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
|
|
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
|
|
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. |