Condition category
Mental and Behavioural Disorders
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
28/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/en/index.htm

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

  1. 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.

Additional files

Editorial Notes