Clinical trial NCT06656585: Exploring Virtual Reality As an Intervention for Food Selectivity: a Clinical Trial
Official title: Evaluation of the Effect of a Food Selectivity Intervention Through Virtual Reality in Children with Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Keywords: autism
children
food selectivity
virtual reality
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
Collaborators: name: Fondazione di Comunità Messina onlus
First posted: 2024-10-24
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* presence of other medical disorders

Primary outcomes:
measure: Brief Autism Mealtime Behavior Inventory (BAMBI)
timeFrame: 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.
measure: Inventory of food preferences
timeFrame: 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.
measure: General assessment
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Istituto per la Ricerca e l'Innovazione Biomedica
Study officials:
affiliation: Istituto per la Ricerca e l'Innovazione Biomedica
name: Flavia Marino
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.