| CTRI Number |
CTRI/2024/11/076356 [Registered on: 07/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing Depression, Anxiety and Stress Among School Adolescents in Belagavi |
|
Scientific Title of Study
|
Prevalence Of Depression, Anxiety And Stress In School Going Adolescents In Belagavi – An Observational Study |
| 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 Deepa Metgud |
| Designation |
Professor of Department of Pediatrics Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy centre department of pediatric
physiotherapy room no.39 sagar floor Belgaum Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
deepametgud@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Metgud |
| Designation |
Professor of Department of Pediatrics Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center Department of Pediatric
Physiotherapy Room no 39 Sagar floor
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
deepametgud@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Metgud |
| Designation |
Professor of Department of Pediatrics Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy centre department of pediatric
physiotherapy room no.39 sagar floor Belgaum Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
deepametgud@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| Government and Private Schools of grades 8, 9, 10, 11 and 12 in Belagavi |
|
|
Primary Sponsor
|
| Name |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar,
Belagavi-590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Deepa Metgud |
KAHER Institute of Physiotherapy |
Advanced
Physiotherapy center
department of pediatric
physiotherapy room no
39 sagar floor Belagavi
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
9845861236
deepametgud@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee of KLEU Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
School going Adolescents aged 13 to 17 years of age studying in 9th to 12th grade. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Adolescents attending English, Hindi, Kannada and Marathi medium schools in the age group of 13 to 17 years (9th, 10th, 11th and 12th standard)2. 2. Both male and female adolescents will be included in the study
3. Adolescents residing in Belagavi city attending school
|
|
| ExclusionCriteria |
| Details |
1. Parents/Adolescents who refuse to give consent or participate in the study
2. Adolescents with speech and hearing impairments, neurological conditions affecting mental functions
3. Adolescents with diagnosed behavior and development disorders
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Depression, Anxiety and Stress Scale (DASS 21) |
T0 at time pre-assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="347"
Sample Size from India="347"
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)
|
17/11/2024 |
| 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
|
This study is being conducted to understand the Prevalence of Depression, Anxiety and Stress in School Going Adolescents in Belagavi aged 13 to 17 years. As the adolescent period is pivotal in human developement which leads ro physical, mental and psychosocial changes and growth. Early assesment and easily adminstered screening tools will help to identify early and help in prevention. We will be using the DASS 21 screening tools to assess the severity of Depression, Anxiety and Stress components. It is a self reported questionnaire filled by the adolescents itself.
|