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
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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Home
Study typeQuality of life
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleA controlled trial of a community based mother-infant intervention in a South African peri-urban settlement
Study objectivesCompared 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) studiedPregnancy
InterventionAn 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 typeOther
Primary outcome measure1. 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 measuresMaternal depression at 6 and 12 months postpartum
Overall study start date01/01/2000
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants300
Key inclusion criteriaPregnant women within a defined area of Khayelitsha, a peri-urban settlement on the outskirts of Cape Town
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/01/2000
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • England
  • South Africa
  • United Kingdom

Study participating centre

University of Reading
Reading
RG6 6AL
United Kingdom

Sponsor information

Funders

Funder type

Charity

Wellcome Trust (grant ref: 057243)
Private sector organisation / International organizations
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.

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