Preliminary Exploration of the Usability of a Structured Plate to Improve Eating Behaviors in Chi… (NCT07516431) | Clinical Trial Compass
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 range
5 Years – 7 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pediatric Eating Assessment Tool (PediEAT)
Timeframe: Baseline (pre-intervention) and 2 months (post-intervention)