| CTRI Number |
CTRI/2014/06/004667 [Registered on: 12/06/2014] 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
|
Do children with learning disabilities suffer more anxiety than regular children? |
|
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 |
|
|
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 |
| Affiliation |
Seth GS Medical College and KEM Hospial |
| Address |
Department of Paediatrics
Seth GS Medical College and KEM Hospital
Parel East
Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224107647 |
| Fax |
|
| Email |
karandesunil@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Karande |
| Designation |
Professor |
| Affiliation |
Seth GS Medical College and KEM Hospial |
| Address |
Department of Paediatrics
Seth GS Medical College and KEM Hospital
Parel East
Mumbai 400012
MAHARASHTRA
400012
India |
| Phone |
02224107647 |
| Fax |
|
| Email |
karandesunil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Karande |
| Designation |
Professor |
| Affiliation |
Seth GS Medical College and KEM Hospial |
| Address |
Department of Paediatrics
Seth GS Medical College and KEM Hospital
Parel East
Mumbai 400012
MAHARASHTRA
400012
India |
| Phone |
02224107647 |
| Fax |
|
| Email |
karandesunil@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sunil Karande |
| Address |
Department of Paediatrics
Seth GS Medical College and KEM Hospital
Parel East
Mumbai 400012 |
| Type of Sponsor |
Other [Professor at medical college] |
|
|
Details of Secondary Sponsor
|
|
|
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 |
Learning Disability Clinic,
Department of Paediatrics,
Seth GS Medical College and KEM Hospital,
Acharya Donde Marg,
Parel East,
Mumbai 400012.
Mumbai
MAHARASHTRA |
02224107647
karandesunil@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Committee for Academic Research Ethics (now called: Institutional Ethics Committee) of Seth GS Medical College and KEM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G988||Other disorders of nervous system, Specific Learning Disabilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Regular (non-learning disabled) children. |
Regular children from 4 schools in Bombay were recruited to be compared with the study group. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children newly diagnosed with specific learning disabilities were recruited in the study group.
Regular school-going non-learning disabled children were recruited in the control group. |
|
| ExclusionCriteria |
| Details |
Children whose parents refused to give consent to participate in the study and children who were unable to understand, read and write in English. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not aplpicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="276"
Sample Size from India="276"
Final Enrollment numbers achieved (Total)= "276"
Final Enrollment numbers achieved (India)="276" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2011 |
| Date of Study Completion (India) |
31/01/2012 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
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)
|
Poor school performance can, significantly impact a child’s mental and physical health. The objective was to compare the levels of anxiety between children with newly diagnosed specific learning disabilities (SpLD) and regular, non-learning disabled children using a cross sectional, questionnaire based study. The study hypothesis was that children with specific learning disabilities have higher levels of anxiety than regular (non-learning disabled) children. |