Food Selectivity Protocol for Children With Autism Spectrum Disorders

NCT06179940 | Unknown

• 1 other identifier: CNR-IRIB-PRO-2023-009
• 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. During these sessions, two plates, a list of foods previously agreed upon with the parents, and the foods needed for each session will be used. The sessions will take place in an environment called "Home Lab"a specially set up as if it were a kitchen to reproduce a home atmosphere.

Conditions

Autism Spectrum Disorder

Keywords

autism; children; food selectivity

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 test need approximately 10 minutes

• 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 test need approximately 20 minutes

• general assessment checklist

  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 test need approximately 15 minutes

Study Arms (2)

Food selectivity group (1) in pairs

EXPERIMENTAL

15 Children in the experimental group who will undergo the treatment perform the procedure in pairs.

Other: Pairwise food selectivity protocol

Food selectivity Group (2) in individual mode

EXPERIMENTAL

15 Children in the comparator group who will undergo the treatment perform the procedure in individual mode.

Other: Individual food selectivity protocol

Interventions

Pairwise food selectivity protocol OTHER

Overall, the intervention aims to gradually expose the child to various foods, starting with familiarization, progressing to exposure without pressure, and finally, shaping positive behaviors using reinforcement and observing reactions to different food items. The experimental group will conduct the protocol activity in pairs.

Food selectivity group (1) in pairs

Individual food selectivity protocol OTHER

Overall, the intervention aims to gradually expose the child to various foods, starting with familiarization, progressing to exposure without pressure, and finally, shaping positive behaviors using reinforcement and observing reactions to different food items. The control group will conduct the activity individually.

Food selectivity Group (2) in individual mode

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
• diagnosis of autism

You may not qualify if:

• presence of other medical disorders

Sponsors & Collaborators

• Istituto per la Ricerca e l'Innovazione Biomedica: lead
• Messina, Italy: collaborator

Study Sites (1)

Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Messina, 98164, Italy

RECRUITING

Related Publications (3)

• 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

• 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

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic 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

Germana Doria

CONTACT

+393465142289; germana.doria@irib.cnr.it

Giovanni Pioggia

CONTACT

+393203390892; 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: Head of Unit

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: November 23, 2023
• Primary Completion: June 28, 2024
• Study Completion: July 17, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)