A controlled trial of a community based mother-infant intervention in a South African peri-urban settlement
ISRCTN | ISRCTN25664149 |
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DOI | https://doi.org/10.1186/ISRCTN25664149 |
Secondary identifying numbers | 057243; B574100 |
- Submission date
- 06/07/2006
- Registration date
- 10/07/2006
- Last edited
- 01/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Peter Cooper
Scientific
Scientific
School of Psychology and Clinical Language Sciences
University of Reading
Reading
RG6 6AL
United Kingdom
Phone | +44 (0)118 378 6617 |
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p.j.cooper@rdg.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Home |
Study type | Quality of life |
Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
Scientific title | A controlled trial of a community based mother-infant intervention in a South African peri-urban settlement |
Study objectives | Compared to a no treatment control group, a mother-infant intervention which provides emotional support and sensitises mothers to infant communicative capacities will lead to more sensitive maternal interactions with more expressions of positive affect and less intrusive behaviour. This will also lead to a higher rate of securely attached infants and, secondarily, will reduce maternal depression. |
Ethics approval(s) | 1. University of Reading ethics and research committee, 21/10/1999, ref: 99/20 2. University of Cape Town Medical School research ethics committee, 02/02/1998, ref: 180/97 |
Health condition(s) or problem(s) studied | Pregnancy |
Intervention | An index intervention is compared with no intervention. All pregnant women within a defined area of Khayelitsha will be randomised to a no treatment control group or the index intervention. The intervention, which runs from late pregnancy until six months postpartum, involves two antenatal and 13 postnatal home visits by community workers trained to provide emotional support and to sensitise mothers to infant communicative capacities. Assessments are made at six, 12 and 18 months postpartum. |
Intervention type | Other |
Primary outcome measure | 1. The quality of the mother-infant relationship at 6 and 12 months (sensitivity, positive effect, intrusiveness) 2. Security of infant attachment at 18 months |
Secondary outcome measures | Maternal depression at 6 and 12 months postpartum |
Overall study start date | 01/01/2000 |
Completion date | 31/12/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 300 |
Key inclusion criteria | Pregnant women within a defined area of Khayelitsha, a peri-urban settlement on the outskirts of Cape Town |
Key exclusion criteria | Does not meet inclusion criteria |
Date of first enrolment | 01/01/2000 |
Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- England
- South Africa
- United Kingdom
Study participating centre
University of Reading
Reading
RG6 6AL
United Kingdom
RG6 6AL
United Kingdom
Sponsor information
The University of Reading (UK)
University/education
University/education
Whiteknights
Reading
RG6 6AL
England
United Kingdom
Phone | +44 (0)118 378 6617 |
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p.j.cooper@rdg.ac.uk | |
Website | http://www.reading.ac.uk |
https://ror.org/05v62cm79 |
Funders
Funder type
Charity
Wellcome Trust (grant ref: 057243)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 14/04/2009 | Yes | No | |
Results article | results | 28/02/2017 | Yes | No |
Editorial Notes
01/03/2017: Publication reference added.