Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000275369
Ethics application status
Approved
Date submitted
15/05/2008
Date registered
29/05/2008
Date last updated
12/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Babies, Bright Futures: Evaluation of the South Australian Family Home Visiting Program
Scientific title
Does the South Australian Family Home Visiting Program improve maternal and infant health and well-being?
Secondary ID [1] 283489 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infant general health, development, communication, environment, and behaviour. Maternal parenting practices, well-being, social support, service use, and children's school readiness at 5 years of age. 3131 0
Condition category
Condition code
Public Health 3293 3293 0 0
Health service research
Public Health 3294 3294 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The South Australian Family Home Visiting Program is a targeted intervention. Participating mothers and infants receive 34 planned home visits delivered by specially trained nurses, commencing when infants are aged 2 to 3 months and finishing when they are aged 2 years.

Goals of the program include (1) enhancing the mental and physical health of children, parents, and families, (2) enhancing the cognitive, social and emotional well-being of children and their families, (3) assisting families in providing a safe and supportive environment for their children, and (4) linking families to available resources and networks within the community.

Longer term goals when children are aged 5 years include (1) better 'school readiness' for children, and (2) better quality relationships between children and their mothers and teachers..
Intervention code [1] 2873 0
Prevention
Comparator / control treatment
Mothers and infants who meet criteria for entry to the SA Family Home Visiting Program, but who live in a region where the program is not yet available
Control group
Active

Outcomes
Primary outcome [1] 4180 0
Infant Outcomes
Social & emotional development: Ages and Stages Questionnaire-Social/Emotional AND
Infant general health: measures from the Longitudinal Study of Australian children
Timepoint [1] 4180 0
When infants are aged 3, 9, 18 and 24 months
Primary outcome [2] 4181 0
Infant Outcomes
Communicative ability / development: Communication & Symbolic Behaviour Scales-Infant/Toddler Checklist AND
Quality & quantity of environmental stimulation: Infant/Toddler-Home Observation for Measurement of the Environment
Timepoint [2] 4181 0
When infants are aged 9, 18 and 24 months
Primary outcome [3] 4182 0
Maternal Outcomes
Parenting: Parenting Stress Index (selected scales) & measures from the Longitudinal Study of Australian Children

Maternal Mental Health: Patient Health Questionnaire-Depression Module and Kessler Psychological Distress Scale

Health-Risk Behaviours: measures from the Longitudinal Study of Australian Children

Family & Community Social Support & Service Use: Measures from the Longitudinal Study of Australian Children
Timepoint [3] 4182 0
When infants are aged 3, 9, 18 & 24 months
Secondary outcome [1] 7066 0
Child outcomes: "School readiness" Australian Early Development Index (AEDI); Behaviour Rating Inventory of Executive Functioning; Child-Parent and Student-Teacher Relationship Scales; Child Behavior Checklist
Timepoint [1] 7066 0
When children are aged 5 years.
Secondary outcome [2] 319227 0
Maternal outcomes Parenting: Parenting Stress Index (selected scales); Patient Health Questionnaire-Depression Module and Kessler Psychological Distress Scale.
Timepoint [2] 319227 0
When children are aged 5 years.

