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CTRI Number  CTRI/2017/11/010633 [Registered on: 24/11/2017] Trial Registered Prospectively
Last Modified On: 21/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational intervention]  
Study Design  Cluster Randomized Trial 
Public Title of Study   A study on effect of intervention on knowledge,attitude,beliefs regarding mental health among high school teachers 
Scientific Title of Study   Effectiveness of a mental health literacy intervention module regarding adolescents among high school teachers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vidya 
Designation  Lecturer 
Affiliation  Melaka Manipal Medical College , Manipal University 
Address  Vidya Lecturer, Department of Community Medicine Melaka Manipal Medical College Manipal University, Udupi district, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  8904569460  
Fax    
Email  vidya.mmmc@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Vidya 
Designation  Lecturer 
Affiliation  Melaka Manipal Medical College  
Address  Vidya Lecturer, Department of Community Medicine Melaka Manipal Medical College Manipal University, Udupi district, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  8904569460  
Fax    
Email  vidya.mmmc@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Vidya 
Designation  Lecturer 
Affiliation  Melaka Manipal Medical College , Manipal University 
Address  Vidya Lecturer, Department of Community Medicine Melaka Manipal Medical College Manipal University, Udupi district, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  8904569460  
Fax    
Email  vidya.mmmc@manipal.edu  
 
Source of Monetary or Material Support  
Partially funded by ICMR. Indian Council of Medical Research V. Ramalingaswami Bhawan P.O. Box No. 4911 Ansari Nagar New Delhi - 110029 India 
 
Primary Sponsor  
Name  Vidya 
Address  Lecturer, Department of Community Medicine Melaka Manipal Medical College, Manipal University, Manipal, Udupi, Karnataka 576104  
Type of Sponsor  Other [Self] 
 
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 
Vidya  Schools of Udupi and Brahmavar Blocks  Udupi and Brahmavara Educational Blocks in Udupi district
Udupi
KARNATAKA 
8904569460

vidya.mmmc@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Hospital- Institutional Ethics Committee, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Assessment of mental health literacy among high school teachers 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intervention module on mental health literacy  A mental health literacy module will be tested by conducting mental health training for intervention group.  
Comparator Agent  Standard  The control arm will not receive an active intervention but will follow standard methods followed in their schools. They will be waitlisted and intervention with the developed module will be provided following the trial. 
 
Inclusion Criteria  
Age From  26.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The high school teachers who are teaching at least six hours in a week with a minimum of five years’ teaching experience will be included in the study.  
 
ExclusionCriteria 
Details  During the intervention, teachers who are leaving, or not planning to continue in the schools for next six months time will be excluded  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mental health literacy and referral practices for adolescent mental health disorders among high school teachers will be explored.  December 2017 to December 2018 
 
Secondary Outcome  
Outcome  TimePoints 
Stakeholders perceptions regarding mental health disorders and remedial measures in adolescents,
Development of an intervention module to train teachers on mental health literacy regarding adolescent mental health disorders and change in mental health literacy and referral practices before intervention, immediately post intervention and after six months
 
January 2019 to October 2021 
 
Target Sample Size   Total Sample Size="420"
Sample Size from India="420" 
Final Enrollment numbers achieved (Total)= "460"
Final Enrollment numbers achieved (India)="460" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2017 
Date of Study Completion (India) 30/07/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/07/2021 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
What predicts mental health literacy among school teachers? 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Studies conducted in India have shown poor mental health literacy (MHL) among teachers and there is the absence of a module to train the teachers on MHL. This study is thus undertaken to assess the MHL among teachers as well as to develop a module to train high school teachers on MHL and to test the effectiveness of the module on mental health literacy among the teachers. A mixed methodology will be adopted. In the quantitative component MHL and referral practices among high school teachers was  assessed through a school-based approach. A total of 145 secondary schools  formed the sampling frame with Udupi and Brahmavar blocks having 81 and 64 schools respectively. Stratified cluster random sampling technique was adopted where schools were stratified into government aided and private and then from each category the schools were selected using simple random sampling technique to achieve the required teacher population under each category calculated.   A total of 460 teachers were included for assessing baseline MHL. A qualitative study design was adopted to understand stakeholders’ perceptions regarding mental health disorders and remedial measures among adolescents. It included focus group discussions (FGDs) and in-depth interviews (IDIs) among teachers, parents and mental health and other health professionals. A training module was developed based on the information collected through the analysis of quantitative and qualitative data. The module was  reviewed and validated by a panel of experts. The final version of the module was developed after incorporating the suggestions given by the experts. To test the effectiveness of the module on MHL among the teachers, a parallel stratified cluster randomized controlled trial study design was employed. A total of 306 teachers were be randomly allocated into intervention and control group. The selection of the schools for the trial was based on responses on the case vignettes at baseline assessment.  Each school where 50% participating teachers are unable to identify at least two conditions appropriately on the case vignettes in the questionnaire were selected. A list of such schools were  prepared.  These schools will then be approached and invited to participate in the intervention. The schools were  randomized into intervention and control groups. The training were conducted for intervention group.  MHL was assessed before intervention and immediately post intervention and after six months among intervention group and baseline and after six months MHL was asssed among control group.  Changes in MHL between baseline and six-month follow-up  was assessed.

 
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