Food Selectivity Protocol for Children With Autism Spectrum Disorders

Autism Spectrum Disorder Clinical Trial

Official title:

Evaluation of the Effect of Food Selectivity Intervention in Children With Autism Spectrum Disorders.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06179940
• Other study ID #: CNR-IRIB-PRO-2023-009
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2023
• Est. completion date: July 17, 2024

Study information

• Verified date: December 2023
• Source: Istituto per la Ricerca e l'Innovazione Biomedica
• Contact: Germana Doria
• Phone: +393465142289
• Email: germana.doria[@]irib.cnr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Food selectivity training is divided into three steps. Step 1- Pairing in the kitchen. Propose highly enjoyed activities to the child in the kitchen. Criterion for moving to step 2: Child stays in the kitchen to play for 5 minutes for 3 consecutive sessions.

Indicate the minutes of playing in the kitchen.

Step 2 Food selectivity training is divided into three steps. Step 1- Pairing in the kitchen. Propose highly enjoyed activities to the child in the kitchen. Criterion for moving to step 2: Child stays in the kitchen to play for 5 minutes for 3 consecutive sessions.

Indicate the minutes of playing in the kitchen. Step 2 At the beginning of the session prepare two identical plates, in each plate there will be 6 foods, arranged in the same way. Place them on the table in the kitchen.

Training

• Transition living room (carpet) - kitchen (table)

• The child is participating in a welcome game with the operator;

• the operator waits 30 sec for the child to spontaneously interact with him: he approaches, stands up and tries to take the operator's hand

• Immediately afterwards, the operator accompanies the child to the kitchen.

• If the child does NOT spontaneously interact with the operator within 30 sec then says, "Let's go."

• If the child does NOT follow the operator's prompt within 30 sec, the operator repeats the prompt once. If the child does not follow the prompt the session will be postponed until the next day.

• NB: If the latter situation occurs (the child does not follow the prompt and therefore the session is postponed) note what happened.

• Procedure

• the operator sits next to the child(ren);

• the operator interacts with the food, without eating it (e.g., touches it, smells it ...).

• During the session, the operator maintains a positive expression, talks about general topics not related to food.

• the practitioner does NOT give any prompt to the child to taste or eat the food.

• The child can walk away at any time. Criterion for moving to stage 3: Child remains seated with plate in front of him/her for 30 sec without emitting problem behaviors for 3 consecutive sessions.

Indicate the time (seconds) in which the child remains sitting with the plate in front of him without stress.

Step 3 - Shaping

• At the beginning of the session prepare two identical plates, in each plate there will be 6 foods, arranged in the same way. Place them on the table in the kitchen.

• Operator inserts comments about the food (e.g., "these carrots are delicious").

• The operator prepares a small container with small pieces with the child's favorite food. The favorite food should only be available at the shaping stage. The container with the favorite food must be out of the child's reach but must be visible to him. The favorite food should not be in the saucer, even in stage 2.

• The caregiver observes any food-related behavior of the child (for example: looks at it, touches it ...). If the child emits any food-related behavior the operator immediately reinforces by praising it and giving it a piece of the favorite food.

The operator defines the target behaviors to be reinforced.

• If the child does not emit any target behavior for more than 15 sec, the operator selects a different target behavior.

• If the child shows any negative emotion at any time during the session, the operator immediately changes the target behavior. To encourage the emergence of different behaviors, the practitioner will differentially reinforce the child's responses. The experimental group will conduct the protocol activity in pairs, and the control group individually.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 17, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

Inclusion Criteria:

• Food selectivity upon parental referral

• diagnosis of autism

Exclusion Criteria:

• presence of other medical disorders

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Other:
• Pairwise food selectivity protocol
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.
• Individual food selectivity protocol
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.

Locations

Country	Name	City	State
Italy	Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)	Messina

Sponsors (2)

Lead Sponsor	Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica	Comune di Messina

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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