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CTRI Number  CTRI/2025/08/093092 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 14/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of a selected non-drug-based intervention in improving developmental outcomes in children aged 1–5 years with developmental delays in Gorakhpur, Uttar Pradesh 
Scientific Title of Study   Effectiveness of the selected non-pharmacological intervention on developmental outcomes in children (1–5 years) with developmental delay in selected Child Development Centers of Gorakhpur Uttar Pradesh: A Randomized Controlled 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  Vanshika 
Designation  M.Sc. Nursing Student  
Affiliation  College of nursing , AIIMS Gorakhpur 
Address  College of Nursing MNC Building AIIMS Gorakhpur Uttar Pradesh 273008 India

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  08920518299  
Fax    
Email  dahiyavanshika555@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Seema S Cahvan 
Designation  Associate Professor 
Affiliation  College of nursing ,AIIMS Gorakhpur 
Address  College of Nursing MNC Building AIIMS Gorakhpur Uttar Pradesh 273008 India

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9353437981  
Fax    
Email  seemaschavan23@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Seema S Cahvan 
Designation  Associate Professor 
Affiliation  College of nursing ,AIIMS Gorakhpur 
Address  College of Nursing MNC Building AIIMS Gorakhpur Uttar Pradesh 273008 India

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9353437981  
Fax    
Email  seemaschavan23@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Vanshika 
Address  College of Nursing MNC Building AIIMS Gorakhpur Uttar Pradesh 273008 India 
Type of Sponsor  Other [Self] 
 
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 
Vanshika  Baba Raghav Das Medical college , Gorakhpur  Child Development Center
Gorakhpur
UTTAR PRADESH 		 8920518299

dahiyavanshika555@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committe AIIMS Gorakhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F88||Other disorders of psychological development,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Non-pharmacological developmental intervention  Structured, play-based and parent-mediated non-pharmacological intervention focused on improving communication, motor, and cognitive skills in children with developmental delay. Sessions will be conducted twice weekly for 8 weeks in a child development center. 
Comparator Agent  Standard Routine Care  Children in the control group will receive standard routine developmental monitoring and advice as per current practice at the child development center. No structured non-pharmacological intervention will be provided. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Children aged 1–5 years diagnosed with developmental delay
Medically stable and attending child development center
Parents and caregivers willing to participate and provide informed consent
 
 
ExclusionCriteria 
Details  Children with known genetic syndromes (e.g., Down syndrome), cerebral palsy, or neurological disorders.
- Children with sensory deficits (e.g., severe hearing or visual impairment).
- Those currently undergoing intensive therapy elsewhere.
- Parents/caregivers unwilling to comply with follow-up or intervention sessions. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in developmental outcomes (cognitive motor and communication domains)  Baseline (Day 0) 4 weeks and 8 weeks after initiation of the intervention 
 
Secondary Outcome  
Outcome  TimePoints 
1. Parental/caregiver stress and satisfaction with the intervention.
2. Adherence to and feasibility of the intervention in clinical settings.
 		 Pre and post-intervention (8 weeks) 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   01/09/2025 
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="4"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  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 - Proposals should be directed to [dahiyavanshika555@gmail.com].

  6. For how long will this data be available start date provided 01-07-2026 and end date provided 01-07-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This randomized controlled trial aims to evaluate the effectiveness of a structured non-pharmacological intervention on developmental outcomes in children aged 1 to 5 years with developmental delay. The study will be conducted in selected Child Development Centers of Gorakhpur. Eligible participants will be randomly assigned to intervention and control groups. The intervention group will receive therapy sessions twice weekly for 8 weeks, while the control group will receive standard care. Developmental outcomes will be assessed pre and post intervention using standardized tools. The study aims to generate evidence to support the use of non-pharmacological approaches in early childhood developmental support.
 
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