Food Selectivity Protocol for Children With Autism Spectrum Disorders
NCT ID: NCT06179940
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2023-11-23
2024-07-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Food selectivity group (1) in pairs
15 Children in the experimental group who will undergo the treatment perform the procedure in pairs.
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.
Food selectivity Group (2) in individual mode
15 Children in the comparator group who will undergo the treatment perform the procedure in individual mode.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* diagnosis of autism
Exclusion Criteria
4 Years
10 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Messina, Italy
OTHER
Istituto per la Ricerca e l'Innovazione Biomedica
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Flavia Marino
Head of Unit
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Flavia Marino
Role: PRINCIPAL_INVESTIGATOR
Istituto per la Ricerca e l'Innovazione Biomedica
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Messina, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Flavia Marino
Role: primary
Giovanni Pioggia
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CNR-IRIB-PRO-2023-009
Identifier Type: -
Identifier Source: org_study_id