FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/096213 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On: 27/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   PANKH Trial:Parenting for Affectionate Nurturing and Kinship for Healthy Relationships 
Scientific Title of Study   Promoting health and wellbeing among children (3-12 years) through establishing safe, stable, nurturing relationships: A hybrid implementation trial 
Trial Acronym  PANKH: Parenting for Affectionate Nurturing and Kinship for Healthy Relationships 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Subodh Sharan Gupta  
Designation  Professor & Head 
Affiliation  Mahatma Gandhi Institute of Medical Sciences 
Address  Department of Community Medicine, MGIMS, Sevagram
Sevagram
Wardha
MAHARASHTRA
442102
India 
Phone  9822926934  
Fax    
Email  subodhsgupta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Subodh Sharan Gupta  
Designation  Professor & Head 
Affiliation  Mahatma Gandhi Institute of Medical Sciences 
Address  Department of Community Medicine, MGIMS, Sevagram
Sevagram
Wardha
MAHARASHTRA
442102
India 
Phone  9822926934  
Fax    
Email  subodhsgupta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Subodh Sharan Gupta  
Designation  Professor & Head 
Affiliation  Mahatma Gandhi Institute of Medical Sciences 
Address  Department of Community Medicine, MGIMS, Sevagram
Sevagram
Wardha
MAHARASHTRA
442102
India 
Phone  9822926934  
Fax    
Email  subodhsgupta@gmail.com  
 
Source of Monetary or Material Support  
ICMR funded 
 
Primary Sponsor  
Name  Indian Council of Medical Research ICMR 
Address  New Delhi,India  
Type of Sponsor  Research institution 
 
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 Subodh Sharan Gupta  Rural and suburban areas of Wardha district  Wardha
Wardha
MAHARASHTRA 		 9822926934

subodhsgupta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee, MGIMS, Sevagram   Approved 
Institutional Ethics Committee, MGIMS, Sevagram   Approved 
Institutional Ethics Committee, MGIMS, Sevagram   No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Developmental disabilities, including cognitive and behavioral disorders in children. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Co-designed Safe, Stable, Nurturing Relationships (SSNR) Parenting Program.  A group-based, context-specific, age-appropriate parenting program delivered by trained facilitators (CHWs, teachers). The program involves participatory approaches like group discussions and role-playing, delivered in sessions every 2 months over a 12-month period 
Comparator Agent  Usual Care / Observation  The control group will receive the standard services available in the community and will not receive the SSNR parenting program during the initial 12-month period. This group serves as the comparator and will be assessed at the same time points before crossing over to receive the intervention 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  ·Participants must be willing to comply with study requirements
·Families where both parents are willing to participate in the parenting program (exception – single parent/caregiver)
·Both parents/ single parent/ caregiver must provide consent to participate in the study. 
 
ExclusionCriteria 
Details  Severely ill participants
Participants who refuse to consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Identification of child cognitive and behavioral disorder through Child Behavior Checklist and Strength and difficulties questionnaire, and referred to the health centers for management.  Baseline (0 months)

12 months

24 months 
 
Secondary Outcome  
Outcome  TimePoints 
Parenting behavior and practices along with their perceived competency in parenting practices and satisfaction in their role as a parent, Assessment of child nutritional status (anthropometric measurements),
Assessment of acceptability, adoption, feasibility, effectiveness of intervention and to delineate the facilitators and barriers for effective implementation
 		 Baseline (0 months)

12 months

24 months 
 
Target Sample Size   Total Sample Size="3600"
Sample Size from India="3600" 
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)   27/10/2025 
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="3"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response (Others) -  Training modules and IEC (Information, Education, and Communication) material.
  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be available for a period of five years following the publication of the primary study results.

  6. For how long will this data be available start date provided 01-06-2029 and end date provided 01-06-2034?
    Response (Others) -  Data will be available for a period of five years following the publication of the primary study results.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Access is limited to qualified researchers with a methodologically sound proposal for secondary analysis. Data sharing is subject to review by the study steering committee and requires a signed data sharing agreement that ensures confidentiality and prohibits re-identification or commercial use.
Brief Summary  

This is a three-year hybrid effectiveness–implementation trial designed as a two-arm, parallel-group, cluster-randomized study with a planned crossover. The trial will be conducted in 80 clusters located in suburban and rural areas of Wardha, Maharashtra, India. The objective is to develop and evaluate the effectiveness of a co-designed convergence model to promote safe, stable, and nurturing relationships (SSNR) among children aged 3–12 years. The intervention will be delivered by trained facilitators, including community health workers, teachers, and other stakeholders, with the aim of improving children’s cognitive and behavioral outcomes.

 A total of 3,600 parent–child dyads will be enrolled. The intervention arm will receive a structured, co-designed program implemented at the family, school, and community levels, while the control arm will continue with usual care and subsequently cross over to the intervention after 12 months.

 
Close