Autism Spectrum DisorderNCT06335030
Sensory and Behavioral Aspects With Particular Attention to Food Selectivity in Children With Autism
An observational study of Autism Spectrum Disorder, run by IRCCS Fondazione Stella Maris at 3 sites in Italy.
Trial 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 . Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 50 participants
- Where
- 3 sitesItaly
- Study dates
- 29 Mar 2021to 30 Nov 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 2 to 6 years
- All sexes
- Child
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).
Who may be able to join
- Children (2-6 years)
- diagnosed with ASD according to DSM-5 criteria at the IRCCS Stella Maris institute (Operational Unit 3 ASD Department)
Who cannot join
- Brain Malformation
- Genetic syndromes
- specifical neurological signs
- prematurity
- epilepsy
- non free diet.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 1 recruiting
- Recruiting
IRCCS Stella Maris
Pisa, PI, 56128
Raffaella Tancredi, +39050886292, raffaella.tancredi@fsm.unipi.it
Roberta Nencioli, +39050886347, roberta.nencioli@fsm.unipi.it
- Terminated
Università degli Studi di Trento-Laboratorio di Osservazione, Diagnosi e Formazione
Rovereto, 38068
- Terminated
Azienda Ospedaliera Borgo Trento
Verona, 37126
About this study
Official title: Relationship Between Sensory and Behavioral Aspects With Particular Attention to Food Selectivity in Children With Autism Spectrum Disorder and Parental Stress Perceived
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.
Read the 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:
- 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.
- Conditions
- Autism Spectrum Disorder
- Keywords
- Food Selectivity, Autism, Parental Stress, Sensory Profile
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: baseline
Observation of child meal-time
On-line observation of child habits during meal-time
Measured: 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
Measured: 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.
Measured: 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.
Measured: baseline
Secondary outcomes (3)
Autism Quotient (AQ)
It is a questionnaire administered to parents separately to evaluate autism traits.
Measured: baseline
Autism Diagnostic Observation Schedule-2 (ADOS-2)
It is a standardized test for the evaluation of socio-communicative skills. In the present study participants completed the Toddler Module (designed specifically for children 12-30 months old with limited language), the Module 1 (used for children aged from 31 months who do not consistently use phrase speech) or the Module 2 (used for children using phrase speech, but who were not verbally fluent) and Module 3(used for children were verbally fluent). To allow comparisons among different modules, ADOS-2 scores (total score, Social Affect, SA, and Restricted and Repetitive Behaviour, RRB, scores) were converted to respective calibrated severity scores (CSS 1-10 indicating absence to severe autism).
Measured: baseline
Vineland-II scales (VABS II)
It assess adaptive behavior in terms of abilities for personal and social functioning in different domains of everyday life. Each domain comprises subdomains (Receptive, Expressive, and Written skills in Communication; Personal, Domestic, and Community skills of Daily Living; Interpersonal relationship, Play and leisure time, and Coping skills of Socialization; and Gross and Fine Motor skills) with item sets assessing specific content areas. In the present study, the scores obtained Communication, Daily living skills, and Socialization domains were used.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start29 Mar 2021
- Primary completion30 Jan 2024
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale Borgo Trento - Verona, Università degli Studi di Trento
- Responsible party
- Principal investigator, Raffaella Tancredi, IRCCS Fondazione Stella Maris
- Investigators
- Raffaella Tancredi, Principal investigator, IRCCS Stella Maris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335030
- Sponsor's protocol ID
- 2.1_AUT-SP2_001_Tancredi
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Local database
Publications
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.
PubMed 26070276Evans 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.
PubMed 22936951Johnson 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.
PubMed 24664635Lukens 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.
PubMed 17578658Muratori 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.
PubMed 28744761Prosperi 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.
PubMed 28861653
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Sensory and Behavioral Aspects With Particular Attention to Food Selectivity in Children With Autism Spectrum Disorder and Parental Stress Perceived
- ClinicalTrials.gov ID
- NCT06335030
- Acronym / sponsor ID
- 2.1_AUT-SP2_001_Tancredi
- Conditions
- Autism Spectrum Disorder
- Keywords
- Food Selectivity, Autism, Parental Stress, Sensory Profile
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Collaborators
- Ospedale Borgo Trento - Verona, Università degli Studi di Trento
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 28 Mar 2024 (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.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Age groups
- Child
- 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).
Key inclusion criteria (2 listed)
- Children (2-6 years)
- diagnosed with ASD according to DSM-5 criteria at the IRCCS Stella Maris institute (Operational Unit 3 ASD Department)
Key exclusion criteria (6 listed)
- Brain Malformation
- Genetic syndromes
- specifical neurological signs
- prematurity
- epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Child Oral and Motor Proficiency Scale (ChOMPS)
Time frame: baseline
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".
Brief Autism Mealtime Behavior Inventory (BAMBI)
Time frame: baseline
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.
Sensory Profile 2 (SP2)
Time frame: baseline
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).
Child Behavior Checklist (CBCL)
Time frame: baseline
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.
Parenting Stress Index (PSI)
Time frame: baseline
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.
Observation of child meal-time
Time frame: baseline
On-line observation of child habits during meal-time
Food Diary
Time frame: baseline
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
Gastrointestinal severity symptom index (GSSI)
Time frame: baseline
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.
Mac Arthur
Time frame: baseline
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.
3 secondary outcomes
Autism Quotient (AQ)
Time frame: baseline
Autism Diagnostic Observation Schedule-2 (ADOS-2)
Time frame: baseline
Vineland-II scales (VABS II)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Background: PubMed 26070276Curtin 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.
- Background: PubMed 22936951Evans 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.
- Background: PubMed 24664635Johnson 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.
- Background: PubMed 17578658Lukens 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.
- Background: PubMed 28744761Muratori 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.
- Background: PubMed 28861653Prosperi 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.
- Description of PSILink provided by the sponsor.
- Description and scoring CBCLLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Local database
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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.
Raffaella Tancredi principal investigator
IRCCS Stella Maris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by IRCCS Fondazione Stella Maris at 3 sites 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 6 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 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Raffaella Tancredi (+39050886292, raffaella.tancredi@fsm.unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Oral and Motor Proficiency Scale (ChOMPS) (time frame: baseline). The study lists 9 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 NCT06335030, which also lists 6 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 28 Mar 2024.