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Clinical Trials/CTRI/2026/01/102314
CTRI/2026/01/102314Not yet recruitingPhase 2/3

EFFECTIVENESS OF PLAY-BASED JUST RIGHT CHALLENGE FEEDING PROTOCOL ON FOOD SELECTIVITY IN CHILDREN WITH AUTISM SPECTRUM DISORDER

Yogalakshmi T1 site in 1 country50 target enrollmentStarted: February 3, 2026Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
The study outcome is measured using PEDIATRIC EATING ASSESSMENT TOOL (pediEAT).

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
3.00 Year(s) to 7.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Children diagnosed with Autism Spectrum Disorder having selective eating behavior.
  • •Age group : 3 to 7 years.

Exclusion Criteria

  • •Children with other medical and neurological conditions , ADHD & Children with severe feeding difficulties .

Outcomes

Primary Outcomes

The study outcome is measured using PEDIATRIC EATING ASSESSMENT TOOL (pediEAT).

Time Frame: 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 Outcomes

No secondary outcomes reported

Investigators

Sponsor
Yogalakshmi T
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Yogalakshmi T

CHETTINAD SCHOOL OF OCCUPATIONAL THERAPY

Study Sites (1)

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