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 childrens emotion recognition abilities and the quality of mothers 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
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
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