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CTRI Number  CTRI/2024/09/074306 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 09/09/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Interpretative sequential mixed method research design 
Study Design  Other 
Public Title of Study   Indian Scale for Assessment of Sensory Issues in Autism children  
Scientific Title of Study   Development and pilot validation of an Indian instrument for severity of sensory reactivity in children with autism spectrum disorder 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajeev Ranjan 
Designation  Associate Professor of Psychiatry  
Affiliation  All India Institute of Medical Sciences, Patna  
Address  Room no. 152, Department of Psychiatry, First Floor, D Block, OPD Building, AIIMS, Phulwarisharif, Patna

Patna
BIHAR
801507
India 
Phone  9717531800  
Fax    
Email  rajeevranjan0087@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajeev Ranjan 
Designation  Associate Professor of Psychiatry  
Affiliation  All India Institute of Medical Sciences, Patna  
Address  Room no. 152, Department of Psychiatry, First Floor, D Block, OPD Building, AIIMS, Phulwarisharif, Patna

Patna
BIHAR
801507
India 
Phone  9717531800  
Fax    
Email  rajeevranjan0087@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajeev Ranjan 
Designation  Associate Professor of Psychiatry  
Affiliation  All India Institute of Medical Sciences, Patna  
Address  Room no. 152, Department of Psychiatry, First Floor, D Block, OPD Building, AIIMS, Phulwarisharif, Patna

Patna
BIHAR
801507
India 
Phone  9717531800  
Fax    
Email  rajeevranjan0087@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Phulwarisharif, Patna, Bihar, India- 801507  
Indian Council of Medical Research, V. Ramalingaswami Bhawan, PO Box No. 4911 Ansari Nagar, New Delhi, India - 110029 
 
Primary Sponsor  
Name  Indian Council of Medical Research, New Delhi 
Address  V.Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
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 Rajeev Ranjan  All India Institute of Medical Sciences, Patna   Room no. 159, Child guidance clinic, Department of Psychiatry, First Floor, D Block, OPD Building
Patna
BIHAR 
97171531800

rajeevranjan0087@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-AIIMS-P ALL INDIA INSTITUTE OF MEDICAL SCIENCES, PATNA  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  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Inclusion criteria:
1. All children clinically diagnosed with ASD as per DSM-5, between the age range of 2 to 6 years.
2. Parents who are willing to provide written informed consent or assent by children.

 
 
ExclusionCriteria 
Details  Exclusion criteria:
1. significant medical or sensory/motor impairments such as blindness or deafness.
2. Any genetic/ neurological condition
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To explore, describe and characterize the sensory reactivity in children with Autism spectrum disorder.
 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To develop & test a valid & reliable instrument for identification & severity of sensory issues in children with Autism spectrum disorder.  Baseline 
 
Target Sample Size   Total Sample Size="620"
Sample Size from India="620" 
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)   01/11/2024 
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="2"
Months="6"
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  

Background: Autism Spectrum disorder (ASD) is a neuro-developmental condition of childhood characterized by qualitative impairment in social and communicative behavior. In our clinical experience, a significant number of children who have been diagnosed with autism have sensory issues. The study of sensory and motor issues in autism is a relatively new frontier for research in ASD. Assessment of sensory symptoms and associated behavioral construct is important as it can help to ascertain the sensory strategies used to regulate the sensory reactivity of a child with ASD.  The current assessment measures have issues related to cultural and clinical applicability, which makes them difficult to be consistently applied in the Indian context. Thus, there is a need for a locally relevant and simple instrument for identification of sensory reactivity in children with ASD.  

Novelty: This would be an indigenously developed severity instrument for sensory symptoms in ASD through a consultative approach, which will be tested with parents of ASD and professionals.

Aims & Objectives:

The overall aim will be to capture the parental experiences and expert perspectives on patterns of sensory reactivity in children with ASD and translate them into a validated severity tool. Primary objective (s):

1. To explore, describe and characterize the sensory reactivity in children with ASD.

2. To develop and pilot test a valid & reliable instrument for identification and severity of sensory issues in children with ASD.

Methods: A step wise approach would be taken for completion of the work. The steps are as follows:

1. Preparation of in-depth interview and focused group discussion guide (Identification of domains) via literature review and consultative iterations

2. Development of a questionnaire/ checklist based upon the inputs from parents of ASD & professionals/ early interventionist  

3. Reviewing of a questionnaire/ checklist by professionals/ early interventionist for content validity and modifications based upon concerns

4. Application of the instrument among parents of children with ASD & parents of typical developing children for pilot validation 

Expected outcome: A severity instrument will be developed for sensory symptoms in ASD children that will be simple, validated, reliable and available in public domain for easy application. It will be precise, more focused and will provide accurate information about sensory issues in children with ASD. So, that we can plan individualized treatment strategy for them.

 
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