CompletedNot Applicable

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

Spain6 participantsStarted 2025-04-20

Plain-language 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.

Who can participate

Age range5 Years – 7 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Pediatric Eating Assessment Tool (PediEAT)

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

Trial details

NCT IDNCT07516431

SponsorUniversidad de Zaragoza

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-19