| CTRI Number |
CTRI/2025/10/096667 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Exploring Psychosocial and Behavioural Aspects of School-Going Adolescents During the COVID-19 Pandemic |
|
Scientific Title of Study
|
A study to examine psycho-social and behavioural domains among school going adolescents during COVID-19 pandemic: Mixed Study Design |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rachna Bhargava |
| Designation |
Professor of Clinical Psychology |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi |
| Address |
Room no. 4085, Fourth Floor, Teaching Block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9999898053 |
| Fax |
|
| Email |
rachnabhargava@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rachna Bhargava |
| Designation |
Professor of Clinical Psychology |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi |
| Address |
Room No. 4085, Fourth Floor, Teaching Block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9999898053 |
| Fax |
|
| Email |
rachnabhargava@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rachna Bhargava |
| Designation |
Professor of Clinical Psychology |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi |
| Address |
Room No. 4085, Fourth Floor, Teaching Block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9999898053 |
| Fax |
|
| Email |
rachnabhargava@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS), New Delhi |
| Indian Council of Medical Research (ICMR), New Delhi |
| Schools under Department of Education (DOE), Chandigarh |
| Schools under Department of Education (DOE), New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Rachna Bhargava |
| Address |
Room no 4085, Fourth floor, Teaching Block, All India Institute of Medical Sciences (AIIMS), New Delhi |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rachna Bhargava |
All India Institute of Medical Sciences (AIIMS), New Delhi |
Room no. 4085, Fourth Floor, Teaching Block, AIIMS, New Delhi
South
DELHI |
9999898053
rachnabhargava@gmail.com |
| Dr Priti Arun |
Government Medical College and Hospital (GMCH) |
Sector-32, Chandigarh
Chandigarh
CHANDIGARH |
9646121612
drpritiarun@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
| Institutional Ethics Committee, GMCH, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of stress and problematic internet use |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTERVENTION |
Strategies for changes in knowledge, skills and confidence in dealing with stress, family and problematic internet use delivered on consecutive days for a total of 4 days (Baseline assessment one day prior and post-assessment within 4 days of intervention). |
| Comparator Agent |
PLACEBO |
Activities on mind-body relationship, myths related to food, dietary patterns and exercise in relation to physical and mental health delivered on consecutive days for a total of 4 days (Baseline assessment one day prior and post-assessment within 4 days of intervention). |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
School-going adolescents studying in 9th-12th grade from Government and Private institutions in New Delhi and Chandigarh; understanding hindi and/or English; willing to provide assent; able to comprehend instructions and respond to questions |
|
| ExclusionCriteria |
| Details |
Adolescents whose parents refuse to give consent (Opt out Consent); Any adolescent having gross chronic neurological /physical illness ; Any known psychotic illness interfering in his/her ability to comprehend instructions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Stress level |
Baseline, Post Assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Knowledge, Skill and Confidence in dealing with stress, family, and problematic internet use |
Baseline, Post Assessment |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/11/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study is a quasi-experimental, single blind, two arm, multi-centre study (Delhi and Chandigarh) with an aim to develop and examine utility of need-based strategies for school-going adolescents. For this, we will have two different groups from two different schools to compare the intervention impact in comparison to the placebo group. There would be four sessions in each group. The primary outcome will be changes in stress level (through ADOlescence Stress Scale) and secondary outcome will be to examine changes in knowledge, skill and, confidence in dealing with stress, family, and excessive internet use. The students will be administered specifically developed scale to examine knowledge, stress level (ADOlescence Stress Scale), Health Quality of Life (KIDSCREEN-52), internet use (Internet Addiction Test), and emotional and behavioural concerns (Strengths and Difficulties Questionnaire). |