| CTRI Number |
CTRI/2025/10/096400 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Trauma Prevention in Schools |
|
Scientific Title of Study
|
Building Safe Minds: A Prospective Interventional Study on Trauma Prevention Education in Schools |
| Trial Acronym |
STEPS Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jitin Bajaj |
| Designation |
Professor |
| Affiliation |
Netaji Subhash Chandra Bose Medical College |
| Address |
Room no. 6, IIIrd floor, Department of Neurosurgery, IIIrd floor, Superspeciality Hospital, Netaji Subhash Chandra Bose Medical College, Jabalpur
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
8696982911 |
| Fax |
|
| Email |
bajaj.jitin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jitin Bajaj |
| Designation |
Professor |
| Affiliation |
Netaji Subhash Chandra Bose Medical College |
| Address |
Room no. 6, IIIrd floor, Department of Neurosurgery, IIIrd floor, Superspeciality Hospital, Netaji Subhash Chandra Bose Medical College, Jabalpur
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
8696982911 |
| Fax |
|
| Email |
bajaj.jitin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jitin Bajaj |
| Designation |
Professor |
| Affiliation |
Netaji Subhash Chandra Bose Medical College |
| Address |
Room no. 6, IIIrd floor, Department of Neurosurgery, IIIrd floor, Superspeciality Hospital, Netaji Subhash Chandra Bose Medical College, Jabalpur
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
8696982911 |
| Fax |
|
| Email |
bajaj.jitin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Multidisciplinary Research Unit, IVth floor, Netaji Subhash Chandra Bose Medical College, Jabalpur - 482003, MP, India |
|
|
Primary Sponsor
|
| Name |
Multidisciplinary Research Unit Netaji Subhash Chandra Bose Medical College |
| Address |
Multidisciplinary Research Unit, IVth floor, Netaji Subhash Chandra Bose Medical College, Jabalpur - 482003, MP, India |
| Type of Sponsor |
Government 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 |
| Prof Jitin Bajaj |
Netaji subhash Chandra Bose Medical College |
Room No. 6, IIIrd floor, Department of Neurosurgery, Netaji subhash Chandra Bose Medical College, Jabalpur - 482003, MP, India
Jabalpur
MADHYA PRADESH |
8696982911
bajaj.jitin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Netaji Subhash Chandra Bose Medical College, Jabalpur (MP) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy school students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Teaching |
Baseline Assessment
· Pre-intervention structured questionnaire to assess knowledge and practices related to trauma prevention.
· Brief survey for students on whether their families follow basic safety practices (helmet use, railing installation, etc.).
Intervention
· 45-minute interactive educational session using:
o Short animated videos
o Practical demonstrations (helmet use, fall prevention at home)
o Real-life examples and group discussion
o Visual posters and take-home leaflets
Immediate Post-Test
· Re-administer the same questionnaire to assess knowledge gain.
Follow-Up at 3 Months
· Repeat the knowledge questionnaire.
· Add a short survey:
o To evaluate changes in students’ safety practices.
o To assess whether parents made any safety changes at home (e.g., started wearing helmets, installed terrace railings, reduced phone use while driving).
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
· Students of Classes 1 to 12
· Regular attendees of selected schools
· Assent from students and consent from parents/guardians
|
|
| ExclusionCriteria |
| Details |
· Prior formal training in trauma or safety education
· Cognitive or learning disabilities that interfere with participation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in students’ trauma prevention knowledge scores between pre-test and immediate post-test. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Retention of knowledge after 3 months
Self-reported behavior change among students & households
Acceptability & perceived usefulness of the session among students & teachers
Feasibility of integrating trauma prevention education into the school curriculum based on qualitative feedback
Reported changes in parents’ or household safety behavior (as per student response)
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
15/11/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bajaj.jitin@gmail.com].
- For how long will this data be available start date provided 02-06-2026 and end date provided 02-01-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Introduction: Trauma is a significant cause of morbidity and mortality worldwide. Common causes include road traffic accidents, falls from height, slipping on wet surfaces, and unsafe home environments. Simple preventive measures—such as wearing helmets and seatbelts, avoiding mobile use while walking or driving, installing railings, and adhering to speed limits—can drastically reduce these injuries. However, these are often neglected due to behavioral inertia. School children are a highly receptive population and can be molded early with safety-conscious behaviors.1,2 Moreover, they can influence the safety practices of their families, making school-based education a powerful community tool. There are no studies from India or any other developing countries regarding this. Objectives: Primary Objective · To assess the effectiveness of a structured educational session on improving knowledge about trauma prevention among school students. Secondary Objectives · To determine the retention of knowledge about trauma prevention after 3 months. · To assess whether the intervention indirectly influenced the safety-related behaviors of students’ parents or households. · To determine the acceptability and perceived usefulness of the session among students and teachers. · To explore the feasibility of integrating trauma prevention education into the existing school curriculum. |