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CTRI Number  CTRI/2025/01/078943 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On: 10/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding communication and interaction in autism spectrum disorder 2 to 8 year  
Scientific Title of Study   Studying the domains of communication and interaction skills according to severity of autism spectrum disorder A cross sectional study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sushant Sarang 
Designation  Associate Professor 
Affiliation  Seth G.S. Medical College and KEM Hopsital  
Address  1st Floor,KEM Orthopaedic centre, Dr Ernest Borges Rd, opposite TATA MEMORIAL HOSPITAL, Parel East, Parel, Mumbai, Maharashtra Seth GSMC and KEMH Occupational Therapy School and Centre Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9819722846  
Fax    
Email  sushantsarang@kem.edu  
 
Details of Contact Person
Scientific Query
 
Name  Yashashree bhand 
Designation  PG STUDENT 
Affiliation  Seth G.S. Medical College and KEM Hopsital  
Address  1st Floor,KEM Orthopaedic centre, Dr Ernest Borges Rd, opposite TATA MEMORIAL HOSPITAL, Parel East, Parel, Mumbai, Maharashtra Seth GSMC and KEMH Occupational Therapy School and Centre Mumbai


MAHARASHTRA
400012
India 
Phone  9167684018  
Fax    
Email  Moth202307@kem.edu  
 
Details of Contact Person
Public Query
 
Name  Sushant Sarang 
Designation  Associate Professor 
Affiliation  Seth G.S. Medical College and KEM Hopsital  
Address  1st Floor,KEM Orthopaedic centre, Dr Ernest Borges Rd, opposite TATA MEMORIAL HOSPITAL, Parel East, Parel, Mumbai, Maharashtra Seth GSMC and KEMH Occupational Therapy School and Centre Mumbai


MAHARASHTRA
400012
India 
Phone  9819722846  
Fax    
Email  sushantsarang@kem.edu  
 
Source of Monetary or Material Support  
1st Floor occupational therapy department 412 kem hospital Mumbai 400012 Maharashtra  
 
Primary Sponsor  
Name  DrSushant Sarang 
Address  1st Floor,KEM Orthopaedic centre, Dr Ernest Borges Rd, opposite TATA MEMORIAL HOSPITAL, Parel East, Parel, Mumbai, Maharashtra Seth GSMC and KEMH Occupational Therapy School and Centre Mumbai MAHARASHTRA 400012   
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Yashashree Ravindra bhand  11 /113,Radhakrishna sai society, kandivali west metro station, link road, kandivali west,mumbai-67 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSushant Sarang  Seth G.S. Medical College  1st Floor,412 Occupational Therapy School and Centre,kem hospital Mumbai 400012 Maharashtra
Mumbai
MAHARASHTRA 
09819722846

sushantsarang@kem.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-III((IEC-III) relating to biomedical and health research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F949||Childhood disorder of social functioning, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Patients with ASD, ASD with ADHD
Male and female gender
Age 2 years to 8 years
Parents who give consent for the study 
 
ExclusionCriteria 
Details  Selective mutism
Intellectual disability without ASD
Stereotypic movement disorder
Social (pragmatic) disorder 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To screen patients using Indian Scale for assessment of Autism (ISAA)  1 week(1 day) 
 
