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ISRCTN
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ISRCTN35514992
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial and economic evaluation of two alternative strategies of providing support for socially disadvantaged inner city families with infants
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Scientific title
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Acronym
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N/A
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Serial number at source
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HTA 95/07/19
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Study hypothesis
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The proposed study will quantify the effectiveness and cost effectiveness of two alternative strategies of providing support for socially disadvantaged inner city families with infants. Families with infants living in a disadvantaged inner city area will be randomly allocated to receive either a home based support programme delivered by a research health visitor, a support programme provided by community based family support organisations, or standard services. The intervention will start when infants are approximately six weeks old and will continue for one year. The primary outcome measures (child injury, parental smoking, maternal psychological ill health) are important causes of mortality, morbidity and costs to the NHS.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Mental and behavioural disorders
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Participants - inclusion criteria
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Families with infants living in a disadvantaged inner city area
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/09/1998
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Anticipated end date
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31/08/2001
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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731
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Interventions
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1. Home based support programme delivered by a research health visitor
2. A support programme provided by community based family support organisations
3. Standard services
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Primary outcome measure(s)
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The primary outcome measures (child injury, parental smoking, maternal psychological ill health) are important causes of mortality, morbidity and costs to the NHS.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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2004 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/15298823
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Contact name
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Prof
Ann
Oakley
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Address
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Social Science Research Unit
London University Inst of Education
18 Woburn Square
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City/town
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London
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Zip/Postcode
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WC1H 0NR
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Country
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United Kingdom
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Tel
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+44 (0)20 7612 6391
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Fax
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+44 (0)20 7612 6400
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Email
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a.oakley@ioe.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Tel
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+44 (0)1132 545 843
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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28/08/2009
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Date ISRCTN assigned
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25/04/2003
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