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CTRI Number  CTRI/2024/11/077301 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 24/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Randomized,Parallel Group Trial]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluating Food Acceptance Outcomes in Children with Autism: Sensory Integration Therapy Alone vs. Combined with Behavioral Intervention 
Scientific Title of Study   To compare effectiveness of Sensory Integration Therapy Alone versus Its Combination with Behavioural Intervention in Enhancing Food Acceptance among Children with Autism: A Randomized Controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Usha Kasar 
Designation  Assistant Professor 
Affiliation  Occupational Therapy Training School and Centre,Seth GSMC & KEMH Mumbai 
Address  Sensory Integration OPD,Occupational Therapy Training School and Centre,Seth GSMC & KEMH Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9323701389  
Fax    
Email  ushakasar@kem.edu  
 
Details of Contact Person
Scientific Query  
Name  Muskaan Kaul 
Designation  Postgraduate Student 
Affiliation  Occupational Therapy Training School and Centre,Seth GSMC & KEMH Mumbai 
Address  Sensory Integration OPD,Occupational Therapy Training School and Centre,Seth GSMC & KEMH Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9967768488  
Fax    
Email  kaulmuskaan10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Muskaan Kaul 
Designation  Postgraduate Student 
Affiliation  Occupational Therapy Training School and Centre,Seth GSMC & KEMH Mumbai 
Address  Sensory Integration OPD,Occupational Therapy Training School and Centre,Seth GSMC & KEMH Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9967768488  
Fax    
Email  kaulmuskaan10@gmail.com  
 
Source of Monetary or Material Support  
Occupational Therapy Training School and Centre,Seth GSMC & KEMH, Mumbai, Maharashtra 400012 India 
 
Primary Sponsor  
Name  Dr Muskaan Kaul 
Address  Occupational Therapy School and Training Centre,Seth GSMC & KEMH,Mumbai,Maharashtra , 400012 India 
Type of Sponsor  Government medical college 
 
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 Muskaan Kaul  Seth GSMC & KEMH Mumbai  Sensory Integration OPD, Occupational Therapy Department (1 floor), Occupational Therapy School and Training Centre
Mumbai
MAHARASHTRA 		 9967768488

kaulmuskaan10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC-II) Relating to biomedical and health research (BHR)  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 
Comparator Agent  SENSORY INTEGRATION THERAPY  Regular Occupational Therapy Protocol which comprises activities based on sensory motor and sensory integration approaches (activities addressing tactile, vestibular, proprioceptive, oral sensory issues) Duration of each session -30 minutes,2 times/week  
Intervention  SENSORY INTEGRATION+BEHAVIORAL INTEREVNTION  In addition to receiving the therapy provided to the control group, participants in the experimental group will also receive behavioural intervention -During each session the child will be presented both the non preferred food textures. -The food will be presented for a duration of 30 seconds. -The therapist will present the 1st non-preferred food texture in front of the child and will give the instruction - ‘take a bite’. -If the child engages with the food, social reinforcer will be presented to the child. -Social reinforcer will be given by the therapist. Commonly used social reinforcers like (praises, claps, high fives) will be used. -If the child fails to engage with the food item within the given time span, no reinforcer will be given, the food item will be removed and the next food item will be presented, and the procedure will be continued. -A total of 6 trials of the food items will be presented during each session (i.e, each food item will be presented to the child three times) -Duration of each session will be around 10-15 minutes ,2 times per week. -This procedure will be continued until the child accepts both the 2 food items or reaches a maximum of 8 weeks. -Parents will be explained to carry out the intervention at home In case the child becomes aggressive, the reinforcer will not be given, the food texture will be removed, either the next food texture will be presented or the session will be terminated and the child will be called for the next follow up. The incident/observation will be noted in the case report. Reinforcer will be presented according to the following hierarchical levels- Description Hierarchical level of acceptance as given in article by (Koegel, Robert & Bharoocha, Amber & Ribnick, Courtney & Ribnick, Ryan & Bucio, Mario & Fredeen, Rosy & Koegel, Lynn. (2011). Using Individualized Reinforcers and Hierarchical Exposure to Increase Food Flexibility in Children with Autism Spectrum Disorders. Journal of autism and developmental disorders. 42. 1574-81. 10.1007/s10803- 011-1392-9.) 0- Refuses to try food (with or without disruptive behaviour) 1- Touches the food and motions it towards mouth (does not include touching the food as an act of disruptive behaviour such as throwing the food) 2- Puts the food to lips 3- Bites the food 4- Bites and puts in mouth, refuses to swallow 5- Chews the food but refuses to swallow 6- Swallow the food reluctantly 7 - Accepts the food without any signs of displeasure or disruptive behaviour 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  -children with autism in the age range
-children receiving regular occupational therapy
-children with feeding problems such as selective eating,meal time more than thirty mintutes,food intake with onky certain preferred food textures 
 
