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Clinical Trials/NCT06656585
NCT06656585
Recruiting
Not Applicable

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

Istituto per la Ricerca e l'Innovazione Biomedica1 site in 1 country30 target enrollmentSeptember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism
Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Enrollment
30
Locations
1
Primary Endpoint
Brief Autism Mealtime Behavior Inventory (BAMBI)
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
July 17, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Responsible Party
Principal Investigator
Principal Investigator

Flavia Marino

Principal Investigator

Istituto per la Ricerca e l'Innovazione Biomedica

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • presence of other medical disorders

Outcomes

Primary Outcomes

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.

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.

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.

Study Sites (1)

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