| CTRI Number |
CTRI/2025/11/097246 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Interventional Study To Assess The Self Esteem, Assertiveness and Quality of Life of Adolescents] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Educational Program to Boost Confidence, Self-Expression, and Life Satisfaction Among School-Going Adolescents |
|
Scientific Title of Study
|
Effectiveness of Tutelage on Improving Self-esteem, Assertiveness and Quality of life among 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 |
SURESH BABU G O |
| Designation |
Ph.D Scholar |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Teerthanker Mahaveer University
PhD Section, Ground Floor, Teerthanker Mahaveer College of Nursing, TeerthankerMahaveer University, NH-24, Bagarpur, Delhi Road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8296533622 |
| Fax |
|
| Email |
sureshnursing@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Kumar |
| Designation |
Professor and Superviser |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Room No 109, Ground Floor, Teerthanker Mahaveer College of Nursing, TeerthankerMahaveer University, NH-24, Bagarpur, Delhi Road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9813893463 |
| Fax |
|
| Email |
dryogesh.nursing@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh Kumar |
| Designation |
Professor and Superviser |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Room No 109, Ground Floor, Teerthanker Mahaveer College of Nursing, TeerthankerMahaveer University, NH-24, Bagarpur, Delhi Road, Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9813893463 |
| Fax |
|
| Email |
dryogesh.nursing@tmu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SURESH BABU G O |
| Address |
Room No 109, Ground Floor, Teerthanker Mahaveer College of Nursing, TeerthankerMahaveer University, NH-24, Bagarpur, Delhi Road,
Moradabad
UTTAR PRADESH
244001
India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Prof Kavita |
IKON Pre University College |
No. 32, Bheemanahalli, BM Road, Bidadi
Bangalore
KARNATAKA |
7676114633
ikonpucollege@gmail.com |
| Suresh Babu G O |
JNANA VIKAS ENGLISH MEDIUM HIGH SCHOOL |
BM Road, Bidadi
Bangalore
KARNATAKA |
08296533622
sureshnursing@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,TEERTHANKER MAHAVEER DENTAL COLLEGE & RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescents age group between 14-17 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intervention Program |
Adolescents in the comparator group will continue with their regular school activities without receiving the self-structured intervention program. This group will serve as a reference to assess the effectiveness of the intervention in enhancing self-esteem, assertiveness, and quality of life over the six-month study period. |
| Intervention |
TUTELAGE |
The self-structured intervention program integrates evidence-based approaches, including assertiveness training, life skills education, stress management, group discussions, role plays, and confidence-building activities, delivered over a duration of six months. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents who are willing to participate in the study
Adolescents who are available at the time of data collection
Adolescents between the ages of 14 and 17 |
|
| ExclusionCriteria |
| Details |
Adolescents with prior knowledge with assertiveness, self-esteem and quality of life.
Adolescents who are unhealthy during the time of data collection. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improves the level of self esteem, assertiveness and quality of life of adolescents through tutelage program |
Baseline, 4 weeks, 8 weeks and 3 months after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/12/2025 |
| 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="1"
Months="6"
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
|
This study
aims to evaluate the effectiveness of a Tutelage program in
improving self-esteem, assertiveness, and quality of life among adolescents.
The intervention integrates evidence-based approaches, including assertiveness
training, life skills education, and group discussion, stress management, role
play, confidence building and is delivered once weekly over a few weeks.
Participants will be assessed at baseline and post-intervention using validated
psychological scales. The study seeks to provide a replicable model for
promoting adolescent mental well-being through psychoeducational group
interventions. |