Condition category
Mental and Behavioural Disorders
Date applied
23/07/2012
Date assigned
26/07/2012
Last edited
08/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
It is clear that children in South Africa are struggling at school and are failing to achieve good grades, especially in reading. We know from studies in other countries, that training mothers how to share books with their babies improves infants' language and literacy. This study tests whether mothers in Khayelitsha can be trained in good book sharing practices and whether this has an impact on their babies’ language and attention skills. As secondary aims, we will investigate whether such training impacts children’s emotion recognition abilities and the quality of mother’s general interactive behaviours.

Who can participate?
Mothers resident in the Khayelitsha area who have a baby aged 14 to 16 months old.

What does the study involve?
Participants will attend training sessions at our research centre on a weekly basis over the course of 8 weeks. They will receive both group lectures and individual sessions with our trainers. They will also be asked to attend an assessment session before starting the training and another immediately after the last training session.

What are the possible benefits and risks of participating?
There are considerable benefits anticipated both for mother and for child: children'’s expressive and receptive vocabulary, attention, and emotion recognition is expected to improve while mothers are expected to become more sensitive, responsive, and attuned to their infants. There are no risks associated with participation in this study.

Where is the study run from?
At our research centre at Grassroots Football in Khayelitsha

When is the study starting and how long is it expected to run for?
July 2012 to May 2013

Who is funding the study?
The study is funded by the DG Murray Trust, Constable & Robinson Publishing, and the Felix Foundation.

Who is the main contact?
Mr Zahir Vally
zvally@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peter Cooper

ORCID ID

Contact details

University of Reading
Winnicott Research Unit
Reading
RG6 6AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MIBSA1

Study information

Scientific title

Promoting Mother-Infant Book sharing: a randomized controlled trial in Khayelitsha, South Africa

Acronym

MIBSA

Study hypothesis

A study will be conducted to determine the efficacy of a program to train mothers in Khayelitsha in sharing books with their infants. We hypothesize that training mothers in good book sharing practices will promote their babies' language development, improve infant attention, as well as infant emotion recognition. Furthermore, we hypothesize that training mothers in Khayelitsha in good book-sharing practices with their infants will improve the general quality of maternal interactive behaviours.

Ethics approval

1. University Research Ethics Committee, School of Psychology & Clinical Language Sciences, University of Reading, UK, 14/03/2012, ref: 2012/007/PC
2. Stellenbosch University Research Ethics Committee, South Africa, May 2013, ref: S12/04/088

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Infant cognitive development

Intervention

There will be two groups: an index group who will receive a book sharing training program and a waitlist control group. The intervention involves weekly training sessions run over 8 weeks.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Child language (i.e. vocabulary and comprehension) assessed as a count at the end of the training phase.
2. Infant attention assessed by two means:
2.1. The longest bout of attention and quality of attention measured during a 5 minute segment of free play and book-sharing
2.2. The longest bout of sustained attention during a computerized vigilance task

Secondary outcome measures

1. Maternal book-sharing practices (i.e. ratings of video-taped episodes of book sharing for maternal sensitivity and facilitation, and pointing, repetitions, and elaborations) assessed as ordinal variables (and, where appropriate, counts) at the end of the training phase.
2. Maternal general interactive behaviours (i.e. ratings of video-taped episodes of joint play for sensitivity, facilitation, and reciprocity) assessed as ordinal variables at the end of the training phase.
3. Infant emotion recognition (i.e. a count of the number of correct child emotions identified (i.e. happy, sad, angry, and fearful).

Overall trial start date

30/07/2012

Overall trial end date

30/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Able (in the investigators opinion) and willing to comply with all study requirements
2. Primary caregiver is able to attend sessions – this may be the mother, father, grandparent, aunt, or other carer
3. Mother is willing and able to give informed consent for participation in the study
4. Mother/ primary caregiver, aged 16 years or above
5 Infant is aged 14, 15, or 16 months old at the time of the first assessment
6. Resident in one of the four catchment areas

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Children which have significant physical or established intellectual impairment
2. Carers suffering from a significant physical or psychiatric condition which would impair their ability to engage in the program

Recruitment start date

30/07/2012

Recruitment end date

30/06/2013

Locations

Countries of recruitment

South Africa

Trial participating centre

University of Reading
Reading
RG6 6AL
United Kingdom

Sponsor information

Organisation

University of Reading (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.reading.ac.uk/

Funders

Funder type

Charity

Funder name

The DG Murray Trust (South Africa)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Constable & Robinson Publishing (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Felix Foundation (USA)

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25399699

Publication citations

Additional files

Editorial Notes

08/04/2016: Publication reference added.