A controlled trial of a community based mother-infant intervention in a South African peri-urban settlement

ISRCTN	ISRCTN25664149
DOI	https://doi.org/10.1186/ISRCTN25664149
Protocol serial number	057243; B574100
Sponsor	The University of Reading (UK)
Funder	Wellcome Trust (grant ref: 057243)

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

School of Psychology and Clinical Language Sciences
University of Reading
Reading
RG6 6AL
United Kingdom

Phone	+44 (0)118 378 6617
Email	p.j.cooper@rdg.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	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(s)	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
Key secondary outcome measure(s)	Maternal depression at 6 and 12 months postpartum
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

United Kingdom
England
South Africa

Study participating centre

University of Reading

Reading
RG6 6AL
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

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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

01/03/2017: Publication reference added.