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ISRCTN
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ISRCTN18991160
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ClinicalTrials.gov identifier
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Public title
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Early Childhood Development: Identifying successful interventions and the mechanisms behind them
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Scientific title
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Early Childhood Development: A cluster-randomised controlled trial to Identify successful interventions and the mechanisms behind them
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Acronym
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ECD
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Serial number at source
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N/A
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Study hypothesis
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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 children’s 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.
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Lay summary
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Ethics approval
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UCL Research Ethics Committee approved on the 28th of January 2009 (ref: 1827/001).
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Study design
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4 arm cluster randomised controlled parallel group trial
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Countries of recruitment
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Colombia
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Disease/condition/study domain
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Early childhood interventions in developing countries, nutritional supplementation; psychosocial stimulation
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Participants - inclusion criteria
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1. Households eligible for the Colombian conditional cash transfer program 'Familias en Accion'
2. Aged between 12 and 24 months
3. Informed consent
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Participants - exclusion criteria
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1. Children outside the 12-24 month age range at the start of the intervention
2. Children with serious congenital abnormalities
3. Twins
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Anticipated start date
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01/01/2010
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Anticipated end date
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30/11/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet.
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Target number of participants
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1500 (96 clusters, with 24 clusters in each treatment arm)
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Interventions
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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 children’s 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)
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Primary outcome measure(s)
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1. Children’s motor and mental development measured using the Bayley Scales of Infant and Toddler Development, third edition.
2. Children’s nutritional status, measured by collecting height and weight, haemoglobin levels (using capillary blood specimens from finger prick samples), and children’s consumption of iron rich food
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Secondary outcome measure(s)
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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.
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Sources of funding
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1. Economic and Social Research Council (ESRC) (UK)
2. Inter-American Development Bank (International)
3. International Growth Centre (UK)
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Trial website
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Publications
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Contact name
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Dr
Emla
Fitzsimons
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Address
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Institute for Fiscal Studies
7 Ridgmount Street
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City/town
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London
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Zip/Postcode
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WC1E 7AE
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Country
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United Kingdom
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Sponsor
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Economic and Social Research Council (ESRC) (UK)
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Address
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Polaris House
North Star Avenue
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City/town
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Swindon
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Zip/Postcode
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SN2 1UJ
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Country
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United Kingdom
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Sponsor website:
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http://www.esrc.ac.uk
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Date applied
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09/12/2009
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Last edited
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18/12/2009
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Date ISRCTN assigned
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18/12/2009
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