Autism Spectrum Disorder (ASD)BAMBI2025NCT07188870
Associations of Autistic Traits and Feeding Difficulties
An observational study of Autism Spectrum Disorder (ASD), run by Semmelweis University at 1 site in Hungary.
Trial summary
The objective is to assess the prevalence of autistic traits and feeding disorders in the general population. Read more about this study
- Who is it for?
- Ages 18 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- How many people
- 600 participants
- Where
- 1 siteHungary
- Study dates
- 10 Jan 2025to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Questionnaires will be made available to parents of Hungarian children between 18 - 72 months, diagnosed with ASD by clinicians involved in their care. Parents of neurotypical or undiagnosed children will be reached through social media platforms and via family pediatricians and health visitors in primary care.
Who may be able to join
- Age between 1.5 and 6 years
- Diagnostic status:
- Diagnosed with autism spectrum disorder;
- Showing signs of ASD without formal diagnosis;
- Neurotypical development
- Children and their parents
- Parental consent to participate in the study
Who cannot join
- Developmental disorders affecting feeding
- Children living in institutional care separated from parents
- Medication affecting feeding behavior
- Malnutrition due to poverty
- Parents with low educational attainment or severe communication difficulties preventing questionnaire completion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Bethesda Children's Hospital
Budapest, 1146
Krisztina Szalkay, MD, +36205699044, szalkayk@gmail.com
About this study
Official title: Investigating the Prevalence and Associations of Autistic Traits, Feeding Difficulties, and Atypical Sensorimotor Integration in the Hungarian Early Childhood Population.
The objective is to assess the prevalence of autistic traits and feeding disorders in the general population.
Read the detailed description
The objective of our research is twofold:
- Firstly, the objective is to assess the prevalence of autistic traits and feeding disorders in the general population. The long-term goal is to develop a widely applicable screening tool for early autism detection that can be widely applied by primary care professionals.
- To implement this survey, it is necessary to translate, adapt, and validate the screening instruments (questionnaires) into Hungarian.
- The objective of the study is to administer the finalised version of the questionnaire to a large sample of parents, with a view to investigating the associations between autism and eating difficulties.
II. Secondly, in the clinical phase of our study, we aim to investigate in greater depth the relationship between feeding difficulties and autism spectrum disorder. In this phase, participants (children in the study group and their parents) will undergo in-person assessments and complete additional questionnaires:
- For the objective observation of eating difficulties and autistic symptoms, as well as to compare these findings with earlier responses to the screening questionnaire;
- To identify potential additional influencing factors, we will assess the child's somatic status and sensory sensitivities, as well as parental attitudes (e.g., anxiety, attachment, attitudes).
- Conditions
- Autism Spectrum Disorder (ASD)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BAMBI_pos | children with BAMBI scores higher than the cut-off | |
| BAMBI_neg | children with BAMBI scores lower than the cut-off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Autism Mealtime Behavior Inventory "BAMBI"scores
Measured: Cross-sectional study. Through study completion, an average of two years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start10 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gábor Csukly, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188870
- Sponsor's protocol ID
- BAMBI2025
- Acronym
- BAMBI2025
- Status last verified
- Sep 2025
- First submitted
- 25 Jul 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Prevalence and Associations of Autistic Traits, Feeding Difficulties, and Atypical Sensorimotor Integration in the Hungarian Early Childhood Population.
- ClinicalTrials.gov ID
- NCT07188870
- Acronym / sponsor ID
- BAMBI2025 / BAMBI2025
- Conditions
- Autism Spectrum Disorder (ASD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 23 Sep 2025 (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.
The objective is to assess the prevalence of autistic traits and feeding disorders in the general population.
Detailed description
The objective of our research is twofold:
- Firstly, the objective is to assess the prevalence of autistic traits and feeding disorders in the general population. The long-term goal is to develop a widely applicable screening tool for early autism detection that can be widely applied by primary care professionals.
- To implement this survey, it is necessary to translate, adapt, and validate the screening instruments (questionnaires) into Hungarian.
- The objective of the study is to administer the finalised version of the questionnaire to a large sample of parents, with a view to investigating the associations between autism and eating difficulties.
II. Secondly, in the clinical phase of our study, we aim to investigate in greater depth the relationship between feeding difficulties and autism spectrum disorder. In this phase, participants (children in the study group and their parents) will undergo in-person assessments and complete additional questionnaires:
- For the objective observation of eating difficulties and autistic symptoms, as well as to compare these findings with earlier responses to the screening questionnaire;
- To identify potential additional influencing factors, we will assess the child's somatic status and sensory sensitivities, as well as parental attitudes (e.g., anxiety, attachment, attitudes).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAMBI_pos | – | –children with BAMBI scores higher than the cut-off |
| BAMBI_neg | – | –children with BAMBI scores lower than the cut-off |
Who may qualify
- Ages
- 18 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Questionnaires will be made available to parents of Hungarian children between 18 - 72 months, diagnosed with ASD by clinicians involved in their care. Parents of neurotypical or undiagnosed children will be reached through social media platforms and via family pediatricians and health visitors in primary care.
Key inclusion criteria (7 listed)
- Age between 1.5 and 6 years
- Diagnostic status:
- Diagnosed with autism spectrum disorder;
- Showing signs of ASD without formal diagnosis;
- Neurotypical development
Key exclusion criteria (5 listed)
- Developmental disorders affecting feeding
- Children living in institutional care separated from parents
- Medication affecting feeding behavior
- Malnutrition due to poverty
- Parents with low educational attainment or severe communication difficulties preventing questionnaire completion
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
Brief Autism Mealtime Behavior Inventory "BAMBI"scores
Time frame: Cross-sectional study. Through study completion, an average of two years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
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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.
1 site 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 (ASD), run by Semmelweis University at 1 site in Hungary.
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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krisztina Szalkay, MD (+36205699044, szalkayk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Autism Mealtime Behavior Inventory "BAMBI"scores (time frame: Cross-sectional study. Through study completion, an average of two years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2025.