| 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
|
|
|
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
|
|
|
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. |