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 |
| Protocol serial number | HTA 95/07/19 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
Scientific
Social Science Research Unit
London University Inst of Education
18 Woburn Square
London
WC1H 0NR
United Kingdom
| Phone | +44 (0)20 7612 6391 |
|---|---|
| a.oakley@ioe.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
The primary outcome measures (child injury, parental smoking, maternal psychological ill health) are important causes of mortality, morbidity and costs to the NHS. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/08/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Social Science Research Unit
London
WC1H 0NR
United Kingdom
WC1H 0NR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
