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Enrolling by invitation NCT07019389

Validation of Turkish Versions Child- and Parent-Rated Scales of Food Allergy Anxiety

Observational Food Hypersensitivity Allergy Phobic Disorders Caregiver Burden

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Turkish Version of the Scale of Food Allergy Anxiety (SOFAA).
Who it may be relevant to
Registry conditions: Food Hypersensitivity, Allergy, Phobic Disorders, Caregiver Burden. Basic parameters: 8 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Assessment of the Validity and Reliability of the Turkish Adaptation of the Child- and Parent-Rated Scales of Food Allergy Anxiety (SOFAA)

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Internal Consistency of the Turkish Version of the SOFAA-C and SOFAA-P [Time frame: Within 1 week of initial administration]
  • Construct Validity of the Turkish Version of SOFAA [Time frame: Within 1 week of initial administration]
  • Test-Retest Reliability of the Turkish Version of SOFAA [Time frame: Approximately 10-14 days after baseline assessment]

Eligibility criteria

Inclusion criteria

  • Diagnosed with IgE-mediated food allergy
  • At least one parent/caregiver willing to participate
  • Fluent in Turkish

Exclusion criteria

  • Major neurodevelopmental or psychiatric disorders that impair ability to complete scales

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization — Istanbul

Publications

  • Protudjer JLP. Scales of Food Allergy Anxiety (SOFAA): A Novel Tool to Assess Anxiety Among Children with Food Allergy and Their Caregivers. J Allergy Clin Immunol Pract. 2022 Jan;10(1):170-171. doi: 10.1016/j.jaip.2021.10.036. No abstract available. PMID 35000731
  • Dahlsgaard KK, Wilkey LK, Stites SD, Lewis MO, Spergel JM. Development of the Child- and Parent-Rated Scales of Food Allergy Anxiety (SOFAA). J Allergy Clin Immunol Pract. 2022 Jan;10(1):161-169.e6. doi: 10.1016/j.jaip.2021.06.039. Epub 2021 Jul 12. PMID 34265450

Identifiers

NCT: NCT07019389 · b.30.2.ODM.0.20.08/111

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