| 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
|
|
|
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
|
|
|
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.
|