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Trial registered on ANZCTR


Registration number
ACTRN12608000473369
Ethics application status
Approved
Date submitted
9/09/2008
Date registered
23/09/2008
Date last updated
28/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects on environmental, child, maternal and family outcomes for children born to at risk mothers (who have one or more risk factors for poorer parental coping) receiving sustained nurse home visiting compared with usual care
Scientific title
Effects on environmental, child, maternal and family outcomes for children born to at risk mothers (who have one or more risk factors for poorer parental coping) receiving sustained nurse home visiting compared with usual care
Secondary ID [1] 710 0
Nil
Universal Trial Number (UTN)
Trial acronym
MECSH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
child development 3655 0
child health 3656 0
Condition category
Condition code
Public Health 3823 3823 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sustained nurse home visiting commencing in the second trimester of pregnancy and continuing to child-age 2 years. Each mother receives 25 visits of 1 hour duration. During visits the nurse provides education and support for the mother and family to enhance their coping and problem solving skills and ability to mobilise resources; foster positive parenting skills; establish supportive relationships in their community; mentor maternal-infant bonding and attachment; and provide primary health care and health education, including but not limited to immunisation, Sudden Infant Death Syndrome risk reduction, infant nutrition and child safety.
Intervention code [1] 3371 0
Prevention
Comparator / control treatment
Standard treatment of one postnatal home visit by a child health nurse from the local community-based primary health care service, additional postnatal or clinic visits with the local primary health care service and access to early childhood services within the local area.
Control group
Active

Outcomes
Primary outcome [1] 4720 0
mean scores on Bayley Scales of Infant Development
Timepoint [1] 4720 0
at child age 18 and 30 months
Primary outcome [2] 4721 0
mean score on Wechsler Preschool & Primary Scale of Intelligence - Australian Standardisation (WPPSI-III Australian)
Timepoint [2] 4721 0
at 6 months post child entry to formal schooling
Primary outcome [3] 4722 0
number of inpatient and outpatient hospital separations
Timepoint [3] 4722 0
at child age 24 months
Secondary outcome [1] 7969 0
mean child behaviour and psychological attribute scores measured using Strengths and Difficulties Questionnaire
Timepoint [1] 7969 0
at child age 4 years and 6 months post entry to formal schooling
Secondary outcome [2] 7970 0
mean National Institute of Child Health and Development (NICHD) parent child interaction scores
Timepoint [2] 7970 0
at child age 18 and 30 months

Eligibility
Key inclusion criteria
Pregnant women, and English speaking, and
Resident in New South Wales, Australia postcode area 2168, and One or more risk factors for poorer parental coping from maternal self report of expected lack of practical and emotional support, stressors in the past 12 months, personality, mental health, history of abuse in the mother’s childhood, and family violence, or Current probably distress measured as Edinburgh Depression Scale score of 10 or more
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Poor English requiring an interpreter or no telephone

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible participants were identified by the Senior Research Officer (SRO) who was provided daily with the records of all new women booking into hospital for pregnancy care. Details of eligible women were entered by the SRO onto a central database and a random selection of cases to receive intervention was made using computer.
Allocation was concealed from all intervention and research staff until after mothers consented to participate in the study and baseline data had been collected by the research assistant who was blinded to the allocation. After baseline measures were completed, women were given a sealed opaque envelope that contained information advising them of their group assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A permuted block design was used to randomly allocate mothers to the intervention or comparison group. Blocks were based on the weekly intake of eligible clients at the antenatal clinic and varied in size. Within each weekly block, a random selection of cases to receive intervention was made using the computer program Statistical Package for the Social Sciences (SPSS).
Masking / blinding
Blinded (masking 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
1/03/2003
Actual
3/02/2003
Date of last participant enrolment
Anticipated
Actual
31/03/2005
Date of last data collection
Anticipated
Actual
Sample size
Target
190
Accrual to date
Final
208
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 3836 0
Government body
Name [1] 3836 0
Australian Research Council
Country [1] 3836 0
Australia
Primary sponsor type
University
Name
University of NSW
Address
University of NSW
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 3445 0
Hospital
Name [1] 3445 0
Sydney South West Area Health Service
Address [1] 3445 0
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country [1] 3445 0
Australia
Secondary sponsor category [2] 3446 0
Government body
Name [2] 3446 0
NSW Department of Health
Address [2] 3446 0
Locked Mail Bag 961
North Sydney NSW 2059
Country [2] 3446 0
Australia
Secondary sponsor category [3] 3447 0
Government body
Name [3] 3447 0
NSW Department of Community Services
Address [3] 3447 0
Locked Bag 4028
Ashfield NSW 2131
Country [3] 3447 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5888 0
Sydney South West Area Health Service (WZ) Human Research Ethics Committee
Ethics committee address [1] 5888 0
Ethics committee country [1] 5888 0
Australia
Date submitted for ethics approval [1] 5888 0
Approval date [1] 5888 0
20/11/2002
Ethics approval number [1] 5888 0
02/119
Ethics committee name [2] 5889 0
University of NSW Human Research Ethics Committee
Ethics committee address [2] 5889 0
Ethics committee country [2] 5889 0
Australia
Date submitted for ethics approval [2] 5889 0
Approval date [2] 5889 0
10/12/2002
Ethics approval number [2] 5889 0
02382
Ethics committee name [3] 5890 0
NSW Department of Education and Training
Ethics committee address [3] 5890 0
Ethics committee country [3] 5890 0
Australia
Date submitted for ethics approval [3] 5890 0
Approval date [3] 5890 0
29/08/2008
Ethics approval number [3] 5890 0
2008027

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

Contacts
Principal investigator
Name 28910 0
Prof Lynn Kemp
Address 28910 0
TReSI, Ingham Institute
Western Sydney University
I Campbell St
Liverpool NSW 2170
Country 28910 0
Australia
Phone 28910 0
+61 2 87389394
Fax 28910 0
Email 28910 0
lynn.kemp@westernsydney.edu.au
Contact person for public queries
Name 12067 0
Lynn Kemp
Address 12067 0
TReSI, Ingham Institute
Western Sydney University
I Campbell St
Liverpool NSW 2170
Country 12067 0
Australia
Phone 12067 0
+61 2 87389394
Fax 12067 0
+61 2 96120762
Email 12067 0
lynn.kemp@westernsydney.edu.au
Contact person for scientific queries
Name 2995 0
Lynn Kemp
Address 2995 0
TReSI, Ingham Institute
Western Sydney University
I Campbell St
Liverpool NSW 2170
Country 2995 0
Australia
Phone 2995 0
+61 2 87389394
Fax 2995 0
+61 2 96120762
Email 2995 0
l.kemp@unsw.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 AIPaths to language development in at risk children: a qualitative comparative analysis (QCA)2019https://doi.org/10.1186/s12887-019-1449-z
N.B. These documents automatically identified may not have been verified by the study sponsor.