| CTRI Number |
CTRI/2025/06/089155 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Impact of implementation of early childhood services through ICDS in Meghalaya |
|
Scientific Title of Study
|
India-Impact Evaluation of Early Childhood Development Mission Meghalaya |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sowmya Ramesh |
| Designation |
Executive Director & Principal Investigator |
| Affiliation |
Population Council Institute |
| Address |
Population Council Institute
Unit No 714
7th floor
DLF Tower B
Jasola
New Delhi 110 025
North East DELHI 110025 India |
| Phone |
01124642903 |
| Fax |
|
| Email |
sramesh@pcinstitute.org.in |
|
Details of Contact Person Scientific Query
|
| Name |
Shamayita Das |
| Designation |
Specialist |
| Affiliation |
PopulationCouncil Consulting Pvt. Ltd. |
| Address |
PopulationCouncil Consulting Pvt. Ltd. 19 A Film City, First Floor, Sector 16A, Noida – 201301
Gautam Buddha Nagar UTTAR PRADESH 201301 India |
| Phone |
9830162067 |
| Fax |
|
| Email |
shamayitadas.2013@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Samiksha Singh |
| Designation |
Director Health Systems and Research |
| Affiliation |
PopulationCouncil Consulting Pvt. Ltd. |
| Address |
PopulationCouncil Consulting Pvt. Ltd. 19 A Film City, First Floor, Sector 16A, Noida – 201301
Gautam Buddha Nagar UTTAR PRADESH 201301 India |
| Phone |
8886111290 |
| Fax |
|
| Email |
drsamikshasingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Asian Development Bank funded to Govt. of Meghalaya for Meghalaya Early Childhood Development Mission (MECDMS) implementation.
The MECDMS is funding the Population Council Institute for the Trial impact evaluation. |
|
|
Primary Sponsor
|
| Name |
Meghalaya Early Childhood Development Mission (MECDMS) |
| Address |
Holy Cross Brookdene, Jowai Road, Shillong - 793001 |
| Type of Sponsor |
Other [Government of Meghalaya ] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hunsi Giri |
Meghalaya Early Childhood Development Mission (MECDMS) |
Holy Cross Brookdene, Jowai Road, Shillong - 793001 East Khasi Hills MEGHALAYA |
9436102006
hunsi.giri2013@gmail.com |
| Mr Sampath Kumar |
Meghalaya Early Childhood Development Mission (MECDMS) |
Holy Cross Brookdene, Jowai Road, Shillong - 793001 East Khasi Hills MEGHALAYA |
9918000079
mecdms2022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| IRB-Population Council Institute |
Approved |
| No Objection Certificate |
No Objection Certificate |
| Sigma IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Child health: Growth and Development |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implementation of age-appropriate ECD packages to the mother-child dyad across the state of Meghalaya |
Implementation of age-appropriate ECD packages to the mother-child dyad across 12 districts of Meghalaya to strengthen the nutrition and ECCE components under ICDS scheme and add age-appropriate interventions for holistic nurturing care. The intervention is designed and implemented by the Meghalaya state government with technical support from partners.
In first step-wedge the age-appropriate interventions packages will be implemented in continuum over 5 years of study period. While in control step-wedges the duration of intervention will be 3.5 and 1.5 years subsequently |
| Comparator Agent |
Routine center-based services at Anganwadi centers in Meghalaya |
The comparator is routine center-based services provided at Anganwadi centers in the state of Meghalaya. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children and their caregiver (mother, father, grandparents)
1. Children of 0-1.5 years, 1.5- 3 years, and 3-6 years who are eligible to receive the age-specific ECD package interventions, and their mothers/caregivers.
2. The study units are eligible if the eligible children and their mothers/caregivers have been residing in the said Anganwadi catchment area in Meghalaya state for past 6 months.
3. Mothers/caregiver who provide consent to participate and provide consent for their children.
Program Implementers
1. District and block officials who all are engaged in ECD intervention in ECD mission in Meghalaya.
2. Anganwadi workers, ECD volunteer from the Anganwadi center catchment area from the selected block in Meghalaya.
3. Program officials, AWC workers, ECD volunteers/ECD Educators who provide consent to participate.
|
|
| ExclusionCriteria |
| Details |
Children and their caregiver (mother, father, grandparents)
1. Participants who are not residing in the said community in Meghalaya.
2. Beneficiaries refused to participate in the study.
3. Severely sick child who is not in a state to receive any of the interventions currently and in the last 6 months.
4. Mother/caregiver who are critically ill and not in a position to respond due to illness.
Program Implementers
1. District and block officials who are not working in ECD mission in Meghalaya.
2. Anganwadi workers, ECD volunteer/ECD educator who are not working in the selected Anganwadi center catchment area in Meghalaya.
