Plain English Summary
Background and study aims
The importance of the first 5 years of life for long-term development is well-established. During this vital period the development of children living in poverty is hindered by malnutrition, illness and unstimulating home environments. Evidence shows that interventions in early childhood can be very important for psychosocial development. However, they are often delivered by experts and hence expensive and not feasible to expand widely. We will implement and evaluate a cost-effective intervention – based on Grantham-McGregor’s curriculum and delivered by local women through weekly home visits over 18 months – targeted to children aged 10-20 months and their mothers/primary caregivers. The intervention aims to promote early child development and maternal-child interactions in a very poor urban environment.
Who can participate?
Children aged 10-20 months and their mothers/primary caregivers from the 54 slums in Cuttack, Odisha, India.
What does the study involve?
The 54 slums will be randomly allocated to either the intervention or the control group. The intervention group will receive weekly home visits lasting around one hour. The 'home visitors' will be local women and will follow the Grantham-McGregors curriculum and protocols specially adapted for the context of Odisha. They will interact with carers and children and will discuss the importance of stimulation and play for child development with the carer. The control group will receive no intervention. We will assess child development and conduct household and slum surveys before and after the intervention. We will also obtain detailed information on the quality of the home environment.
What are the possible benefits and risks of participating?
Benefits to participants include information on the child's development and also, within the intervention households, advice on how to improve child development. We do not foresee any risks for study participants.
Where is the study run from?
The Institute for Fiscal Studies (UK)
When is the study starting and how long is it expected to run for?
November 2014 to May 2015
Who is funding the study?
The study is funded by a gift from Mr Martin Rushton-Tuner and the Waterloo Foundation.
Who is the main contact?
Dr Marta Rubio-Codina (marta_r@ifs.org.uk)
Dr Britta Augsburg (brita_a@ifs.org.uk)
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Early Childhood Development in the slums of Cuttack, Odisha, India
Acronym
ECD Cuttack
Study hypothesis
Child cognitive and language development will be improved by introducing a systematic psychosocial stimulation curriculum delivered weekly by local women (home visitors) aimed at promoting maternal-child interactions and the quality of the home environment.
Ethics approval
1. IMFR, 27/06/2013, ref: IRB00007107; FWA00014616; IORG0005894
2. UCL Ethics Committee, Graduate School Office, 02/09/2013, ref: 2168/001
Study design
Two-arm cluster (slum) randomised 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
Early childhood development
Intervention
Slum-based intervention to promote early childhood development. 54 clusters in total will be randomised to either the intervention or the control group.
1. Intervention group: 27 clusters will receive psychosocial stimulation through weekly home visits - lasting around one hour - to mothers/primary carers of children aged 10-20 months. The 'home visitors' will be local women and will follow the Grantham-McGregors curriculum and protocols specially adapted for the context of Odisha. They will interact with carers and children and will discuss the importance of stimulation and play for child development with the carer.
2. Control group: 27 clusters will receive no intervention.
Total duration of intervention: 12 months (2 periods of 1 month of data collection will precede and follow the interventions)
Updated 25/11/2015:
Total duration of intervention: 18 months (2 periods of 1 month of data collection will precede and follow the interventions)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Current primary outcome measures as of 25/11/2015:
Children’s cognitive, receptive language, expressive language, and fine motor development (assessed using Bayley-III at follow-up).
Previous primary outcome measures:
Children's cognitive, language, motor and socio-emotional development (ASQ-3 test at baseline; Bayley-III at follow-up or DAS-II [TBC])
Secondary outcome measures
Current secondary outcome measures as of 25/11/2015:
1. Quality of the home stimulation environment (as measured by the 'play activities' and 'play materials' subscales of the Family Care Indicators) at baseline in the home; at follow-up in the assessment centre and in the home
2. Maternal time spent on high stimulation activities with children (as measured by time use module in household questionnaire) both at baseline and at follow-up in the home
3. Mother's knowledge of child development (as measured by a subset of selected items from the KIDI instrument) both at baseline and at follow-up in the home
Previous secondary outcome measures:
1. Children´s height, weight and morbidity (standard WHO methods and definitions -- height and weight will only be collected at baseline)
2. Quality of the home environment: play activities and play materials (FCI instrument -- baseline and follow-up)
3. Maternal depressive symptoms (FCI questions from CES-D -- baseline and follow-up)
4. Maternal and household socio-economic characteristics (household survey -- baseline and follow-up)
Overall trial start date
12/08/2013
Overall trial end date
31/03/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children aged 10-20 months from the 54 slums in Cuttack, Odisha, India
2. Informed consent
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
400 children and their mothers/caregivers in 54 slums (27 treatment, 27 control)
Participant exclusion criteria
1. Children outside the 10-20 month age range
2. Mentally or physically disabled children
3. Children born as twins
Recruitment start date
11/11/2013
Recruitment end date
15/12/2014
Locations
Countries of recruitment
India
Trial participating centre
Institute for Fiscal Studies
London
WC1E 7AE
United Kingdom
Sponsor information
Organisation
Institute for Fiscal Studies (UK)
Sponsor details
7 Ridgmount Street
London
WC1E 7AE
United Kingdom
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
Gift from Mr Martin Rushton-Turner (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Waterloo Foundation (UK)
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
Basic results (scientific)
Publication list