastfeeding and maternal wellbeing, and meeting family psychosocial needs. 2) process of implementing FDCC and: (implementation evaluation – future Phase 2 of study not applicable to current ANZCTR). 3) cost-effectiveness of FDCC. (economic evaluation – future Phase 2 of study not applicable to current ANZCTR). FDCC is a non-randomised study of newly arrived migrants and refugee women from culturally and linguistically diverse backgrounds who are:newly arrived migrant (< 10 years in Australia) or self-identified refugee (< 10 years in Australia); expectant mothers > 20 weeks gestation or or mother who has recently given birth at the abovementioned hospitals and has not been discharged from postnatal ward; attending antenatal clinics or postnatal wards in SESLHD (St George Hospital), NSLHD (Royal North Shore/Hornsby Hospital) and SWSLHD (Liverpool Hospital). Potential participants will be identified by the midwifery and, where available, the cross-cultural worker service. The study compares markers of attendance and completion of CFH checks, child health and development measured by Ages and Stages Questionnaire, Body Mass Index, and Emergency Department Presentations, rates of breastfeeding, and mother’s social and health needs (depression, quality of life and other psychosocial stressors) between those attending FDCC (an integrated CFH hub with navigation support) and those attending usual care not through FDCC.

Interventions

Intervention Arm: FDCC- An integrated child and family health (CFH) Hub with navigation support. Expectant mothers who live in a defined geographic area (postcode) serviced by an established CFH Hub site in Rockdale, Miller and Ryde, are actively referred to and participate in the FDCC intervention. The intervention comprises of: 1) An integrated CFH Hub. Hubs are both a physical building and a way of working that facilitates service collaboration, integration and fosters a community led approa

Intervention Arm: FDCC- An integrated child and family health (CFH) Hub with navigation support. Expectant mothers who live in a defined geographic area (postcode) serviced by an established CFH Hub site in Rockdale, Miller and Ryde, are actively referred to and participate in the FDCC intervention. The intervention comprises of: 1) An integrated CFH Hub. Hubs are both a physical building and a way of working that facilitates service collaboration, integration and fosters a community led approach to local needs. Hubs most commonly operate out of a host building, from which partner community-based or public services are delivered. Hubs present an opportunity to work in partnership and integrate services to provide more responsive and holistic care. In our Hub model, CFH services are co-located with Non-Government Organisations (NGOs) and families are linked with psychosocial support services including financial counselling, general practitioners, playgroups, domestic violence support, mental health support, early childhood education, and welfare. Within the Hub services, existing CFH and NGO services will support families to navigate through the system and engage with other health services including general practitioners, early childhood services, education, welfare and psychosocial support to address their needs. 2) Navigation support through the Hubs with increased continuity from maternity to the CFH services. A key worker will be identified at each Hub to actively engage women/families with Hub services and link them with the services they need. Women will be recruited from antenatal clinics between 20 weeks gestation and birth, or on the postnatal ward if they have recently giving birth and have not yet been discharged home . All women in the intervention arm will participate in an approximately 1-hour antenatal/postnatal consultation with the CFH Hub Linker to identify any needs and support services required, followed by another consultation between birth and 8 weeks postpartum. Further consultations with the Hub Linker will occur on a needs-basis for each participant. Following discharge of mothers and infants from birthing services, women will access CFHN and CFH services via the Hub, as well as a range of psychosocial support services that will be suited to the mothers and infants needs and preferences. Per routine care, all women and their babies will have an appointment (approximately 1 hour) with CFHN at 1-4 weeks postpartum, 6-8 weeks postpartum, 6 months postpartum and 12 months postpartum. All women will complete paper-based research surveys with the research project officer at recruitment (antenatal), 6 months postpartum and 12 months postpartum. Consultations (with Hub linker, research project officer and CFHN) and psychosocial services offered in the Hub will be offered face-to-face and a one-to-one basis. Some specific services such as play group or mothers groups may be offered in a group setting. Mothers and their babies will have access to the Hub intervention for 12 months. Attendance at the Hub and services received will be recorded in local health district electronic medical records, Hub Linker service records, and research surveys completed by study participants.

Sponsors

Susan Woolfenden
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Attending antenatal clinics or postnatal wards at St George, Royal North Shore, Hornsby, Liverpool or Fairfield Hospitals • Residing in geographical catchment for the respective antenatal clinic or postnatal ward areas of study • Expectant mother, 16 years of age or older and greater than 20 weeks gestation, or or mother who has recently given birth at the abovementioned hospitals and has not been discharged from postnatal ward • Newly arrived migrant (< 10 years in Australia) or self-identified refugee (< 10 years in Australia), from a non-English speaking background; and • Provide a signed and dated informed consent form.

Exclusion criteria

• Do not comprehend the recruitment invitation (determined by limited capacity to communicate proficiently in English with the Project officer and/or potential participant declines the offer of an interpreter in their home language). • Already enrolled and assigned a research participant ID. • Have no mechanism for contact (telephone or email). • Already an active client in a targeted support services (e.g. Sustained Nurse Home Visiting/Perinatal case conferencing) • Less than 16 years of age at enrollment. • Migrant > 10 years in Australia or who does not identify as a refugee, or migrant < 10 years in Australia from an English speaking background. • Not residing in geographical area of study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026