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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
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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
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Secondary ID [1]
710
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Nil
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Universal Trial Number (UTN)
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Trial acronym
MECSH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
child development
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child health
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Condition category
Condition code
Public Health
3823
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Prevention
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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mean scores on Bayley Scales of Infant Development
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Assessment method [1]
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Timepoint [1]
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at child age 18 and 30 months
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Primary outcome [2]
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mean score on Wechsler Preschool & Primary Scale of Intelligence - Australian Standardisation (WPPSI-III Australian)
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Assessment method [2]
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Timepoint [2]
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at 6 months post child entry to formal schooling
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Primary outcome [3]
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number of inpatient and outpatient hospital separations
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Assessment method [3]
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Timepoint [3]
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at child age 24 months
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Secondary outcome [1]
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mean child behaviour and psychological attribute scores measured using Strengths and Difficulties Questionnaire
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Assessment method [1]
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Timepoint [1]
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at child age 4 years and 6 months post entry to formal schooling
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Secondary outcome [2]
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mean National Institute of Child Health and Development (NICHD) parent child interaction scores
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Assessment method [2]
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Timepoint [2]
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at child age 18 and 30 months
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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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Poor English requiring an interpreter or no telephone
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/03/2003
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Actual
3/02/2003
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Date of last participant enrolment
Anticipated
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Actual
31/03/2005
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
190
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Accrual to date
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Final
208
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Australian Research Council
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Address [1]
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1st Floor, 8 Brindabella Circuit
Brindabella Business Park
Canberra Airport ACT 2609
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of NSW
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Address
University of NSW
Sydney NSW 2052
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Sydney South West Area Health Service
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Address [1]
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Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
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Country [1]
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Australia
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Secondary sponsor category [2]
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Government body
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Name [2]
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NSW Department of Health
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Address [2]
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Locked Mail Bag 961
North Sydney NSW 2059
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Country [2]
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Australia
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Secondary sponsor category [3]
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Government body
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Name [3]
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NSW Department of Community Services
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Address [3]
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Locked Bag 4028
Ashfield NSW 2131
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Country [3]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney South West Area Health Service (WZ) Human Research Ethics Committee
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Ethics committee address [1]
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Locked Bag 7103
Liverpool BC NSW 1871
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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20/11/2002
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Ethics approval number [1]
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02/119
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Ethics committee name [2]
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University of NSW Human Research Ethics Committee
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Ethics committee address [2]
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University of NSW
Sydney NSW 2052
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
5889
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Approval date [2]
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10/12/2002
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Ethics approval number [2]
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02382
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Ethics committee name [3]
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NSW Department of Education and Training
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Ethics committee address [3]
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GPO Box 33
Sydney NSW 2001
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Ethics committee country [3]
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Australia
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Date submitted for ethics approval [3]
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Approval date [3]
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29/08/2008
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Ethics approval number [3]
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2008027
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Summary
Brief summary
Home visiting programs comprising intensive and sustained nurse home visits over the entire first two years of life (SNHV) show promise as interventions to promote child health and family functioning, and ameliorate disadvantage. This study is the first Australian randomised trial to determine the impact of a comprehensive SNHV program commencing antenatally in a population group living in an area of known disadvantage. As such this trial is a best-practice demonstration model for professional home visiting in Australia, with significant implications for the development of early childhood policy and strategy throughout Australia.
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Trial website
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Trial related presentations / publications
Kemp L, Harris E, McMahon C, Matthey S, Vimpani G, Anderson T, Schmied V, Aslam H, Zapart S. (2011) Child and family outcomes of a long-term nurse home visitation program: a randomised controlled trial. Archives of Disease in Childhood 96:533-540.
Kemp L, Harris E. (2012) The challenges of establishing and researching a sustained nurse home visiting programme within the universal child and family health service system. Journal of Research in Nursing 17:139-141.
Kemp L, Harris E, McMahon C, Matthey S, Vimpani G, Anderson T, Schmied V, Aslam H. (2013) Benefits of psychosocial intervention and continuity of care by child and family health nurses in the pre and postnatal period: Process evaluation. Journal of Advanced Nursing 69(8), 1850-1861.
Zapart S, Knight J, Kemp L (2016) ‘It was easier because I had help’: mothers’ reflections on the long-term impact of sustained nurse home visiting. Maternal and Child Health Journal 20(1)196-204.
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Public notes
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Contacts
Principal investigator
Name
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Prof Lynn Kemp
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Address
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TReSI, Ingham Institute
Western Sydney University
I Campbell St
Liverpool NSW 2170
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Country
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Australia
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Phone
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+61 2 87389394
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Lynn Kemp
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Address
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TReSI, Ingham Institute
Western Sydney University
I Campbell St
Liverpool NSW 2170
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Country
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Australia
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Phone
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+61 2 87389394
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Fax
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+61 2 96120762
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Lynn Kemp
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Address
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TReSI, Ingham Institute
Western Sydney University
I Campbell St
Liverpool NSW 2170
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Country
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Australia
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Phone
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+61 2 87389394
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Fax
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+61 2 96120762
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Dimensions AI
Paths to language development in at risk children: a qualitative comparative analysis (QCA)
2019
https://doi.org/10.1186/s12887-019-1449-z
N.B. These documents automatically identified may not have been verified by the study sponsor.
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