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

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.

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Key information

Conditions

Food Hypersensitivity Allergy Anxiety Anxiety Disorders Behavior Behavioral Symptoms Caregiver Burden Cross-Cultural Comparison Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Mental Disorders Parents Pediatrics Phobic Disorders Stress, Psychological Validation Study

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Internal Consistency of the Turkish Version of the SOFAA-C and SOFAA-P

Time frame: Within 1 week of initial administration

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.
Construct Validity of the Turkish Version of SOFAA

Time frame: Within 1 week of initial administration

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.
Test-Retest Reliability of the Turkish Version of SOFAA

Time frame: Approximately 10-14 days after baseline assessment

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).

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Jun 13, 2025
Registry last updated: Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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