NCT07516431

Preliminary Exploration of the Usability of a Structured Plate to Improve Eating Behaviors in Children With Autism Spectrum Disorder and Its Impact on the Family: A Pilot Study

Exploración Preliminar de la Usabilidad de un Plato Estructurado Para Mejorar la Conducta Alimentaria de niños y niñas Con Trastorno Del Espectro Autista y el Impacto en la Familia: Estudio Piloto.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Universidad de Zaragoza · Academic / Other
• Sex: All
• Age: 5 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

This pilot interventional study aims to evaluate the usability and preliminary effects of a structured plate designed to support eating behaviors in children with Autism Spectrum Disorder (ASD), as well as its perceived psychosocial impact on their families. Feeding difficulties are common in children with ASD and may include food selectivity, behavioral challenges during mealtimes, and family stress. In this single-group pre-post study, children aged 5 to 7 years with ASD and significant feeding difficulties will use the structured plate during school lunchtime three times per week for two months under the supervision of an occupational therapist. Outcomes will assess changes in feeding behaviors and mealtime functioning, as well as caregiver-reported psychosocial impact. Assessments will be conducted at baseline and after the intervention. Findings from this pilot study will inform the feasibility and design of future larger-scale controlled studies.

Detailed description

This pilot interventional study is designed to examine the usability, feasibility, and preliminary effects of a structured compartment plate used during school lunchtime in children with Autism Spectrum Disorder (ASD) who present significant feeding difficulties. Feeding problems in children with ASD are often multifactorial and may involve sensory processing differences, food selectivity, behavioral challenges during meals, and difficulties with mealtime routines, all of which may affect eating participation and family well-being. The study will use a single-group pre-post design conducted in a special education school setting. Following baseline assessment, participants will use the structured plate during individual lunchtime sessions three times per week over a two-month period under the supervision of an occupational therapist with experience in feeding intervention. The plate is designed to provide visual organization of food portions through 10 separate compartments. Food is presented in small, clearly delimited portions, and each compartment is covered after completion in order to reduce visual overload and support attention, sequencing, and engagement during the meal. The evaluation strategy combines caregiver-reported and observational data. Standardized assessments will be administered at baseline and post-intervention to examine changes in feeding difficulties and in the psychosocial impact of the child's feeding on the family. In addition, repeated structured observations during intervention sessions will document behavioral indicators related to mealtime organization, sustained attention, impulse control, flexibility, emotional regulation, autonomy in feeding, acceptance of novel foods, and food selectivity. Given the exploratory nature of this pilot study and the small sample size, analyses will focus on usability and feasibility indicators, as well as preliminary pre-post change patterns using descriptive, visual, and nonparametric methods. Findings are intended to support refinement of study procedures and to inform the design of future controlled studies.

Conditions

• Autism Spectrum Disorder
• Feeding and Eating Disorders
• Childhood

Interventions

Type	Name	Description
DEVICE	Structured Plate	The intervention consists of the use of a structured plate specifically designed to support feeding behavior in children with Autism Spectrum Disorder (ASD). The plate is a compartmentalized device with a matrix of multiple sections that allows food to be presented in small, visually organized portions. Each compartment contains a discrete amount of food, promoting clarity regarding quantity and sequence of intake. During the intervention, the child is guided to consume the food compartment by compartment. After each portion is consumed, the corresponding compartment is covered, reducing visual and sensory load and helping the child focus on the remaining food. This design aims to enhance predictability, support attentional regulation, and reduce anxiety associated with mealtimes. The structured plate is used during school lunchtime in individual sessions, three times per week over a two-month period, under the supervision of an occupational therapist.

Timeline

• Start date: 2025-04-20
• Primary completion: 2025-06-19
• Completion: 2025-07-14
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

1 site across 1 country: Spain