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Completed

NCT Number: 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

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.

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Key information

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de Ciencias de la Salud

Zaragoza, 50009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Structured Plate

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Official study title

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.

Acronym: PlaTEA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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