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CTRI Number  CTRI/2024/11/076329 [Registered on: 06/11/2024] Trial Registered Prospectively
Last Modified On: 05/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Adaptation of a scale to assess Joint Attention in school children in India 
Scientific Title of Study   Adaptation of Childhood Joint Attention Rating Scale in school aged children in the Indian context. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Safa Kabeer 
Designation  Post Graduate Student 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing, Manipal College of Health Professions (MCHP),6th floor, LH-5, Manipal Academy of Higher Education (MAHE), Manipal, Udupi, Karnataka,576104, India

Udupi
KARNATAKA
576104
India 
Phone  9148610214  
Fax    
Email  safa.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivani Tiwari 
Designation  Associate Professor and Guide 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing, Manipal College of Health Professions (MCHP),4th floor, 409, Manipal Academy of Higher Education (MAHE), Manipal, Udupi, Karnataka,576104, India

Udupi
KARNATAKA
576104
India 
Phone  9986448718  
Fax    
Email  shivani.tiwari@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Shivani Tiwari 
Designation  Associate Professor and Guide 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing, Manipal College of Health Professions (MCHP),4th floor, 409, Manipal Academy of Higher Education (MAHE), Manipal, Udupi, Karnataka,576104, India

Udupi
KARNATAKA
576104
India 
Phone  9986448718  
Fax    
Email  shivani.tiwari@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal, Karnataka, 576104 
 
Primary Sponsor  
Name  Safa Kabeer  
Address  Department of Speech and Hearing, 6th floor, LH5, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal 
Type of Sponsor  Other [Self] 
 
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 Shivani Tiwari  Manipal College of Health Professions  Department of Speech and Hearing, Pre clinical Laboratory, Room no 416, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, 576104
Udupi
KARNATAKA 
9986448718

shivani.tiwari@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - Student Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Parents of school age autistic children and parents of children who are typically developing. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not applicable  Not applicable 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Parents of both typically developing and autistic children aged between 8 to 16 yrs.

2. Participants who are fluent in English. 
 
ExclusionCriteria 
Details  1. Parents of children who would not be able to be assessed due to severe motor, visual, hearing, or persistent health issues.
2. Participants who are not fluent in English. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Total score on C-JARS and scores on its domains.  Outcome measures will be administered twice between a gap of 15-20 days during October 2024 to Feb 2025 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   03/09/2025 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Joint attention is when two individuals focus on a common object or an incident together. This helps in communication, mutual understanding and for building connections between people. Joint attention develops early in child’s development years. This can be assessed in typically developing children by four to six months, and by eight to nine months of age, in young children who may have autism spectrum disorders. Impairment of joint attention can lead to difficulties in understanding and responding to cues. Also causes inability to form social relationship with others, delay in language development and in the acquisition of new skills. Impairment of joint attention prior to one year of age is one of the first signs of autism. Intervention that is focused on joint attention has shown to improve language learning and communicative outcomes in individuals with autism. Hence there is a significant need for developing and validating tools to evaluate joint attention, particularly in school aged children.
Currently, there is a scarcity of culturally sensitive tools for evaluating joint attention skills in children with ASD, particularly in diverse populations like India. Existing assessment tools predominantly focus on non-verbal or younger children, limiting their applicability to school-aged children across the ASD spectrum. 
By adapting the C-JARS for the Indian Context, this study aims to bridge this gap by providing a culturally relevant and validated tool for assessing joint attention in school aged children with ASD. The need for such research is underscored by the importance of early detection and intervention in ASD, where joint attention plays a crucial role in social communication development. 
By filling this research gap, the study will contribute to a better understanding of joint attention abilities in school-aged children with ASD in India, facilitating tailored interventions and support for this population.
 
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