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CTRI Number  CTRI/2020/06/025853 [Registered on: 12/06/2020] Trial Registered Prospectively
Last Modified On: 12/06/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Mental Health of children during Covid-19 Pandemic 
Scientific Title of Study   Impact of Coronavirus pandemic on mental health of children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jyoti Bagla 
Designation  Professor 
Affiliation  ESIC PGIMSR, Basaidarapur, New Delhi 
Address  Office of the Head of the department, Dept of Pediatrics,ESIC PGIMSR, Basaidarapur, New Delhi

West
DELHI
110015
India 
Phone    
Fax    
Email  jyotibagla.dr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mahima Rajan 
Designation  Senior Resident 
Affiliation  ESIC PGIMSR, Basaidarapur, New Delhi 
Address  Office of the Head of the Dept, Dept of Pediatrics, ESIC PGIMSR, Basaidarapur, New Delhi

West
DELHI
110015
India 
Phone  07387109658  
Fax    
Email  rajanmahima@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mahima Rajan 
Designation  Senior Resident 
Affiliation  ESIC PGIMSR, Basaidarapur, New Delhi 
Address  Office of the Head of the Department, Dept of Pediatrics,ESIC PGIMSR, Basaidarapur, New Delhi

West
DELHI
110015
India 
Phone    
Fax    
Email  rajanmahima@gmail.com  
 
Source of Monetary or Material Support  
ESIC PGIMSR, Basaidarapur 
 
Primary Sponsor  
Name  ESIC PGIMSR 
Address  Basaidarapur, New Delhi 
Type of Sponsor  Research institution and hospital 
 
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 
Mahima Rajan  ESIC PGIMSR  Basaidarpur
West
DELHI 
07387109658

rajanmahima@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, ESIC PGIMSR, Basaidarpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F439||Reaction to severe stress, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  School going children aged 6-17 years of health care workers working in ESI PGIMSR and associated hospital, Basaidarpur and from general population 
 
ExclusionCriteria 
Details  Children with known psychiatric, neurological, developmental and other chronic illnesses will be excluded. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Prevalence of psychosocial problems among the Indian school going children during the pandemic covid-19  10 days 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the perception of covid -19 by children of Indian HCWs and those from general population.

 
10 Days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   17/06/2020 
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="0"
Months="0"
Days="10" 
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)?  

Brief Summary  

Aims and Objectives

 

 To study the impact of Covid-19 pandemic on mental health of school going children

 

Primary Objective: Impact of Covid-19 pandemic on mental health of school going children

Secondary Objective: Compare the effects of covid-19 pandemic on children of Healthcare workers (HCWs) and those from general population.

 

Material and methods

 

Place of study: Department of Pediatrics, ESI PGIMSR, Basaidarapur, New Delhi

Study Design: It will be an observational cross sectional study

Sampling:  Children will be enrolled in two groups. Group A: Children of Health care workers and Group B: Children from general population. We propose to recruit 50 children in each group by interviewing their parent/ guardian. We will use the snowball sampling technique for the same.

Inclusion Criteria: School going children aged 6-17 years of health care workers working in ESI PGIMSR and associated hospital, Basaidarpur and from general population.

Exclusion Criteria: Children with known psychiatric, neurological, developmental and other chronic illnesses will be excluded.

 

Methodology:

DSM-5 Parent/Guardian-Rated Level 1 Cross-Cutting Symptom Measure—Child Age 6–17 questionnaire will be used for evaluation. This measure developed by American Psychiatric Association can be reproduced without permission by researchers and by clinicians for use with their patients. Necessary approval will be taken from IEC.

 

The DSM-5 Parent/Guardian-Rated Level 1 Cross-Cutting Symptom Measure—Child Age 6–17 assesses mental health domains that are important across psychiatric diagnoses.

The measure consists of 25 questions that assess 12 psychiatric domains, including depression, anger, irritability, mania, anxiety, somatic symptoms, inattention, suicidal ideation/attempt, psychosis, sleep disturbance, repetitive thoughts and behaviors, and substance use.

 Each item asks the parent or guardian to rate how much (or how often) his or her child has been bothered by the specific symptom during the past 2 weeks.

Nineteen of the 25 items on the measure are each rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day). The suicidal ideation, suicide attempt, and substance abuse items are each rated on a “Yes, No, or Don’t Know” scale. The score on each item within a domain will be reviewed by clinician. A guide provided in the manual will help clinician outline the threshold score to interpret whether the symptom is worrisome and needs further inquiry or not.

 

A questionnaire comprising demographic details, questions from DSM-5 and few self prepared questions regarding covid-19 will be sent to HCWs working in ESI PGIMSR for group A and known contacts of the investigators for group B. The answers will be received back online. Results from both the groups will be analyzed and compared using standard protocols.

 

 

Outcome measures

 

Primary Outcome measures: Prevalence of psychosocial problems among the Indian school going children during the pandemic covid-19

Secondary Outcome measures: comparison of perception of covid -19 by children of Indian HCWs and those from general population.

 

 
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