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

NCT07019389 | Enrolling By Invitation

• 1 other identifier: b.30.2.ODM.0.20.08/111
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Food Hypersensitivity; Allergy; Phobic Disorders; Caregiver Burden; Validation Study; Cross-Cultural Comparison; Parents; Anxiety; Pediatrics

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  Approximately 10-14 days after baseline assessment

Study Arms (2)

Children with Food Allergy

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 of Children with Food Allergy

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)

Interventions

Turkish Version of the Scale of Food Allergy Anxiety (SOFAA) OTHER

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.

Children with Food Allergy; Parents of Children with Food Allergy

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 8-18 with food allergy and their parents, recruited from pediatric allergy outpatient clinics in Turkey.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (1)

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Food Hypersensitivity; Hypersensitivity; Phobic Disorders; Caregiver Burden; Anxiety Disorders

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Immune System Diseases; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Clinical Fellow in Pediatric Allergy and Immunology

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 13, 2025
• Study Start: July 13, 2023
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• 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.

Locations

TU (1)