Randomised controlled trial and economic evaluation of two alternative strategies of providing support for socially disadvantaged inner city families with infants

ISRCTN	ISRCTN35514992
DOI	https://doi.org/10.1186/ISRCTN35514992
Secondary identifying numbers	HTA 95/07/19

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 08/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ann Oakley
Scientific

Social Science Research Unit
London University Inst of Education
18 Woburn Square
London
WC1H 0NR
United Kingdom

Phone	+44 (0)20 7612 6391
Email	a.oakley@ioe.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Scientific title	Randomised controlled trial and economic evaluation of two alternative strategies of providing support for socially disadvantaged inner city families with infants
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/09/1998
Completion date	31/08/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	731
Key inclusion criteria	Families with infants living in a disadvantaged inner city area
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/09/1998
Date of final enrolment	31/08/2001

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Social Science Research Unit

London
WC1H 0NR
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	HTA monograph	01/08/2004		Yes	No

Editorial Notes

08/11/2022: Internal review.