Associations of Autistic Traits and Feeding Difficulties

NCT ID: NCT07188870

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-10

Study Completion Date

2027-09-30

Brief Summary

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The objective is to assess the prevalence of autistic traits and feeding disorders in the general population.

Detailed Description

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The objective of our research is twofold:

I. 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.

1. To implement this survey, it is necessary to translate, adapt, and validate the screening instruments (questionnaires) into Hungarian.
2. 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:

1. For the objective observation of eating difficulties and autistic symptoms, as well as to compare these findings with earlier responses to the screening questionnaire;
2. 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

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Autism Spectrum Disorder (ASD)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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BAMBI_pos

children with BAMBI scores higher than the cut-off

No interventions assigned to this group

BAMBI_neg

children with BAMBI scores lower than the cut-off

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Gábor Csukly

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bethesda Children's Hospital

Budapest, , Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Krisztina Szalkay, MD

Role: CONTACT

+36205699044

Facility Contacts

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Krisztina Szalkay, MD

Role: primary

+36205699044

Other Identifiers

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BAMBI2025

Identifier Type: -

Identifier Source: org_study_id

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