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CTRI Number  CTRI/2022/11/047135 [Registered on: 09/11/2022] Trial Registered Prospectively
Last Modified On: 07/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Depression in school going students 
Scientific Title of Study   Depression anxiety and stress Among school Going students in Bareilly district, A cross sectional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arun Singh 
Designation  Professor and HOD 
Affiliation  Rohilkhand Medical College and Hospital 
Address  Department of Community Medicine Room no 2133 ,Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly - 243006

Bareilly
UTTAR PRADESH
243006
India 
Phone  9956008272  
Fax    
Email  arunspm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr DEEPAK SHARMA 
Designation  JUNIOUR RESISDENT 
Affiliation  Rohilkhand Medical College and Hospital 
Address  Department of Community Medicine Room no 2133,Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly - 243006

Bareilly
UTTAR PRADESH
243006
India 
Phone  9837503074  
Fax    
Email  drluckysharma011@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr DEEPAK SHARMA  
Designation  JUNIOUR RESISDENT 
Affiliation  Rohilkhand Medical College and Hospital 
Address  Department of Community Medicine Room no 2133 Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly - 243006

Bareilly
UTTAR PRADESH
243006
India 
Phone  9837503074  
Fax    
Email  drluckysharma011@gmail.com  
 
Source of Monetary or Material Support  
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL Opposite Suresh Sharma Nagar ,Near Pilibit Bypass Road Bareilly  
 
Primary Sponsor  
Name  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL 
Address  Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly - 243006 
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 DEEPAK SHARMA   ROHILKHAND MEDICAL COLLEGE AND HOSPITAL  Department of Community Medicine Room no 2133 ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, PILIBHIT BYPASS ROAD, BAREILLY - 243006
Bareilly
UTTAR PRADESH 
9837503074

drluckysharma011@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, RMCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  DASS Questionnare will be asked to school going students of Bareilly District to rule out mental illness 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  19.00 Year(s)
Gender  Both 
Details  School going children aged 10-19 years. School going children whose parents will give consent to allow their children to participate in the study.
 
 
ExclusionCriteria 
Details  The students who are likely to take transfer during the study period. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of depression, anxiety and stress  1 Day 
 
Secondary Outcome  
Outcome  TimePoints 
Association & correlation between the levels of depression, anxiety and stress and socio-demographic factors  1 Day 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   10/11/2022 
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   1. Karki A, Thapa B, Pradhan PM, Basel P. Depression, anxiety and stress among high school students: A cross-sectional study in an urban municipality of Kathmandu, Nepal. PLOS Global Public Health. 2022;2(5):e0000516. 2. Kumar KS, Akoijam BS. Depression, anxiety and stress among higher secondary school students of Imphal, Manipur. Indian J Community Med. 2017;42(1):94-6. 3. Adolescent Mental Health. [Last accessed on 2022]. Available from: https://www.who.int/news-room/factsheets/detail/adolescent-mental-health.pdf .  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Mental illnesses account for a significant share of the disease burden in all civilizations. Depression, anxiety, and stress are among the most common causes of illness and disability in children. Teenagers are predisposed to a range of mental health difficulties due to the physical, psychological, and behavioural variations during this time. Poor academic performance, lack of communication with friends and family members, substance misuse, feelings of abandonment, homicidal thoughts, and suicide ideation are all signs of these three diseases. 

For at least two weeks, depression is defined by persistent unhappiness and a loss of interest in activities that you generally love, as well as an incapacity to function in everyday life. Anxiety is a sensation of tension accompanied by concerned thoughts and bodily changes such as elevated blood pressure. Anxiety disorders are characterized by recurrent intrusive thoughts or concerns

Nearly 20% of children suffer from a diagnosable mental illness. In addition, numerous mental health illnesses emerge during adolescence. Before reaching adulthood, between 20%–30% of children will experience at least one significant depressive episode. For a quarter of people, mood disorders such as depression first appear throughout adolescence. Anxiety disorders and impulse control disorders (such as conduct disorder or attention deficit/hyperactivity disorder) effect 50–70 percent of adolescents during their adolescence. As children enter puberty, existing mental health issues become more complex and acute. Adolescents with untreated mental health issues are more likely to perform poorly in school, drop out, have strained family connections, abuse substances, and engage in risky sexual practises.

Being away from home, grade, stream of study, academic performance and examination-related concerns, and cyber bullying have all been connected to depression in previous studies. According to earlier studies, sex, grade level of pupils, and kind of school (public or private), family type, not living with parents, educational level of parents, and high academic stress were all factors of anxiety.

Globally, depression is one of the leading causes of illness and disability. Even in developed nation’s depression is a known health burden among children, adolescents, and adults. One in four children in the age group of 13–15 years in India suffers from depression, which affects 86 million people in the South-East Asia region, the World Health Organization. In adolescents, major depression is projected to rank second-most cause of human illness by the year 2020.

To battle the burden of juvenile mental health concerns, researchers must investigate the extent and risk factors of symptoms of depression, anxiety, and stress. Nevertheless, anxiety and depression in early teens commonly go undetected and untreated, particularly in developing countries like India, due to limited access to psychological and psychiatric care as well as the enormous societal stigma regarding mental health concerns.

Majority of population in Bareilly district is under served by health care delivery system and reside in rural area & urban slums and adolescents’ subgroup of population is very prone for mental health disorders and less research has been conducted on this topic in this area. Keeping these points in mind, an attempt will be made to assess the depression, anxiety and stress among school students in Bareilly City, Uttar Pradesh as very few studies have been conducted in this age group.


 
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