| CTRI Number |
CTRI/2024/11/077514 [Registered on: 29/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of Play Therapy versus Expressive Art Therapy on sensory processing skills, motor skills and social interaction skills in children with autism |
|
Scientific Title of Study
|
Effectiveness of Sensory Integration Therapy along with Play therapy versus Sensory Integration Therapy along with expressive art therapy in children with ASD on sensory issues, motor skills and social interaction: A Comparative 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 |
Priyanka Sehrawat |
| Designation |
Postgraduate student(Master in Occupational Therapy) |
| Affiliation |
Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences |
| Address |
Second floor, Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences, Sec-C, Vasant Kunj, Delhi-110070
South West
DELHI
110070
India |
| Phone |
8700989534 |
| Fax |
|
| Email |
psehrawat524@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Vijay |
| Designation |
Associate professor, Occupational Therapy department |
| Affiliation |
Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences |
| Address |
Second floor, Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences, Sec-C, Vasant Kunj, Delhi-110070
South West
DELHI
110070
India |
| Phone |
9910631430 |
| Fax |
|
| Email |
priyanka_vijay02@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Vijay |
| Designation |
Associate professor, Occupational Therapy department |
| Affiliation |
Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences |
| Address |
Second floor, Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences, Sec-C, Vasant Kunj, Delhi-110070
South West
DELHI
110070
India |
| Phone |
9910631430 |
| Fax |
|
| Email |
priyanka_vijay02@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Chetna Foundation
C-14, Basement, Nangal Dewat, Sector D, Vasant Kunj, New Delhi, Delhi 110070 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [Nil] |
|
|
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 Santosh Kumar |
Chetna Foundation (Child Development Centre)) |
C-14, underground, Chetna Foundation, Nangal Dewat, Sector-D, Vasant Kunj, Delhi-110070
South West
DELHI |
9911338017
krsantosh12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Chetna Foundation |
Approved |
| Institutional Ethics Committee Indian Spinal Injuries Centre |
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 |
| Comparator Agent |
Expressive art therapy |
Circle time- 5 mins
Art and craft time including painting, colouring, collage making, clay moulding, music and dance activity and hand craft activity- 30 mins
Snacks time- 5 mins
Bye-bye time- 5 mins |
| Intervention |
Play Therapy |
Circle time- 5 mins
Play time including ball catch and throw, running and tagging, obstacle courses, puzzles, passing the parcel and block designing- 30 mins
Snacks time- 5 mins
Bye-bye time- 5 mins |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children between age group 3 to 5 of both genders and diagnosed with ASD |
|
| ExclusionCriteria |
| Details |
Children diagnosed with autism having other neurological conditions like stroke, brain tumor etc.
Children with associated problems like severe or profound mental retardation, visual or hearing impairments, physical disabilities etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sensory Processing Measure-Primary
Social responsiveness scale
Gross Motor Function Measure |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
13/12/2024 |
| 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="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
|
Autism spectrum disorder is a neurodevelopmental disorder characterized by deficits in social interaction and communication and presence of restricted and repetitive behaviours. Children with autism need services in health, educational, behavioural, leisure, family support and other areas. They have issues in sensory processing and delayed motor development including speech delay. These issues affect their functioning in daily life and thus need occupational therapy services. According to a study published in the Indian Journal of Pediatrics in 2021, the prevalence of autism in India is around 1 in 68 children. Sensory Integration therapy is widely used as conventional method of treatment for autism, though studies have examined additional benefits of play therapy and art-based therapy to address specific skills such as problem solving and social interaction and symptoms yet no study has been done to compare the effects of play therapy and expressive art therapy to find out which one is more effective. In this study, the participants will be taken from Chetna Foundation and will be selected on the basis of inclusion criteria. The study design will be experimental and total sample size is 30. Participants will then be divided into two groups i.e. Group A that will be receiving play therapy and Group B that will be receiving Expressive art therapy. there will be 15 participants in each group. Pre and post intervention assessment will be done using Sensory Processing Measure- Primary (SPM-P). Statistical procedure will be analyzed on SPSS. The intervention will be given for 45 minutes, 5 days a week for 8 weeks. |