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Trial registered on ANZCTR


Registration number
ACTRN12616001721493
Ethics application status
Approved
Date submitted
7/12/2016
Date registered
14/12/2016
Date last updated
8/01/2019
Date data sharing statement initially provided
8/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of a sustained nurse home visiting intervention for Aboriginal infants compared with non-Aboriginal infants and with Aboriginal infants receiving usual child health care: a quasi-experimental trial
Scientific title
The effectiveness of a sustained nurse home visiting intervention for Aboriginal infants compared with non-Aboriginal infants and with Aboriginal infants receiving usual child health care: a quasi-experimental trial
Secondary ID [1] 290635 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Bulundidi Gudaga
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child development 301153 0
Breastfeeding 301154 0
Body mass index 301155 0
Child vocabulary development 301156 0
Condition category
Condition code
Public Health 300921 300921 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention groups received the Maternal (formerly Miller) Early Childhood Sustained Home-visiting (MECSH) program, consisting of at least 25 home visits (actual number of visits determined by need) primarily by the same program nurse, commencing at approximately 26 weeks gestation and continuing through the first 2 years post birth. The nurse is supported by a social worker, and nurses working with Aboriginal families are also supported by Aboriginal Health Workers. The nurses, social worker and Aboriginal Health Workers work as an integrated, collocated multidisciplinary team providing both single and joint visits to families as appropriate and interdisciplinary support.
All intervention staff (nurses, Aboriginal health workers and social worker) receive additional training in the program model and cultural competency. Program model training consisted of three face-to-face days and completion of a six-module online course within the first 6 months of MECSH practice. The training is delivered by the MECSH Support Service at Western Sydney University (formerly at University of NSW).
The MECSH program home visits are standardised as follows:
a) Antenatal and postnatal care in accordance with the NSW Supporting Families Early Health Home Visiting Practice Guidelines: antenatal home visits at least 2nd weekly and postnatal visits within one week of birth, and then at least weekly until 6 weeks; second weekly till 12 weeks; 3-weekly to 6 months; 6-weekly to 1 year; then bi-monthly until 2 years, with continuity of nurse provider throughout. The content of each home visit was individually tailored by the nurse to the mother’s needs, skills, strengths, capacity and cultural needs, including engaging the multidisciplinary team as required.
b) Structured child development parent education program: Parents as Teachers.
c) Facilitated access to Aboriginal and non-Aboriginal early childhood health services, volunteer home visiting services and family support services within the Campbelltown area.
d) Group activities and community links, and linking into community activities in the local area.
Quality of service delivery was monitored by the MECSH Support Service including collection of data on visit delivery schedule and content, and client satisfaction and impact. The MECSH Support Service conducts a biannual feedback and quality improvement workshop with the intervention teams.
Intervention code [1] 296516 0
Prevention
Intervention code [2] 296517 0
Behaviour
Comparator / control treatment
The historical non-intervention group (Group C) is a population birth cohort of Aboriginal infants born in Campbelltown hospital between October 2005 and May 2007 (the Gudaga cohort). The Gudaga cohort study continued with 6-monthly data collection to child-age 9 years (completed October 2016), using the same research measures as the intervention groups (Groups A and B). The historical data are available for Aboriginal infants only.
The non-intervention historical cohort group received usual care for families in the Macarthur area, that is:
a) Antenatal care according to NSW Health maternity care and SafeStart guidelines and protocols
b) One postnatal home visit by a nurse from the regular child and family nursing service (within 2 weeks of baby’s birth)
c) Additional postnatal home or clinic visits with the regular child and family nursing service as indicated by protocols in usual care.
d) Volunteer home visiting services and family support services within the local area.
Control group
Historical

