Condition category
Not Applicable
Date applied
02/12/2015
Date assigned
03/12/2015
Last edited
02/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The first three years of life lay the basis for lifelong outcomes due to the rapid development of the brain. During this time, children are also vulnerable to negative influences of factors such as malnutrition, illness and unstimulating environments. These factors may be caused by poverty and may have a detrimental effect on children’s health and development, including physical, cognitive, language and motor development. Research has shown that approaches to early childhood development (ECD) that involve psychosocial stimulation and/or nutrition are effective in mitigating the influences of negative factors. Our aim is to understand the effects, sustainability and costs of such an approach and the mechanisms needed for these early years’ interventions to be effective in poor populations. We need to know how the interventions change beliefs, knowledge and parenting practices as well as the specific investments (in time and resources) that parents and caregivers make in child rearing. The aim of this study is to evaluate two different ways of delivering an ECD intervention together with nutritional information in 192 villages in rural Odisha. Odisha provides an excellent setting for the study as it has low levels of stimulation, high malnutrition, poor developmental outcomes and extreme levels of poverty. The study will permit us to learn the extent to which an early childhood stimulation and nutrition intervention is feasible and effective in improving child health and development in low-income and disadvantaged environments.

Who can participate?
Children aged 7-16 months and their families living in communities in rural areas of Odisha, India.

What does the study involve?
Participating villages are randomly allocated to one of four groups. Families in the first group receive nutritional education through home visits from local women hired and trained for the project (facilitators). Families in the second group receive the stimulation curriculum (mother and child play and learning activities) and nutritional education via home visits from facilitators. Families in the third group receive group stimulation, where the facilitator delivers the stimulation curriculum and nutritional education to a group of mothers and children. Families in the fourth group receive only a basic intervention to strengthen links with existing health and nutritional services (this is also available to the other three groups).

What are the possible benefits and risks of participating?
The benefits include better and more frequent parent-child interactions, improved cognitive, language and motor development of the children, and knowledge gained regarding the importance of psychosocial stimulation and nutrition in the early years. There are no known risks.

Where is the study run from?
Pratham Education Foundation (India).

When is the study starting and how long is it expected to run for?
August 2012 to June 2019.

Who is funding the study?
National Institutes of Health (NIH), World Bank Strategic Impact Evaluation Fund (SIEF), Economic and Social Research Council (ESRC), Yale University, University of Pennsylvania.

Who is the main contact?
Costas Meghir

Trial website

Contact information

Type

Public

Primary contact

Ms Safija Jusupovic

ORCID ID

Contact details

Institute for Fiscal Studies (IFS)
Centre for the Evaluation of Development Policies (EDePo)
London
WC1E 7AE
United Kingdom

Type

Scientific

Additional contact

Prof Costas Meghir

ORCID ID

Contact details

Department of Economics
Yale University
PO Box 208264
New Haven
CT 06520-8264
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Early Childhood Development for the Poor: Impacting at Scale - a cluster randomised controlled trial

Acronym

ECD

Study hypothesis

It is hypothesised that early childhood stimulation and improved parental practices in terms of these practices as well as related to nutrition will have long-term positive effects on child's physical, cognitive, language and motor development. Approaches to child development that involve cognitive and psychosocial stimulation and/or nutrition are effective in mitigating influences of negative factors induced by poverty such as malnutrition, illnesses and un-stimulating home environments.

