NCT07516431

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
Last Updated

April 8, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 25, 2026

Last Update Submit

March 31, 2026

Conditions

Keywords

Autism Spectrum DisorderFeeding DifficultiesFood SelectivityOccupational TherapyStructured Plate

Outcome Measures

Primary Outcomes (1)

  • Pediatric Eating Assessment Tool (PediEAT)

    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 Outcomes (15)

  • Caregiver Psychosocial Impact

    Baseline (pre-intervention) and 2 months (post-intervention)

  • Study-Specific Structured Mealtime Observation Protocol: Meal Initiation Within 3 Minutes

    During the 2-month intervention period (3 sessions per week)

  • Study-Specific Structured Mealtime Observation Protocol: Sequenced Consumption

    During the 2-month intervention period (3 sessions per week)

  • Study-Specific Structured Mealtime Observation Protocol: Meal Completion

    During the 2-month intervention period (3 sessions per week)

  • Study-Specific Structured Mealtime Observation Protocol: Sustained Attention to Meal

    During the 2-month intervention period (3 sessions per week)

  • +10 more secondary outcomes

Study Arms (1)

Structured Plate Intervention

EXPERIMENTAL

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

Interventions

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.

Structured Plate Intervention

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Ciencias de la Salud

Zaragoza, 50009, Spain

Location

Related Publications (11)

  • Plaza-Diaz J, Flores-Rojas K, Torre-Aguilar MJ, Gomez-Fernandez AR, Martin-Borreguero P, Perez-Navero JL, Gil A, Gil-Campos M. Dietary Patterns, Eating Behavior, and Nutrient Intakes of Spanish Preschool Children with Autism Spectrum Disorders. Nutrients. 2021 Oct 10;13(10):3551. doi: 10.3390/nu13103551.

    PMID: 34684552BACKGROUND
  • Oliveira BMF, Frutuoso MFP. [Far beyond nutrients: experiences and connections with autistic children based on cooking and sharing meals]. Cad Saude Publica. 2021 Apr 30;37(4):e00132020. doi: 10.1590/0102-311X00132020. eCollection 2021. Portuguese.

    PMID: 33950088BACKGROUND
  • Sharp WG, Postorino V, McCracken CE, Berry RC, Criado KK, Burrell TL, Scahill L. Dietary Intake, Nutrient Status, and Growth Parameters in Children with Autism Spectrum Disorder and Severe Food Selectivity: An Electronic Medical Record Review. J Acad Nutr Diet. 2018 Oct;118(10):1943-1950. doi: 10.1016/j.jand.2018.05.005. Epub 2018 Jul 10.

    PMID: 30005820BACKGROUND
  • Ranjan S, Nasser JA. Nutritional status of individuals with autism spectrum disorders: do we know enough? Adv Nutr. 2015 Jul 15;6(4):397-407. doi: 10.3945/an.114.007914. Print 2015 Jul.

    PMID: 26178024BACKGROUND
  • van der Wurff I, Oenema A, de Ruijter D, Vingerhoets C, van Amelsvoort T, Rutten B, Mulkens S, Kohler S, Schols A, de Groot R. A Scoping Literature Review of the Relation between Nutrition and ASD Symptoms in Children. Nutrients. 2022 Mar 26;14(7):1389. doi: 10.3390/nu14071389.

    PMID: 35406004BACKGROUND
  • Kittana M, Ahmadani A, Williams KE, Attlee A. Nutritional Status and Feeding Behavior of Children with Autism Spectrum Disorder in the Middle East and North Africa Region: A Systematic Review. Nutrients. 2023 Jan 30;15(3):711. doi: 10.3390/nu15030711.

    PMID: 36771417BACKGROUND
  • Malhi P, Venkatesh L, Bharti B, Singhi P. Feeding Problems and Nutrient Intake in Children with and without Autism: A Comparative Study. Indian J Pediatr. 2017 Apr;84(4):283-288. doi: 10.1007/s12098-016-2285-x. Epub 2017 Jan 12.

    PMID: 28078576BACKGROUND
  • Brzoska A, Kazek B, Koziol K, Kapinos-Gorczyca A, Ferlewicz M, Babraj A, Makosz-Raczek A, Likus W, Paprocka J, Matusik P, Emich-Widera E. Eating Behaviors of Children with Autism-Pilot Study. Nutrients. 2021 Aug 3;13(8):2687. doi: 10.3390/nu13082687.

    PMID: 34444847BACKGROUND
  • Bourne L, Mandy W, Bryant-Waugh R. Avoidant/restrictive food intake disorder and severe food selectivity in children and young people with autism: A scoping review. Dev Med Child Neurol. 2022 Jun;64(6):691-700. doi: 10.1111/dmcn.15139. Epub 2022 Feb 2.

    PMID: 35112345BACKGROUND
  • Baraskewich J, von Ranson KM, McCrimmon A, McMorris CA. Feeding and eating problems in children and adolescents with autism: A scoping review. Autism. 2021 Aug;25(6):1505-1519. doi: 10.1177/1362361321995631. Epub 2021 Mar 2.

    PMID: 33653157BACKGROUND
  • Esposito M, Mirizzi P, Fadda R, Pirollo C, Ricciardi O, Mazza M, Valenti M. Food Selectivity in Children with Autism: Guidelines for Assessment and Clinical Interventions. Int J Environ Res Public Health. 2023 Mar 14;20(6):5092. doi: 10.3390/ijerph20065092.

    PMID: 36982001BACKGROUND

Related Links

MeSH Terms

Conditions

Autism Spectrum DisorderFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2026

First Posted

April 8, 2026

Study Start

April 20, 2025

Primary Completion

June 19, 2025

Study Completion

July 14, 2025

Last Updated

April 8, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations