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

NCT ID: NCT06656585

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-07-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Food selectivity Group (2)

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

Group Type: EXPERIMENTAL

Traditional food selectivity protocol

Intervention Type: 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 (1)

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

Group Type: EXPERIMENTAL

Individual food selectivity protocol

Intervention Type: 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.

Interventions

Individual food selectivity protocol

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.

Intervention Type: OTHER

Traditional food selectivity protocol

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• presence of other medical disorders

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione di Comunità Messina onlus

UNKNOWN

Sponsor Role: collaborator

Istituto per la Ricerca e l'Innovazione Biomedica

OTHER

Sponsor Role: lead

Responsible Party

Flavia Marino

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flavia Marino

Role: PRINCIPAL_INVESTIGATOR

Istituto per la Ricerca e l'Innovazione Biomedica

Locations

Istituto per la Ricerca e l'Innovazione Biomedica

Messina, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Flavia Marino

Role: CONTACT

flavia.marino@irib.cnr.it

+393395798263

Giovanni Pioggia

Role: CONTACT

giovanni.pioggia@irib.cnr.it

Facility Contacts

Flavia Marino

Role: primary

flavia.marino@irib.cnr.it

+393395798263

M.Valeria Maiorana

Role: backup

Giovanni Pioggia

Role: backup

Flavia Marino

Role: backup

Germana Doria

Role: backup

Chiara Failla

Role: backup

Noemi Vetrano

Role: backup

Ileana Scarcella

Role: backup

Roberta Minutoli

Role: backup

Paola Chilà

Role: backup

Anna Meduri

Role: backup

Chiara Marraffa

Role: backup

Gaia Roccaforte

Role: backup

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 32006380 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36982001 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31642526 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12365739 (View on PubMed)

Other Identifiers

CNR-IRIB-PRO-2024-011

Identifier Type: -

Identifier Source: org_study_id