Contact information
Type
Scientific
Primary contact
Prof Ann Oakley
ORCID ID
Contact details
Social Science Research Unit
London University Inst of Education
18 Woburn Square
London
WC1H 0NR
United Kingdom
+44 (0)20 7612 6391
a.oakley@ioe.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 95/07/19
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Mental and behavioural disorders
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary outcome measures (child injury, parental smoking, maternal psychological ill health) are important causes of mortality, morbidity and costs to the NHS.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/1998
Overall trial end date
31/08/2001
Reason abandoned
Eligibility
Participant inclusion criteria
Families with infants living in a disadvantaged inner city area
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
731
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/1998
Recruitment end date
31/08/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Social Science Research Unit
London
WC1H 0NR
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2004 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/15298823
Publication citations
-
HTA monograph
Wiggins M, Oakley A, Roberts I, Turner H, Rajan L, Austerberry H, Mujica R, Mugford M, The Social Support and Family Health Study: a randomised controlled trial and economic evaluation of two alternative forms of postnatal support for mothers living in disadvantaged inner-city areas., Health Technol Assess, 2004, 8, 32, iii, ix-x, 1-120.