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CTRI Number  CTRI/2025/07/091642 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Improving awareness about childhood developmental disorders among ASHA workers through a training program 
Scientific Title of Study   A pilot study on the awareness building program on common neurodevelopmental disorders for ASHA workers. 
Trial Acronym  ASHA- Accredited Social Health Activist 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ann Mary Antony 
Designation  MPhil Psychiatric Social Work Trainee 
Affiliation  Kasturba Medical College,Manipal 
Address  MPhil Psychiatric Social Work Trainee Department of Psychiatry Kasturba Medical College, Manipal, 576104 Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9071276569  
Fax    
Email  ann.kmcmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Umesh Thonse 
Designation  Associate Professor 
Affiliation  Kasturba Medical College,Manipal 
Address  Psychiatric Social Work Department of Psychiatry Kasturba Medical College, Manipal,576104

Udupi
KARNATAKA
576104
India 
Phone  9743579781  
Fax    
Email  umesh.thonse@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Umesh Thonse 
Designation  Associate Professor 
Affiliation  Kasturba Medical College,Manipal 
Address  Psychiatric Social Work Department of Psychiatry Kasturba Medical College, Manipal,576104

Udupi
KARNATAKA
576104
India 
Phone  9743579781  
Fax    
Email  umesh.thonse@manipal.edu  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Ann Mary Antony 
Address  MPhil Psychiatric Social Work Trainee Department of Psychiatry Kasturba Medical College, Manipal,576104  
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 
Ann Mary Antony  Kasturba Medical College  Department of Psychaitry Kasturba Medical College,Manipal 576104
Udupi
KARNATAKA 		 9071276569

annmariascv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe,Kasturba Medical College and Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Nil-Training Module for ASHA Workers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Awareness-building training program on common neurodevelopmental disorders  A structured training module developed and validated in Kannada, focusing on autism spectrum disorder, attention-deficit/hyperactivity disorder, and intellectual developmental disorder. The intervention includes a lecture-based session (approximately 8 hours), pre- and post-assessment using a validated self-structured questionnaire, and follow-up focus group discussions to gather feedback and refine the program. 
Comparator Agent  No active comparator/control group  As this is a single-arm pilot interventional study, there is no separate control or comparator; the comparison is made between pre- and post-intervention scores within the same group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. Working as ASHA workers in Udupi District under Hebri Community Health Centre(CHC)
2. Person who gives consent to participate in the present study
3. Minimum of one year experience in the field. 
 
ExclusionCriteria 
Details  1. Person who does not give consent for the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Study will find out the pre and post knowledge of the ASHA workers and the validity of the Module.  Study will find out the pre and post knowledge of the ASHA workers and the validity of the Module and it takes 1 year . 
 
Secondary Outcome  
Outcome  TimePoints 
Acceptability and feasibility of the training program among ASHA workers  POST assessment after the training session; participation rate recorded at the end of the training day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   18/08/2025 
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="0"
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   The pilot study aims to assess the feasibility of an awareness-building program on common neurodevelopmental disorders for ASHA workers. It involves developing and validating a training module and questionnaire in Kannada to enhance their knowledge of Autism, ADHD, and IDD. 30 ASHA workers from Hebri community health center will be selected through convenience sampling. The study includes pre and post-assessments to evaluate the knowledge gained. The research highlights the need for early detection of developmental issues in children and the crucial role of ASHA workers in rural health systems. The lack of awareness and limited access to trained professionals contribute to delays in diagnosis and care. By equipping frontline workers with structured and validated tools, the program seeks to bridge these gaps. Ethical guidelines will be strictly followed, and potential risks minimized by flexible scheduling, emotional support, and participant consent. The study is self-sponsored. 
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