| CTRI Number |
CTRI/2019/05/019195 [Registered on: 16/05/2019] Trial Registered Prospectively |
| Last Modified On: |
14/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [intervention is about administering an education module on Mental Health Literacy] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Study to assess the effectiveness of an education module on mental health literacy |
|
Scientific Title of Study
|
Effectiveness of an education module on Mental Health Literacy among Undergraduate students- A Cluster Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ECR/146/lnst/ka/2013/RR-16 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aswathi Raj Lathika |
| Designation |
PhD Scholar |
| Affiliation |
Manipal Academy of Higher Education (MAHE) |
| Address |
Master of Social Work Programme (MSW)
Prasanna School of Public Health (PSPH)
Manipal Academy of Higher Education (MAHE)
Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7406053990 |
| Fax |
918202570062 |
| Email |
aswathiraj939@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lena Ashok |
| Designation |
Associate Professor and Coordinator |
| Affiliation |
Manipal Academy of Higher Education (MAHE) |
| Address |
Master of Social Work Programme (MSW)
Prasanna School of Public Health (PSPH)
Manipal Academy of Higher Education (MAHE)
Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448984732 |
| Fax |
918202570062 |
| Email |
lena.ashok@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Aswathi Raj Lathika |
| Designation |
PhD Scholar |
| Affiliation |
Manipal Academy of Higher Education (MAHE) |
| Address |
Master of Social Work Programme (MSW)
Prasanna School of Public Health (PSPH)
Manipal Academy of Higher Education (MAHE)
Madhav Nagar, Manipal
KARNATAKA
576104
India |
| Phone |
7406053990 |
| Fax |
918202570062 |
| Email |
aswathiraj939@gmail.com |
|
|
Source of Monetary or Material Support
|
| Prasanna School of Public Health (PSPH)
Mnaipal Academy of Higher Education (MAHE)
Madhav Nagar, Manipal
Udupi-576104
|
|
|
Primary Sponsor
|
| Name |
Aswathi Raj L |
| Address |
PhD Scholar
Master of Social Work Programme (MSW)
Prasanna School of Public Health (PSPH)
Manipal Academy of Higher Education (MAHE)
Madhav Nagar, Manipal
|
| 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 |
| Aswathi Raj L |
Kasturba hospital |
Room no: 42
Department of Social Work
Prasanna School Public Health (PSPH)
Manipal Academy of Higher Education
Madhav Nagar, Mnaipal-576104
Udupi
KARNATAKA |
07406053990
918202570062
aswathiraj939@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mentally and physically healthy students who are completed the age of 18 years are the study participants.
Candidate who has any kind of physical and mental conditions not involved in this study.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intervention of a Mental Health Literacy education module |
A mental health literacy module will be developed based on the cross sectional survey.This education module will be administered among undergraduate students to asses the effectiveness of this education module. frequency of administering education module is once. Route of administering education module is through delivering lectures to students. Total duration of intervention is six months |
| Comparator Agent |
Intervention of Mental health literacy education module is not given for control group.
|
Intervention is not given for control group.
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Both |
| Details |
Students who have completed 18 years and studying second year degree program in Arts,Science and Commerce are included in this study |
|
| ExclusionCriteria |
| Details |
students who are doing professional degree program such as medicine,engineering are not included in this study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of an education module on mental health literacy |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing Mental health litercay |
8 months |
| Exploration of perceptions on mental health literacy |
3 months |
| Development of an education module |
6 months |
|
|
Target Sample Size
|
Total Sample Size="2034"
Sample Size from India="2034"
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)
|
02/06/2019 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of this study is to assess the effectiveness of an education module on mental health literacy among undergraduate students in Udupi district. Main purpose of this study is to improve the mental health literacy among undergraduate students who are in risk of getting mental illness due to various reasons which include family problems,physical changes,Academic stress,social factors ,friends, relationship, and influence of media.Main outcome is achieved through different objectives such as assessing the mental health literacy,exploring the perceptions of mental health literacy which leads to the development of an education module.finally,to assess the effectiveness of an education module on mental health literacy. Null hypothesis is ,there is an association between mental heal literacy and mental health education module. Alternate hypothesis is ,there is no association between mental health literacy and education module. To conclude this study definitely help youth to improve their mental health literacy through an effective education module |