| CTRI Number |
CTRI/2024/11/076230 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Parental Views on Children Screen Use and Awareness of Digital Risks |
|
Scientific Title of Study
|
A study on parents’ perspective on digital device use and awareness about virtual autism among toddlers: A cross-sectional study in Kundapura, Udupi district |
| 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 Meghana Manoj |
| Designation |
Primary Student Researcher |
| Affiliation |
Prasanna School of Public Health,MAHE |
| Address |
Room number 60,Department of Global Public Health Policy and Governance, Prasanna School of Public Health,MAHE,Manipal,Karnataka,
Udupi
KARNATAKA
576104
India |
| Phone |
9110613567 |
| Fax |
|
| Email |
meghana.psphmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varalakshmi Chandra Sekaran |
| Designation |
Associate Professor |
| Affiliation |
Prasanna School of Public Health,MAHE |
| Address |
Room number 60, Department of Global Public Health Policy and Governance, Prasanna School of Public Health,MAHE,Manipal,Karnataka,
India
Udupi
KARNATAKA
576104
India |
| Phone |
9535810325 |
| Fax |
|
| Email |
varalakshmi.cs@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varalakshmi Chandra Sekaran |
| Designation |
Associate Professor |
| Affiliation |
Prasanna School of Public Health,MAHE |
| Address |
Room number 60, Department of Global Public Health Policy and Governance, Prasanna School of Public Health,MAHE,Manipal,Karnataka,
India
Udupi
KARNATAKA
576104
India |
| Phone |
9535810325 |
| Fax |
|
| Email |
varalakshmi.cs@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Prasanna School of Public Health, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka,India 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Meghana Manoj |
| Address |
Room number 60, Department of Global Public Health Policy and Governance, Prasanna School of Public Health, MAHE, Manipal, Karnataka 576104 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Varalakshmi Chandra Sekaran |
Prasanna School of Public Health |
Room number 60,Department of Global Public Health Policy and Governance, Prasanna School of Public Health,MAHE,Manipal,Karnataka,
India
Udupi
KARNATAKA |
9535810325
varalakshmi.cs@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Either father or mother of children from 0-2 years from the selected Anganwadi areas in Kundapura. |
|
| ExclusionCriteria |
| Details |
Parents who have cognitive disabilities or mental health problems who are not able to provide informed consent are excluded.
Parents of children with confirmed diagnosis of autism spectrum disorder, cerebral palsy, genetic disorders like Down syndrome or Fragile X syndrome, or any other neurodevelopmental disorders will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess parents’ perspective on digital device use and awareness about virtual autism among toddlers in Kundapura. |
Study duration from 20/11/2024 to 30/06/2024 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess factors associated with digital device use and virtual autism among toddlers in Kundapura. |
Study duration from 20/11/2024 to 30/06/2024 |
|
|
Target Sample Size
|
Total Sample Size="404"
Sample Size from India="404"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="404" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/11/2024 |
| Date of Study Completion (India) |
20/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
Modification(s)
|
The study on parents perspective on digital device use and awareness about virtual autism among toddlers aims to assess digital device use among toddlers and the awareness about virtual autism among parents. The use of digital devices has tremendously increased over the past few years with children less than 6 months old reporting device use. Excessive use can lead to health concerns in children. Virtual autism is a newly defined condition due to excessive device use in children less than 3 years of age. There are limited studies on digital device use and virtual autism. Thus, this study aims to evaluate and assess parental knowledge regarding device usage and virtual autism. |