CTRI

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CTRI Number

CTRI/2026/03/105354 [Registered on: 05/03/2026] Trial Registered Prospectively

Last Modified On:

02/03/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Screening
Behavioral

Study Design

Other

Public Title of Study

Screening and Early Intervention for Harmful Technology Use and Mental Health Concerns in Youth

Scientific Title of Study

To develop and test effectiveness of a Screening, Brief Intervention and Referral to Treatment (SBIRT) package aimed at early detection and intervention for excessive and problematic use of technology (internet/ smartphone/ gaming/ social media use/ gambling/ screentime) and mitigate the associated stress, depression, anxiety among the youth (children, adolescent, young adults).

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 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 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 South West DELHI 110029 India
Phone	01126593236
Fax
Email	YPSBALHARA@GMAIL.COM

Source of Monetary or Material Support

ICMR ANSARI NAGAR NEW DELHI

Primary Sponsor

Name	ICMR
Address	ICMR, ANSARI NAGAR NEW DELHI
Type of Sponsor	Research institution

Details of Secondary Sponsor

Name	Address
NIL	NIL

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 MADHYA PRADESH	8800484381 tanmayjoshi89@gmail.com
DR YATAN PAL SINGH BALHARA	AIIMS NEW DELHI	AIIMS ANSARI NAGAR NEW 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
AIIMS NEW DELHI INSTITUTE ETHICS COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: F99\|\|Mental disorder, not otherwise specified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	NIL	NIL
Intervention	Screening, Brief Intervention and Referral to Treatment (SBIRT) package	Screening, Brief Intervention and Referral to Treatment (SBIRT) package aimed at early detection and intervention for excessive and problematic use of technology (internet/ smartphone/ gaming/ social media use/ gambling/ screentime) and mitigate the associated stress, depression, anxiety among the youth (children, adolescent, young adults).

Inclusion Criteria

Age From	12.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	For development of SBIRT intervention For youth (children, adolescents, young adults)- Registered as a student in a school or a college Aged 12 years or older 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- Aged 18 years or older Willing to participate in the study and provide written informed consent For teachers- Teaching in a school or college Aged 18 years or older Willing to participate in the study and provide written informed consent For mental health experts- Practicing mental health expert Experience of clinical or research in the area of addictive behaviors Aged 18 years or older Willing to participate in the study and provide written informed consent For public health experts- Working in area of public health Aged 18 years or older Willing to participate in the study and provide written informed consent For program and policy experts- Experience and expertise in domain of health or education program or policy Aged 18 years or older Willing to participate in the study and provide written informed consent For effectiveness testing of SBIRT intervention For youth (children, adolescents, young adults)- Registered as a student in a school or a college Aged 12 years or older 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)

ExclusionCriteria

Details

For development of SBIRT intervention
For youth (children, adolescents, young adults)-
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)
For parents and teachers-
Not willing to participate in the study or provide assent/ consent
For mental health experts, public health expert, program or policy expert-
Not willing to participate in the study or provide assent/ consent
For effectiveness testing of SBIRT intervention
For youth (children, adolescents, young adults)-
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

At the end of the study, a validated Screening, Brief Intervention and Referral to Treatment (SBIRT) package for early detection and intervention of excessive and problematic technology use among youth will be developed. Grounded in established psychological and behavioural theories and co-developed with stakeholders, the SBIRT package will be validated across different regions of the country and is expected to have good acceptability.

2 years

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="588"
Sample Size from India="588"
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="3"
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 test effectiveness of a Screening, Brief Intervention and Referral to Treatment (SBIRT) package aimed at early detection and intervention for excessive and problematic use of technology (internet/ smartphone/ gaming/ social media use/ gambling/ screentime) and mitigate the associated stress, depression, anxiety among the youth (children, adolescent, young adults).