Sensory and Behavioral Aspects With Particular Attention to Food Selectivity in Children With Autism

NCT06335030 | Recruiting

• 1 other identifier: 2.1_AUT-SP2_001_Tancredi
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Autism Spectrum Disorder

Keywords

Food Selectivity; Autism; Parental Stress; Sensory Profile

Outcome Measures

Primary Outcomes (9)

• Child Oral and Motor Proficiency Scale (ChOMPS)

  It is a questionnaire that evaluates the motor and oral-motor skills that underlie the eating and drinking ability for children aged six months to seven years. It consists of a score total divided into four different subscales: "basic movement patterns", "oral-motor skills fundamentals", "oral-motor coordination" and "complex movement patterns".

  baseline

• Brief Autism Mealtime Behavior Inventory (BAMBI)

  It is a questionnaire consisting of 15 items for the evaluation of food problems referable to a food selectivity framework (total score greater than or equal to 34). It includes four different domains "food selectivity", "destructive behaviors during meals", "food refusal","rigidity during meals" and a total score.

  baseline

• Sensory Profile 2 (SP2)

  This questionnaire administered to parents, has the purpose of identifying atypical sensory processing and in particular impairments referable to sensory processing that could be related to food selectivity (normal profile,moderately atypical or clearly atypical for age in the processing of individuals sensory channels, in modulation, in behavior and emotional responses).

  baseline

• Child Behavior Checklist (CBCL)

  It is used to evaluate developmental psychopathology through scales that assess specific dimensions (Anxiety/Depression; Withdrawal/Depression; Somatic Complaints; Social Problems; Thinking Problems; Attention Problems; Rule-Breaking Behaviors; Aggressive Behaviors), general (Internalizing, Externalizing, and Total Problems), emotional-behavioral problems according to some of the DSM diagnostic categories (Affective Problems; Anxiety Problems; Somatic Problems; Attention-Deficit/Hyperactivity Problems; Oppositional-Provocative Problems; Conduct Problems). In the present study parent form is used.

  baseline

• Parenting Stress Index (PSI)

  It is a questionnaire that measures parental stress level in the parent-child system. It is made up of two domains, Child Domain and Parent Domain composed by 4 sub-scales, which together form the Total Stress scale.The Short Form of PSI-4 (PSI-4-SF) is organized into three sub-scales, Parental Distress, Parent-Child Interaction dysfunctional and Difficult Child. There is also the Defensive Response, which allows you to have information on the respondent's defensive attitude.

  baseline

• Observation of child meal-time

  On-line observation of child habits during meal-time

  baseline

• Food Diary

  It was adapted from the original one of the "Zoom8"survey financed by the Istituto Superiore di Sanità, which studies adherence to the Mediterranean diet in school-age children in Italy. The parents of each child included in the study will record the usual eating habits of his/her child refer to the last year. Its administration has the aim of analyzing the types of foods taken by children with ASD with or without food selectivity

  baseline

• Gastrointestinal severity symptom index (GSSI)

  It is a questionnaire to evaluate presence of gastrointestinal symptoms. It takes 5-10 minutes to compile. A score of 4 or higher (with at least 3 points deriving from the first 6 items which specifically investigate the most common symptoms gastrointestinal) is considered clinically significant to identify relevant gastrointestinal symptoms. There is also an additional section on behaviors associated (verbal and motor) which have been linked to the presence of gastrointestinal symptoms in subjects with ASD.

  baseline

• Mac Arthur

  It is a questionnaire to evaluate the linguistic level. It collects important information on the development of children's abilities in language, including receptive vocabulary, production, gestures repertoire and grammar.

  baseline

Secondary Outcomes (3)

• Autism Quotient (AQ)

  baseline

• Autism Diagnostic Observation Schedule-2 (ADOS-2)

  baseline

• Vineland-II scales (VABS II)

  baseline

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Age Groups: Child (0-17)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead
• Ospedale Borgo Trento - Verona: collaborator
• Università degli Studi di Trento: collaborator

Study Sites (3)

IRCCS Stella Maris

Pisa, PI, 56128, Italy

RECRUITING

Università degli Studi di Trento-Laboratorio di Osservazione, Diagnosi e Formazione

Rovereto, 38068, Italy

TERMINATED

Azienda Ospedaliera Borgo Trento

Verona, 37126, Italy

TERMINATED

Related Publications (6)

• 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.

  PMID: 26070276 BACKGROUND

• 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.

  PMID: 22936951 BACKGROUND

• 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.

  PMID: 24664635 BACKGROUND

• 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.

  PMID: 17578658 BACKGROUND

• 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.

  PMID: 28744761 BACKGROUND

• 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.

  PMID: 28861653 BACKGROUND

Related Links

• Description of PSI
• Description and scoring CBCL

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Raffaella Tancredi

  IRCCS Stella Maris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raffaella Tancredi

CONTACT

+39050886292; raffaella.tancredi@fsm.unipi.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Director Clinical Unit

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 28, 2024
• Study Start: March 29, 2021
• Primary Completion: January 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

IT (3)