| CTRI Number |
CTRI/2025/09/094010 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Experimental |
| Study Design |
Other |
|
Public Title of Study
|
A Study To Assess The Training Program on Early Detection And Managing Childhood Developmental Delays In Terms Of Skills Of Community Health Officers And ASHA And Anganwadi Workers in Health And Wellness Centres of Haryana |
|
Scientific Title of Study
|
A Study To Develop And Evaluate The Effectiveness Of The ToT Program On Early Detection And Managing Childhood Developmental Delays In Terms Of Skills Of Community Health Officers And Frontline Workers At Selected Health And Wellness Centres of Haryana |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SGeetha Rajkumar |
| Designation |
Ph.D Canditate 1923801 |
| Affiliation |
Maharishi Markandeshwar University, Ambala |
| Address |
Maharishi Markandeshwar College Of Nursing
Maharishi Markandeshwar Deemed To Be University
Mullana Ambala
HARYANA
133207
India |
| Phone |
8920991015 |
| Fax |
|
| Email |
sgeetharajkumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SGeetha Rajkumar |
| Designation |
Ph.D Canditate 1923801 |
| Affiliation |
Maharishi Markandeshwar University, Ambala |
| Address |
Maharishi Markandeshwar College Of Nursing
Maharishi Markandeshwwar Deemed To Be Univesity
Mullana Ambala
HARYANA
133207
India |
| Phone |
8920991015 |
| Fax |
|
| Email |
sgeetharajkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SGeetha Rajkumar |
| Designation |
Ph.D Canditate 1923801 |
| Affiliation |
Maharishi Markandeshwar University, Ambala |
| Address |
Type 4 Quarter no 4RAK College of Nursing Lajpat Nagar New Delhi 110024
South
DELHI
110024
India |
| Phone |
8920991015 |
| Fax |
|
| Email |
sgeetharajkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Health and Wellness Centre Jhjjar Haryana under NHM Govt of India |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar College Of Nursing |
| Address |
Maharishi Markandeshwar Deemed To Be Univesity Mullana Ambala Haryana |
| Type of Sponsor |
Research institution |
|
|
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 |
| S Geetha Rajkumar |
Health and Wellness Centre |
Health and Wellness Centre
Haryana Under NHM GOI
Jhajjar
HARYANA |
8920991015
8920991015
sgeetharajkumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharishi Markandeshwar Institute of Medical Sciences And Research Mullana Amabala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy CHO and Front line Workers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
willing to give consent to participate in the study
Knows Hindi and English |
|
| ExclusionCriteria |
| Details |
The CHO and Front line workers not available during the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Skills of CHO will improved in early indentification of developmental delays in children |
Early Identification of Developmental Delays in children will reduce burden on children mortality rates & helps to attain SDG |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved Skills of Community Health Officers And Front Line Workers on Early Detection Of Developmental Delays in Children |
It will help to achieve SDG |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
25/09/2025 |
| 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="0"
Months="3"
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 study mainly focus on the early identification of developmental delays in children by Community Health Officers and Front line workers. As it is increased burden of developmental delays in childrent leads to great morbidity in under five .This study may enhancs the knowledge and skill among gross root level workers in the Health Infrastructure. |