Early Childhood Development: Identifying successful interventions and the mechanisms behind them

ISRCTN	ISRCTN18991160
DOI	https://doi.org/10.1186/ISRCTN18991160
Secondary identifying numbers	N/A

Submission date: 09/12/2009
Registration date: 18/12/2009
Last edited: 01/10/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Emla Fitzsimons
Scientific

Institute for Fiscal Studies
7 Ridgmount Street
London
WC1E 7AE
United Kingdom

Study information

Study design	Four-arm cluster randomised controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	Early Childhood Development: A cluster-randomised controlled trial to Identify successful interventions and the mechanisms behind them
Study acronym	ECD
Study objectives	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(s)	UCL Research Ethics Committee, 28/01/2009, ref: 1827/001
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2010
Completion date	30/11/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	12 Months
Upper age limit	24 Months
Sex	Both
Target number of participants	1500 (96 clusters, with 24 clusters in each treatment arm)
Key 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
Key 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
Date of first enrolment	01/01/2010
Date of final enrolment	30/11/2011

Locations

Countries of recruitment

Colombia
England
United Kingdom

Study participating centre

Institute for Fiscal Studies

London
WC1E 7AE
United Kingdom

Sponsor information

Economic and Social Research Council (ESRC) (UK)
Research council

Polaris House
North Star Avenue
Swindon
SN2 1UJ
United Kingdom

Website	http://www.esrc.ac.uk
"ROR"	https://ror.org/03n0ht308

Funders

Funder type

Research council

Economic and Social Research Council (ESRC) (UK)
Government organisation / National government

Alternative name(s): ESRC
Location: United Kingdom

Inter-American Development Bank (International)
Private sector organisation / International organizations

Alternative name(s): Banco Interamericano de Desarrollo, Banco Interamericano de Desenvolvimento, Banque Interaméricaine de Développement, IADB, BID, IDB
Location: United States of America

International Growth Centre (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/09/2014		Yes	No