Condition category
Mental and Behavioural Disorders
Date applied
04/11/2013
Date assigned
10/12/2013
Last edited
02/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The importance of the first 5 years of life for long-term development is well-established. During this vital period the development of children living in poverty is hindered by malnutrition, illness and unstimulating home environments. Evidence shows that interventions in early childhood can be very important for psychosocial development. However, they are often delivered by experts and hence expensive and not feasible to expand widely. We will implement and evaluate a cost-effective intervention – based on Grantham-McGregor’s curriculum and delivered by local women through weekly home visits over 18 months – targeted to children aged 10-20 months and their mothers/primary caregivers. The intervention aims to promote early child development and maternal-child interactions in a very poor urban environment.

Who can participate?
Children aged 10-20 months and their mothers/primary caregivers from the 54 slums in Cuttack, Odisha, India.

What does the study involve?
The 54 slums will be randomly allocated to either the intervention or the control group. The intervention group will receive weekly home visits lasting around one hour. The 'home visitors' will be local women and will follow the Grantham-McGregor’s curriculum and protocols specially adapted for the context of Odisha. They will interact with carers and children and will discuss the importance of stimulation and play for child development with the carer. The control group will receive no intervention. We will assess child development and conduct household and slum surveys before and after the intervention. We will also obtain detailed information on the quality of the home environment.

What are the possible benefits and risks of participating?
Benefits to participants include information on the child's development and also, within the intervention households, advice on how to improve child development. We do not foresee any risks for study participants.

Where is the study run from?
The Institute for Fiscal Studies (UK)

When is the study starting and how long is it expected to run for?
November 2014 to May 2015

Who is funding the study?
The study is funded by a gift from Mr Martin Rushton-Tuner and the Waterloo Foundation.

Who is the main contact?
Dr Marta Rubio-Codina (marta_r@ifs.org.uk)
Dr Britta Augsburg (brita_a@ifs.org.uk)

Trial website

Contact information

Type

Scientific

Primary contact

Ms Safija Jusupovic

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 in the slums of Cuttack, Odisha, India

Acronym

ECD Cuttack

Study hypothesis

Child cognitive and language development will be improved by introducing a systematic psychosocial stimulation curriculum delivered weekly by local women (home visitors) aimed at promoting maternal-child interactions and the quality of the home environment.

Ethics approval

1. IMFR, 27/06/2013, ref: IRB00007107; FWA00014616; IORG0005894
2. UCL Ethics Committee, Graduate School Office, 02/09/2013, ref: 2168/001

Study design

Two-arm cluster (slum) randomised controlled 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 development

Intervention

Slum-based intervention to promote early childhood development. 54 clusters in total will be randomised to either the intervention or the control group.

1. Intervention group: 27 clusters will receive psychosocial stimulation through weekly home visits - lasting around one hour - to mothers/primary carers of children aged 10-20 months. The 'home visitors' will be local women and will follow the Grantham-McGregor’s curriculum and protocols specially adapted for the context of Odisha. They will interact with carers and children and will discuss the importance of stimulation and play for child development with the carer.

2. Control group: 27 clusters will receive no intervention.

Total duration of intervention: 12 months (2 periods of 1 month of data collection will precede and follow the interventions)

Updated 25/11/2015:
Total duration of intervention: 18 months (2 periods of 1 month of data collection will precede and follow the interventions)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Current primary outcome measures as of 25/11/2015:
Children’s cognitive, receptive language, expressive language, and fine motor development (assessed using Bayley-III at follow-up).

Previous primary outcome measures:
Children’'s cognitive, language, motor and socio-emotional development (ASQ-3 test at baseline; Bayley-III at follow-up or DAS-II [TBC])

Secondary outcome measures

Current secondary outcome measures as of 25/11/2015:
1. Quality of the home stimulation environment (as measured by the 'play activities' and 'play materials' subscales of the Family Care Indicators) at baseline in the home; at follow-up in the assessment centre and in the home
2. Maternal time spent on high stimulation activities with children (as measured by time use module in household questionnaire) both at baseline and at follow-up in the home
3. Mother's knowledge of child development (as measured by a subset of selected items from the KIDI instrument) both at baseline and at follow-up in the home

Previous secondary outcome measures:
1. Children´s height, weight and morbidity (standard WHO methods and definitions -- height and weight will only be collected at baseline)
2. Quality of the home environment: play activities and play materials (FCI instrument -- baseline and follow-up)
3. Maternal depressive symptoms (FCI questions from CES-D -- baseline and follow-up)
4. Maternal and household socio-economic characteristics (household survey -- baseline and follow-up)

Overall trial start date

12/08/2013

Overall trial end date

31/03/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 10-20 months from the 54 slums in Cuttack, Odisha, India
2. Informed consent

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

400 children and their mothers/caregivers in 54 slums (27 treatment, 27 control)

Participant exclusion criteria

1. Children outside the 10-20 month age range
2. Mentally or physically disabled children
3. Children born as twins

Recruitment start date

11/11/2013

Recruitment end date

15/12/2014

Locations

Countries of recruitment

India

Trial participating centre

Institute for Fiscal Studies
London
WC1E 7AE
United Kingdom

Sponsor information

Organisation

Institute for Fiscal Studies (UK)

Sponsor details

7 Ridgmount Street
London
WC1E 7AE
United Kingdom

Sponsor type

Research organisation

Website

http://www.ifs.org.uk

Funders

Funder type

Charity

Funder name

Gift from Mr Martin Rushton-Turner (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Waterloo Foundation (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

Publication citations

Additional files

Editorial Notes

On 25/11/2015 the following changes were made to the trial record: 1. The overall trial start date was changed from 11/11/2013 to 12/08/2013. 2. The overall trial end date was changed from 15/12/2014 to 31/03/2016.