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CTRI Number  CTRI/2025/02/079860 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Knowledge Attitude and Practice 
Study Design  Other 
Public Title of Study   CNBB KAP Study 
Scientific Title of Study   Child Neurodevelopment Beyond Borders 
Trial Acronym  CNBB 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Archana Patel 
Designation  Program Director 
Affiliation  Lata Medical Research Foundation 
Address  Lata Medical Research Foundation, 9/1, Vasant Nagar, Nagpur 440022, M.S

Nagpur
MAHARASHTRA
440022
India 
Phone  07122249569  
Fax    
Email  dr_apatel@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Archana Patel 
Designation  Program Director 
Affiliation  Lata Medical Research Foundation 
Address  Lata Medical Research Foundation, 9/1, Vasant Nagar, Nagpur 440022, M.S

Nagpur
MAHARASHTRA
440022
India 
Phone  07122249569  
Fax    
Email  dr_apatel@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Archana Patel 
Designation  Program Director 
Affiliation  Lata Medical Research Foundation 
Address  Lata Medical Research Foundation, 9/1, Vasant Nagar, Nagpur 440022, M.S

Nagpur
MAHARASHTRA
440022
India 
Phone  07122249569  
Fax    
Email  dr_apatel@yahoo.com  
 
Source of Monetary or Material Support  
Indiana Clinical and Translational Sciences Institute CTSI through RECIPROCAL INNOVATION PLANNING GRANTS 410 W. 10th St., Suite 1000 Indianapolis, IN 46202-3002 317-278-2874 
 
Primary Sponsor  
Name  Indiana Clinical and Translational Sciences Institute CTSI 
Address  The U.S. National Center for Advancing Translational Sciences 410 W. 10th St., Suite 1000 Indianapolis, IN 46202-3002 317-278-2874  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
IU School of Medicine  Division of Childrens Health Services Research, Department of Pediatrics, IUSM, USA 
 
Countries of Recruitment     India
United States of America  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Archana Patel   Lata Medical Research Foundation  C/o 9/1, Kinkine Kutir, Vasant Nagar,Nagpur 440022
Nagpur
MAHARASHTRA 
09823350019

smita_ysp@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lata Medical Research Foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Caregivers of children with or without autism 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  Intervention or comparator agent NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  We will deploy a quantitative autism KAP survey
to caregivers in both India (n=100) and Indiana (n=100) to inform the development of qualitative interviews 
 
ExclusionCriteria 
Details  1. Non caregivers
2. Caregivers of children aged more than 12 years 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A scoping review on autism detection and diagnosis in India (underway currently with plan to submit to Review Journal of Autism Spectrum Disorders)  At the end of the study 
 
Secondary Outcome  
Outcome  TimePoints 
the submission of a reciprocal innovation demonstration
proposal in the 2025 CTSI cycle focused on adapting and implementing autism screening in India and Indian-
American communities in Indiana. 
At end of the study 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="100" 
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)   13/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  13/02/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Autism is a neurodevelopmental disability that affects 1-3% of children globally. Epidemiological studies among Indians living in India and the United States suggest a vast underestimate of prevalence. This is due to unique cultural factors that impact identification and healthcare access in both ethnocultural communities. However, the shared cultural challenges among both Indians in India and Indiana presents a rich opportunity to build a global research collaboration that seeks to understand the influence of indigenous viewpoints on autism diagnosis as well as support the development of culturally grounded autism detection methods. Reciprocal innovation is a key framework for designing and implementing sustainable and scalable health system solutions across diverse settings. Leveraging these principles,

the objective of this application is to build a collaborative US-India partnership to deepen our understanding of the knowledge, attitudes, and practices (KAP) regarding autism detection and diagnosis in individuals of Indian origin. The aims of this proposal are aligned with CTSI priority health challenges: infant and maternal health, mental health, and increasing access to quality healthcare.

In Aim 1, we will travel to Nagpur, India to establish a collaborative team to co-develop and refine a reciprocally beneficial approach to understanding knowledge, attitudes, and practices regarding autism diagnosis among Indians. Additionally, the US team will also deepen collaboration with Hindu Temple of Central Indianapolis to understand how cultural viewpoints impact autism service access in Indian-American communities. We will specifically target bi-directional information exchange about facilitators and barriers for autism detection and diagnosis, and the feasibility of improving screening and

diagnosis among Indian populations in both settings.

In Aim 2, we will conduct a pilot KAP evaluation of autism detection in both communities using a mixed methods sequential explanatory approach. We will disseminate a KAP screening tool to caregivers in both regions; the quantitative results will inform the

development of qualitative interviews that will be conducted with Indian and Indian American caregivers.

Expected Outcomes: The immediate outcome of this planning award will be 1) a scoping review on autism identification in both ethnocultural groups and 2) the submission of a reciprocal innovation demonstration proposal in the 2025 CTSI cycle focused on adapting and implementing autism screening in India and Indian- American communities in Indiana. The long-term goal of this work is to develop an NIH-R level proposal to conduct an implementation-effectiveness trial of a culturally-adapted autism screening process in the US and India.

 
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