3. District and block officials, Anganwadi workers, ECD volunteer/ECD educator refused to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in child growth and development for 0-1.5 years, and 1.5-3 years, and 3-6 years across the domains (cognitive, socio-emotional, motor, language) and school readiness (4-6 years) assessed by following standard growth and development scales:
a. 0-3 years: mean Caregiver Reported Early Development Instruments (CREDI) score,
b. 3-6 years: mean Caregiver Reported Early Development Instruments (IDELA) score
c. 0-3 years: Bayley Scales of Infant and Toddler Development- IV (BSID- IV) mean scores |
4 times with the interval of 1.5 years between the assessments |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Growth Indicator: mean scores of height for age, weight for age, weight for height assessed by anthropometric measurement
Home environment: mean score of Home Observation Measurement of the Environment- Short Form (HOME-SF) scale
Anganwadi environment: mean score of Early Childhood Environment Rating Scale (ECERS) scale
Women mental health: Mean score of Patient Health Questionnaire-9 (PHQ 9) |
4 times with the interval of 1.5 years between the assessments |
|
|
Target Sample Size
|
Total Sample Size="3375" Sample Size from India="3375"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Govt. of Meghalaya is rolling-out age appropriate ECD packages for the mother-child dyad in whole state over a span of 5 years (2024-2028) through Early Childhood Development Mission (MECDM) constituted in partnership with the health, women and child health (WCD), social welfare, and rural livelihood development departments. The age appropriate ECD package is developed based on nurturing care framework and includes age-appropriate early stimulation and responsiveness, nutrition, health and child safety; to be delivered via home, AWCs or community outreach; using existing FLWs and additional human resource i.e. ECD educator to support AWWs in providing centre-based ECD to 1.5-3year-old children. The aim of MECDM is to deliver the ECD package to impact early child development (0-6 years) by improving institutional readiness through AWC upgradation, improving human resource capacity, providing supplementary nutrition, introducing group-based parenting programs, and improving access and quality of childcare; with secondary objective to improve gender equity by re-positioning AWCs as daycare centres to alleviate women’s time poverty and to encourage participation of fathers. Population Council Institute (PCI), an independent monitoring and evaluation partner, is solely responsible to evaluate the ECD program with technical support from Johns Hopkins Bloomberg school of Public Health (no financial bearing on PCI or the Meghalaya state). The evaluation team has no role in program design and implementation. The evaluation aims to understand to what extent the ECD outcomes can be improved and how much the program improvements contribute to that outcome improvement. The evaluation is composed of an impact evaluation component to assess program effectiveness, and a process evaluation to review the implementation fidelity and strength, sustainability and scalability. The findings will help in explaining the change pathways in the theory of change proposed by the program. The learnings could be scaled or used by the other state governments. in India. The impact evaluation will adopt stepped wedge design (3 steps) with random allocation of ECD package at block level and measurement of child and women caregiver level outcomes. The team will conduct the surveys in a total of 4 time points- Baseline and then 3 rounds of surveys for each step. Children of 0-1.5 years, 1.5- 3 years, and 3-6 years who are eligible to receive the age-specific ECD package interventions, and their mothers/caregivers will be the study participant including Anganwadi workers, and program implementers. For the outcomes assessment, structured and semi-structured survey schedules are developed along with the inclusion of some standard neurodevelopmental assessment tools (CREDI, IDELA, BSID-IV).†The process evaluation includes periodic observations at AWCs, attending program review meetings at state, district and block; and periodic qualitative surveys with stakeholders to understand the processes, barriers and facilitators. Observation checklists, interview and FGD guides are developed to facilitate the interviews and discussions. The study will be conducted as per ICMRs Guidelines for GCLP. Data will be suitably and confidentially managed and analysed as per the analysis plan. Results will be disseminated in consultation with Meghalaya Government. |