Autism Spectrum DisorderPlaTEANCT07516431
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
A study testing Structured Plate in people with Autism Spectrum Disorder and Childhood, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Autism Spectrum Disorder, Childhood, Feeding Difficulties
- What is being tested?
- Structured Plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- 20 Apr 2025to 14 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the detailed description
This single-arm pilot study examined the usability and feasibility of a structured, compartmentalized plate intervention for children with Autism Spectrum Disorder (ASD) and feeding difficulties, alongside exploratory changes in feeding-related behaviors and family impact. Feeding difficulties in children with ASD may involve sensory processing differences, food selectivity, food refusal, behavioral challenges, and difficulties with mealtime routines, potentially affecting eating participation and family well-being.
The study used a single-group pre-post design in a special education school in Zaragoza, Spain. Six children aged 6-7 years participated. Following baseline assessment, the structured plate was used during routine mid-morning snacks in the classroom, five days per week (Monday to Friday), over an eight-week period (April 28-June 19, 2025), with a maximum of 38 planned sessions per participant.
The structured plate consisted of 10 separate compartments designed to organize food presentation into small, visually delimited portions. After a child completed a compartment, it was covered with a lid to reduce the amount of visible food and provide visual feedback regarding meal progression. The intervention was incorporated into existing classroom snack routines without changes to the school schedule.
Two school meal aides implemented the intervention after receiving training and under the supervision of an occupational therapist experienced in pediatric feeding difficulties. Individualized assistance, including verbal, visual, gestural, and physical guidance when necessary, was provided according to each child's needs.
The evaluation combined caregiver-reported assessments and repeated structured observations. The Pediatric Eating Assessment Tool (PediEAT) was administered before and after the intervention to describe feeding difficulties, while the Feeding Impact Scales (FIS) assessed the perceived impact of feeding difficulties on parents, caregivers, and family functioning. Session-by-session observations documented indicators related to mealtime organization, sustained attention, adaptation to changes, emotional responses, autonomy, food acceptance, avoidance behaviors, and tolerance of food variation.
Feasibility was described through participant retention, session completion, implementation within regular school routines, and availability of observational data. Caregiver-reported outcomes were examined using descriptive statistics and exploratory nonparametric pre-post comparisons. Observational data were summarized descriptively and visually. Given the small sample size and uncontrolled design, findings were considered exploratory and were not intended to establish intervention efficacy.
The original ethics-approved protocol, dated February 13, 2025, specified three intervention sessions per week (Monday, Wednesday, and Friday), delivered by an occupational therapist. During study implementation, two procedural modifications were introduced. First, the intervention frequency was increased to five days per week (Monday to Friday) to integrate the structured plate into the children's regular weekly feeding routine and facilitate familiarization with the device. Second, the intervention was delivered by two school meal aides who routinely supported the children during mid-morning snacks, while the occupational therapist provided training and supervision. These modifications were intended to facilitate integration into the natural school environment and continuity of implementation. They were introduced without prior submission of a protocol amendment to the Research Ethics Committee of Aragón (CEICA).
The original eligibility criteria included age-specific PediEAT cut-off scores. During recruitment, two participants with scores below the specified thresholds were included based on clinical assessment, school staff reports, and observations indicating persistent feeding difficulties affecting participation during school snacks. This represented a deviation from the original eligibility criteria.
- Conditions
- Autism Spectrum Disorder, Childhood, Feeding Difficulties
- Being tested
- Structured Plate
- Keywords
- Autism Spectrum Disorder, Feeding Difficulties, Food Selectivity, Occupational Therapy, Structured Plate
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured PlateDevice
A structured plate with 10 compartments was used during routine mid-morning snacks in the classroom. Foods were presented in small, visually separated portions and each compartment was covered with a lid after completion. The plate was used Monday to Friday for eight weeks (April 28-June 19, 2025), with 38 sessions planned per child. Two school meal aides, trained and supervised by an occupational therapist, supported the children according to individual needs. The procedure was embedded in the usual school routine. During study implementation, frequency increased from the three weekly sessions in the original protocol to five weekly sessions.
| Study group | Role | What they receive |
|---|---|---|
| Structured Plate Intervention | Experimental | Participants received a structured plate intervention during routine mid-morning snacks in a special education classroom. The plate had 10 compartments containing small, visually separated food portions; each compartment was covered after completion. The plate was used Monday to Friday over eight weeks (April 28-June 19, 2025), with 38 planned sessions per child. Two school meal aides, who routinely supported the children during snacks, delivered the intervention after training and under the supervision of an occupational therapist. Individualized verbal, visual, gestural, or physical assistance was provided when needed. The intervention was incorporated into the regular classroom snack routine. Receives: Device: Structured Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-intervention) and 2 months (post-intervention)
Secondary outcomes (15)
Caregiver Psychosocial Impact
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.
