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CTRI Number  CTRI/2025/07/090881 [Registered on: 14/07/2025] Trial Registered Prospectively
Last Modified On: 21/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Descriptive Study 
Study Design  Other 
Public Title of Study   Screen Time and Its Possible Relationship with Autism-like Symptoms in Preschoolers 
Scientific Title of Study   An association between screen time and autistic- Like Symptoms in Children aged 4-6 years- A Questionnaire based study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Vinisha Shivnani 
Designation  Postgraduate scholar 
Affiliation  Dr. D.Y. Patil College of Physiotherapy, Pune. 
Address  Department Of Electrotherapy and Electrodiagnosis, 3rd Floor, Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune- 411018.
Department Of Electrotherapy and Electrodiagnosis, 3rd Floor, Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune- 411018.
Pune
MAHARASHTRA
411017
India 
Phone  8237986360  
Fax    
Email  vinisha.shivnani24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pramod Palekar 
Designation  Associate Professor 
Affiliation  Dr. D.Y. Patil College of Physiotherapy, Pune. 
Address  Department Of Electrotherapy and Electrodiagnosis, 3rd Floor, Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune.
Department Of Electrotherapy and Electrodiagnosis, 3rd Floor, Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India 
Phone  9689481499  
Fax    
Email  pramod.palekar@dpu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Ms Vinisha Shivnani 
Designation  Postgraduate scholar 
Affiliation  Dr. D.Y. Patil College of Physiotherapy, Pune. 
Address  Department Of Electrotherapy and Electrodiagnosis, 3rd Floor, Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune.
Department Of Electrotherapy and Electrodiagnosis, 3rd Floor, Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA
411017
India 
Phone  8237986360  
Fax    
Email  vinisha.shivnani24@gmail.com  
 
Source of Monetary or Material Support  
Dr. D. Y. Patil College Of Physiotherapy, Pimpri, Pune- 411018. 
 
Primary Sponsor  
Name  Ms Vinisha Shivnani 
Address  Dr. D. Y. Patil College Of Physiotherapy, Pimpri, Pune- 411018. 
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 
Dr Vinisha Shivnani  Rise N Shine Preschool   1st Floor, Near Ramanand Higher Secondary School, Jai Hind School Road, Pimpri Colony-411017
Pune
MAHARASHTRA 
08237986360

vinisha.shivnani24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee of Dr. D. Y. Patil College of Physiotherapy, Pune.  No Objection Certificate 
Institutional Ethics Committee of Dr. D. Y. Patil College of Physiotherapy, Pune.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal Children aged between 4 to 6 years. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Children aged 4 to 6 years
Both male and female
Parents consent
 
 
ExclusionCriteria 
Details  Age less than 4 years and greater than 6 years
Children with any neurological impairments and mental illness.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Questions about screen exposure
Indian Autism Screening Questionnaire (IASQ)
 
Baseline assessment only
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2025 
Date of Study Completion (India) 27/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 27/02/2026 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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  
Autism Spectrum Disorder (ASD) is a mental disorder brought on by a combination of genetic, biochemical, psychological, and environmental factors. ASD development is 50% likely due to environmental, one of which appears to be children’s screen time, which may cause disparities in early neuropsychological development. In 2000, ASD prevalence was 6.7/1000 in eight years old American children. While in 2010, this prevalence increased to 14.7/1000 and in 2014, it reached 16.8/1000. World Health Organization (WHO) recommends a watch time of one hour a day for children aged 4-6 years. A study in Japan demonstrated average cellphone use was 24 hours /week and screen time use between five to seven hours/day in American children. But excessive exposure to screen has detrimental effects on a child’s brain development and overall healthAdverse effects like poor social interaction and language development, mood disorders, and autism-like behaviours, such as hyperactivity, irritability, limited attention span, and altered capability to process are observed. Many studies have found an association between excessive screen usage and autism-like symptomsThe Social Communication Questionnaire (SCQ) is a developed screening tool based on the revised version of the Autism Diagnostic Interview (ADI), to assess the association between screen exposure time and the development of ASD. Hence, the aim of this study is to explore the association and impact of screen time on autistic -like symptoms in children aged four to six years using SCQ via interviewing parents of preschoolers in PCMC.

Especially in recent years with the outbreak of COVID-19, the percentage of preschool children who use screens more than two hours a day has risen to 84.1%(39). Most households had television (97%), tablets (83%), and smartphones (77%). At age 4, half the children had their own television and three-fourths their own mobile device. New clinical case studies have found that many children who spend a lot of time in front of mobile phone, computer, television or tablet screens may develop a new type of autistic spectrum disorder – virtual autism. Excessive screen time and virtual exposure can cause or mimic autism -like characteristics, such as social disengagement, sensory overload, or speech issues, that may contribute to delays in social communication skills, language development, and attention span, all of which are key developmental areas typically affected in children with Autism -Spectrum Disorder (ASD), even if digital platforms can be therapeutic or helpful for social connection. Additionally, parents gave children devices when doing house chores (70%), to keep them calm (65%), and at bedtime (29%). As the research on virtual autism in Indian scenario remains underdeveloped, this study aims to determine whether screen time is associated with autistic-like characteristics in children aged 4-6 years and which will guide for holistic measures for little one’s to foster healthier and more balanced lifestyles. 

AIM: To find an association between screen time and autistic-like symptoms, in children aged 4-6 years.
OBJECTIVES:
1.      To investigate the association between duration of daily screen time and the severity of autistic-like symptoms.
2.      To investigate the association between age of child exposed to screen time and the severity of autistic-like symptoms.

 

 
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