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CTRI Number  CTRI/2022/08/044980 [Registered on: 26/08/2022] Trial Registered Prospectively
Last Modified On: 24/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Quantitative Research Approach and Descriptive Design 
Study Design  Other 
Public Title of Study   Stress and Coping among School Going Adolescents during Covid-19 Pandemic 
Scientific Title of Study   A Study on Stress, Coping and Mental Health Status among School Going Adolescents during Covid-19 Pandemic in Shillong, Meghalaya  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Leah Meiling Shangpliang 
Designation  MPhil Student 
Affiliation  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur 
Address  Department of Psychiatric Social Work, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur

Sonitpur
ASSAM
784001
India 
Phone  8259054223  
Fax    
Email  leahshangpliang@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Indrajeet Banerjee 
Designation  Assistant Professor, Department of Psychiatric Social Work 
Affiliation  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur 
Address  Department of Psychiatric Social Work, LGB Regional Institute of Mental Health, Tezpur

Sonitpur
ASSAM
784001
India 
Phone  9435704216  
Fax    
Email  indraj2015@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Indrajeet Banerjee 
Designation  Assistant Professor, Department of Psychiatric Social Work 
Affiliation  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur 
Address  Department of Psychiatric Social Work, LGB Regional Institute of Mental Health, Tezpur

Sonitpur
ASSAM
784001
India 
Phone  9435704216  
Fax    
Email  indraj2015@gmail.com  
 
Source of Monetary or Material Support  
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur 
 
Primary Sponsor  
Name  Leah Meiling Shangpliang 
Address  Department of Psychiatric Social Work, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur - 784001 
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 
Leah Meiling Shangpliang  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur, Assam  Department of Psychiatric Social Work, 4th Floor, LGBRIMH, Tezpur, Sonitpur, Assam. PIN:784001
Sonitpur
ASSAM 
8259054223

leahshangpliang@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Stress, coping and mental health status 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  19.00 Year(s)
Gender  Both 
Details  1. School going adolescents between the age of 13-19 years.
2. Both gender (male and female) from English medium school.
3. The adolescents who provide their assent.
4. Parental consent for their child’s participation. 
 
ExclusionCriteria 
Details  1. Those with incomplete proforma will be excluded
2. Those who are not present on the day of data collection
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The expected outcome from this study will reveal the status of stress, coping and mental health in the school going adolescent among the Covid-19 pandemic. It can lead to provide valuable information for the development of interventions that can improve students’ well-being and training for effective coping strategies for daily stress and this pandemic situation.  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
It can lead to provide valuable information for the development of interventions that can improve students’ well-being and training for effective coping strategies for daily stress and this pandemic situation.  12 months 
 
Target Sample Size   Total Sample Size="377"
Sample Size from India="377" 
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)   06/09/2022 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Background: There are physical and social changes related to COVID-19. As stress increases and access to healthy coping decreases for the school going adolescent, they are more at risk for developing a host of problems and psychological issues which if left untouched could lead to further problems even into adulthood. It’s highly important to reduce stress in a growing mind and teach healthy habits for coping with stress which will result in better mental health status in the individual. Aim: This study aims to assess the stress, coping, and mental health status among school going adolescents during the Covid-19 pandemic. Objectives: To identify the socio-demographic profile of the school going adolescent, to assess the stress, coping, and mental health status among school going adolescents in the Covid-19 pandemic, to see the association between selected socio-demographic variables, stress, coping and mental health status among school going adolescents in the Covid-19 pandemic. Methodology: This study is using a quantitative research approach and descriptive design and will be conducted among school going adolescents from the age of 13 to 19 years studying in private schools in Shillong, Meghalaya. After obtaining the study population (universe), the sample size will be calculated using Krejcie & Morgan’s table. The list of schools will be generated according to the need of the study. Simple random sampling (lottery method) will be used and permission will be sought from the selected private schools in Shillong. The sample collection will be done by using the total enumeration method. The process will be continued until the desired data is obtained. In this study, the tools of data collection are: socio-demographic profile sheet, responses to stress questionnaire (RSQ) – Covid-19 child [self-report], and strengths and difficulties questionnaire (SDQ). Data will be analyzed using the appropriate statistical tools using SPSS 25.0 software packages. Conclusion: Findings of this study can lead to provide valuable information for the development of interventions that can improve students’ well-being and training for effective coping strategies for daily stress and this pandemic situation.

 
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