NCT07188870

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
Jan 2025Sep 2027

Study Start

First participant enrolled

January 10, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 23, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

July 25, 2025

Last Update Submit

September 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Brief Autism Mealtime Behavior Inventory "BAMBI"scores

    Cross-sectional study. Through study completion, an average of two years.

Study Arms (2)

BAMBI_pos

children with BAMBI scores higher than the cut-off

BAMBI_neg

children with BAMBI scores lower than the cut-off

Eligibility Criteria

Age18 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bethesda Children's Hospital

Budapest, 1146, Hungary

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Krisztina Szalkay, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 25, 2025

First Posted

September 23, 2025

Study Start

January 10, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

September 23, 2025

Record last verified: 2025-09

Locations