Outcomes
Primary outcome [1] 300333 0
Breastfeeding measured by parent self-report of engagement in any breastfeeding at 1 month, 6 months and 12 months post-birth, or report of child age when breastfeeding ceased.
Timepoint [1] 300333 0
Data at 1, 6, and 12 months post-birth, collated at 12 months as total weeks of any breastfeeding.
Primary outcome [2] 300334 0
Body mass index
Timepoint [2] 300334 0
4 years
Primary outcome [3] 300335 0
Child development measured using the Griffiths Mental Development Scales (GMDS) (1996 Revision).
Timepoint [3] 300335 0
18 months and 4 years of child age
Secondary outcome [1] 329715 0
Birthweight as measured and recorded in the midwifery data system.
Timepoint [1] 329715 0
Birth
Secondary outcome [2] 329716 0
Child dental health (dmft: decayed, missing and filled primary teeth) assessed by a trained Dental Hygienist
Timepoint [2] 329716 0
Child age 48 months
Secondary outcome [3] 329717 0
Quality of the home environment (HOME Inventory)
Timepoint [3] 329717 0
Child age 12, 24, 36 months
Secondary outcome [4] 329718 0
Child illness composite of parental self-report and hospitalization records of number of 6 month periods in which child experiences respiratory, gastrointestinal or other illness requiring hospitalization, collated at 24 and 48 months.
Timepoint [4] 329718 0
Child age 6, 12, 18, 24, 36 and 48 months, collated at child age 24, 48 months
Secondary outcome [5] 329719 0
Maternal health self-report using the General Health question (In general would you say your health is: excellent, very good, good, fair, poor).
Timepoint [5] 329719 0
Child age 1, 24, 48 months
Secondary outcome [6] 329720 0
Maternal smoking self report of any cigarette smoking.
Timepoint [6] 329720 0
Child age 1, 24, 36, 48 months
Secondary outcome [7] 329721 0
Maternal and child use of services assessed by parent self-report.
Timepoint [7] 329721 0
Child age 1, 12, 24, 36, 48 months
Secondary outcome [8] 329722 0
Parental enablement measured by a modified Patient Enablement Index (Howie et al 1998)
Timepoint [8] 329722 0
Child age 1, 12, 24, 36, 48 months
Secondary outcome [9] 329723 0
Child age at first solids assessed by parent self-report.
Timepoint [9] 329723 0
Child age 6 and 12 months, collated at 12 months.
Secondary outcome [10] 329724 0
Child age appropriate immunization assessed by parent self-report and verified by the researchers through sighting of the child's personal health record (PHR - 'Blue Book') where the parent makes it available upon request.
Timepoint [10] 329724 0
Child age 6, 12, 18, 48 months
Secondary outcome [11] 329725 0
Maternal knowledge of SIDS risk factors assessed by parent self-report of three actions that can be taken to prevent SIDS, with researcher assessment of answers against current SIDS guidelines.
Timepoint [11] 329725 0
Child age 1, 6 months
Secondary outcome [12] 329726 0
Maternal social support assessed by parental self-report using items from the NSW Child Health Survey 2001.
Timepoint [12] 329726 0
Child age 1, 12, 24, 36, 48 months
Secondary outcome [13] 329727 0
Family functioning assessed by parental self-report using the McMaster Family Assessment Device
Timepoint [13] 329727 0
Child age 1, 12, 24, 36, 48 months
Secondary outcome [14] 329728 0
Household smoking assessed by parental self-report of household smoking behavior.
Timepoint [14] 329728 0
Child age 1, 12, 24, 36, 48 months
Secondary outcome [15] 330091 0
Child injury composite of parental self-report and hospitalization records of number of 6 month periods in which child experiences an injury requiring hospitalization, collated at 24 and 48 months.
Timepoint [15] 330091 0
Child age 6, 12, 18, 24, 36 and 48 months, collated at child age 24, 48 months
Secondary outcome [16] 330125 0
Child dental health: Significant Caries Index (SiC)) assessed by a trained Dental Hygienist
Timepoint [16] 330125 0
Child age 48 months

Eligibility
Key inclusion criteria
Mothers in Group A were eligible if they are pregnant with an Aboriginal infant, that is, they or the baby’s father are an Aboriginal person, and had one or more of the following vulnerability factors identified from the routine assessment:
Vulnerability factors: maternal age under 20 years; unsupported parent determined as those mothers who were not married or living with partner; late antenatal care (after 20 weeks); major stressors in the past 12 months determined by a positive response to the question “Have you had any major stressors, changes or losses recently?”; current or history of mental health problem or disorder determined by the mother reporting current or past treatment for emotional problems; current probable psychosocial distress determined by an Edinburgh Depression Scale score of 10 or more; relationship issues with the mother’s parents if they report that they were hurt or abused as a child in any way; current substance misuse will be determined by a positive response to questions about the use of prohibited substances and/or alcohol; history of domestic violence if they report that they get so angry that they hit or hurt their partner, that their partner or anyone else hits them, hurts them or makes them afraid.
Mothers in Group B were eligible if they were pregnant with a non-Aboriginal infant, that is, neither they nor the baby’s father are an Aboriginal person, and had one or more of the vulnerability factors described above.
Historical data for Group C were eligible if there were data available on the antenatal risk profile of mother, and they had any of the above risk factors.
Minimum age
15 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Mothers who had insufficient English-language proficiency to undertake the antenatal risk assessment in English (that is, those who required the use of a translated assessment instrument or an interpreter) were ineligible to participate.

