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

NCT06656585 | Recruiting

• 1 other identifier: CNR-IRIB-PRO-2024-011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism; Autism Spectrum Disorder

Keywords

autism; children; food selectivity; virtual reality

Outcome Measures

Primary Outcomes (3)

• Brief Autism Mealtime Behavior Inventory (BAMBI)

  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.

  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.

• Inventory of food preferences

  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.

  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.

• General assessment

  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.

  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.

Study Arms (2)

Food selectivity Group (2)

EXPERIMENTAL

15 children in the comparator group who will undergo the treatment perform the procedure individually using the traditional method.

Other: Traditional food selectivity protocol

Food selectivity group (1)

EXPERIMENTAL

15 children in the experimental group who will undergo the treatment perform the procedure individually with exposure to foods through Oculus

Other: Individual food selectivity protocol

Interventions

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.

Food selectivity group (1)

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

Food selectivity Group (2)

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• presence of other medical disorders

Sponsors & Collaborators

• Istituto per la Ricerca e l'Innovazione Biomedica: lead
• Fondazione di Comunità Messina onlus: collaborator

Study Sites (1)

Istituto per la Ricerca e l'Innovazione Biomedica

Messina, Italy, 98164, Italy

RECRUITING

Related Publications (5)

• M. M. Essa, M. W. Qoron!eh (eds.), Personalized Food Intervention and Therapy for Autism Spectrum Disorder Management, Advances in Neurobiology 24, https://doi.org/10.1007/978-3-030-30402-7_26

  BACKGROUND

• Banire B, Khowaja K, Mansoor B, Qaraqe M, Al Thani D. Reality-Based Technologies for Children with Autism Spectrum Disorder: A Recommendation for Food Intake Intervention. Adv Neurobiol. 2020;24:679-693. doi: 10.1007/978-3-030-30402-7_26.

  PMID: 32006380 BACKGROUND

• Esposito 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.

  PMID: 36982001 BACKGROUND

• Peterson KM, Piazza CC, Ibanez VF, Fisher WW. Randomized controlled trial of an applied behavior analytic intervention for food selectivity in children with autism spectrum disorder. J Appl Behav Anal. 2019 Oct;52(4):895-917. doi: 10.1002/jaba.650.

  PMID: 31642526 BACKGROUND

• Piazza CC, Patel MR, Santana CM, Goh HL, Delia MD, Lancaster BM. An evaluation of simultaneous and sequential presentation of preferred and nonpreferred food to treat food selectivity. J Appl Behav Anal. 2002 Fall;35(3):259-70. doi: 10.1901/jaba.2002.35-259.

  PMID: 12365739 BACKGROUND

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Flavia Marino

  Istituto per la Ricerca e l'Innovazione Biomedica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Flavia Marino

CONTACT

+393395798263; flavia.marino@irib.cnr.it

Giovanni Pioggia

CONTACT

giovanni.pioggia@irib.cnr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 24, 2024
• Study Start: September 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: July 17, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)