Condition category
Pregnancy and Childbirth
Date applied
06/07/2006
Date assigned
10/07/2006
Last edited
21/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

Approval received by the University of Reading ethics and research committee on the 21st October 1999 (ref: 99/20) and the University of Cape Town Medical School research ethics committee on the 2nd Febraury 1998 (ref: 180/97).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient 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 six and 12 months (sensitivity, positive effect, intrusiveness)
2. Security of infant attachment at 18 months

Secondary outcome measures

Maternal depression at six and 12 months postpartum.

Overall trial start date

01/01/2000

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Participants are 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

No exclusion criteria.

Recruitment start date

01/01/2000

Recruitment end date

31/12/2006

Locations

Countries of recruitment

South Africa

Trial participating centre

School of Psychology and Clinical Language Sciences
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

http://www.reading.ac.uk

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 057243)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

  1. 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.

Additional files

Editorial Notes