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CTRI Number  CTRI/2025/08/093535 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Single Arm Study 
Public Title of Study   A digital training program to help physical education teachers support the mental health of adolescent student-athletes in school sports 
Scientific Title of Study   Enhancing Adolescent Sports Mental Health Literacy among physical education teachers through a digital mental health program: An interventional study among physical education teachers in Udupi district 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Anjali Pradhan 
Designation  PhD Scholar 
Affiliation  Prasanna School of Public Health 
Address  Room No. 29, First floor, Department of Healthcare and Hospital Management, Prasanna School of Public Health, Manipal Academy of Higher Education (MAHE), Manipal, Udupi, Karnataka-576104, India
Nil
Udupi
KARNATAKA
576104
India 
Phone  7989684156  
Fax    
Email  anjali1.psphmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Ms Anjali Pradhan 
Designation  PhD Scholar 
Affiliation  Prasanna School of Public Health 
Address  Room No. 29, First floor, Department of Healthcare and Hospital Management, Prasanna School of Public Health, Manipal Academy of Higher Education (MAHE), Manipal, Udupi, Karnataka-576104, India
Nil
Udupi
KARNATAKA
576104
India 
Phone  7989684156  
Fax    
Email  anjali1.psphmpl2024@learner.manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Usha Rani 
Designation  Associate Professor and Head 
Affiliation  Prasanna School of Public Health 
Address  Room No. 68, Ground Floor, Department of Healthcare and Hospital Management, Prasanna School of Public Health, Manipal Academy of Higher Education (MAHE), Manipal, Udupi, Karnataka-576104, India
Nil
Udupi
KARNATAKA
576104
India 
Phone  9480980246  
Fax    
Email  usha.rani@manipal.edu  
 
Source of Monetary or Material Support  
Intramural Funding from Manipal Academy of Higher Education (MAHE), Manipal, Udupi, Karnataka, India 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education (MAHE) 
Address  Prasanna School of Public Health, Manipal Academy of Higher Education (MAHE), Manipal, Udupi, Karnataka-576104, India 
Type of Sponsor  Other [Academic Institution] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ms Anjali Pradhan  Prasanna School of Public Health (PSPH), Manipal Academy of Higher Education (MAHE)  Department of Healthcare and Hospital Management, Room No. 29, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka-576104, India
Udupi
KARNATAKA 		 7989684156

anjali1.psphmpl2024@learner.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  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  No clinical health condition, study focused on adolescent sports mental health literacy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Digital Adolescent Sports Mental Health Literacy Program  Educational or behavioral intervention delivered via an app-based digital platform, including interactive modules, videos, case-based scenarios, quizzes, and referral pathways. The intervention involves the digital Adolescent Sports Mental Health (ASMHL) platform and differs from traditional verbal discussions or training. No randomization will be used. Safety monitoring and user feedback will be integrated through in-app surveys. Participants may withdraw from the intervention at any time, with partial data retained anonymously if ethically acceptable. The total duration of the intervention is twelve weeks (three months), and participants have access to the program throughout this period with flexible, self-paced engagement expected. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Physical Education Teachers (PETs) currently working in schools of the Udupi district

2. Actively involved in school sports programs

3. Minimum 1 year experience with adolescent student-athletes (for qualitative phase)

4. Own and use a smartphone (for digital platform evaluation phase)

5. Willing to participate and provide written informed consent 
 
ExclusionCriteria 
Details  1. PETs not involved in school sports programs

2. PETs not willing to participate or not providing consent

3. PETs outside the Udupi district

4. PETs with less than 1 year of experience working with adolescent student-athletes (for qualitative phase)

5. PETs without access to a smartphone (for digital platform evaluation phase) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Adolescent Sports Mental Health Literacy (ASMHL), measured by the standardized ASMHL Scale, assessing knowledge, attitudes, and practices of physical education teachers toward adolescent student-athletes mental health.  Measured at baseline (prior to intervention) and at 12 weeks (3 months) post-intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Engagement with the digital mental health platform, measured by login frequency, module completion rates, & user interaction metrics.  Continuously monitored during the intervention period, with analysis at 12 weeks (3 months). 
 
Target Sample Size   Total Sample Size="371"
Sample Size from India="371" 
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)   01/10/2025 
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="27"
Months="10"
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 interventional study aims to enhance adolescent sports mental health literacy among physical education teachers in the Udupi district through a digital mental health program. The primary objective is to develop and evaluate a digital platform that delivers an Adolescent Sports Mental Health Literacy (ASMHL) module for physical education teachers. The study will use a multi-phase design, including scale and module development, expert validation using the Delphi method, baseline assessment, qualitative interviews, and quasi-experimental evaluation of the digital intervention. Approximately 80% of the district’s physical education teachers will be targeted, with pilot testing and iterative refinement at each stage. The primary outcome is the improvement in ASMHL scores among teachers before and after the intervention. Secondary outcomes include platform engagement, changes in attitudes, identification of knowledge gaps, barriers, coping strategies, and user feedback for further refinement. The main hypothesis is that the digital platform will significantly improve ASMHL among physical education teachers.


 
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