ExclusionCriteria 
Details  Children diagnosed with any other comorbidity
-Children with dysphagia, tube feeding or any other oral motor impairment. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study will determine the effectiveness of
integrating behavioural strategies with sensory integration therapy to
increase the acceptance of non-preferred food texture in children with ASD
aged 3 years 0 months to 6 years 11 months.
The secondary outcome will be to correlate the acceptance of non preferred food textures with severity of autism 		 Baseline assessment (0 weeks)
Mid-week assessment (4 weeks)
Post intervention assessment (8 weeks)  
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome is to correlate the acceptance of non preferred food textures with severity of autism  Baseline assessment (0 weeks)
Mid-week assessment (4 weeks)
Post intervention assessment (8 weeks)  
 
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)   12/12/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

SUMMARY OF PROTOCOL

 

TITLE- To compare effectiveness of Sensory Integration Therapy Alone versus Its Combination with Behavioural Intervention in Enhancing Food Acceptance among Children with Autism: A Randomized Controlled Trial

 

AIM- The aim of the study is to provide empirical evidence on whether the combination of sensory integration therapy and behavioural intervention can offer a more effective solution in increasing acceptance of non-preferred food

 

OBJECTIVES- The primary objective of the study is to determine the effectiveness of integrating behavioural strategies with sensory integration therapy to increase the acceptance of non-preferred food textures in children with ASD aged 3 years 0 months to 6 years 11 months.

 

STUDY DESIGN- Randomized controlled trial


 

STUDY SETTING- Data will be collected from children and their parents coming

to paediatrics (Sensory Integration) OPD of Occupational therapy Department.

 

 

INCLUSION CRITERIA-

-Children with autism in the age group 3 years 0 months- 6 years 11 months

-Children receiving regular occupational therapy

-Children with feeding problems such as selective eating, meal time> 30 mins, food intake with only certain preferred food textures

 

 

 

 

EXCLUSION CRITERIA-

Children diagnosed with any other comorbidity

-Children with dysphagia, tube feeding or any other oral-motor impairment

 

 

METHODOLOGY-

Written consent will be taken from all the participated parents/caregivers.

-Demographic data of the child will be collected

Child will be screened using Indian Scale for assessment of Autism (ISAA) for severity of ASD and child sensory profile-2

Parents will be asked about their child’s food preferences based on texture and will have to complete a non-preferred food texture checklist , where they will be asked to write down 2 most non-preferred food textures of the child.

Children will be randomly allocated to the groups

Child will need to have a 60-70% attendance to remain included in the study

 

INTERVENTION

CONTROL GROUP -

Regular Occupational Therapy Protocol which comprises activities based on sensory motor and sensory integration approaches

(activities addressing tactile, vestibular, proprioceptive, oral sensory issues)

Duration of each session -30 minutes,2 times/week

 

EXPERIMENTAL GROUP-

In addition to receiving the therapy provided to the control group, participants in the experimental group will also receive the following additional intervention

 

During each session the child will be presented both the non-preferred food textures.

The therapist will present the 1st non preferred food texture in front of the child and will give the instruction - ‘take a bite’.

 

If the child engages with the food, social reinforcer will be presented to the child.

Social reinforcer will be given by the therapist. Commonly used social reinforcers like (praises, claps, high fives) will be used.

The food will be presented for a duration of 30 seconds

If the child fails to engage with the food item within the given time span, no reinforcer will be given, the food item will be removed and the next food item will be presented, and the procedure will be continued.

A total of 6 trials of the food items will be presented during each session (i.e., each food item will be presented to the child three times)

Duration of each session will be around 10-15 minutes ,2 times per week

This procedure will be continued until the child accepts both the 2 food items or reaches a maximum of 8 weeks.

 

Parents will be explained to carry out the intervention at home

 

 

Reinforcer will be presented according to the following hierarchical levels-

(Adapted from- Koegel, Robert & Bharoocha, Amber & Ribnick, Courtney & Ribnick, Ryan & Bucio, Mario & Fredeen, Rosy & Koegel, Lynn. (2011). Using Individualized Reinforcers and Hierarchical Exposure to Increase Food Flexibility in Children with Autism Spectrum Disorders. Journal of autism and developmental disorders. 42. 1574-81. 10.1007/s10803-011-1392-9.)

 

 

Description

 

Hierarchical level of acceptance

 

0

Refuses to try food (with or without disruptive behaviour)

 

1

Touches the food and motions it towards mouth (does not include touching the food as an act of disruptive behaviour such as throwing the food)

 

2

Puts the food to lips

3

Bites the food

 

4

Bites and puts in mouth, refuses to swallow

 

5

Chews the food but refuses to swallow

 

6

Swallow the food reluctantly

 

7

Accepts the food without any signs of displeasure or disruptive behaviour

 

 

 

 

Baseline assessment (0 weeks)

Mid-week assessment (4 weeks)

Post intervention assessment (8 weeks)

Procedure- Child will be presented the food item one by one and asked to take a bite and will be observed for eating behaviour

 

                        

 

 

 

 

 

 
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