Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Early Childhood Development: A cluster-randomised controlled trial to Identify successful interventions and the mechanisms behind them
Acronym
ECD
Study hypothesis
The importance of the first 5 years of life for long-term development is well-established. During this vital period many children - particularly in developing countries - are surrounded by poverty, and do not receive adequate physical, mental or emotional nourishment. As adults they are likely to be at a disadvantage in terms of their education levels and health, to have high fertility rates, and to provide inadequate stimulation and resources for their own children, thus contributing to the intergenerational transmission of poverty and to economic inequality.
There is increasing evidence that interventions in early childhood are very important for physiological and psychological development. However, if - as is often the case - they are implemented by experts who live outside the communities, they are both expensive and infeasible to expand widely. In this research we aim to develop and evaluate a cost-effective and sustainable intervention to promote early child development. The intervention will be implemented using local community resources, thus providing a viable model for scaling up if successful. Our setting is Colombia.
To evaluate the intervention, some communities will be chosen randomly to receive it, others not. Surveys will be conducted twice - before the intervention starts, and 18 months later when it ends. The main outcomes we will measure are the childrens motor, cognitive and socio-emotional development, and their health. To this end, we will administer Bayleys tests to children before and after the intervention, as well as collect detailed data on their health status. We will also obtain detailed information on various socio-economic characteristics of the household, in order to be able to understand the constraints that poor households face when making choices relevant to their children's development, and ultimately to investigate why the intervention works or not.
Ethics approval
UCL Research Ethics Committee, 28/01/2009, ref: 1827/001
Study design
Four-arm cluster randomised controlled parallel group 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 interventions in developing countries, nutritional supplementation; psychosocial stimulation
Intervention
Community-based intervention to promote early childhood development. 96 clusters in total.
1. Stimulation group
24 clusters will receive stimulation through weekly home visits - lasting around one hour - to mothers/primary carers of children aged between 12 and 24 months, for a period of 18 months. The home visitors will interact with carers and children and will discuss the importance of psychosocial stimulation for child development with the carer. The home visitors will be drawn from local female elected representatives, and will receive extensive guidance and preparation for their role.
2. Nutrition group
24 clusters will receive micronutrients in the form of 'Nutritional Anemia Formulation Sprinkles' to children between 12 and 24 months at the start of the study, also for a duration of 18 months. Sprinkles are sachets containing a blend of micronutrients in powder form, which are easily sprinkled onto foods prepared in the home. Any homemade food can be instantly fortified by adding Sprinkles. Coating of the iron prevents changes to the taste, colour or texture of the food to which Sprinkles are added. Sprinkles were developed by the Sprinkles Global Health Initiative to prevent and treat micronutrient deficiencies among young children and other vulnerable groups at risk.
3. Stimulation and nutrition group
24 clusters will receive both home visits and Sprinkles. This set up will allow us to test whether the intervention is more likely to be successful if childrens nutrition is also targeted - an important ongoing debate.
4. Control group
24 clusters will receive no intervention.
Total duration of interventions: 18 months (2 periods of 3 months of data collection will precede and follow the interventions)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Childrens motor and mental development measured using the Bayley Scales of Infant and Toddler Development, third edition.
2. Childrens nutritional status, measured by collecting height and weight, haemoglobin levels (using capillary blood specimens from finger prick samples), and childrens consumption of iron rich food
Secondary outcome measures
1. Maternal depression measured using the 10-item CESD Scale.
2. Investigate the constraints that poor households face when making choices relevant to their children's development, and ultimately to investigate why the intervention works or not. We will do this by building a structural model using detailed socio-economic data at the household level.
Overall trial start date
01/01/2010
Overall trial end date
30/11/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Households eligible for the Colombian conditional cash transfer program 'Familias en Accion'
2. Aged between 12 and 24 months
3. Informed consent
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
1500 (96 clusters, with 24 clusters in each treatment arm)
Participant exclusion criteria
1. Children outside the 12-24 month age range at the start of the intervention
2. Children with serious congenital abnormalities
3. Twins
Recruitment start date
01/01/2010
Recruitment end date
30/11/2011
Locations
Countries of recruitment
Colombia
Trial participating centre
Institute for Fiscal Studies
London
WC1E 7AE
United Kingdom
Sponsor information
Organisation
Economic and Social Research Council (ESRC) (UK)
Sponsor details
Polaris House
North Star Avenue
Swindon
SN2 1UJ
United Kingdom
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Economic and Social Research Council (ESRC) (UK)
Alternative name(s)
ESRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
Inter-American Development Bank (International)
Alternative name(s)
Banco Interamericano de Desarrollo, Banco Interamericano de Desenvolvimento, Banque Interaméricaine de Développement, IDB, BID
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United States of America
Funder name
International Growth Centre (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
Results - basic reporting
Publication summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25266222
Publication citations
-
Results
Attanasio OP, Fernández C, Fitzsimons EO, Grantham-McGregor SM, Meghir C, Rubio-Codina M, Using the infrastructure of a conditional cash transfer program to deliver a scalable integrated early child development program in Colombia: cluster randomized controlled trial., BMJ, 2014, 349, g5785.