| CTRI Number |
CTRI/2024/12/078253 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Health Education] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
"Helping Teachers to Support Adolescent Mental Health in Rural Schools" |
|
Scientific Title of Study
|
Empowering Rural School Teachers for Screening Mental Illness among Rural Adolescent Boys and Girls-A Health Educational Intervention 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 PradeepTS |
| Designation |
Associate Professor |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Room no-23,2nd floor,
College Block,
Sri Devaraj Urs Medical College,
Sri Devaraj Urs Academic of Higher Education and Research,
Tamaka,Kolar
Kolar District
Karnataka
India
Pincode - 563101
Kolar
KARNATAKA
563101
India |
| Phone |
782950465 |
| Fax |
|
| Email |
dr.pradeep.ts@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PradeepTS |
| Designation |
Associate Professor |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Room no-23,2nd floor,
College Block,
Sri Devaraj Urs Medical College,
Sri Devaraj Urs Academic of Higher Education and Research,
Tamaka,Kolar
Kolar District
Karnataka
India
Pincode - 563101
Kolar
KARNATAKA
563101
India |
| Phone |
782950465 |
| Fax |
|
| Email |
dr.pradeep.ts@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PradeepTS |
| Designation |
Associate Professor |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
ROOM NO - 203
Sri Devaraj URS MEDICAL COLLEGE,
Sri Devaraj URS ACADEMY OF HIGHER EDUCATION,
TAMAKA,
KOLAR,
KARNATAKA,
INDIA,
PINCODE - 563101
Kolar
KARNATAKA
563101
India |
| Phone |
782950465 |
| Fax |
|
| Email |
dr.pradeep.ts@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj URS ACADEMY OF HIGHER EDUCATION,
TAMAKA,
KOLAR,
KARNATAKA,
INDIA,
PINCODE - 563101 |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Medical College |
| Address |
Sri Devaraj Urs Medical College,SDUAHER,Tamaka,Kolar,Karnataka,India,563101 |
| Type of Sponsor |
Private medical college |
|
|
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 Pradeep TS |
Sri Devaraj Urs Medical College |
Room no-23,2nd floor,
College Block,
Sri Devaraj Urs Medical College,
Sri Devaraj Urs Academic of Higher Education and Research,
Tamaka,Kolar
Kolar District
Karnataka
India
Pincode - 563101
Kolar
KARNATAKA |
7892950465
dr.pradeep.ts@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Devaraj Urs Academy of Higher Education and Research and Development Cell/Central Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
The study focuses on mental health problems, specifically anxiety and depression among rural adolescent boys and girls. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Leaflet Intervention Group |
10 schools in and around Kolar will be randomly selected. List of High schools selected are from Aavani, Yellagundalli, Devarayanasamudra, Kothmangala, Kashipura, Angadalli, Uthnoor, Huthoor, Hanumanahalli and Yalagundalli
Each school will be considered as a cluster.
Randomization will be planned using online software randomization.com.
Baseline survey to assess the knowledge will be done by principal investigator (PI), department of Community Medicine after which 5 schools to Lecture intervention group and 5 schools to Leaf lets intervention will be randomly allotted. School teachers will screen for anxiety and depression which will later verified by be Psychiatrists. Sensitivity and specificity will be calculated later. |
| Intervention |
Lecture Module Group |
10 schools in and around Kolar will be randomly selected. List of High schools selected are from Aavani, Yellagundalli, Devarayanasamudra, Kothmangala, Kashipura, Angadalli, Uthnoor, Huthoor, Hanumanahalli and Yalagundalli
Each school will be considered as a cluster.
Randomization will be planned using online software randomization.com.
Baseline survey to assess the knowledge will be done by principal investigator (PI), department of Community Medicine after which 5 schools to Lecture intervention group and 5 schools to Leaf lets intervention will be randomly allotted. School teachers will screen for anxiety and depression which will later verified by be Psychiatrists. Sensitivity and specificity will be calculated later. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Professors with five years of experience in clinical teaching. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is the effectiveness of health education modules (lecture module vs. leaflets module) in training school teachers to screen for anxiety and depression among adolescents. |
Assessed during the 8-month intervention phase of the study. Baseline knowledge will be compared to post-intervention knowledge using pre-test and post-test scores |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| School teachers to identify ANxiety depression among children cross verified by psychiatrist by calculating sensitivity and specificity along with kappa statistics |
Assessed during the 8 month intervention phase of the study. Baseline knowledge will be compared to post-intervention knowledge using pre-test and post-test scores |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
31/12/2024 |
| 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="0"
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 focuses on training rural school teachers to recognize signs of anxiety and depression in adolescents, helping them play a vital role in early mental health care. Teachers will be trained using two methods—interactive lectures and informational leaflets—and their effectiveness will be tested in 10 schools in Kolar. By empowering teachers with the right tools and knowledge, the study aims to bridge the gap in mental health support for rural youth, ensuring timely identification and referral for those in need. |