Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/12/2009
Date assigned
18/12/2009
Last edited
01/10/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emla Fitzsimons

ORCID ID

Contact details

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

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 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.

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 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)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

http://www.esrc.ac.uk

Funders

Funder type

Research council

Funder name

Economic and Social Research Council (ESRC) (UK)

Alternative name(s)

ESRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

Additional files

Editorial Notes