Secondary Outcome  
Outcome  TimePoints 
To administer ACIS (Assessment of communication and interaction skills) scale in mild, moderate and severe group of children with autism spectrum disorder.
3. To study the various domains of communication and interaction skills within mild, moderate and severe group of participants with autism spectrum disorder.
4. To study relationship between the various domains of assessment of communication and interaction skills according to the severity of autism spectrum disorder. 
1 week(1day) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   30/01/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 domains of communication and interaction skills 
according to severity of autism spectrum disorder a cross sectional  study
Aim This study attempts to study the relationship between severity of autism and communication and interaction skills
 Objectives-
1 To screen patients using Indian Scale for assessment of Autism (ISAA)
2. To administer ACIS (Assessment of communication and interaction skills) scale in mild, moderate and severe group of children with autism spectrum disorder.
3. To study the various domains of communication and interaction skills within mild, moderate and severe group of participants with autism spectrum disorder.
4. To study relationship between the various domains of assessment of communication and interaction skills according to the severity of autism spectrum disorder.
Study Design : Quantitative, cross sectional observational study
Study Duration: 18 months
Study Setting: Study will be conducted in a tertiary care hospital.
Sampling Technique: Stratified Sampling
Sample Size: 60 (mild-20, moderate-20 , severe20)
Extensive literature review and existing research on the outcome of children with autism revealed limited references articles.
Conducting both pilot and final study is unfeasible due to several constraints such as absence of multicenter participation, time limitations and limited number of cases meeting the inclusion criteria . It is planned to enrol a total number of 60 participants (mild-20, moderate- 20 , severe20) over the course by including all the patients who meet inclusion criteria. 
INCLUSION CRITERIA
Patients with ASD, ASD with ADHD
Male and female gender
Age 2 years to 8 years
Parents who give consent for the study
EXCLUSION CRITERIA
Selective mutism
Intellectual disability without ASD
Stereotypic movement disorder
Social (pragmatic) disorder
PROCEDURE
Approval  taken from EIC.
Permission for use of ACIS (Assessment of communication
and interaction skills) scale taken.
Child with autism spectrum disorder referred in
occupational therapy department would be enrolled in
study with the consent.
Demographic details would be noted. Demographics will be
discussed in discussion .
ISAA (Indian scale for assessment of autism) scale would be
administered in an area other than the sensory integration
unit. i.e, Occupational therapy mental health OPD unit.
Depending on ISAA score participants would be grouped as
mild, moderate and severe.
 ACIS scale would be administered in the sensory integration
unit.
Open, simulated life role situation (sensory integration unit)
would be used for assessment of ACISAccording to ASICS, ‘Simulated life role situation’ is defined as - the therapist attempts to simulate communication and  interaction situations that reflects the clients life role.  
 According to ACIS  is defined as client is in an
unstructured situation.
Relationship between the severity of autism spectrum
disorder and communication and interaction skills will be
studied.
Session 1- Demographics would be taken, ISAA would be
administered
Session 2- ACIS would be done in open, simulated life role
situation, SI unit.
Study toolsIndian scale for assessment of autism (ISAA)
ISAA is an objective assessment tool for persons with autism which uses observation, clinical evaluation of behavior, testing by  interaction with the subject and also information supplemented by parents or caretakers in order to diagnose autism. ISAA consists of 40 items rated on a 5-point scale ranging from 1 (never) to 5 (always).  
The 40 items of ISAA are divided under six domains as given
Domain-I Social Relationship and Reciprocity
Domain-II Emotional Responsiveness
 Domain-III Speech - Language and Communication
Domain-IV Behaviour Patterns
 Domain-V Sensory Aspects
Domain-IV Cognitive Component
Interpretation:
1. <70 -no autism
2. 70“ 106 - mild autism
3. 107-153 -moderate autism
4. >153 -severe autism
Total time taken for administration of ISAA is 20-30 minutes.19
Assessment of communication and interaction skills (ACIS)
The ACIS is an observational assessment that gathers data on the skill that persons demonstrate when communicating and interacting with others in an occupation. The ACIS gathers data on skill as it is  exhibited during performance of an occupational form and/or within a social group of which the person is a part. 
The scale will be administered on participants in open setting. The settings were open, parallel group, cooperative group and one-onone.  
The scale has three domains namely physicality, information
exchange and relations. Each domain is further divided into
subdomains which are;
Physicality- Contacts, Gazes, Gestures, Maneuvres, Orients,
Posture.
Information Exchange - Articulates, Asserts, Asks, Engages,
Expresses, Modulates, Shares, Speaks, Sustains.
Relations - Collaborates, Confirms, Focuses, Relates, Respects.
 Each of the above can be rated between 1 to 4;
4 = skill supports ongoing social action
3 = questionable skill, however there is no disruption in ongoing
social action
2 = ineffective skill which impacts ongoing social action
1 = deficit skill which causes an unacceptable delay or break down in social action 
The total administration time varies from 20-60 minutes.
Observation time ranges from 15-45 minutes.
 Rating time ranges from 5-20 minutes depending on
experience using the ACIS.

 
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