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 (PlaTEA)

March 31, 2026 updated by: Sandra Martina Espín Tello, Universidad de Zaragoza

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50009
        • Facultad de Ciencias de la Salud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children aged 5 to 7 years.
  • Clinical diagnosis of Autism Spectrum Disorder (ASD) confirmed by a qualified healthcare professional (e.g., neuropediatrics, early intervention services, or child and adolescent mental health services), as documented by caregivers.
  • Presence of significant feeding difficulties, defined as a total score above the established cut-off on the Pediatric Eating Assessment Tool (PediEAT): ≥94 for children aged 5-6 years and ≥82 for children aged 6-7 years.
  • Availability of a parent, caregiver, or legal guardian able to provide information regarding the child's feeding behavior and psychosocial impact.
  • Written informed consent provided by the parent or legal guardian.

Exclusion Criteria:

  • Severe medical conditions affecting feeding (e.g., significant gastrointestinal disorders requiring ongoing medical management).
  • Food allergies that substantially restrict dietary variety during the intervention.
  • Severe neurological comorbidities that interfere with participation in the intervention (e.g., uncontrolled epilepsy).
  • Concurrent participation in another feeding intervention program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Structured Plate Intervention

Participants assigned to this single experimental arm will receive a structured plate intervention during school lunchtime. The structured plate consists of a matrix of multiple compartments designed to visually organize food portions and guide the sequence of intake. Each compartment contains a small portion of food, and once consumed, it is covered to reduce sensory overload and support attentional focus on the remaining food.