Measured: Baseline (pre-intervention) and 2 months (post-intervention)
Study-Specific Structured Mealtime Observation Protocol: Meal Initiation Within 3 Minutes
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
Measured: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Sequenced Consumption
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: Does not follow the sequence; Follows part of the sequence; Follows the sequence completely.
Measured: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Meal Completion
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.
Measured: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Sustained Attention to Meal
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: Very distracted; Slightly distracted; Moderately attentive; Fully attentive
Measured: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Avoidance of Premature Compartment Switching
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.
Measured: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Adaptation to Changes in Food Arrangement
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: Does not adapt; Adapts with difficulty; Adapts with some ease; Adapts without any problems
Measured: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Following Compartment-Order Instructions
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.
Measured: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Positive Attitude Toward the Structured Plate
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.
Measured: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Frustration Management Related to Portion Limits
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: Shows significant frustration or anxiety; Shows mild frustration or anxiety; Shows slight discomfort; Shows comfort and acceptance.
Measured: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Independent Use of the Structured Plate
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: Not autonomous; Partially autonomous; Mostly autonomous; Fully autonomous.
Measured: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Confidence in Choosing the First Compartment
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.
Measured: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Acceptance of Novel Foods
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: Total rejection; Accepts but does not try; Tries but does not consume; Accepts and consumes.
Measured: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Repeated Consumption of Novel Foods
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: Shows no reduction; Shows a slight reduction; Shows a moderate reduction; Shows a significant reduction.
Measured: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Tolerance of Varied Food Textures and Temperatures
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: Does not tolerate any variation; Tolerates one variation; Tolerates two variations; Tolerates three or more variations.
Measured: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start20 Apr 2025
- Primary completion19 Jun 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Martina Espín Tello, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516431
- Sponsor's protocol ID
- C.I. PI25/009
- Acronym
- PlaTEA
- Status last verified
- Oct 2026
- First submitted
- 25 Mar 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34684552Oliveira 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.
PubMed 33950088Sharp 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.
PubMed 30005820Ranjan 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.
PubMed 26178024van 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.
PubMed 35406004Kittana 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.
PubMed 36771417Malhi 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.
PubMed 28078576Brzoska 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.
PubMed 34444847Bourne 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.
PubMed 35112345Baraskewich 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.
PubMed 33653157Esposito 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.
PubMed 36982001
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07516431
- Acronym / sponsor ID
- PlaTEA / C.I. PI25/009
- Conditions
- Autism Spectrum Disorder, Childhood, Feeding Difficulties
- Keywords
- Autism Spectrum Disorder, Feeding Difficulties, Food Selectivity, Occupational Therapy, Structured Plate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This single-arm pilot study examined the usability and feasibility of a structured, compartmentalized plate intervention for children with Autism Spectrum Disorder (ASD) and feeding difficulties, alongside exploratory changes in feeding-related behaviors and family impact. Feeding difficulties in children with ASD may involve sensory processing differences, food selectivity, food refusal, behavioral challenges, and difficulties with mealtime routines, potentially affecting eating participation and family well-being.
The study used a single-group pre-post design in a special education school in Zaragoza, Spain. Six children aged 6-7 years participated. Following baseline assessment, the structured plate was used during routine mid-morning snacks in the classroom, five days per week (Monday to Friday), over an eight-week period (April 28-June 19, 2025), with a maximum of 38 planned sessions per participant.
The structured plate consisted of 10 separate compartments designed to organize food presentation into small, visually delimited portions. After a child completed a compartment, it was covered with a lid to reduce the amount of visible food and provide visual feedback regarding meal progression. The intervention was incorporated into existing classroom snack routines without changes to the school schedule.
Two school meal aides implemented the intervention after receiving training and under the supervision of an occupational therapist experienced in pediatric feeding difficulties. Individualized assistance, including verbal, visual, gestural, and physical guidance when necessary, was provided according to each child's needs.
The evaluation combined caregiver-reported assessments and repeated structured observations. The Pediatric Eating Assessment Tool (PediEAT) was administered before and after the intervention to describe feeding difficulties, while the Feeding Impact Scales (FIS) assessed the perceived impact of feeding difficulties on parents, caregivers, and family functioning. Session-by-session observations documented indicators related to mealtime organization, sustained attention, adaptation to changes, emotional responses, autonomy, food acceptance, avoidance behaviors, and tolerance of food variation.
Feasibility was described through participant retention, session completion, implementation within regular school routines, and availability of observational data. Caregiver-reported outcomes were examined using descriptive statistics and exploratory nonparametric pre-post comparisons. Observational data were summarized descriptively and visually. Given the small sample size and uncontrolled design, findings were considered exploratory and were not intended to establish intervention efficacy.
The original ethics-approved protocol, dated February 13, 2025, specified three intervention sessions per week (Monday, Wednesday, and Friday), delivered by an occupational therapist. During study implementation, two procedural modifications were introduced. First, the intervention frequency was increased to five days per week (Monday to Friday) to integrate the structured plate into the children's regular weekly feeding routine and facilitate familiarization with the device. Second, the intervention was delivered by two school meal aides who routinely supported the children during mid-morning snacks, while the occupational therapist provided training and supervision. These modifications were intended to facilitate integration into the natural school environment and continuity of implementation. They were introduced without prior submission of a protocol amendment to the Research Ethics Committee of Aragón (CEICA).
The original eligibility criteria included age-specific PediEAT cut-off scores. During recruitment, two participants with scores below the specified thresholds were included based on clinical assessment, school staff reports, and observations indicating persistent feeding difficulties affecting participation during school snacks. This represented a deviation from the original eligibility criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Structured Plate Intervention | Experimental | Device: Structured PlateParticipants received a structured plate intervention during routine mid-morning snacks in a special education classroom. The plate had 10 compartments containing small, visually separated food portions; each compartment was covered after completion. The plate was used Monday to Friday over eight weeks (April 28-June 19, 2025), with 38 planned sessions per child. Two school meal aides, who routinely supported the children during snacks, delivered the intervention after training and under the supervision of an occupational therapist. Individualized verbal, visual, gestural, or physical assistance was provided when needed. The intervention was incorporated into the regular classroom snack routine. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured PlateA structured plate with 10 compartments was used during routine mid-morning snacks in the classroom. Foods were presented in small, visually separated portions and each compartment was covered with a lid after completion. The plate was used Monday to Friday for eight weeks (April 28-June 19, 2025), with 38 sessions planned per child. Two school meal aides, trained and supervised by an occupational therapist, supported the children according to individual needs. The procedure was embedded in the usual school routine. During study implementation, frequency increased from the three weekly sessions in the original protocol to five weekly sessions. | Device | Structured Plate Intervention |
Primary outcome
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.
15 secondary outcomes
Caregiver Psychosocial Impact
Time frame: Baseline (pre-intervention) and 2 months (post-intervention)
Study-Specific Structured Mealtime Observation Protocol: Meal Initiation Within 3 Minutes
Time frame: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Sequenced Consumption
Time frame: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Meal Completion
Time frame: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Sustained Attention to Meal
Time frame: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Avoidance of Premature Compartment Switching
Time frame: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Adaptation to Changes in Food Arrangement
Time frame: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Following Compartment-Order Instructions
Time frame: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Positive Attitude Toward the Structured Plate
Time frame: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Frustration Management Related to Portion Limits
Time frame: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Independent Use of the Structured Plate
Time frame: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Confidence in Choosing the First Compartment
Time frame: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Acceptance of Novel Foods
Time frame: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Repeated Consumption of Novel Foods
Time frame: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Study-Specific Structured Mealtime Observation Protocol: Tolerance of Varied Food Textures and Temperatures
Time frame: During the 8-week intervention period (up to 38 planned sessions per participant, Monday to Friday).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 34684552Plaza-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.
- Background: PubMed 33950088Oliveira 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.
- Background: PubMed 30005820Sharp 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.
- Background: PubMed 26178024Ranjan 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.
- Background: PubMed 35406004van 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.
- Background: PubMed 36771417Kittana 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.
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- Autismo España. (2022). Datos de alumnado general no universitario con trastorno del espectro del autismo.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Plate in people with Autism Spectrum Disorder and Childhood, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Eating Assessment Tool (PediEAT) (time frame: Baseline (pre-intervention) and 2 months (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07516431, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.