Plain English Summary
Background and study aims
Anganwadi centers are early childhood development centers under the Integrated Child Development Programme of India (ICDS). Over time, their focus on early childhood education and development activities has reduced and their current activities mostly revolve around nutritional supplementation and assisting the health workers in Maternal and Child Health services. This study aims to enhance the behavioural and cognitive development of children under 6 years of age by actively engaging with Anganwadi workers, parents, caregivers and the community, improving the curriculum, and assisting Anganwadi workers, caregivers and parents through continuous guidance. We also intended to increase the parents’ and caregivers’ knowledge and skills for health and early childhood development.
Who can participate?
Children under 6 years and their families
What does the study involve?
Participating anganwadi centers are randomly allocated to either the intervention or the control group. The control group receive the standard Anganwadi Worker Program. The intervention group receive the intervention described below. A family centred early childhood development and positive parenting curriculum is developed and delivered through the Anganwadi centers, targeting children aged 3 to 6 years. The parenting program is delivered through group meetings and home visits and primarily targets the parents of children under three years of age. The project actively engages with private preschool, higher education institutions and the community for assessments and continues monitoring and coaching Anganwadi workers and project staff for continued quality improvement. The study participants are assessed for changes in cognitive development at the end of the study.
What are the possible benefits and risks of participating?
Participating children may benefit from improved cognitive and behavioural development. Parents and caregivers may benefit from improved knowledge and skills for positive parenting. The Anganwadi Workers and teachers may benefit from improved knowledge and skills to deliver the enhanced curriculum. We anticipate no risks for participants.
Where is the study run from?
Datta Meghe Institute of Medical Sciences (India)
When is the study starting and how long is it expected to run for?
December 2015 to September 2016
Who is funding the study?
Grand Challenges Canada
Who is the main contact?
1. Dr Abhay Gaidhane
2. Dr Zahir Quazi
Trial website
Contact information
Type
Scientific
Primary contact
Dr Abhay Gaidhane
ORCID ID
http://orcid.org/0000-0002-4814-2695
Contact details
Project Cell
Jawaharlal Nehru Medical College
Datta Meghe Institute of Medical Sciences
Sawangi Meghe
Wardha
442001
India
Type
Public
Additional contact
Dr Zahir Quazi
ORCID ID
http://orcid.org/0000-0002-1435-899X
Contact details
Project Cell
Jawaharlal Nehru Medical College
Datta Meghe Institute of Medical Sciences
Sawangi Meghe
Wardha
442001
India
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Scaling early childhood development at Anganwadi Centers in India
Acronym
Study hypothesis
400 (50%) of the total children enrolled in the intervention arm show at least 0.3SD changes in cognitive/behavioral measures compared to the control.
Ethics approval
Datta Meghe Institute of Medical Sciences Ethics Committee, 30/03/2015, Ref. No. DMIMS (DU)/IEC/2014-15/1203
Study design
Interventional multicenter cluster randomised trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Six domains of child development
Intervention
Anganwadi workers (AWW), local community-based workers under the Integrated Child Development Scheme (ICDS), established in 1975, provide supplementary nutrition, preschool education, nutrition and health education and referral services. Despite their significant role in child development, AWW are often overburdened due to administrative and documentation related work.
Our innovation is the integration and enhancement of the existing government Anganwadi Program (AWP) and Anganwadi Worker (AWW) with local resources in the private and education sectors to create a higher-impact program for early childhood development (ECD) of indigenous tribal groups. Novel elements are:
1. Creation of a tailored curriculum for a family-centered approach and certification of baby-friendly couples (BFC) to increase caregiver capacities for health and ECD
2. Deploying a tablet-PC smart register application as a tool for the AWW to adequately track child growth and ECD and progress through the curriculum, highlight gaps in care for targeted action, and reduce administrative and reporting burdens
3. Creating training and apprentice partnerships between the public AWP/AWW and private high quality preschools as a mechanism for AWW performance incentives and training including recognition as an upgraded Anganwadi Center (Anganwadi Plus)
4. Establish partnerships with local community colleges and medical schools for continuous data driven quality improvement and training.