The intervention will be delivered individually, three times per week (Monday, Wednesday, and Friday) over a two-month period, under the supervision of an occupational therapist experienced in feeding interventions. The structured plate is intended to support feeding behavior by enhancing organization, predictability, and sensory regulation during mealtimes.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Eating Assessment Tool (PediEAT)
Time Frame: Baseline (pre-intervention) and 2 months (post-intervention)
The PediEAT is a 78-item caregiver-reported measure of problematic feeding behaviors in children aged 6 months to 7 years who are offered solid foods. Parents score each item on a 6-point Likert scale (Never, Almost Never, Sometimes, Often, Almost Always, Always). Total scores range from 0 to 390, with higher scores indicating more problematic feeding and therefore a worse outcome. Domains include physiological symptoms, problematic mealtime behaviors, selective/restrictive eating, and oral processing.
Baseline (pre-intervention) and 2 months (post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Psychosocial Impact
Time Frame: Baseline (pre-intervention) and 2 months (post-intervention)
Caregiver psychosocial impact will be assessed using the total score of the Feeding Impact Scales. This caregiver-reported instrument includes a 13-item Family Impact scale and a 12-item Parent Impact scale. The total score is calculated by summing both scales and ranges from 25 to 125, with higher scores indicating greater psychosocial impact of the child's feeding on the parent and family, and therefore a worse outcome.
Baseline (pre-intervention) and 2 months (post-intervention)
Study-Specific Structured Mealtime Observation Protocol: Meal Initiation Within 3 Minutes
Time Frame: During the 2-month intervention period (3 sessions per week)
Frequency of intervention sessions in which the child begins eating within the first 3 minutes after food is served, as recorded by the study-specific Structured Mealtime Observation Protocol. Higher frequency indicates better mealtime organization. Answer options: Yes or No
During the 2-month intervention period (3 sessions per week)
Study-Specific Structured Mealtime Observation Protocol: Sequenced Consumption
Time Frame: During the 2-month intervention period (3 sessions per week)
Frequency of intervention sessions in which the child follows a defined sequence to consume foods from the structured plate, as recorded by the study-specific Structured Mealtime Observation Protocol. Higher frequency indicates better meal organization and planning. Answer options: Yes or No.
During the 2-month intervention period (3 sessions per week)
Study-Specific Structured Mealtime Observation Protocol: Meal Completion
Time Frame: During the 2-month intervention period (3 sessions per week)
Frequency of intervention sessions in which the child consumes all foods presented on the structured plate, as recorded by the study-specific Structured Mealtime Observation Protocol. Higher frequency indicates better task completion during meals. Answer options: Yes or No.
During the 2-month intervention period (3 sessions per week)
Study-Specific Structured Mealtime Observation Protocol: Sustained Attention to Meal
Time Frame: During the 2-month intervention period (3 sessions per week)
Frequency of intervention sessions in which the child remains focused on the meal without distraction, as recorded by the study-specific Structured Mealtime Observation Protocol. Higher frequency indicates better sustained attention during meals. Answer options: Yes or No.
During the 2-month intervention period (3 sessions per week)
Study-Specific Structured Mealtime Observation Protocol: Avoidance of Premature Compartment Switching
Time Frame: During the 2-month intervention period (3 sessions per week)
Frequency of intervention sessions in which the child avoids changing to another compartment before finishing the food in the current compartment, as recorded by the study-specific Structured Mealtime Observation Protocol. Higher frequency indicates better impulse control during meals. Answer options: Yes or No.
During the 2-month intervention period (3 sessions per week)
Study-Specific Structured Mealtime Observation Protocol: Adaptation to Changes in Food Arrangement
Time Frame: During the 2-month intervention period (3 sessions per week)
Frequency of intervention sessions in which the child adapts to changes in the arrangement or sequence of foods on the structured plate, as recorded by the study-specific Structured Mealtime Observation Protocol. Higher frequency indicates better cognitive flexibility during meals. Answer options: Yes or No.
During the 2-month intervention period (3 sessions per week)
Study-Specific Structured Mealtime Observation Protocol: Following Compartment-Order Instructions
Time Frame: During the 2-month intervention period (3 sessions per week)
Frequency of intervention sessions in which the child follows instructions regarding the order in which plate compartments should be used, as recorded by the study-specific Structured Mealtime Observation Protocol. Higher frequency indicates better flexibility and response to guidance during meals. Answer options: Yes or No.
During the 2-month intervention period (3 sessions per week)
Study-Specific Structured Mealtime Observation Protocol: Positive Attitude Toward the Structured Plate
Time Frame: During the 2-month intervention period (3 sessions per week)
Frequency of intervention sessions in which the child shows a calm and positive attitude while using the structured plate, as recorded by the study-specific Structured Mealtime Observation Protocol. Higher frequency indicates better emotional regulation during meals. Answer options: Yes or No.
During the 2-month intervention period (3 sessions per week)
Study-Specific Structured Mealtime Observation Protocol: Frustration Management Related to Portion Limits
Time Frame: During the 2-month intervention period (3 sessions per week)
Frequency of intervention sessions in which the child manages the limited amount of food presented in each compartment without observable anxiety or frustration, as recorded by the study-specific Structured Mealtime Observation Protocol. Higher frequency indicates better emotional regulation during meals. Answer options: Yes or No.
During the 2-month intervention period (3 sessions per week)
Study-Specific Structured Mealtime Observation Protocol: Independent Use of the Structured Plate
Time Frame: During the 2-month intervention period (3 sessions per week)
Frequency of intervention sessions in which the child uses the structured plate without adult assistance, as recorded by the study-specific Structured Mealtime Observation Protocol. Higher frequency indicates better autonomy in feeding. Answer options: Yes or No.
During the 2-month intervention period (3 sessions per week)
Study-Specific Structured Mealtime Observation Protocol: Confidence in Choosing the First Compartment
Time Frame: During the 2-month intervention period (3 sessions per week)
Frequency of intervention sessions in which the child confidently decides which compartment to use first, as recorded by the study-specific Structured Mealtime Observation Protocol. Higher frequency indicates better autonomy and decision-making during meals. Answer options: Yes or No.
During the 2-month intervention period (3 sessions per week)
Study-Specific Structured Mealtime Observation Protocol: Acceptance of Novel Foods
Time Frame: During the 2-month intervention period (3 sessions per week)
Frequency of intervention sessions in which the child accepts a novel food presented in one of the plate compartments, as recorded by the study-specific Structured Mealtime Observation Protocol. Higher frequency indicates greater acceptance of new foods. Answer options: Yes or No.
During the 2-month intervention period (3 sessions per week)
Study-Specific Structured Mealtime Observation Protocol: Repeated Consumption of Novel Foods
Time Frame: During the 2-month intervention period (3 sessions per week)
Frequency of intervention sessions in which the child repeats consumption of a novel food across different observation sessions, as recorded by the study-specific Structured Mealtime Observation Protocol. Higher frequency indicates greater maintenance of acceptance of new foods. Answer options: Yes or No.
During the 2-month intervention period (3 sessions per week)
Study-Specific Structured Mealtime Observation Protocol: Tolerance of Varied Food Textures and Temperatures
Time Frame: During the 2-month intervention period (3 sessions per week)
Frequency of intervention sessions in which the child consumes foods with varied textures and temperatures, as recorded by the study-specific Structured Mealtime Observation Protocol. Higher frequency indicates lower food selectivity and better tolerance of sensory variation in foods. Answer options: Yes or No.
During the 2-month intervention period (3 sessions per week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Zaragoza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2025

Primary Completion (Actual)

June 19, 2025

Study Completion (Actual)

July 14, 2025

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.I. PI25/009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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