Eligibility
Key inclusion criteria
Mothers and infants who have the characteristics that may make them eligible for the SA Family Home Visiting Program
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Families who are too distressed 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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2008
Actual
4/06/2008
Date of last participant enrolment
Anticipated
Actual
3/02/2011
Date of last data collection
Anticipated
Actual
5/06/2015
Sample size
Target
900
Accrual to date
Final
891
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3369 0
Government body
Name [1] 3369 0
Strategic Health Research Fund, Department of Health
Country [1] 3369 0
Australia
Funding source category [2] 3370 0
Charities/Societies/Foundations
Name [2] 3370 0
Australian Rotary Health Research Fund
Country [2] 3370 0
Australia
Funding source category [3] 292474 0
Charities/Societies/Foundations
Name [3] 292474 0
Channel 7 Children's Research Foundation
Country [3] 292474 0
Australia
Primary sponsor type
Hospital
Name
Children, Youth and Women's Health Service
Address
Women's and Children's Hospital
72 King William Road
NORTH ADELAIDE SA 5006
Country
Australia
Secondary sponsor category [1] 3015 0
University
Name [1] 3015 0
University of Adelaide
Address [1] 3015 0
South Australia
Country [1] 3015 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5394 0
Children, Youth and Women's Health Service Ethics Committee
Ethics committee address [1] 5394 0
Women's and Children's Hospital
72 King William Road
NORTH ADELAIDE SA 5006
Ethics committee country [1] 5394 0
Australia
Date submitted for ethics approval [1] 5394 0
Approval date [1] 5394 0
25/02/2008
Ethics approval number [1] 5394 0
REC2029/12/16

Summary
Brief summary
The aim of this project is to evaluate the extent to which the SA Family Home Visiting Program improves the health and well-being of mothers and infants during the two years after families enroll in the program.
To evaluate the longer term effectiveness of the program when children are age 5 years.
Trial website
Trial related presentations / publications
Sawyer MG, Borojevic N, Lynch J. The challenges of providing effective support for young children and their families: Examples from the Family Home Visiting Program in South Australia and the Family Nurse Partnership in the UK. Public Health Bulletin SA, 2010; 7(3):44-48.

Sawyer MG, Frost L, Bowering K, Lynch J. Effectiveness of nurse home-visiting for disadvantaged families: results of a natural experiment. BMJ Open, 2013; 3(4): e002720. doi:10.1136/bmjopen-2013-002720

Sawyer MG, Barnes J, Frost L, Jeffs D, Bowering K, Lynch J. Nurse perceptions of family home-visiting programmes in Australia and England. Journal of Paediatrics and Child Health, 2013; 49(5):369-374

Sawyer AC, Lynch J, Bowering K, Jeffs D, Clark J, Mpundu-Kaambwa, Sawyer M. An equivalence evaluation of a nurse-moderated group-based internet support program for new mothers versus standard care: A pragmatic preference randomised controlled trial. BMC Pediatrics, 2014; 14(14):119

Sawyer M, Pfeiffer, S, Sawyer A, Bowering K, Jeffs D, Lynch J. Effectiveness of nurse home-visiting for families in rural South Australia. Journal of Paediatrics and Child Health. 2014, 50(12): 1013-1022 (doi: 10.1111/jpc.12679)
Public notes

Contacts
Principal investigator
Name 28579 0
Prof Michael Sawyer
Address 28579 0
Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia 5006
Country 28579 0
Australia
Phone 28579 0
+61 8 8161 7207
Fax 28579 0
Email 28579 0
michael.sawyer@adelaide.edu.au
Contact person for public queries
Name 11736 0
Jenny Sawyer
Address 11736 0
Research and Evaluation Unit
Women's and Children's Hospital
72 King William Rd
NORTH ADELAIDE SA 5006
Country 11736 0
Australia
Phone 11736 0
8161 7207
Fax 11736 0
Email 11736 0
Jennifer.clark@adelaide.edu.au
Contact person for scientific queries
Name 2664 0
Professor Michael Sawyer
Address 2664 0
Research and Evaluation Unit
Women's and Children's Hospital
72 King William Rd
NORTH ADELAIDE SA 5006
Country 2664 0
Australia
Phone 2664 0
8161 7207
Fax 2664 0
Email 2664 0
michael.sawyer@adelaide.edu.au

No information has been provided regarding IPD availability


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
Dimensions AIEffectiveness of nurse home-visiting for disadvantaged families: results of a natural experiment2013https://doi.org/10.1136/bmjopen-2013-002720
N.B. These documents automatically identified may not have been verified by the study sponsor.