Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06179940
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2023-12-12
Brief Title:
Food Selectivity Protocol for Children With Autism Spectrum Disorders
Sponsor:
Istituto per la Ricerca e lInnovazione Biomedica
Organization:
Istituto per la Ricerca e lInnovazione Biomedica
Study Overview
Official Title:
Evaluation of the Effect of Food Selectivity Intervention in Children With Autism Spectrum Disorders
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childrens 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 Laba specially set up as if it were a kitchen to reproduce a home atmosphere
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 Laba 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 operators 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 Lets go
If the child does NOT follow the operators 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 children
the operator interacts with the food without eating it eg 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 himher 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 eg these carrots are delicious
The operator prepares a small container with small pieces with the childs favorite food The favorite food should only be available at the shaping stage The container with the favorite food must be out of the childs 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 childs responses The experimental group will conduct the protocol activity in pairs and the control group individually
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 operators 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 Lets go
If the child does NOT follow the operators 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 children
the operator interacts with the food without eating it eg 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 himher 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 eg these carrots are delicious
The operator prepares a small container with small pieces with the childs favorite food The favorite food should only be available at the shaping stage The container with the favorite food must be out of the childs 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 childs responses The experimental group will conduct the protocol activity in pairs and the control group individually
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None