| CTRI Number |
CTRI/2025/08/093861 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of factors affecting the mental health of adolescents living in urban slums of Nagpur city, Maharashtra |
|
Scientific Title of Study
|
A study on multilevel factors affecting the resilience level and mental well-being of adolescents residing in the urban slums of Nagpur city, Maharashtra |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonu Meher |
| Designation |
PhD Scholar |
| Affiliation |
IIHMR University, Jaipur |
| Address |
Room no. 11, Department of Health Management Research, IIHMR University, 1, Prabhu Dayal Marg, Near Sanganer Airport, Maruti Nagar, Jaipur, Rajasthan
Jaipur RAJASTHAN 302029 India |
| Phone |
7588883272 |
| Fax |
|
| Email |
sonu.phd10@iihmr.in |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Tripti Bisawa |
| Designation |
Professor and Guide |
| Affiliation |
IIHMR University, Jaipur |
| Address |
Room no. 4, Department of Health Management Research, IIHMR University, 1, Prabhu Dayal Marg, Near Sanganer Airport, Maruti Nagar, Jaipur, Rajasthan
Jaipur RAJASTHAN 302029 India |
| Phone |
8875500082 |
| Fax |
|
| Email |
tripti@iihmr.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Sonu Meher |
| Designation |
PhD Scholar |
| Affiliation |
IIHMR University, Jaipur |
| Address |
Room no. 11, Department of Health Management Research, IIHMR University, 1, Prabhu Dayal Marg, Near Sanganer Airport, Maruti Nagar, Jaipur, Rajasthan
Jaipur RAJASTHAN 302029 India |
| Phone |
7588883272 |
| Fax |
|
| Email |
sonu.phd10@iihmr.in |
|
|
Source of Monetary or Material Support
|
| Education & Health Departments, Nagpur Municipal Corporation, 6th Floor, Mahanagar Palika Marg, near Vidhan Bhavan, Collectors Colony, Civil Lines, Nagpur, Maharashtra 440001 India. |
|
|
Primary Sponsor
|
| Name |
Dr Sonu Meher |
| Address |
1, Prabhu Dayal Marg, Near Sanganer Airport, Maruti Nagar, Jaipur, Rajasthan 302029 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonu Meher |
Jaitala Madhyamik Prathamik Shala |
Room no. 5, Department of Secondary Education, Jaitala, Nagpur, Maharashtra 440036 India Nagpur MAHARASHTRA |
7588883272
sonu.phd10@iihmr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board, IIHMR University, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mental Well-being |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents of 14 to 16 years of age group currently studying in 8th to 10th grades of Nagpur Municipal Corporation (NMC) schools situated in the urban slum areas of Nagpur
|
|
| ExclusionCriteria |
| Details |
Adolescents with severe physical or mental disorders.
school dropout.
Not able to read or write
Who are not capable of answering the questions
Those do not provide consent of parents.
Those do not provide assent after receiving consent from a parent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Resilience |
at baseline, 4 weeks & 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mental well-bing of adolescent |
at baseline, 4 weeks & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="800" Sample Size from India="800"
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)
|
29/09/2025 |
| 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="1" Months="6" Days="30" |
|
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 research is an observational, cross-sectional study aimed at examining the effect of multilevel factors on the resilience and mental well-being of adolescents living in the urban slums of Nagpur city. The study will be conducted across 10 schools under the Nagpur Municipal Corporation (NMC). Adolescents aged between 14 and 16 years, enrolled in grades 8th to 10th, will be selected as primary participants using a multistage stratified random sampling technique. In addition to adolescents, key stakeholders in the adolescents’ environment, including parents, school teachers/principals, and local ward members, will be purposively sampled to explore the contextual and environmental factors influencing adolescent resilience and mental well-being. The primary outcome of the study will be the level of resilience among adolescents, as self-reported during structured interviews. The secondary outcome will focus on assessing their mental well-being. This multilevel approach aims to generate actionable insights to inform future interventions promoting adolescent mental health in urban low-resource settings. |