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临床试验/CTRI/2026/01/102314
CTRI/2026/01/102314尚未招募2/3 期

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

Yogalakshmi T1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年2月3日最近更新:
适应症
相关药物

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
The study outcome is measured using PEDIATRIC EATING ASSESSMENT TOOL (pediEAT).

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
3.00 Year(s) 至 7.00 Year(s)(—)
性别
All

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: 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)

次要结局

未报告次要终点

研究者

发起方
Yogalakshmi T
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Yogalakshmi T

CHETTINAD SCHOOL OF OCCUPATIONAL THERAPY

研究点 (1)

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