Contact information
Type
Scientific
Primary contact
Prof Peter Cooper
ORCID ID
Contact details
School of Psychology and Clinical Language Sciences
University of Reading
Reading
RG6 6AL
United Kingdom
+44 (0)118 378 6617
p.j.cooper@rdg.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
057243; B574100
Study information
Scientific title
A controlled trial of a community based mother-infant intervention in a South African peri-urban settlement
Acronym
Study hypothesis
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
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
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/01/2000
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Pregnant women within a defined area of Khayelitsha, a peri-urban settlement on the outskirts of Cape Town
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
300
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/01/2000
Recruitment end date
31/12/2006
Locations
Countries of recruitment
South Africa
Trial participating centre
University of Reading
Reading
RG6 6AL
United Kingdom
Sponsor information
Organisation
The University of Reading (UK)
Sponsor details
Whiteknights
Reading
RG6 6AL
United Kingdom
+44 (0)118 378 6617
p.j.cooper@rdg.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust (grant ref: 057243)
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
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
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19366752
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28245280
Publication citations
-
Results
Cooper PJ, Tomlinson M, Swartz L, Landman M, Molteno C, Stein A, McPherson K, Murray L, Improving quality of mother-infant relationship and infant attachment in socioeconomically deprived community in South Africa: randomised controlled trial., BMJ, 2009, 338, b974.