An observational study in Food Hypersensitivity, Allergy and Phobic Disorders, sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization · Observational
This study aims to evaluate the psychometric properties of the Turkish adaptation of the Scale of Food Allergy Anxiety (SOFAA), including both the child-report and parent-report versions. The SOFAA is a validated tool originally developed to assess the specific anxiety related to food allergies. The Turkish versions of the scales will undergo a comprehensive validation process, including assessments of internal consistency, test-retest reliability, and construct validity.
Participants will include children diagnosed with IgE-mediated food allergies and their primary caregivers. The study will investigate whether the translated scales maintain the original structure and effectively measure food allergy-related anxiety in the Turkish pediatric population. The findings are expected to contribute to clinical assessment practices and research on food allergy-related psychosocial impacts in Turkeyy.
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's planned enrollment of 105 is below the median of 151 across 120 observational studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization is the lead sponsor of 87 studies on the registry; 15 are open to participants now.
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Children aged 8-18 with food allergy and their parents, recruited from pediatric allergy outpatient clinics in Turkey.
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Exclusion Criteria:
Children aged 8 to 18 years diagnosed with IgE-mediated food allergy, recruited from pediatric allergy clinics. Participants complete the Turkish-translated child version of the Scale of Food Allergy Anxiety (SOFAA-C).
Other: Turkish Version of the Scale of Food Allergy Anxiety (SOFAA)
Parents or primary caregivers of the participating children complete the parent version of the Turkish-translated Scale of Food Allergy Anxiety (SOFAA-P)
Other: Turkish Version of the Scale of Food Allergy Anxiety (SOFAA)
Participants will complete the Turkish-translated versions of the Scale of Food Allergy Anxiety (SOFAA). Children will complete the SOFAA-C; their parents will complete the SOFAA-P. The study aims to evaluate the reliability and validity of the translated scales through internal consistency, factor analysis, and test-retest reliability methods.
Internal Consistency of the Turkish Version of the SOFAA-C and SOFAA-P
Internal consistency of the Turkish child- and parent-reported versions of the Scale of Food Allergy Anxiety (SOFAA) will be evaluated using Cronbach's alpha coefficient. A value of ≥ 0.70 will be considered acceptable.
Time frame: Within 1 week of initial administration
Construct Validity of the Turkish Version of SOFAA
Construct validity of the Turkish version of the SOFAA will be assessed using exploratory and/or confirmatory factor analysis based on responses from children and parents. Factor structure will be compared with the original version.
Time frame: Within 1 week of initial administration
Test-Retest Reliability of the Turkish Version of SOFAA
A subsample of participants will complete the SOFAA again after a 10-14 day interval. Test-retest reliability will be evaluated using intraclass correlation coefficient (ICC).
Time frame: Approximately 10-14 days after baseline assessment
Plan to share: Yes — Only aggregate results (e.g., internal consistency coefficients, summary statistics) will be shared. Individual participant data (IPD), even in de-identified form, will not be made publicly available. Access to data may be considered upon reasonable request and with appropriate ethical approvals.
Supporting information: Clinical study report
Time frame: Aggregate data will be available beginning 6 months after study completion and for a period of up to 5 years thereafter.
Access criteria: Researchers with a methodologically sound proposal may request access to the aggregated study data. Requests should be submitted to the principal investigator and will require appropriate ethical approval and a signed data-sharing agreement.
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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization