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Trial registered on ANZCTR


Registration number
ACTRN12621001088831
Ethics application status
Approved
Date submitted
15/06/2021
Date registered
18/08/2021
Date last updated
20/04/2022
Date data sharing statement initially provided
18/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
First 2000 Days Care Connect (FDCC) – a holistic first 2000 days model of antenatal care for pregnant migrants or refugees
Scientific title
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
Secondary ID [1] 304432 0
None
Universal Trial Number (UTN)
Trial acronym
FDCC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy
322248 0
Refugee and migrant maternal health 322249 0
Maternal health 322250 0
Infant health 322251 0
Condition category
Condition code
Reproductive Health and Childbirth 319937 319937 0 0
Antenatal care
Reproductive Health and Childbirth 320375 320375 0 0
Normal pregnancy
Reproductive Health and Childbirth 320376 320376 0 0
Childbirth and postnatal care
Public Health 320377 320377 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.


Intervention code [1] 320836 0
Treatment: Other
Comparator / control treatment
Control arm: usual care - Expectant mothers attending the participating hospitals antenatal clinics or mothers who have recently birthed at the participating hospitals (not yet discharged home from postnatal ward) who meet eligibility criteria but do not live in the geographic area will be allocated to a control cohort and receive routine care (e.g. receive information on CFHN services at discharge).
Control group
Active

Outcomes
Primary outcome [1] 327809 0
Attendance at child & family health services for checks. Proportion of mothers, children and families who attend child & family health services at FDCC Hub for checks assessed from patient medical records.
Timepoint [1] 327809 0
1-4 weeks postpartum; 6-8 weeks postpartum, 6 months postpartum and 12 months postpartum.
Primary outcome [2] 328215 0
Completion of age appropriate health checks. Proportion of mothers, children and families who are up to date with age appropriate health checks, either via child & family health services or GP assessed from patient medical records.
Timepoint [2] 328215 0
1-4 weeks postpartum; 6-8 weeks postpartum, 6 months postpartum and 12 months postpartum.
Secondary outcome [1] 396660 0
Maternal mental health: Proportion of women identified as at risk of experiencing depression on the Edinburgh Depression Scale
Timepoint [1] 396660 0
Baseline, 1-4 weeks postpartum; 6-8 weeks postpartum, 6 months postpartum and 12 months postpartum.
Secondary outcome [2] 396661 0
Maternal unmet psychosocial needs: Proportion of women identified as having more than one unmet social need on the THRIVE We Care questionnaire
Timepoint [2] 396661 0
Baseline, 6 months postpartum and 12 months postpartum.
Secondary outcome [3] 396662 0
Maternal psychosocial vulnerability: Proportion of women identified as experiencing psychosocial vulnerability on NSW Health psychosocial screening tools (Safe Start)
Timepoint [3] 396662 0
Baseline, 1-4 weeks postpartum; 6-8 weeks postpartum, 6 months postpartum and 12 months postpartum.
Secondary outcome [4] 396664 0
Maternal quality of life: Proportion of mothers reporting poor quality of life onEQ-5D quality of life questionnaire
Timepoint [4] 396664 0
Baseline, 6 months postpartum and 12 months postpartum.
Secondary outcome [5] 396665 0
Infant growth parameters: heights, weight and head circumference using infantometer, digital scale and measuring tape respectively.
Timepoint [5] 396665 0
1-4 weeks postpartum; 6-8 weeks postpartum, 6 months postpartum and 12 months postpartum.
Secondary outcome [6] 396666 0
Breastfeeding: Proportion of women exclusively breastfeeding /predominately breastfeeding/partially breastfeeding/ artificially feeding collected via routine electronic medical records.
Exclusively breastfed defined as infant has received only breast milk from his/her mother or a wet nurse, or expressed breast milk, and no other liquids or solids, with the exception of drops or syrups consisting of vitamins, mineral supplements or medicines.
Predominately breastfed defined as the infant's predominant source of nourishment has been breast milk. However, the infant may also have received water or water-based drinks (sweetened or flavoured water, teas, infusions etc); fruit juice; oral re hydration salt solutions; drop and syrup forms of vitamins, minerals and medicine; and ritual fluids. With the exception of fruit juice and sugar-water, no food-based fluid (such as infant formula or non-human milk) is allowed under this definition.
Partial breastfed defined as the infant received both breast milk and any other fluid or food, including infant formula.
Artificial feeding defined as infant being fed fully or predominately with infant formula, and receiving no breastmilk.
Timepoint [6] 396666 0
1-4 weeks postpartum; 6-8 weeks postpartum, 6 months postpartum and 12 months postpartum.
Secondary outcome [7] 396667 0
Infant developmental vulnerability Proportion of children identified as at developmental risk by CFHN using the Learn the Signs Act Early (LtSAE) Screening tool and Ages and Stages questionnaire (ASQ)
Timepoint [7] 396667 0
6-8 weeks postpartum (LtSAE), 6 months postpartum (LtSAE and ASQ) and 12 months postpartum (LtSAE and ASQ)
Secondary outcome [8] 396668 0
Proportion of children who attend hospital (ED presentations).
Timepoint [8] 396668 0
NSW-wide Emergency Department Data Collection at 6-month postpartum and 12-month postpartum