Ethics approval

1. Yale University Human Subjects Committee, 09/01/2014, ref: 1112009492
2. University College London (UCL), UCL Ethics Committee, 24/02/2012, ref: 2168/002
3. Indian Council of Medical Research (ICMR); 20/03/2013 (ICMR), ref: 5/7/822/2012/RCH
4. University of Pennsylvania (Penn), Office of Regulatory Affairs, 02/01/2014, ref: 815027 IRB#8
5. Pratham Education Foundation (Pratham), FWA for the Protection of Human Subjects, 31/01/2013, ref: FWA00019832
6. Institute for Financial Management and Research (IFMR), Human Subjects Committee, 24/08/2014, ref: IRB00007107; FWA00014616; IORG0005894

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

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

Child development

Intervention

We will carry out a psycho-social stimulation programme coupled with nutrition education that aims to improve interactions between mothers or principal caregivers and their infants/children with the aim of achieving better child outcomes. The ECD intervention follows a systematic weekly curriculum based on the natural developmental stages of the child. Alternative service provisions include delivery of the curriculum by local women either (i) during weekly individual home visits to mother and child, or (ii) in a suitably modified way, within the context of weekly mother-child group meetings. These two versions of the ECD intervention will be coupled with an educational nutritional intervention. The delivery of these interventions will last for 24 months and will be evaluated using a randomised control trial. We will collect data on child development outcomes and detailed maternal and household level data before the start, halfway through and at the end of the intervention. Our focus will be on communities in rural areas of Odisha and will involve children aged 7-16 months. We propose to implement and compare four variants of our intervention:

1. Provision of education on nutritional issues (hereafter referred to as NE): Regular visits to the home will be carried out by local women hired and trained for the project (henceforth referred to as educators) to deliver the nutritional education curriculum, which will be designed to produce positive changes in food choice, preparation and storage.
2. Individual Stimulation via Home Visits (IS) (+ NE): Weekly visits to the home will be carried out by local women hired and trained for the project (henceforth referred to as facilitators) to deliver the stimulation curriculum and involve mother and child in play and learning activities.
3. Group Stimulation (GS) (+ NE): In this variant, the facilitator will deliver a specially-designed version of the stimulation curriculum to a group of mothers and children. The group will meet weekly and is planned to have a maximum of 9 mothers and children.
4. Health and Nutritional Services Link (HNSL): A basic intervention that strengthens links with the existing services will be available to all study arms, including the control group. The aim of offering the basic service to all is to create a baseline where the current policy framework is well understood. We then measure our intervention over and above a status quo, which encourages take-up of policy as is now.

The evaluation design will be based on a cluster randomized trial in which a target sample of 192 villages with the selected facilitators/educators will be allocated randomly to intervention variants 1 to 3 described above and a control group. In total, there will be 48 villages in each intervention arm, including in the control.

Within each village we intend to treat and collect data on and offer the intervention to all children aged 7-16 months at the start of the intervention. Our initial estimate was that in the average study community there would be 7.5 children in this age group. This estimate was based on data from our sanitation project in similar villages. However, in our final sample of 192 villages, this average was around 14. Since our budget did not allow for treatment of so many more children, we adopted the following approach:
1. In villages with 8 children or less (one third of the 192 villages), we took all children to be part of the study.
2. In the remaining villages, we chose one eligible child at random and thereafter included in the sample those additional seven children that live geographically speaking closest to the randomly chosen child.

This approach ensures that even in villages with relatively large populations and spread, our target children would come from the same neighbourhood, hence facilitating intervention implementation. Similarly, it allows to have a clear criteria for inclusion into (exclusion out of) the intervention. On the one hand, we have a clear age cut-off, on the other hand a geographical clustering. It may also improve the quality of the intervention if all mothers of children in a particular age group in the villages interact and provide social support for each other regarding child-rearing practices. Finally, this will be consistent with scaling-up the program to full coverage.

Communities are randomised to the different intervention arms as we expect the interventions to have spillover within villages. By randomizing across communities we allow for possible spillovers within villages that may increase the overall impacts.

