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CTRI Number  CTRI/2025/02/080837 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 10/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Development of a mobile app as a tool for parents to coach their children with autism to improve in social communication and play. 
Scientific Title of Study   Development of mobile application for parents of children with autism, a randomised control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjeev Padmanabhan R 
Designation  3rd year MD Psychiatry student 
Affiliation  Saveetha Institute of medical and technical sciences  
Address  Room number 50, fourth floor, Department of psychiatry, Saveetha medical college hospital, Saveetha Nagar, 162, Poonamallee High Road, Poonamallee, Chennai, Kuthambakkam

Chennai
TAMIL NADU
600077
India 
Phone  9769020468  
Fax    
Email  sanjeevpadmanabhanr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjeev Padmanabhan R 
Designation  Post Graduate , MD PSYCHIATRY 
Affiliation  Saveetha Institute of medical and technical sciences  
Address  Room 50,fourth floor, Department of Psychiatry, Saveetha medical college hospital, Saveetha Nagar, 162, Poonamallee High Road, Poonamallee, Chennai, Kuthambakkam, Tamil Nadu

Chennai
TAMIL NADU
600077
India 
Phone  9769020468  
Fax    
Email  sanjeevpadmanabhanr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjeev Padmanabhan R 
Designation  Post graduate MD Psychiatry 3rd year 
Affiliation  Saveetha Institute of medical and technical sciences  
Address  Room 50, fourth floor, department of psychiatry,Saveetha medical college hospital, Saveetha Nagar, 162, Poonamallee High Road, Poonamallee, Chennai, Kuthambakkam, Tamil Nadu

Chennai
TAMIL NADU
600077
India 
Phone  9769020468  
Fax    
Email  sanjeevpadmanabhanr@gmail.com  
 
Source of Monetary or Material Support  
Saveetha medical college hospital, Saveetha Nagar, 162, Poonamallee High Road, Poonamallee,Kuthambakkam, Chennai 600077, Tamil Nadu 
 
Primary Sponsor  
Name  Saveetha medical college hospital  
Address  162, Poonamallee High Road, Poonamallee, Chennai, Kuthambakkam,600077 
Type of Sponsor  Private hospital/clinic 
 
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 sanjeev   Saveetha medical college hospital   Ward 120, pediatrics, Child development centre, Saveetha medical college hospital, number 162, Poonamallee High Road, Poonamallee, Chennai, Kuthambakkam, Tamil Nadu 600077
Chennai
TAMIL NADU 		 9769020468

sanjeevpadmanabhanr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee (SMCH-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Autism care Mobile application   Mobile app to train parents for home based Interventions for children with autism  
Comparator Agent  Hand out   Printed hand out about autism for parents  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Parents of Children with Autism:
- Parents of children diagnosed with autism spectrum disorder (ASD) aged between 2 to 12 years.
- Parents who are willing and able to participate in the study and engage with the mobile application for home-based interventions.

2. Children with Autism:
- Children diagnosed with autism spectrum disorder (ASD) aged between 2 to 12 years.
- Children who have not undergone any significant changes in their treatment or therapy in the past three months.

3. Technology Access:
- Parents who have access to a smartphone (Android or Apple) and are comfortable using mobile applications.
4. Willingness to Participate:
- Parents who provide informed consent to participate in the study and engage with the mobile application for the duration of the research study.


 
 
ExclusionCriteria 
Details  1. Parents of Children with Autism:
- Parents who are unable or unwilling to provide informed consent to participate in the study.

2. Children with Autism:
- Children diagnosed with severe intellectual disabilities or other coexisting medical conditions that may significantly impact participation or response to the intervention.
- Children who have undergone significant changes in their treatment or therapy within the past three months.
- Children who are currently participating in other research studies or interventions targeting autism spectrum disorder (ASD).

3. Technology Access:
- Parents who do not have access to a smartphone (Android or Apple) or are not comfortable using mobile applications.

4. Willingness to Participate:
- Parents who are unable or unwilling to commit to engaging with the mobile application for the duration of the research study. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
A) To develop a mobile application equipped with comprehensive training modules to empower parents to support their children with autism in key domains, in addition to standard care.
B)To implement and evaluate the use of the Childhood Autism Rating Scale (CARS) questionnaire for continuous child progress monitoring through the app. 		 1 month from period of recruitment  
 
Secondary Outcome  
Outcome  TimePoints 
To train parents to effectively utilize the app for home-based interventions, enhancing their skills in supporting their child.  1month 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/03/2025 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 proposed study aims to develop and evaluate a mobile application designed to empower parents of children with autism through comprehensive training modules and the integration of the Childhood Autism Rating Scale (CARS) questionnaire for progress monitoring. The study addresses the challenges faced by parents in accessing tailored support and seeks to enhance parental skills, improve child development outcomes, and foster collaboration with healthcare professionals. Conducted as a prospective interventional study at Saveetha Medical College, it involves 40 children with autism (aged 2-12 years) and their parents (20 in handout arm and 20 in mobile app arm) . Feasibility testing, data analysis, and feedback will assess the app’s usability, functionality, and impact. The research aspires to contribute valuable insights to autism care by leveraging technology to improve parental training and home-based interventions. 
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