CTRI

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CTRI Number

CTRI/2024/09/074005 [Registered on: 18/09/2024] Trial Registered Prospectively

Last Modified On:

14/09/2024

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Development of an education module for parents of preschool children having screen time related social communication issues.

Scientific Title of Study

Development of a parental education module for screen-dependent preschool children with social communication deficit

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Joe Mathew V J
Designation	PG Student
Affiliation	Manipal College of Health Professions
Address	Department of Speech and Hearing, 6th floor LH5 Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal Udupi KARNATAKA 576104 India
Phone	9605708122
Fax
Email	joe.mchpmpl2023@learner.manipal.edu

Details of Contact Person
Scientific Query

Name	Dr Shivani Tiwari
Designation	Associate Professor and Guide
Affiliation	Manipal College of Health Professions
Address	Department of Speech and Hearing ,4th floor, room no 409, Manipal College of Health Professions(MCHP), Manipal Academy of Higher Education(MAHE), Manipal Udupi KARNATAKA 576104 India
Phone	9986448718
Fax
Email	shivani.tiwari@manipal.edu

Details of Contact Person
Public Query

Name	Dr Shivani Tiwari
Designation	Associate Professor and Guide
Affiliation	Manipal College of Health Professions
Address	Department of Speech and Hearing ,4th floor, room no 409, Manipal College of Health Professions(MCHP), Manipal Academy of Higher Education(MAHE), Manipal Udupi KARNATAKA 576104 India
Phone	9986448718
Fax
Email	shivani.tiwari@manipal.edu

Source of Monetary or Material Support

Kasturba Medical College, Eshwar Nagar, Manipal, Karnataka, India. PIN 576104

Primary Sponsor

Name	Joe Mathew V J
Address	Department of Speech and Hearing,6th Floor, LH5 Manipal College of Health Professions(MCHP), Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India. PIN 576104
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
Joe Mathew V J	Manipal College of Health Professions	Department of Speech and Hearing, Pre clinical Laboratory, Room no 416, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, 576104 Udupi KARNATAKA	9605708122 joe.mchpmpl2023@learner.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	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: F59\|\|Unspecified behavioral syndromes associated with physiological disturbances and physical factors,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Not applicable	Not applicable
Comparator Agent	Not applicable	Not applicable

Inclusion Criteria

Age From	30.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Qualified professionals having valid registration in the field of health care. 2. A minimum clinical experience of three years. 3. Professionals should be practising in the field of developmental impairments in children.

ExclusionCriteria

Details

1. Professionals who do not deal with pediatric population will be excluded.
2. Professionals who has not come across with cases of screen-time issues in children will be excluded.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Social communication skills in preschool children with increased screentime will be identified.	3 months and 8 months

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="4"
Sample Size from India="4"
Final Enrollment numbers achieved (Total)= "4"
Final Enrollment numbers achieved (India)="4"

Phase of Trial

N/A

Date of First Enrollment (India)

25/09/2024

Date of Study Completion (India)

25/04/2025

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="10"
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

Numerous studies report about the negative effects of screen time, including behavioural issues, sleep deprivation, speech and language delay, etc. Few studies also report about the parental knowledge and concerns related to screen time in children and its effects. Given the increasing trend of screen time and its impact on overall development of children in their early years, there is an immediate need for parental intervention programme to reduce screen time in young preschool children.

Despite the literature on the effects of screen time in children with or without social communication deficit and increasing parental awareness of its effects, there is only limited research focusing on intervention to address this issue.

This study aims to develop a parent educational module to educate the parents of screen-dependent typically developing preschool children with social communication deficits. The module will be developed based on literature search and parental interview for content development which will be reviewed by a panel of professionals for their opinion and changes. This module can be validated and will be a helpful tool in intervention for children having screen time-related social communication deficits.