The Pediatric Eating Assessment Tool

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: SWALLOWING EVALUATION; Other: The Functional Independence Measure; Other: The PEDI-EAT-10

• Registration Number: NCT02909127
• Lead Sponsor: Hacettepe University

Brief Summary

There is no dysphagia spesific and patient/parent centered outcome instrument in the pediatric population. The purpose of this investigation is to develop the Pediatric version of the Eating Assessment Tool (PEDI-EAT-10) and investigate its validity and reliability.

Detailed Description

The evaluation of pediatric swallowing disorders includes clinical and instrumental techniques. The clinical evaluation is important for clinical decision-making and to assess the need for an instrumental evaluation of swallowing. A recent systematic review suggested that the currently available non-instrumental assessments for clinicians to evaluate swallowing and feeding function in the pediatric population have wide variations in design, assessment domains, and target groups. It was concluded that there is a significant need for standardized assessment tools with good psychometric properties in the pediatric population. The existing instruments measure the presence or absence and frequency of challenges related to eating/feeding problems in pediatrics, they do not comprehensively measure oropharyngeal phase swallowing problems or do not reflect the severity of oropharyngeal dysphagia symptoms. The 10-item Eating Assessment Tool (EAT-10), which was designed for adult patients, is a good model for this current research. It has proven highly successful in quantifying initial dysphagia symptom severity and in monitoring treatment efficacy in a vast array of dysphagia etiologies. Although the EAT-10 is a symptom survey, it has been able to predict objective evidence of swallowing dysfunction. There is no dysphagia spesific and patient/parent centered outcome instrument in the pediatric population such as the EAT-10. The purpose of this investigation is to develop the Pediatric version of the Eating Assessment Tool (PEDI-EAT-10) and investigate its validity and reliability.

Study Timeline

• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-09-16
• Study Start: 2016-09-21
• Study First Posted: 2016-09-21
• Primary Completion: 2016-12-30
• Study Completion: 2016-12-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cerebral palsied children	SWALLOWING EVALUATION	The inclusion criteria are age above 18 months, fed orally, referred due to parent complaints about their child's swallowing function and not admitted a swallowing center before. Swallowing evaluation will be performed. The Functional Independence Measure and PEDI-EAT-10 will be filled.
Cerebral palsied children	The Functional Independence Measure	The inclusion criteria are age above 18 months, fed orally, referred due to parent complaints about their child's swallowing function and not admitted a swallowing center before. Swallowing evaluation will be performed. The Functional Independence Measure and PEDI-EAT-10 will be filled.
Cerebral palsied children	The PEDI-EAT-10	The inclusion criteria are age above 18 months, fed orally, referred due to parent complaints about their child's swallowing function and not admitted a swallowing center before. Swallowing evaluation will be performed. The Functional Independence Measure and PEDI-EAT-10 will be filled.
Healthy children	The PEDI-EAT-10	Healthy children above the age of 18 months with no medical history of voice, swallowing, reflux, airway, neurologic, rheumatologic, or neoplastic disorders will be included for normative data generation. The PEDI-EAT-10 will be filled.

Primary Outcome Measures

Name	Time	Method
Development of the scale steps	10 days	A comprehensive pediatric dysphagia literature review and the validated items from the other scales will be used to create the items of the PEDI-EAT-10. The PEDI-EAT-10 was designed as a parent-report measure of dysphagia symptom severity. Content validity will also be investigated because it is the first stage of instrument development. An expert panel with Delphi rounds will be convened to determine the initial content validity. The experts will be scored each item of the scale as ''necessary'', ''insufficent'' or ''unnecessary'' and the content validity index (CVI) will be calculated.

Secondary Outcome Measures

Name	Time	Method
Investigation of the psychometric properties of the scale	6 MONTHS	The PEDI-EAT-10 will be administered to the primary feeders of the CP children on two separate occasions separated by at least 48 hours to evaluate test-retest reliability. The criterion-related validity of the PEDI-EAT-10 will be assessed by the correlation between the PEDI-EAT-10 and swallowing evaluation results.

Trial Locations

Locations (1)

Hacetttepe University; 🇹🇷 Ankara, Turkey