Research Assistants in the project will support the impact evaluation, coordinate between community colleges/medical colleges and private school teachers with the AWW, and provide technical support for the application.
The proof of concept for this project is that the intervention can be effectively delivered through a public-private partnership (shown by attendance in AWC increasing from 30% to at least 50%).
We are using a cluster randomized controlled trial to evaluate the impact of the intervention. This will include 50 clusters comprised of an Anganwadi Center (AWC). The selected AWC will be randomly allocated to either intervention or control. We anticipate equal distribution of unaccounted variables across both groups. The baseline comparability will be assessed as a proxy for general comparability.
The intervention group is receiving the intervention as described steps 1-7 below, and the control will receive the standard Anganwadi Worker Program. Information on the fidelity of implementation related to training and deployment will be collected. Attendance of children at the AWC, engagement with parents and use of the smart register application to manage clients and provide customized feedback to parents will also be tracked.
Intervention:
Step 1: to develop an enhanced AWP curriculum through integration and adaptation of early childhood education tools. The curriculum will be family-focused with a substantial parental role in child interaction skills and a supportive home environment.
Step 2: training and certification of staff to deliver the new curriculum and procedures, first for private preschool teachers who will also be trained as trainers, and then for AWW.
Step 3: concurrent with Step 2, we will develop the smart register application and tablet PCs for the AWW to manage their clients.
Step 4: the AWW workers in tribal areas “go live” with the enhanced curriculum, BFC sessions and tablets.
Step 5: private preschool teachers will begin their role as mentors by visiting AWC/AWW for coaching and quality assessments.
Step 6: engaging local academics and scholars at a local college/medical school and train them to review the AWW register data, and analyse and identify service gaps.
Step 7: monthly community meetings held with the AWW, supervisors, mentors from the private preschools, academics and community members. At these meetings the stakeholders discuss the successes and failures at the AWC/AWW and formulate a plan to improve services based on the data.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. 400 (50%) of the total children enrolled in the intervention arm show at least 0.3SD changes in cognitive/behavioral measures compared to the control.
2. Increase in AWC attendance from 30% to 50%
3. Increase in the number of Baby Friendly Couples
Primary and secondary outcomes will be measured at Endline i.e. in September 2016. Battery of tools to be used for assessment are Developmental Milestones Checklist - III (DMC-III), Profile of Socio-Emotional Development (PSED), Home Scale Coding, Early Childhood Home Inventory, Memory Game and Windows Task, Maternal Depression Agency and Depression.
Secondary outcome measures
1. Number of Anganwadi workers enrolled and benefited in the intervention arm
2. Number of families benefited through positive parenting sessions
Primary and secondary outcomes will be measured at Endline i.e. in September 2016
Overall trial start date
01/12/2015
Overall trial end date
30/09/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children aged 0-6 years
2. Family members of children aged 0-6 years
Participant type
Mixed
Age group
Mixed
Gender
Both
Target number of participants
50 clusters with total 1600 children minimum
Participant exclusion criteria
Children older than 6 years of age
Recruitment start date
01/12/2015
Recruitment end date
30/09/2016
Locations
Countries of recruitment
India
Trial participating centre
Datta Meghe Institute of Medical Sciences, Sawangi (M), Wardha
Sawangi Meghe Wardha
Wardha
442001
India
Sponsor information
Organisation
Grand Challenges Canada
Sponsor details
Grand Challenges Canada at the Sandra Rotman Centre
MaRS Centre
South Tower
101 College Street Suite 406
Toronto
M5G1L7
Canada
+1 (0)416 673 6568
info@grandchallenges.ca
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Grand Challenges Canada
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We intend to publish the overall process of the development of the curriculum and enhanced ECD and parenting curriculum manuals.
We intend to publish the study protocol and findings from the baseline data.
The report on the effectiveness of our intervention on cognitive and behavioural development in children will be published in a peer-reviewed international journal after completion of end-line assessment and analysis.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list