| 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
|
|
|
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. |