FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/089966 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 27/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Impact of School and Home-Based Strategies in Reducing Screen Time Among Pre-school Children 
Scientific Title of Study   Impact of School and Home-Based Strategies in Reducing Screen Time Among Pre-school Children: A Clustered 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  Anshu Singh 
Designation  Resident Doctor 
Affiliation  Government Medical College, Akola 
Address  Department of Community Medicine, Government Medical College, Akola

Akola
MAHARASHTRA
444001
India 
Phone  9341093471  
Fax    
Email  doctoranshusingh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Umesh Kawalkar 
Designation  Assistant Professor 
Affiliation  Government Medical College, Akola 
Address  Department of Community Medicine, Government Medical College, Akola

Akola
MAHARASHTRA
444001
India 
Phone  9730196442  
Fax    
Email  umeshkawalkar01@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anshu Singh 
Designation  Resident Doctor 
Affiliation  Government Medical College, Akola 
Address  Department of Community Medicine, Government Medical College, Akola

Akola
MAHARASHTRA
444001
India 
Phone  9341093471  
Fax    
Email  doctoranshusingh@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College, Akola Maharashtra India 444001 
 
Primary Sponsor  
Name  Dr Anshu Singh 
Address  Department of Community Medicine, Government Medical College, Akola, Maharashtra, India-444001  
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 Anshu Singh  Government Medical College, Akola  Room no.2 Department of Community Medicine, Government Medical College, Akola 444001
Akola
MAHARASHTRA 		 9341093471

doctoranshusingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Medical College, Akola  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Screentime among Childrens 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Health Education  Educational Module for 3 Months brainstorming sessions with seminars will be conducted 
Comparator Agent  Health educational module without session  Educational module without brainstorming session 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Schools willing to participate in the study.
Children aged 3-6 years and their parental/guardian assent for participation.
Parent and teachers those giving consent for the study. 
 
ExclusionCriteria 
Details  Children with developmental delays affecting screen time behaviours.
Parents and school not willing to comply with follow-up requirements. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in daily screen time (minutes per day) measured via parental self-report and a validated screen time log diary.  Reduction in daily screen time (30-minutes per day) 
 
Secondary Outcome  
Outcome  TimePoints 
Behavioural changes in children  Attention span,
Social interactions,
Engagement in non-screen activities will be assessed at baseline & every four weeks 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   01/08/2025 
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="1"
Months="0"
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 three-arm cluster randomized controlled trial aims to evaluate the effectiveness of school-based and parent-based interventions in reducing daily screen time among 3–6-year-old preschool children in Akola city, Maharashtra. A total of 12 pre-primary schools will be randomly allocated to one of three groups: (1) Control group (no intervention other than educational module), (2) School Recommendations + Teacher Education, and (3) Parent Education via structured modules and workshops. The study will measure changes in daily screen exposure (primary outcome) and behavioural parameters such as attention span, social interaction, sleep patterns, and engagement in non-screen activities (secondary outcomes) at baseline, 3 months, and 6 months. The sample size is 300 children (100 per arm), accounting for clustering effects. The trial includes capacity-building for teachers and awareness modules for parents, and it seeks to generate evidence-based strategies for promoting healthier screen habits in early childhood. Data will be analyzed using mixed-effect regression models and intention-to-treat analysis. 
Close