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CTRI Number  CTRI/2023/06/054318 [Registered on: 22/06/2023] Trial Registered Prospectively
Last Modified On: 21/06/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   What are the things in place in schools to address mental health issues among students?  
Scientific Title of Study   Improving school ethos towards mental health through whole school mental health interventions: Implementation science approach 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SRF-SR/09/AUG-2022 dated 02/09/2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vijaya Raghavan 
Designation  Consultant Psychiatrist  
Affiliation  Schizophrenia Research Foundation (India) 
Address  Room 36, Department of Youth Mental Health, Department of Psychiatry, Schizophrenia Research Foundation (India) R/7A, North Mail Road, Anna Nagar West Extension

Chennai
TAMIL NADU
600101
India 
Phone  9043705687  
Fax    
Email  vijayaraghavan@scarfindia.org  
 
Details of Contact Person
Scientific Query
 
Name  Vijaya Raghavan 
Designation  Consultant Psychiatrist  
Affiliation  Schizophrenia Research Foundation (India) 
Address  Room 36, Department of Youth Mental Health, Department of Psychiatry, Schizophrenia Research Foundation (India) R/7A, North Mail Road, Anna Nagar West Extension

Chennai
TAMIL NADU
600101
India 
Phone  9043705687  
Fax    
Email  vijayaraghavan@scarfindia.org  
 
Details of Contact Person
Public Query
 
Name  Vijaya Raghavan 
Designation  Consultant Psychiatrist  
Affiliation  Schizophrenia Research Foundation (India) 
Address  Room 36, Department of Youth Mental Health, Department of Psychiatry, Schizophrenia Research Foundation (India) R/7A, North Mail Road, Anna Nagar West Extension

Chennai
TAMIL NADU
600101
India 
Phone  9043705687  
Fax    
Email  vijayaraghavan@scarfindia.org  
 
Source of Monetary or Material Support  
Advanced In-Country Research Award (AICRA) as part of the Psychiatric Research Infrastructure for Intervention and Implementation In India (PRIIIA) medium-term training program funded by National Institutes of Health, USA 
 
Primary Sponsor  
Name  National Instututes of Health NIH 
Address  9000 Rockville Pike Bethesda, Maryland 20892 301-496-4000 TTY 301-402-9612 
Type of Sponsor  Government funding agency 
 
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 
Vijaya Raghavan  Schizophrenia Research Foundation (India)  Room No.:36 Department of Youth Mental Health, Department of Psychiatry, R/7A, North Main Road, Anna Nagar West Extension
Chennai
TAMIL NADU 
9043705687

vijayaraghavan@scarfindia.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Schizophrenia Research Foundation - Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  School students  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil   Nil  
Comparator Agent  Nil   Nil  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  School students will be recruited into the study  
 
ExclusionCriteria 
Details  No specific exclusion criteria  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the is to understand the school ethos towards mental health of school students in the private and public funded schools of Chennai  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   03/07/2023 
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="1"
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  

Background: Previous research from the western world has highlighted the acceptability, feasibility, and effectiveness of school based mental health interventions in the developed countries. But very few research initiatives have happened in this direction from the low- and middle- income countries. It is important to understand the challenges in implementing school based mental health interventions and implement measures that could be developed to circumvent these challenges from low- and middle- income perspective. Novelty: The proposed research proposal (1) is a theory-driven study of implementation barriers; (2) occurs within a relevant real-world practice setting; (3) development of model based on implementation science and (4) involves interdisciplinary cooperation (public health, clinical, and education). Objective: The overarching objective of the proposed research proposal are to identify the challenges and opportunities existing within the school ethos in implementing evidence-based interventions to improve youth mental health and to identify the most appropriate implementation strategies for improving mental health among young people in schools in Chennai, a city in India, a low- and middle- income country. Methods: The proposed research project will be conducted in two schools in Chennai. A qualitative research methodology will be used to collect relevant data to understand the ethos of the school towards mental health and factors influencing them leading to the development of the whole school approach intervention Expected outcome: It is to understand the school ethos towards mental health and develop appropriate intervention to promote to mental health in schools.

 
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