NCT07516431Completed
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.
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
This completed single-arm pilot study examined the usability of a structured plate during routine classroom mid-morning snacks in children with autism spectrum disorder and feeding difficulties. Six children aged 6-7 years used a plate with 10 compartments over eight weeks in a special education school in Zaragoza, Spain. Two trained school meal aides delivered the intervention five days per week under occupational therapy supervision. Caregivers completed the Pediatric Eating Assessment Tool (PediEAT) and Feeding Impact Scales (FIS) before and after the intervention. Repeated structured observations described mealtime behavior and participation. The study also described implementation feasibility and exploratory pre-post changes; its uncontrolled design does not permit conclusions about efficacy. Changes from the original protocol are detailed in the Detailed Description.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 25 Mar 2026
- Start date
- 20 Apr 2025
- Primary completion date
- 19 Jun 2025
- Lead sponsor
- Universidad de Zaragoza
- Diseases
- Autism
- NCT number
- NCT07516431
What you commit to
- Study type: Interventional
- Participants enrolled: 6
- From 20 Apr 2025 to the primary completion date, 19 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another feeding intervention program.
Other illness
- 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).
Who the study is looking for
- 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.
Age in the registry: 5 years to 7 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Facultad de Ciencias de la Salud Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.