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CTRI Number  CTRI/2023/10/059181 [Registered on: 27/10/2023] Trial Registered Prospectively
Last Modified On: 23/10/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Problems in adolescents in schools 
Scientific Title of Study   Psychosocial problems of 13-16 year-olds during the recovery phase of the COVID-19 pandemic 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Samir Kumar Praharaj 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Room no 33, Department of Psychiatry, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8971026304  
Fax    
Email  samirpsyche@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Samir Kumar Praharaj 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Room no 33, Department of Psychiatry, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8971026304  
Fax    
Email  samirpsyche@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Samir Kumar Praharaj 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Room no 33, Department of Psychiatry, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8971026304  
Fax    
Email  samirpsyche@yahoo.co.in  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal, Karnataka, India 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal 
Address  Madhav Nagar, Manipal, Karnataka, India - 576104 
Type of Sponsor  Private medical college 
 
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 
Dr Samir Kumar Praharaj  Kasturba Medical College Manipal  Room no 33, Department of Psychiatry, Kasturba Medical College, Manipal
Udupi
KARNATAKA 
8971026304

samirpsyche@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adolescents 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  13-16 years old children and adolescents living in Udupi District will be invited to participate in this survey.  
 
ExclusionCriteria 
Details  Those attending special schools for students with intellectual disabilities will be excluded.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Bullying behavior  Baseline (single assessment) 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
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)   04/11/2023 
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  

There is a global concern about the negative impact of the COVID-19 pandemic on mental health of children and adolescents. Some studies suggest that psychiatric symptoms of children and adolescents have indeed increased during the pandemicDisease containment measures, such as lockdowns, school closures, remote school, cessation of hobbies, quarantines and social isolation have changed people’s lives dramatically, exposing children and adolescents to several stressors, including fear of contracting the disease, frustration, boredom, information overload, family financial loss and changes in daily activity patterns. Parallel with the COVID-19 pandemic, other global crises threaten the mental health of children and adolescents globally. There is evidence that climate change -related psychological distress with affective, cognitive and behavioural dimensions exists and children and adolescents are particularly prone to it. Repeated cross-sectional studies employing the same instruments, protocol and study sites in different time-points can help to understand the factors and reasons behind the changes. We studied adolescent wellbeing in 2000 children in 2015, and will repeat the same to study the changes over time. We will study 2000 adolescents in Udupi district (sample similar to our previous study).

13-16 years old children and adolescents living in Udupi District will be invited to participate in this survey. Those attending special schools for students with intellectual disabilities will be excluded. A student and a teacher survey will be conducted. The student survey will be in bilingual form.

Written permission will be obtained from block education officer. We will collect data from the same schools which we had included in our previous 2016 study. The school authorities will be approached and asked to participate, and the teachers will receive a detailed information letter explaining the aims and the rationale behind the study. All respondents will be given a letter of consent, which needs to be returned to the researchers. The students will be asked to complete the questionnaires during class. They will not be asked to provide their name or address. The students will be informed that they give their consent to participate in the research by filling in the questionnaire and that they can decline their participation by leaving the questionnaire blank. Before responding to the questionnaire, the students will be given detailed explanations on how to proceed.

Department scientific committee and approval from IEC will be obtained. Permission from BEO and school principal will be taken. Participation in the study planned is completely voluntary for the students. Parents, students, and teachers will be informed about the study prior to conducting the survey. The survey will be conducted during school hours and students will not be asked to provide their names or addresses in the questionnaires. The data will only be used for this scientific research. Data gathering, storing, and processing will be conducted confidentially. There will not be any compensation for participating in this study.

 
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