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CTRI Number  CTRI/2025/08/093466 [Registered on: 22/08/2025] Trial Registered Prospectively
Last Modified On: 21/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to develop and test a new tool (TEEN-CARE) to check the health and well-being of adolescents. 
Scientific Title of Study   Development and Validation of TEEN-CARE (Teen Comprehensive Assessment and Risk Evaluation) tool for the well-being of adolescents. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jophy Elezabeth George 
Designation  PhD Scholar 
Affiliation  Maharishi Markandeshwar Institute of Medical Sciences & Research, Mullana, Ambala 
Address  Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana 133207, India

Ambala
HARYANA
133207
India 
Phone  8827375337  
Fax    
Email  jophyegeorge5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinay Kumari 
Designation  Vice-Principal cum Professor 
Affiliation  Maharishi Markandeshwar Institute of Medical Sciences & Research, Mullana, Ambala 
Address  Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana 133207, India

Ambala
HARYANA
133207
India 
Phone  7973596469  
Fax    
Email  viceprincipalmmcn@mmumullana.org  
 
Details of Contact Person
Public Query  
Name  Jophy Elezabeth George 
Designation  PhD Scholar 
Affiliation  Maharishi Markandeshwar Institute of Medical Sciences & Research, Mullana, Ambala 
Address  Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana 133207, India

Ambala
HARYANA
133207
India 
Phone  8827375337  
Fax    
Email  jophyegeorge5@gmail.com  
 
Source of Monetary or Material Support  
Maharishi Markandeshwar Institute of Medical Sciences & Research, Mullana, Ambala, Haryana 133207, India 
 
Primary Sponsor  
Name  Jophy Elezabeth George 
Address  Maharishi Markandeshwar Institute of Medical Sciences & Research, Mullana, Ambala, Haryana 133207, India 
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 
Jophy Elezabeth George  St. Thomas Sr. Sec. School  St Thomas School, United Christian Institute Campus, Grand Trunk Rd, Suranussi, Jalandhar, Punjab-144021
Jalandhar
PUNJAB 		 08827375337

jophyegeorge5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Maharishi Markandeshwar Institute of Medical Sciences & Research, Mullana, Ambala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NORMAL ADOLESCENTS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  19.00 Year(s)
Gender  Both 
Details  1. Adolescents aged 13 to 19 years at the time of enrolment.
2. Adolescent proficient in the study language to ensure comprehension of survey or interview questions.
3. Adolescent who provide informed assent with parental or guardian consent or independent consent if legally emancipated.
4. Willing to participate in all study phases (qualitative interviews, surveys).
 
 
ExclusionCriteria 
Details  1. Adolescents with Severe cognitive or developmental impairments.
2. Adolescents with acute psychiatric distress.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Internal consistency of TEEN-CARE tooL and domain scores.   At baseline.  
 
Secondary Outcome  
Outcome  TimePoints 
Item–total correlations and flagging of poorly performing items.  At baseline.  
Clarity/relevance ratings from adolescents.   8 weeks 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   15/09/2025 
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="6"
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  
Adolescence is a crucial stage of growth and development, during which young people encounter physical, emotional, social, and behavioral challenges that can influence their overall well-being. At present, India lacks a comprehensive and validated tool to assess adolescent well-being in an integrated manner. This study aims to develop and validate the TEEN-CARE (Teen Comprehensive Assessment and Risk Evaluation) tool to systematically measure well-being across key domains including physical health, mental and emotional health, social and environmental factors, behavioral risks, and academic/digital influences.

This is a methodological, cross-sectional study that will be conducted among approximately 500 adolescents in Jalandhar, Punjab. Tool development will involve item generation through literature review and expert input, followed by expert panel content validation. Psychometric testing will be performed using exploratory and confirmatory factor analysis, and additional reliability and validity measures.

Primary outcome: Psychometric validation of the TEEN-CARE tool, including internal consistency, construct validity, and test–retest reliability.
Secondary outcomes: Item analysis, known-groups validity, convergent validity with existing adolescent well-being scales, feasibility and acceptability (completion time, missing responses, participant feedback).
 
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