Study design
Purpose of the study
Prevention
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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All families meeting eligibility are offered the intervention for intervention groups A and B. The comparator group is an historic control.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Recruitment of 149 subjects (Group A) and 82 (Group B) was achieved during the recruitment periods. A sample size of 75 subjects per intervention Group A and 132 subject in non-intervention Group C has power of .80 at the 95% level to detect a 5 point difference in the Griffiths Quotient (GQ), and a 5 week longer duration in breastfeeding.
All analyses will be intention to treat. Comparison of the adjusted treatment effects for primary outcomes (duration [number of weeks] of breastfeeding, child development and educational development) will be made using t-tests, comparing outcomes of (1) Aboriginal children who did (Group A) and did not receive SNHV (Group C), and (2) Aboriginal and non-Aboriginal children receiving SNHV (Group A compared with Group B). Patterns of difference in secondary outcomes between the three groups will be analysed using ChiSquare test for proportions (categorical data) and ANOVA (continuous data), together with 95% confidence intervals. Multilevel analyses will be used for analyses of secondary outcomes collected at multiple time points (eg. maternal health), with time at level 1 and the repeated outcome at level 2. Multiple regression analyses will be used to identify the impact of secondary measures as potential mediators of effects on the primary outcomes, for example, the impact of social support on the duration of breast feeding, and the impact of the quality of the home environment and maternal health on child development.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/10/2011
Date of last participant enrolment
Anticipated
Actual
20/12/2013
Date of last data collection
Anticipated
22/12/2017
Actual
23/07/2018
Sample size
Target
240
Accrual to date
Final
231
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7002 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 14732 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 295069 0
Government body
Name [1] 295069 0
National Health and Medical Research Council
Country [1] 295069 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 293879 0
University
Name [1] 293879 0
University of New South Wales
Address [1] 293879 0
UNSW Sydney NSW 2052
Country [1] 293879 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296411 0
South Western Sydney Local Health District
Ethics committee address [1] 296411 0
Ethics committee country [1] 296411 0
Australia
Date submitted for ethics approval [1] 296411 0
26/07/2010
Approval date [1] 296411 0
26/11/2010
Ethics approval number [1] 296411 0
HREC/10/LPOOL/98
Ethics committee name [2] 296412 0
Aboriginal Health and Medical Research Council of NSW
Ethics committee address [2] 296412 0
Ethics committee country [2] 296412 0
Australia
Date submitted for ethics approval [2] 296412 0
20/07/2010
Approval date [2] 296412 0
23/08/2010
Ethics approval number [2] 296412 0
739/10
Ethics committee name [3] 296413 0
South Western Sydney Local Health District
Ethics committee address [3] 296413 0
Ethics committee country [3] 296413 0
Australia
Date submitted for ethics approval [3] 296413 0
22/06/2015
Approval date [3] 296413 0
23/09/2015
Ethics approval number [3] 296413 0
HREC/15/LPOOL/361

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

Contacts
Principal investigator
Name 70802 0
Prof Lynn Kemp
Address 70802 0
TReSI Group
Ingham Institute
Level 3, 1 Campbell Street
Liverpool NSW 2170
Country 70802 0
Australia
Phone 70802 0
+61 2 87389387
Fax 70802 0
Email 70802 0
lynn.kemp@westernsydney.edu.au
Contact person for public queries
Name 70803 0
Lynn Kemp
Address 70803 0
TReSI Group
Ingham Institute
Level 3, 1 Campbell Street
Liverpool NSW 2170
Country 70803 0
Australia
Phone 70803 0
+61287389387
Fax 70803 0
Email 70803 0
lynn.kemp@westernsydney.edu.au
Contact person for scientific queries
Name 70804 0
Lynn Kemp
Address 70804 0
TReSI Group
Ingham Institute
Level 3, 1 Campbell Street
Liverpool NSW 2170
Country 70804 0
Australia
Phone 70804 0
+61287389387
Fax 70804 0
Email 70804 0
lynn.kemp@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Aboriginal data that is owned and controlled by the Aboriginal community. No sharing is possible without their direct consent.


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
SourceTitleYear of PublicationDOI
EmbaseThe effectiveness of a sustained nurse home visiting intervention for Aboriginal infants compared with non-Aboriginal infants and with Aboriginal infants receiving usual child health care: a quasi-experimental trial - the Bulundidi Gudaga study.2018https://dx.doi.org/10.1186/s12913-018-3394-1
N.B. These documents automatically identified may not have been verified by the study sponsor.