| CTRI Number |
CTRI/2025/08/093832 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Parental understanding and beliefs related to communication support in children with autism |
|
Scientific Title of Study
|
Parental awareness and attitude towards Augmentative and Alternative Communication by children with autism spectrum disorder. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dibyamani Bayan |
| Designation |
Postgraduate student pursuing Masters in Speech Language Pathology |
| Affiliation |
Manipal College of Health Professions Manipal Academy of Higher Education Manipal |
| Address |
Department of Speech and Hearing Manipal College of Health Professions Manipal
Academy of Higher Education Manipal,
Udupi
Udupi KARNATAKA 576104 India |
| Phone |
6002646648 |
| Fax |
|
| Email |
dibyamani.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shivani Tiwari |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Speech and Hearing Manipal College of Health Professions Manipal
Academy of Higher Education Manipal,
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 |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Speech and Hearing Manipal College of Health Professions Manipal
Academy of Higher Education Manipal,
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 |
Dibyamani Bayan |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal
Academy of Higher Education, Manipal,576104 ,India, |
| 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 |
| Dibyamani Bayan |
Manipal College of Health Professions |
Department of Speech and Hearing,
Manipal College of Health
Professions, Manipal Academy of Higher Education, Manipal-576104, India Udupi KARNATAKA |
6002646648
dibyamani.mchpmpl2024@learner.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 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
parents of children with autism spectrum disorder |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable to all |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
48.00 Year(s) |
| Gender |
Both |
| Details |
Parents who can understand and communicate in the Hindi and/or English language.
Parent who resides with the child and are familiar with the child’s communication needs and status.
Parents of children with non-verbal ASD attending or have attended regular speech-language therapy in last 6 months. |
|
| ExclusionCriteria |
| Details |
Parents of individuals with ASD who are above 18 years of age.
Parents who are unwilling to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Present study aims to investigate parental awareness and attitude towards use of AAC in children with autism in India |
16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
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)
|
08/09/2025 |
| 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="8" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Augmentative and Alternative Communication (AAC) refers to methods, tools, and strategies used to support or replace spoken language. It includes simple gestures and picture boards, as well as sophisticated speech-generating devices. AAC helps individuals express themselves when verbal communication is limited or absent. Children with autism often experience challenges with expressive and/or receptive language. AAC provides them a way to communicate their needs, thoughts, and emotions, enhancing social interaction. It also supports language development, improves behavior by giving them a voice, and provides independence in everyday settings. There is a need for research on parental awareness and attitudes towards Augmentative and Alternative Communication for children with ASD in India to understand the unique challenges and opportunities for implementing and maintaining AAC for children with ASD in the socio-cultural context of India. There is limited research investigating parental awareness, attitudes, and experience in the use of AAC for children with ASD in the Indian context. There is a lack of data on how cultural, socioeconomic, and educational factors influence parental attitudes towards the use of AAC in the Indian context. |