Clinical trial NCT06179940: Food Selectivity Protocol for Children With Autism Spectrum Disorders
Official title: Evaluation of the Effect of Food Selectivity Intervention in Children With Autism Spectrum Disorders.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: autism
children
food selectivity
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
Collaborators: name: Messina, Italy
First posted: 2023-12-22
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. 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Food selectivity upon parental referral
* diagnosis of autism

Exclusion Criteria:

* presence of other medical disorders

Primary outcomes:
measure: Brief Autism Mealtime Behavior Inventory (BAMBI)
timeFrame: The test need approximately 10 minutes
measure: inventory of food preferences
timeFrame: The test need approximately 20 minutes
measure: general assessment checklist
timeFrame: The test need approximately 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Study officials:
affiliation: Istituto per la Ricerca e l'Innovazione Biomedica
name: Flavia Marino
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.