Part of our evaluation design is to measure such spillovers, to understand the importance of this conduit for propagating and reinforcing good practice in child rearing. To do so, we will in addition to our target children, interview households of mothers with children below and above the target age range (2-6 months and 17-20 months). In total, 767 such spillover households will be included in the sample.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Children’s child cognitive, language and motor development - We will assess cognitive, language and motor development at the time of the follow-up surveys using the third version of the Bayley Scales of Infant and Toddler Development (Bayley-III), suitably adapted for the context.
2. Children’s nutritional status - We will measure height and weight both at baseline and at the two follow ups, using standard methods. We will also collect information on feeding practices by food type, frequency and quantity.
3. Children’s morbidity - We will collect data on the incidence of diarrhoea, fever and respiratory infections using the definitions of the WHO as measures of morbidity. We will also collect records of immunisations.

Secondary outcome measures

1. Child rearing practices: level of stimulation in the home - The presence of toys and learning materials in the house will be assessed together with parental involvement with the child, the child’s routines and organisation of the child’s time inside and outside the family house. This will be assessed using the Family Care Indicators, developed by UNICEF, and possibly selected subscales of the Home Observation for the Measurement of the Environment (HOME).
2. Maternal knowledge of child rearing practices - We will collect information on the mother’s knowledge of nutrition and stimulation, and her beliefs regarding the importance of these for children’s development. To test knowledge, we will rely on a selection of items from the Knowledge of Infant Development (KIDI).

Overall trial start date

17/08/2012

Overall trial end date

30/06/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Children aged 7 - 16 months and their families

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

Total sample size is 1,451 families with children in the 7 - 16 months age range at project start and 767 children outside the treatment age range distributed among three groups of 48 intervention villages and one group of 48 control villages.

Participant exclusion criteria

Children outside of this age range

Recruitment start date

27/11/2015

Recruitment end date

27/11/2017

Locations

Countries of recruitment

India

Trial participating centre

Pratham Education Foundation (Odisha head office)
Holding no.-1/N/5 Arundoya Nagar
Cuttack
753012
India

Trial participating centre

Pratham Education Foundation
At-Dahipur Po-Radhaballabhpur Soro
Balasore
756045
India

Trial participating centre

Pratham Education Foundation
At-Sapanpur PO-Sisua
Cuttack
754202
India

Trial participating centre

Pratham Education Foundation
At/Po- Puintala (Near Puintala block)
Balangir
767071
India

Sponsor information

Organisation

Yale University (USA)

Sponsor details

Grant and Contract Administration
47 College Street
Suite 203
PO Box 208047
New Haven
CT
06520-8047
United States of America

Sponsor type

University/education

Website

http://economics.yale.edu/

Organisation

Institute for Fiscal Studies (UK)

Sponsor details

7 Ridgmount Street
London
WC1E 7AE
United Kingdom

Sponsor type

Research organisation

Website

www.ifs.org.uk

Organisation

The Abdul Latif Jameel Poverty Action Lab (J-PAL) South Asia (India)

Sponsor details

Institute for Financial Management and Research
Sub-regional office: AADI
Lower Ground Floor 2
Balbir Saxena Marg
Hauz Khas
Delhi
110016
India

Sponsor type

Charity

Website

http://www.povertyactionlab.org

Organisation

Pratham Education Foundation-ASER Centre (India)

Sponsor details

B 4/54 Safdarjang Enclave
Delhi
110029
India

Sponsor type

Charity

Website

http://www.pratham.org

Organisation

Centre for Early Childhood Education and Development (CECED) (India)

Sponsor details

Room No. 307
Admin Block
Ambedkar University Delhi
Lothian Road
Kashmere Gate Campus
Delhi
110006
India

Sponsor type

Government

Website

www.ceced.net

Organisation

University of Pennsylvania (USA)

Sponsor details

Philadelphia
Philadelphia
PA 19104
United Kingdom

Sponsor type

University/education

Website

http://www.upenn.edu

Funders

Funder type

Government

Funder name

National Institute of Child Health and Human Development

Alternative name(s)

NICHD

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Funder name

Economic and Social Research Council

Alternative name(s)

ESRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Yale University

Alternative name(s)

Yale

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United States of America

Funder name

University of Pennsylvania

Alternative name(s)

Penn

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United States of America

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes