Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06656585

Exploring Virtual Reality As an Intervention for Food Selectivity: a Clinical Trial

Food selectivity is a common challenge among children with Autism Spectrum Disorder (ASD), with significant impacts on their nutrition and well-being. The main purpose of this study is to promote children's active participation in mealtime routines and encourage experimentation with new foods through an approach that emphasizes joy and serenity during mealtimes. The study will involve children with ASD between the ages of 4 and 10 years, of both sexes. Food selectivity will be assessed through interviews with parents and the use of specially created cards.

The protocol will include 45-minute sessions, twice a week, for a total of 48 sessions. The children will wear an Oculus headset and be exposed to the foods through this virtual reality tool, enhancing their engagement and willingness to try new foods in a fun and immersive way.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto per la Ricerca e l'Innovazione Biomedica

Messina, Italy, 98164

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Food selectivity upon parental referral
  • Child with diagnosis of autism

Exclusion criteria

  • presence of other medical disorders

Treatment and study plan

Individual food selectivity protocol

Other

Children in the experimental group wear Oculus headsets and interact with virtual foods for 20 minutes. In the "Pairing in the Kitchen" phase, Oculus is removed. Two identical plates with 6 foods are placed in front of the child. The operator, seated next to the child, interacts with the food without eating it, maintaining a positive expression, and discussing non-food topics. No prompts to eat are given, and the child can leave at any time. Progress to the next phase if the child sits calmly for 30 seconds across 3 sessions.

Shaping Phase: Two identical plates are prepared. The operator comments on the food and keeps a small container of the child's favorite food visible but out of reach. Any food-related behavior is reinforced with praise and the favorite food. Target behaviors are adjusted if no response occurs for 15 seconds or if negative emotions are observed. Differential reinforcement is used.

Traditional food selectivity protocol

Other

Step 1:Pairing in the Kitchen Propose enjoyable activities in the kitchen. Move to Step 2 when the child plays in the kitchen for 5 minutes over 3 consecutive sessions.

Step 2:Transition to Kitchen Two plates with 6 identical foods are placed in the kitchen. The operator engages the child in a welcome game, waiting 30 seconds for spontaneous interaction. If no response, the operator prompts the child to go to the kitchen. If the child doesn't follow within 30 seconds, the session is postponed. The operator sits next to the child and interacts with the food, without encouraging the child to eat. Progress when the child stays seated for 30 seconds without problem behavior for 3 sessions.

Step 3:Shaping Two plates are prepared, and the operator comments on the food. A visible container with the child's favorite food is used for reinforcement. Target behaviors are reinforced with praise and the favorite food. Adjust behaviors if there's no response for 15 seconds or negative emotions occur

Primary outcomes

  1. Brief Autism Mealtime Behavior Inventory (BAMBI)

    Time frame: The evaluation sessions will be scheduled pre and post intervention.The test needs approximately 20 minutes to complete for parents. The tests will be scheduled pre intervention and at the study conclusion,about after 6 months.

    the Bambi measures food selectivity, disruptive behavior, food refusal and rigidity at mealtime

    The 18-item Brief Autism Mealtime Behavior Inventory (BAMBI) is a parent-report questionnaire that was created to identify mealtime habits unique to kids with ASD.

    The BAMBI is rated on a Likert scale of 1 to 5, where 1 represents "never" occurring behavior during mealtime and 5 represents "always" occurring behavior. For four of the items that rate constructive mealtime behaviors, reversed scoring is applied. The sum of the 18 elements is used to create the total frequency score, with higher scores indicating more issues with behavior during meals.

  2. Inventory of food preferences

    Time frame: The evaluation sessions will be scheduled pre and post intervention.The test needs approximately 20 minutes to complete for parents. The tests will be scheduled pre intervention and at the study conclusion, about after 6 months.

    The food preference inventory includes a list of foods that is submitted to the parent. Asked how often the food is consumed by the child and family.

  3. General assessment

    Time frame: The evaluation sessions will be scheduled pre and post intervention.The test needs approximately 15 minutes to complete for parents. The tests will be scheduled pre intervention and at the study conclusion,about after 6 months.

    The general assessment includes a personal data sheet, the section relating to nutrition and therefore to the dietary regime, the type of selectivity and dysfunctional behaviours. Finally there is the adaptive functioning card relating to autonomy during meals.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Collaborators

  • Fondazione di Comunità Messina onlus

Registry information

Official study title

Evaluation of the Effect of a Food Selectivity Intervention Through Virtual Reality in Children with Autism Spectrum Disorders

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 24, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.