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CTRI Number  CTRI/2025/02/080683 [Registered on: 17/02/2025] Trial Registered Prospectively
Last Modified On: 16/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Diagnostic accuracy study 
Study Design  Other 
Public Title of Study   Evaluation of Hindi Version of Developmental component of Mother and Child Protection Card against Bayley Scales of Infant and Toddler Development IV  
Scientific Title of Study   Validation of Hindi Version of Developmental component of Mother and Child Protection Card against Bayley Scales of Infant and Toddler Development IV  
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 Jahanvi Anand 
Designation  Post Graduate Resident , Maulana Azad Medical College and associated Lok Nayak Hospital  
Affiliation   
Address  Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital

Central
DELHI
110002
India 
Phone  9643717567  
Fax    
Email  jahanvianand03@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Monica Juneja  
Designation  Director Professor and Head of Department  
Affiliation  Maulana Azad Medical College and associated Lok Nayak Hospital  
Address  Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital

Central
DELHI
110002
India 
Phone  23233400  
Fax    
Email  drmonicajuneja@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Monica Juneja  
Designation  Director Professor and Head of Department  
Affiliation  Maulana Azad Medical College and associated Lok Nayak Hospital  
Address  Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital

Central
DELHI
110002
India 
Phone  23233400  
Fax    
Email  drmonicajuneja@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College and associated Lok Nayak Hospital 2, Bahadur Shah Zafar Marg, Delhi-110002, India 
 
Primary Sponsor  
Name  Maulana Azad Medical College  
Address  2, Bahadur Shah Zafar Marg, Delhi -110002, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jahanvi Anand   Maulana Azad Medical College   Pediatric OPD and ward, Maulana Azad Medical College and associated Lok Nayak
Central
DELHI 		 9643717567

jahanvianand03@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Maulana Azad Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Apparently healthy children  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  2.00 Month(s)
Age To  36.00 Month(s)
Gender  Both 
Details  Children attending Department of Pediatrics OPD and their healthy siblings aged 2-36 months 
 
ExclusionCriteria 
Details  1.children with diagnosed neurodevelopmental disorder
2.Children brought with concerns of developmental delay or hearing or visual problems
3.Children with severe visual or hearing impairment
4. Children whose caregiver is unable to converse in hindi
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio of Developmental component of MCP card against BSID IV in children aged 2-36 months  Single time at the time of evaluation of the child  
 
Secondary Outcome  
Outcome  TimePoints 
Sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio of Developmental component of MCP card against DSM V for Autism spectrum disorder in children aged 18-36 months  Single time at the assessment of the child 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   27/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  27/02/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Developmental component is the new addition in already existing MCP card for children aged 2-36 months by Government of India. Apart from developmental screening, this component also educates parents regarding age appropriate developmental stimulation activities. This is a promising tool as it helps the parents/ caregivers in keeping a track on their child’s development and identify the delays early. This tool is available in various Indian languages, thereby allowing its use in almost all Indian states. However, despite all these features, there is a dearth of information about its psychometric properties. This study intends to establish the psychometric properties of Hindi version of Mother and Child Protection Card against a gold standard development assessment tool.

 
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