| CTRI Number |
CTRI/2025/07/091314 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Group counselling of parents & caretakers and home visits by Frontline workers for better Early Childhood Development among children aged 0-3 years in urban slums of Bhubaneswar |
|
Scientific Title of Study
|
Effectiveness of Group counselling and home visits for Early Childhood Development among children aged 0-3 years in urban slums of Bhubaneswar: A cluster Randomised trial |
| 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 Prajna Paramita Giri |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar Odisha |
| Address |
Dept of CM & FM
3rd Floor
Academic Block
All India Institute of Medical Sciences (AIIMS) Bhubaneswar Odisha
Qr no C1
ISO Compound
Kanika Chhak
Tulashipur
Cuttack
753008
Cuttack
ORISSA
751019
India |
| Phone |
9437386404 |
| Fax |
|
| Email |
prajnaparamita.giri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prajna Paramita Giri |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar Odisha |
| Address |
Dept of CM & FM
3rd Floor
Academic Block
All India Institute of Medical Sciences (AIIMS) Bhubaneswar Odisha
Qr no C1
ISO Compound
Kanika Chhak
Tulashipur
Cuttack
753008
Cuttack
ORISSA
751019
India |
| Phone |
9437386404 |
| Fax |
|
| Email |
prajnaparamita.giri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajna Paramita Giri |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar Odisha |
| Address |
Dept of CM & FM
3rd Floor
Academic Block
All India Institute of Medical Sciences (AIIMS) Bhubaneswar Odisha
Qr no C1
ISO Compound
Kanika Chhak
Tulashipur
Cuttack
753008
Cuttack
ORISSA
751019
India |
| Phone |
9437386404 |
| Fax |
|
| Email |
prajnaparamita.giri@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Khordha
PIN:751019
Odisha
India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Sijua
Patrapada
Bhubaneswar
751019 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prajna Paramita Giri |
All India Institute of Medical Sciences Bhubaneswar |
Dept. of Community Medicine & Family Medicine
3rd Floor
Academic Block
Sijua
Patrapada
Bhubaneswar
751019
Khordha
ORISSA |
09437386404
prajnaparamita.giri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children aged 0 to 3 years, their parents, guardian, Front Line Workers such as ANM, AWW, ASHA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group Counselling & Home Visits |
1. Development of a Module: (For Training of frontline Workers, MAS members and Mothers/caregivers). The module will have the 3 parts 1. Part I: Different developmental milestone for under-5 children 2. Part II: Growth pattern and how to measure growth in under-5 children (Anthropometric Measurement) 3. Part III: Age appropriate play/games for children by parents/caregivers and in the community 4. Part IV: a. Topics for Counselling to mothers and caregivers (Breastfeeding, complementary feeding, growth monitoring, monitoring of developmental milestones etc.) b. Techniques of Interpersonal (for home visits) and group counselling This module will be prepared by referring to the available resources from WHO, UNICEF, CDC and Government of India & Odisha’s website 2. Training of Frontline Workers (ASHA & AWW & ANM) and MAS members: ASHA & AWW & ANM (Front Line Workers (FLW)) and MAS members will be trained in how to measure developmental milestones in under-5 children and imparting interpersonal & group counselling to mothers and caregivers. After baseline study, the frontline workers will be giving group counseling to mothers/caregivers and will do home visits every month in the intervention arm. During home visits, they will be doing Inter Personal Counseling of mothers/caregivers and will measure the developmental milestone and growth monitoring and record any morbidity of the child. There should be a minimum gap of 2 weeks between the group counseling and home visits. The group counseling and home visits by the FLW will be supervised by the trained field staff of AIIMS, Bhubaneswar. |
| Comparator Agent |
No Group Counselling or Home visits |
After baseline study, the frontline workers will do home visits at 3rd, 6th and 8th month to collect data of the children on anthropometry and developmental milestone. They will also collect data on morbidity at the end of 9th month. There would be no group counselling or monthly home visits |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
36.00 Month(s) |
| Gender |
Both |
| Details |
All the children aged 0-3 years whose family is residing in the particular slum for more than 1 year and the child/ mother is being enrolled in the respective AWC who will give consent to participate in the study will be included |
|
| ExclusionCriteria |
| Details |
Children with physical and mental disability
Mothers/ caregivers with terminally ill and not able to comprehend
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Children’s development as per their age (Gross Motor, Fine Motor, Communication/social, cognitive development),
2. Growth of children (Anthropometric measurements), and
3. Morbidity pattern among children in last 9 moths
|
3 months
6 months
9 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome:
1. Difference in knowledge and attitude of ASHA, AWW, ANM and MAS members towards ECD
2. Difference in knowledge and attitude of mothers & caregivers towards ECD
|
Baseline and End line |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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)
|
31/07/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This cluster-randomised trial aims to evaluate the effectiveness of structured group counselling and regular home visits by trained frontline workers (AWWs, ASHAs, ANMs) in promoting early childhood development (ECD) among children aged 0–3 years living in urban slums of Bhubaneswar. Sixteen Anganwadi Centres (AWCs) will be randomly assigned to either the intervention or control arm. The intervention includes training FLWs and MAS members on ECD modules, followed by monthly group counselling sessions of parents and home visits over a 9-month period. Developmental milestones, anthropometric growth, will be measured at 3rd, 6th and 9 the month of the baseline survey and morbidity of children will be assessed at baseline and endline. Additionally, knowledge and attitudes of FLWs and caregivers toward ECD will be evaluated. This study uses existing health infrastructure and workforce, making it scalable and policy-relevant for similar low-resource urban settings. |