| 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
|
|
|
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
|
|
|
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. |