| CTRI Number |
CTRI/2025/02/080490 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Managing Emotions and Mental Health Challenges Among School going teenage Students in Udupi District, Karnataka |
|
Scientific Title of Study
|
Emotion Regulation and Psychological Distress among
school going Adolescents in Udupi district of Karnataka |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nitin K Thomas |
| Designation |
Post Graduate Student |
| Affiliation |
Prasanna school of public health |
| Address |
Department of Social and Health Innovation, Room No:64, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9567815688 |
| Fax |
|
| Email |
nitin.psphmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lena Ashok |
| Designation |
Professor |
| Affiliation |
Prasanna school of public health |
| Address |
Department of Social and Health Innovation, Room No:62, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9448984732 |
| Fax |
|
| Email |
lena.ashok@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lena Ashok |
| Designation |
Professor |
| Affiliation |
Prasanna school of public health |
| Address |
Department of Social and Health Innovation, Room No:62, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9448984732 |
| Fax |
|
| Email |
lena.ashok@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Nitin K Thomas
Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal Udupi Karnataka India 576104
|
|
|
Primary Sponsor
|
| Name |
Nitin K Thomas |
| Address |
Prasanna school of public health
Room no:64
Manipal Academy of Higher Education Manipal Udupi Karnataka India 576104 |
| 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 Lena Ashok |
Prasanna School of Public Health |
Department of Social and Health Innovation, Room No:64, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal Udupi Karnataka India 576104
Udupi
KARNATAKA |
9448984732
lena.ashok@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee -2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Secondary school students who are willing to participate.
Secondary school students who get parental consent to participate.
|
|
| ExclusionCriteria |
| Details |
Students above the age of 18 years. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Emotion regulation and psychological distress among school-going adolescents.
Well-being of school-going adolescents
|
3 MONTHS 15 DAYS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Primary outcomes can be shared in scientific forums like international conferences |
3 months 15 days |
|
|
Target Sample Size
|
Total Sample Size="438"
Sample Size from India="438"
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)
|
24/02/2025 |
| 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="15" |
|
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 is a cross-sectional study, which will be conducted with secondary school going students participating voluntarily, with informed consent from parents and student assent. to assess emotion regulation, well-being, and psychological distress. |