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CTRI Number  CTRI/2019/01/016949 [Registered on: 07/01/2019] Trial Registered Prospectively
Last Modified On: 05/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study to Find Out the Emotional Intelligence of Students Who Find It Difficult To Read Write and Do Mathematics 
Scientific Title of Study   Emotional Intelligence of Students with Specific Learning Disabilities 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sunil Karande 
Designation  Professor of Pediatrics 
Affiliation  Seth G S Medical College and K E M Hospital Mumbai 
Address  Department of Pediatrics Seth GS Medical College and KEM Hospital Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9322934309  
Fax  912224112871  
Email  karandesunil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sunil Karande 
Designation  Professor of Pediatrics 
Affiliation  Seth G S Medical College and K E M Hospital Mumbai 
Address  Department of Pediatrics Seth GS Medical College and KEM Hospital Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9322934309  
Fax  912224112871  
Email  karandesunil@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhavani S 
Designation  PG Student 
Affiliation  Seth G S Medical College and K E M Hospital Mumbai 
Address  Department of Pediatrics Seth GS Medical College and KEM Hospital Parel Mumbai

Mumbai
MAHARASHTRA
40012
India 
Phone  7598361268  
Fax    
Email  bhavanisundar93@gmail.com  
 
Source of Monetary or Material Support  
Seth GS Medical College and KEM Hospital Acharya Donde Marg Parel Mumbai 400012 Maharashtra India 
 
Primary Sponsor  
Name  KEM Hospital 
Address  Acharya Donde Road Parel Mumbai 
Type of Sponsor  Government 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 Sunil Karande  KEM Hospital  Learning Disability Clinic Department of Pediatrics Acharya Donde Road parel Mumbai
Mumbai
MAHARASHTRA 
9322934309

karandesunil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee II Seth G S Medical College and K E M Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F810||Specific reading disorder, (2) ICD-10 Condition: F812||Mathematics disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Students with specific learning disabilities studying in 7th 8th and 9th standards in English or Marathi medium schools 
 
ExclusionCriteria 
Details  Students with specific learning disabilities with co-morbid chronic medical conditions or having co-morbid language barrier. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out Emotional Intelligence of students with specific learning disabilities  Each students emotional intelligence score will be calculated within 7 days after he/she has completed the questionnaire. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the impact of sociodemographic variables on Emotional Intelligence of students with specific learning disabilities  At the time data analysis 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2019 
Date of Study Completion (India) 30/11/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is observational, descriptive type of questionnaire based cross sectional study to assess the Emotional Intelligence of 100 students with specific learning disabilities. The study also tries to assess the impact of sociodemographic variables on Emotional Intelligence of students with specific learning disabilities. 
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