Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335030
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-04
Brief Title:
Sensory and Behavioral Aspects With Particular Attention to Food Selectivity in Children With Autism
Sponsor:
IRCCS Fondazione Stella Maris
Organization:
IRCCS Fondazione Stella Maris
Study Overview
Official Title:
Relationship Between Sensory and Behavioral Aspects With Particular Attention to Food Selectivity in Children With Autism Spectrum Disorder and Parental Stress Perceived
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Brief Summary Eating problems and in particular food selectivity is a condition that worsens a long-life disorder such as Autism Spectrum Disorder ASD both on an individual level both on family and social ones
Children 2-6 years diagnosed with ASD according to Diagnostic and Statistical Manual of Mental Disorders 5 Edition DSM5 criteria were enrolled in an observational cross-sectional and multicentric study conducted by three different Italian clinical centers Regarding this sample principal aims of the study are to describe characteristics of food selectivity to evaluate its correlation with ASD symptoms with cognitive and adaptive functioning of ASD preschoolers to describe its impact on parental stress
Children 2-6 years diagnosed with ASD according to Diagnostic and Statistical Manual of Mental Disorders 5 Edition DSM5 criteria were enrolled in an observational cross-sectional and multicentric study conducted by three different Italian clinical centers Regarding this sample principal aims of the study are to describe characteristics of food selectivity to evaluate its correlation with ASD symptoms with cognitive and adaptive functioning of ASD preschoolers to describe its impact on parental stress
Detailed Description:
Background Eating problems and in particular food selectivity is a condition that worsens a long-life disorder such as ASD both on an individual level both on family and social ones Regarding factors that contribute to this eating behavior have been identified sensory atypia rigid behaviors and behavioral problems however the problem has not yet been fully clarified
Objective The study aims to
a evaluate the presence and characteristics of food selectivity in a sample of preschool children with ASD the impact of this on the childs height and weight growth the possible correlation with gastrointestinal symptoms and with oro-motor skills b assess the correlation between food selectivity and the characteristics of ASD sensory atypia repetitive behaviors level of severity of symptoms the cognitive developmentability quotient adaptive functioning and the presence of behavioral disorders c highlight the impact of food selectivity of ASD children on parental stressThese aims are relevant in order to identify possible future therapeutic interventions that rate both the childs needs and parents involvement
Methods children 2-6 years diagnosed with ASD according to DSM-5 criteria at the IRCCS Stella Maris institute Clinical Unit ASD Department were enrolled in an observational cross-sectional and multicentric study conducted by three different Italian clinical centers IRCCS Stella Maris Foundation Pisa Regional Center for Autism Spectrum Disorders - Verona Observation Diagnostic Training Lab - Trento This study received the approval of the Tuscany Regional Ethics Committee for the pediatric age Meyer
In detail the study involves parents by administering an anamnestic interview regarding the medical history and development of the child the rehabilitation and pharmacological intervention in progress the collection of a video recording of two meals in a family context Parents complete a series of questionnaires including Child Oral and Motor Proficiency Scale ChOMPS Brief Autism Mealtime Behavior Inventory BAMBI Sensory Profile 2 SP2 Child Behavior Checklist CBCL 15-5 or 6-18 Parenting Stress Index PSI Food diary Autism-Spectrum Quotient Test AQ Gastrointestinal Symptom Severity Index GISSI Mac Arthur questionnaire The study includes the evaluation of children cognitive functioning through the administration of a psychometricdevelopmental test the administration of a standardized test for the evaluation of socio-communicative skills Autism Diagnostic Observation Schedule 2 Edition and the observation of a meal of the child at the institute The study provides a database dedicated to the collection data obtained
As regards the statistical analyses the researchers want to examine subjects affected by food selectivity identified and compared with the remaining group A clinical characterization of children with food selectivity will be defined to describe any differences in the sensory profile and in eating difficulties based on the characteristics of the ASD and the cognitive abilities of the children Then the impact of the same eating difficulties will be evaluated on the childs adaptive and emotional difficulties and on parental stress index
Objective The study aims to
a evaluate the presence and characteristics of food selectivity in a sample of preschool children with ASD the impact of this on the childs height and weight growth the possible correlation with gastrointestinal symptoms and with oro-motor skills b assess the correlation between food selectivity and the characteristics of ASD sensory atypia repetitive behaviors level of severity of symptoms the cognitive developmentability quotient adaptive functioning and the presence of behavioral disorders c highlight the impact of food selectivity of ASD children on parental stressThese aims are relevant in order to identify possible future therapeutic interventions that rate both the childs needs and parents involvement
Methods children 2-6 years diagnosed with ASD according to DSM-5 criteria at the IRCCS Stella Maris institute Clinical Unit ASD Department were enrolled in an observational cross-sectional and multicentric study conducted by three different Italian clinical centers IRCCS Stella Maris Foundation Pisa Regional Center for Autism Spectrum Disorders - Verona Observation Diagnostic Training Lab - Trento This study received the approval of the Tuscany Regional Ethics Committee for the pediatric age Meyer
In detail the study involves parents by administering an anamnestic interview regarding the medical history and development of the child the rehabilitation and pharmacological intervention in progress the collection of a video recording of two meals in a family context Parents complete a series of questionnaires including Child Oral and Motor Proficiency Scale ChOMPS Brief Autism Mealtime Behavior Inventory BAMBI Sensory Profile 2 SP2 Child Behavior Checklist CBCL 15-5 or 6-18 Parenting Stress Index PSI Food diary Autism-Spectrum Quotient Test AQ Gastrointestinal Symptom Severity Index GISSI Mac Arthur questionnaire The study includes the evaluation of children cognitive functioning through the administration of a psychometricdevelopmental test the administration of a standardized test for the evaluation of socio-communicative skills Autism Diagnostic Observation Schedule 2 Edition and the observation of a meal of the child at the institute The study provides a database dedicated to the collection data obtained
As regards the statistical analyses the researchers want to examine subjects affected by food selectivity identified and compared with the remaining group A clinical characterization of children with food selectivity will be defined to describe any differences in the sensory profile and in eating difficulties based on the characteristics of the ASD and the cognitive abilities of the children Then the impact of the same eating difficulties will be evaluated on the childs adaptive and emotional difficulties and on parental stress index
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