| CTRI Number |
CTRI/2026/01/102314 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Play based just right challenge feeding protocol] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Play-Based Feeding Activities on Food Selectivity in Children with Autism spectrum disorder |
|
Scientific Title of Study
|
EFFECTIVENESS OF PLAY-BASED JUST RIGHT CHALLENGE FEEDING PROTOCOL ON
FOOD SELECTIVITY IN CHILDREN WITH AUTISM SPECTRUM DISORDER |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yogalakshmi T |
| Designation |
UG STUDENT |
| Affiliation |
CHETTINAD SCHOOL OF OCCUPATIONAL THERAPY |
| Address |
OT Pediatric Division Ward No 24 Department of Occupational Therapy Chettinad General Hospital Chettinad Health City Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu India 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
6380282227 |
| Fax |
|
| Email |
yogalakshmithavasundaram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Angelin blessy Y |
| Designation |
Assistance professor |
| Affiliation |
CHETTINAD SCHOOL OF OCCUPATIONAL THERAPY |
| Address |
OT Pediatric Division Ward No 24 Department of Occupational Therapy Chettinad General Hospital Chettinad Health City Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu India 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7358676117 |
| Fax |
|
| Email |
angelinblessy@care.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Angelin blessy Y |
| Designation |
Assistance professor |
| Affiliation |
CHETTINAD SCHOOL OF OCCUPATIONAL THERAPY |
| Address |
OT Pediatric Division Ward No 24 Department of Occupational Therapy Chettinad General Hospital Chettinad Health City Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu India 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7358676117 |
| Fax |
|
| Email |
angelinblessy@care.edu.in |
|
|
Source of Monetary or Material Support
|
| OT Pediatric Division
Ward No 24 Department of Occupational Therapy Chettinad General Hospital Chettinad Health City Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu India 603103 |
|
|
Primary Sponsor
|
| Name |
Yogalakshmi T |
| Address |
OT Pediatric Division
Ward No 24 Department of Occupational Therapy Chettinad General Hospital Chettinad Health City Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu India 603103 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Yogalakshmi T |
CHETTINADGENERAL HOSPITAL |
OT Pediatric Division Ward No 24 Department of Occupational Therapy Chettinad General Hospital Chettinad Health City Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu India 603103
Kancheepuram
TAMIL NADU |
6380282227
yogalakshmithavasundaram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR STUDENT RESEARCH |
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 |
PEDIATRIC EATING ASSESSMENT TOOL (pediEAT) |
The effect of the intervention will be assessed by comparing the results of the pre test collected in the beginning and post test after completing 4 week intervention period |
| Intervention |
Play based just right challenge feeding protocol |
Before enrolling
each child in the study, informed consent will be obtained from their patients/guardian, along
with assent from the participants, using consent forms approved by the Institutional Review
Board of Chettinad University Hospital (CHRI, CARE). A total of 50 individuals, aged 3 to 7 years
diagnosed with autism spectrum disorder with food selectivity will be recruited from the
Occupational Therapy Department at Chettinad Hospital and Clinics in the Chengalpattu District
. Eligibility will be confirmed through initial screening using the DSM-5 for ASD and for food
selectivity it will be assessed through parental interview. After obtaining consent and confirming
inclusion criteria, participants will be randomly assigned into two groups: an intervention group
(n = 25) and a control group (n = 25). Pre- intervention assessment of the independency will be
conducted using the pediatric eating assessment tool (pediEAT).The experimental group will
receive the Play based just a right challenge feeding protocol, while the Control Group will not
receive any intervention by researcher during this time. Eg: Each session will last 45 minutes, 3
days per week, for 4 weeks. After the 4 weeks intervention period, the food acceptance and
selective eating behaviour will be reassessed using the same tool: pediatric eating assessment
tool (pediEAT). Pre- and post-intervention scores will be statistically analyzed to evaluate the
effectiveness of the intervention. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with Autism Spectrum Disorder having selective eating behavior.
Age group : 3 to 7 years |
|
| ExclusionCriteria |
| Details |
Children with other medical
and neurological conditions , ADHD & Children with severe feeding difficulties . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study outcome is measured using PEDIATRIC EATING ASSESSMENT TOOL (pediEAT).
|
Food selectivity will be assessed using PEDIATRIC EATING ASSESSMENT TOOL (pediEAT) at baseline (pre-intervention), and reassessed after completion of four weeks of play based just right challenge feeding protocol (post-intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2026 |
| 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="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
|
This study is a randomized, parallel group, active controlled trial evaluating the effectiveness of play based just right challenge feeding protocol on food selectivity in children with autism spectrum disorder.A total of 50 children aged 3–7 years diagnosed with ASD and exhibiting food selectivity will be recruited from the Chettinad Hospital and Clinics. Informed consent from parents/guardians and assent from participants will be obtained following approval from the Institutional Review Board, Chettinad University Hospital (CHRI, CARE). Diagnosis of ASD will be confirmed using DSM-5 criteria, and food selectivity will be identified through parental interview. Eligible participants will be randomly allocated into an intervention group (n=25) and a control group (n=25). Baseline assessment of feeding independence and selective eating behavior will be conducted using the Pediatric Eating Assessment Tool (PediEAT). The intervention group will receive the play-based feeding protocol for 45 minutes per session, three times per week for four weeks, while the control group will receive no researcher-led intervention during this period. Post-intervention assessment will be conducted using the same outcome measure. Pre- and post-intervention PediEAT scores will be statistically analyzed to determine the effectiveness of the intervention in improving food acceptance and reducing selective eating behaviors. |