Autism Spectrum DisorderNCT06179940
Food Selectivity Protocol for Children With Autism Spectrum Disorders
A study testing Pairwise food selectivity protocol and Individual food selectivity protocol in people with Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Pairwise food selectivity protocol and Individual food selectivity protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 23 Nov 2023to 17 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Food selectivity upon parental referral
- diagnosis of autism
Who cannot join
- presence of other medical disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Messina, 98164
Flavia Marino, +393395798263, flavia.marino@irib.cnr.it
Giovanni Pioggia, +393203390892, giovanni.pioggia@irib.cnr.it
About this study
Official title: Evaluation of the Effect of Food Selectivity Intervention in Children With Autism Spectrum Disorders.
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Pairwise food selectivity protocol, Individual food selectivity protocol
- Keywords
- autism, children, food selectivity
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pairwise food selectivity protocolOther
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 protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Food selectivity group (1) in pairs | Experimental | 15 Children in the experimental group who will undergo the treatment perform the procedure in pairs. Receives: 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. Receives: Other: Individual food selectivity protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: The test need approximately 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start23 Nov 2023
- Primary completion28 Jun 2024 (estimated)
- Study completion17 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Collaborators
- Messina, Italy
- Responsible party
- Principal investigator, Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica
- Investigators
- Flavia Marino, Principal investigator, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179940
- Sponsor's protocol ID
- CNR-IRIB-PRO-2023-009
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12365739Esposito 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.
PubMed 36982001Peterson 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.
PubMed 31642526
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Food Selectivity Intervention in Children With Autism Spectrum Disorders.
- ClinicalTrials.gov ID
- NCT06179940
- Acronym / sponsor ID
- CNR-IRIB-PRO-2023-009
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, children, food selectivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- Messina, Italy
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 28 Jun 2024 (estimated)
- Study completion
- 17 Jul 2024 (estimated)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food selectivity group (1) in pairs | Experimental | Other: Pairwise food selectivity protocol15 Children in the experimental group who will undergo the treatment perform the procedure in pairs. |
| Food selectivity Group (2) in individual mode | Experimental | Other: Individual food selectivity protocol15 Children in the comparator group who will undergo the treatment perform the procedure in individual mode. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Food selectivity upon parental referral
- diagnosis of autism
Key exclusion criteria (1 listed)
- presence of other medical disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pairwise food selectivity protocolOverall, 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. | Other | Food selectivity group (1) in pairs |
| Individual food selectivity protocolOverall, 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. | Other | Food selectivity Group (2) in individual mode |
Primary outcome
Brief Autism Mealtime Behavior Inventory (BAMBI)
Time frame: The test need approximately 10 minutes
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 test need approximately 20 minutes
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 checklist
Time frame: The test need approximately 15 minutes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Background: PubMed 12365739Piazza 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.
- Background: PubMed 36982001Esposito 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.
- Background: PubMed 31642526Peterson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flavia Marino principal investigator
Istituto per la Ricerca e l'Innovazione Biomedica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pairwise food selectivity protocol and Individual food selectivity protocol in people with Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Germana Doria (+393465142289, germana.doria@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Autism Mealtime Behavior Inventory (BAMBI) (time frame: The test need approximately 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06179940, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.