| CTRI Number |
CTRI/2025/07/091806 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Social interaction in siblings with and without autism |
|
Scientific Title of Study
|
Engagement in Shared Social Activities Among Adolescent Siblings of Individuals with and without Autism |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sree Santhoshi S |
| 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
KARNATAKA
576104
India |
| Phone |
8377041389 |
| Fax |
|
| Email |
sreesanthoshi02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunila John |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech & Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202937409 |
| Fax |
|
| Email |
sunila.john@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunila John |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech & Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202937409 |
| Fax |
|
| Email |
sunila.john@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka
576104
India |
|
|
Primary Sponsor
|
| Name |
Sree Santhoshi S |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India 576104 |
| 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 |
| Dr Sunila John |
Manipal College of Health Professions |
Department of Speech
and Hearing, Manipal
College of Health
Professions, Manipal
Academy of Higher
Education,
Manipal-576104
Udupi
KARNATAKA |
08202937409
sunila.john@manipal.com |
|
|
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 |
Sibings of individuals with and without Autism Spectrum Disorder |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Group 1
Typically developing siblings aged 12-16 years, who can read and understand English/ Kannada. Having a sibling diagnosed with Autism Spectrum Disorder as per DSM-5 or ICD-10 guidelines determined from a clinical diagnostic set up and with mild to moderate severity.
Group 2
Typically developing sibling aged 12-16 years, who can read and understand English/ Kannada, and does not have a family member with clinically diagnosed ASD
|
|
| ExclusionCriteria |
| Details |
Group 1:
For typically developing siblings, diagnosed with any communication disorders/ neurological disorders/ hearing problems/ chronic health/ mental health conditions are excluded. siblings who don’t spend 50% of their childhood in the same household will be excluded.
For siblings diagnosed with ASD, non-verbal individuals with severe socio-communication deficits; siblings diagnosed with any other communication disorders/ neurological disorders/ hearing problems/ chronic health/ mental health conditions are excluded. siblings who don’t spend 50% of their childhood in the same household will be excluded.
In Group 2, Siblings diagnosed with any communication disorders/ neurological disorders/ hearing problems/ chronic health/ mental health conditions are excluded; siblings who don’t spend 50% of their childhood in the same household will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of activities engaged by siblings, the frequency of activity participation in the named activity, and enjoyment ratings in shared activities |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Three subdomain scores - warmth, rivalry, & conflict |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
08/08/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Justification for the study: There is a need to explore the self-perception of social communication of adolescent siblings of a person with ASD. The distinct needs and challenges, understanding sibling dynamics in shared activities among typically developing siblings of an individual with ASD need to be tapped. This will aid in providing tailored intervention that encourages better communication and facilitates constructive relationships among siblings. The data of participants from both groups (adolescent siblings of individuals with autism and without autism) will be compared to understand the nature of engagement in shared social activities.
Aim of the study: To compare engagement in shared social activities among siblings of individuals with and without autism. Objectives of the study: To investigate engagement in shared social activities (nature, frequency, and enjoyment) among typically developing siblings of individuals with and without autism. To correlate the nature of engagement with the quality of sibling relationships among individuals with and without autism. |