Clinical trial NCT06335030: Sensory and Behavioral Aspects With Particular Attention to Food Selectivity in Children With Autism
Official title: Relationship Between Sensory and Behavioral Aspects With Particular Attention to Food Selectivity in Children With Autism Spectrum Disorder and Parental Stress Perceived
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autism Spectrum Disorder
Keywords: Food Selectivity
Autism
Parental Stress
Sensory Profile
Lead sponsor: IRCCS Fondazione Stella Maris
Sponsor class: OTHER
Collaborators: name: Ospedale Borgo Trento - Verona
name: Università degli Studi di Trento
First posted: 2024-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children (2-6 years) diagnosed with ASD according to DSM-5 criteria at the IRCCS Stella Maris institute (Operational Unit 3 ASD Department), were enrolled in an observational, cross-sectional and multicentric study conducted by three different Italian clinical centers (IRCCS Fondazione Stella Maris - Pisa, Regional Center for Autism Spectrum Disorders - Verona, ODFLab - Trento).

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.

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 child's 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 development/ability quotient, adaptive functioning and the presence of behavioral disorders; c) highlight the impact of food selectivity of ASD children on parental stress.These aims are relevant in order to identify possible future therapeutic interventions that rate both the child's 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) 1.5-5 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 psychometric/developmental 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 child's adaptive and emotional difficulties and on parental stress index.

Eligibility criteria: Inclusion Criteria

* Children (2-6 years)
* diagnosed with ASD according to DSM-5 criteria at the IRCCS Stella Maris institute (Operational Unit 3 ASD Department)

Exclusion Criteria:

* Brain Malformation
* Genetic syndromes
* specifical neurological signs
* prematurity
* epilepsy
* non free diet.

Primary outcomes:
measure: Child Oral and Motor Proficiency Scale (ChOMPS)
timeFrame: baseline
measure: Brief Autism Mealtime Behavior Inventory (BAMBI)
timeFrame: baseline
measure: Sensory Profile 2 (SP2)
timeFrame: baseline
measure: Child Behavior Checklist (CBCL)
timeFrame: baseline
measure: Parenting Stress Index (PSI)
timeFrame: baseline
measure: Observation of child meal-time
timeFrame: baseline
measure: Food Diary
timeFrame: baseline
measure: Gastrointestinal severity symptom index (GSSI)
timeFrame: baseline
measure: Mac Arthur
timeFrame: baseline
Secondary outcomes:
measure: Autism Quotient (AQ)
timeFrame: baseline
measure: Autism Diagnostic Observation Schedule-2 (ADOS-2)
timeFrame: baseline
measure: Vineland-II scales (VABS II)
timeFrame: baseline
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: IRCCS Stella Maris
state: PI
city: Rovereto
country: Italy
facility: Università degli Studi di Trento-Laboratorio di Osservazione, Diagnosi e Formazione
city: Verona
country: Italy
facility: Azienda Ospedaliera Borgo Trento
Study officials:
affiliation: IRCCS Stella Maris
name: Raffaella Tancredi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Curtin C, Hubbard K, Anderson SE, Mick E, Must A, Bandini LG. Food selectivity, mealtime behavior problems, spousal stress, and family food choices in children with and without autism spectrum disorder. J Autism Dev Disord. 2015 Oct;45(10):3308-15. doi: 10.1007/s10803-015-2490-x.
citation: Evans EW, Must A, Anderson SE, Curtin C, Scampini R, Maslin M, Bandini L. Dietary Patterns and Body Mass Index in Children with Autism and Typically Developing Children. Res Autism Spectr Disord. 2012;6(1):399-405. doi: 10.1016/j.rasd.2011.06.014.
citation: Johnson CR, Turner K, Stewart PA, Schmidt B, Shui A, Macklin E, Reynolds A, James J, Johnson SL, Manning Courtney P, Hyman SL. Relationships between feeding problems, behavioral characteristics and nutritional quality in children with ASD. J Autism Dev Disord. 2014 Sep;44(9):2175-84. doi: 10.1007/s10803-014-2095-9.
citation: Lukens CT, Linscheid TR. Development and validation of an inventory to assess mealtime behavior problems in children with autism. J Autism Dev Disord. 2008 Feb;38(2):342-52. doi: 10.1007/s10803-007-0401-5. Epub 2007 Jun 20.
citation: Muratori F, Tonacci A, Billeci L, Catalucci T, Igliozzi R, Calderoni S, Narzisi A. Olfactory Processing in Male Children with Autism: Atypical Odor Threshold and Identification. J Autism Dev Disord. 2017 Oct;47(10):3243-3251. doi: 10.1007/s10803-017-3250-x.
citation: Prosperi M, Santocchi E, Balboni G, Narzisi A, Bozza M, Fulceri F, Apicella F, Igliozzi R, Cosenza A, Tancredi R, Calderoni S, Muratori F. Behavioral Phenotype of ASD Preschoolers with Gastrointestinal Symptoms or Food Selectivity. J Autism Dev Disord. 2017 Nov;47(11):3574-3588. doi: 10.1007/s10803-017-3271-5.