| CTRI Number |
CTRI/2026/03/105278 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Building and Testing Prevention Programs for Technology Overuse Among the Youth |
|
Scientific Title of Study
|
To develop and validate a comprehensive package of prevention- focused interventions targeted at youth (children, adolescents, young adults), parents and teachers for excessive and problematic use of technology (internet/ smartphone/ social media/gaming/ /gambling/ screen time) among the youth (children, adolescent, young adults). As part of Centre for Advanced Research on Addictive Behaviours (CAR-AB): Implementation focused initiative for delivering evidence-based interventions targeting excessive and problematic use of technology (smartphone/gaming/social media/gambling/screentime) and associated stress, depression, anxiety, addiction. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
YATAN PAL SINGH BALHARA |
| Designation |
PROFESSOR |
| Affiliation |
AIIMS NEW DELHI |
| Address |
ROOM NO 4096, 4TH FLOOR, TEACHING BLOCK, AIIMS, ANSARI NAGAR NEW DELHI 110029
South West
DELHI
110029
India |
| Phone |
01126593236 |
| Fax |
|
| Email |
YPSBALHARA@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
YATAN PAL SINGH BALHARA |
| Designation |
PROFESSOR |
| Affiliation |
AIIMS NEW DELHI |
| Address |
ROOM NO 4096, 4TH FLOOR, TEACHING BLOCK, AIIMS, ANSARI NAGAR NEW DELHI 110029
South West
DELHI
110029
India |
| Phone |
01126593236 |
| Fax |
|
| Email |
YPSBALHARA@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
YATAN PAL SINGH BALHARA |
| Designation |
PROFESSOR |
| Affiliation |
AIIMS NEW DELHI |
| Address |
ROOM NO 4096, 4TH FLOOR, TEACHING BLOCK, AIIMS, ANSARI NAGAR NEW DELHI 110029
South West
DELHI
110029
India |
| Phone |
01126593236 |
| Fax |
|
| Email |
YPSBALHARA@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
ICMR ANSARI NAGAR NEW DELHI |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tanmay Joshi |
AIIMS BHOPAL |
Saket Nagar Bhopal
Bhopal
MADHYA PRADESH |
8800484381
tanmayjoshi89@gmail.com |
| YATAN PAL SINGH BALHARA |
AIIMS NEW DELHI |
AIIMS ANSARI NAGAR NEW DELHI
South West
DELHI
South West
DELHI |
01126593236
YPSBALHARA@GMAIL.COM |
| Dr Rajeev Ranjan |
AIIMS Patna |
Patna
Patna
BIHAR |
9717531800
rajeevranjan0087@gmail.com |
| Dr Vishal Diman |
AIIMS Rishikesh |
Rishikesh
Dehradun
UTTARANCHAL |
9717329148
vishaldhiman102@gmail.com |
| Dr Ragul Ganesh |
JIPMER Puducherry |
Puducherry
Pondicherry
PONDICHERRY |
7838478898
ragunganesh.r@gmail.com |
| Dr Subhash Das |
NEIGRIHMS Shillong |
Mawdiangdiang Shillong
East Khasi Hills
MEGHALAYA |
9646121613
asthus10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Ethics Committee AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
May or may not have excessive and problematic use of technology. |
| Patients |
(1) ICD-10 Condition: F99||Mental disorder, not otherwise specified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A comprehensive package of prevention- focused interventions |
A comprehensive package of prevention- focused interventions targeted at youth (children, adolescents, young adults), parents and teachers for excessive and problematic use of technology (internet/ smartphone/ social media/gaming/ /gambling/ screen time) and mitigate the risk of associated stress, depression, anxiety, addiction among youth shall be developed. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
For youth (children, adolescents, young adults)-
Registered as a student in a school or a college
Aged 12 years or older
Currently not screened positive for excessive and problematic use of technology
(internet/ social media/ gaming/ gambling) as assessed by the study questionnaires
Willing to participate in the study and provide written informed consent (if older than 18
years) or assent (if younger that 18 years)
Parents/ legal guardians willing to provide written consent (if student is younger than 18
years)
For parents-
Currently not screened positive for excessive and problematic use of technology
(internet/ social media/ gaming/ gambling) as assessed by the study questionnaires
Aged 18 years or older
Willing to participate in the study and provide written informed consent
For teachers-
Currently not screened positive for excessive and problematic use of technology
(internet/ social media/ gaming/ gambling) as assessed by the study questionnaires
Teaching in a school or college
Aged 18 years or older
Willing to participate in the study and provide written informed consent |
|
| ExclusionCriteria |
| Details |
For youth (children, adolescents, young adults)-
Screened positive for excessive and problematic use of technology (internet/ social
media/ gaming/ gambling) as assessed by the study questionnaires
Not willing to participate in the study or provide assent/ consent
Parents/ legal guardians not willing to provide consent (if student younger than 18 years) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| By the end of the study, a validated and comprehensive package of prevention-focused interventions for youth (children, adolescents, young adults), parents and teachers to address excessive and problematic technology use (internet, smartphone, social media, gaming, gambling, screen time) will be developed. It will be theory-based, co-developed with stakeholders, acceptable, and tested across regions. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
02/06/2026 |
| 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="2"
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
|
The study is aimed to develop and validate a comprehensive package of prevention- focused interventions targeted at youth (children, adolescents, young adults), parents and teachers for excessive and problematic use of technology (internet/ smartphone/ social media/gaming/ /gambling/ screen time) among the youth (children, adolescent, young adults). |