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable. This study follows a Quasi-randomisation allocation procedure where participants are randomized to intervention arm based on their residential postcode., i.e. whether or not they reside in the local catchment for the FDCC hub,
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on our pilot data we anticipate that the percentage of children who will have their CFH check done by a CFHN will be 60% in the intervention group and 30% in the control group. Therefore, 72 children will be needed for each arm of (i.e. intervention versus control) in order to provide 80% power to detect the magnitude of such an increase with p value < 0.05. Allowing for a 40% attrition rate (i.e. loss-to-follow-up) as this is a vulnerable community we will aim to recruit 120 children in each arm or 240 children in total across the three sites.
Statistical analysis will include descriptive analysis of participating mothers and children’s outcomes at each assessment (Table 1). We will compare the outcomes between intervention and control groups using the Fisher’s test for binary outcomes, Chi-square method for categorical outcomes, non-parametric method (e.g. Wilcoxon rank-sum test) and parametric methods (e.g. t-test) for continuous variables and ordinal variables. As the outcomes will be measured repeatedly, multi-level regression analysis will be undertaken to examine the impact of intervention on the outcomes controlling for the plausible confounders at the individual (e.g. mother’s sociodemographic characteristics, geographic area of residence) and community (e.g. neighbourhood socioeconomic factors) levels at baseline. Generalised estimating equations method will be used in the regression analysis considering the potential clustering effect by site. We will conduct the analysis with an “intention to treat” approach.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/11/2021
Actual
29/11/2021
Date of last participant enrolment
Anticipated
31/07/2022
Actual
Date of last data collection
Anticipated
31/07/2023
Actual
Sample size
Target
240
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19674 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 19675 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 19676 0
St George Hospital - Kogarah
Recruitment hospital [4] 19677 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [5] 21619 0
Fairfield Hospital - Prairiewood
Recruitment postcode(s) [1] 34306 0
2170 - Liverpool
Recruitment postcode(s) [2] 34307 0
2065 - St Leonards
Recruitment postcode(s) [3] 34308 0
2217 - Kogarah
Recruitment postcode(s) [4] 34309 0
2077 - Hornsby
Recruitment postcode(s) [5] 36547 0
2176 - Prairiewood

Funding & Sponsors
Funding source category [1] 308796 0
Government body
Name [1] 308796 0
Ministry of Health Translational Research Grants Scheme
Country [1] 308796 0
Australia
Primary sponsor type
Individual
Name
Susan Woolfenden
Address
Associate Professor Sue Woolfenden
NHMRC Senior Research Fellow School of Women and Children’s Health, UNSW Sydney
Level 8 Bright Alliance, High Street, Randwick 2031, NSW Australia
Country
Australia
Secondary sponsor category [1] 309772 0
None
Name [1] 309772 0
Address [1] 309772 0
Country [1] 309772 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308709 0
South Eastern Sydney Local Health District
Ethics committee address [1] 308709 0
Ethics committee country [1] 308709 0
Australia
Date submitted for ethics approval [1] 308709 0
26/04/2021
Approval date [1] 308709 0
13/07/2021
Ethics approval number [1] 308709 0
2020/ETH03295

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

Contacts
Principal investigator
Name 111638 0
A/Prof Susan Woolfenden
Address 111638 0
Associate Professor Sue Woolfenden
NHMRC Senior Research Fellow School of Women and Children’s Health, UNSW Sydney
Level 8 Bright Alliance, High Street, Randwick 2031, NSW Australia
Country 111638 0
Australia
Phone 111638 0
+61293828183
Fax 111638 0
Email 111638 0
susan.woolfenden@health.nsw.gov.au
Contact person for public queries
Name 111639 0
Susan Woolfenden
Address 111639 0
Associate Professor Sue Woolfenden
NHMRC Senior Research Fellow School of Women and Children’s Health, UNSW Sydney
Level 8 Bright Alliance, High Street, Randwick 2031, NSW Australia
Country 111639 0
Australia
Phone 111639 0
+61293828183
Fax 111639 0
Email 111639 0
susan.woolfenden@health.nsw.gov.au
Contact person for scientific queries
Name 111640 0
Susan Woolfenden
Address 111640 0
Associate Professor Sue Woolfenden
NHMRC Senior Research Fellow School of Women and Children’s Health, UNSW Sydney
Level 8 Bright Alliance, High Street, Randwick 2031, NSW Australia
Country 111640 0
Australia
Phone 111640 0
+61293828183
Fax 111640 0
Email 111640 0
susan.woolfenden@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not approved.


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.