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CTRI Number  CTRI/2017/08/009512 [Registered on: 28/08/2017] Trial Registered Retrospectively
Last Modified On: 31/08/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How anxious are regular school going children in the city of Mumbai? 
Scientific Title of Study   A study to evaluate the anxiety levels in children having specific learning disabilities [SpLD] compared to regular [non-learning disabled] children 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
EC/OA-78/2010  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sunil Karande 
Designation  Professor and Head of Unit 
Affiliation  Seth G.S. Medical College and KEM Hospital 
Address  Department of Pediatrics, Seth G.S. Medical College and KEM Hospital. Acharya Donde Marg. Parel (East) Mumbai 400102.
Seth G.S. Medical College and KEM Hospital. Acharya Donde Marg. Parel (East) Mumbai 400102.
Mumbai
MAHARASHTRA
400102
India 
Phone  9322934309  
Fax    
Email  karandesunil@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunil Karande 
Designation  Professor and Head of Unit 
Affiliation  Seth G.S. Medical College and KEM Hospital 
Address  Department of Pediatrics, Seth G.S. Medical College and KEM Hospital. Acharya Donde Marg. Parel (East) Mumbai 400102.
Seth G.S. Medical College and KEM Hospital. Acharya Donde Marg. Parel (East) Mumbai 400102.
Mumbai
MAHARASHTRA
400102
India 
Phone  9322934309  
Fax    
Email  karandesunil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sunil Karande 
Designation  Professor and Head of Unit 
Affiliation  Seth G.S. Medical College and KEM Hospital 
Address  Department of Pediatrics, Seth G.S. Medical College and KEM Hospital. Acharya Donde Marg. Parel (East) Mumbai 400102.
Seth G.S. Medical College and KEM Hospital. Acharya Donde Marg. Parel (East) Mumbai 400102.
Mumbai
MAHARASHTRA
400102
India 
Phone  9322934309  
Fax    
Email  karandesunil@gmail.com  
 
Source of Monetary or Material Support  
The study is funded with some left over funds in the department development fund with the institute 
 
Primary Sponsor  
Name  Seth GS Medical College and KEM Hospital 
Address  Department of Pediatrics Mumbai - 12  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
None  Not Applicable 
 
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  Learning Disability Clinic  First Floor Multi storeyed Building Pediatrics OPD block KEM Hospital Mumbai - 400012
Mumbai
MAHARASHTRA 		 9322934309

karandesunil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Anxiety 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Children of either gender, between 8-15 years of age, conversant in English and who have a consistently average academic performance (obtaining 60-90% marks or Grade B) were included in the study.  
 
ExclusionCriteria 
Details  Exclusions were children with chronic health conditions (such as epilepsy, asthma, allergic rhinitis, Attention Deficit Hyperactivity Disorder and obesity), children who have been reported to be inattentive, hyperactive or disruptive in the classroom, those with poor academic performance (obtaining less than 60% marks or Grade C and below) or those excelling in studies (achieving more than 90% marks or Grade A and above). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Presence [or absence] of anxiety using the SCAS scoring system  One single time point. This is when the actual interview will take place, this being a cross sectional tudy 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the impact of socio-demographic characteristics of the school children on their anxiety level.  To evaluate the impact of socio-demographic characteristics of the school children on their anxiety levels. 
 
Target Sample Size   Total Sample Size="493"
Sample Size from India="493" 
Final Enrollment numbers achieved (Total)= "493"
Final Enrollment numbers achieved (India)="493" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/07/2013 
Date of Study Completion (India) 30/09/2013 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="10"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Published. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Background and Objectives:Anxiety disorders usually remain undiagnosed in school students owing to the internalized nature of its symptoms. The present study was conducted with the primary objective of evaluating the prevalence of anxiety in school children in Mumbai city. A secondary objective was to assess the impact of confoundingfactors on anxiety. 

Materials and Methods: Thestudy cases (aged 8-15 years) were recruited from four English medium schools in Mumbai, India. The SCAS T-scores (total and subscales) of the students were calculated and cut-off T-scores>60 was considered as indicative of elevated anxiety levelas recommended.

Results:One-tenth (10.8%) of regular school students had “clinical anxiety”. A significantly higher proportion of regular students “aged 12-15 years” (18.0% vs. 4.8%, crude OR = 4.36, 95% CI 2.27 to 8.39, P < 0.0001) had “clinical anxiety” as compared to regular students “aged 8-11 years”regardless ofgender, absence or presence of sibling(s), the type of school board curriculum and type of school attended. All the five types of anxiety disorders were present in the study cases; with “obsessions/compulsions” and “fears of physical injury” being the commonest (in 29.6% and 27.2%, respectively). Significantly higher proportions ofolder students (aged 12-15 years) and male students had greater odds of having specific subtypes of anxiety disorders such as “obsessions/compulsions” and “social anxiety.”

Interpretation and Conclusions:The results of the present study suggest that there is an urgent need to start screening school students in our city for anxiety disorders.

 
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