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

NCT ID: NCT07019389

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-13

Study Completion Date

2027-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

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

Intervention Type 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.

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)

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

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role lead

Responsible Party

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Hilal Gungor

Medical Doctor, Clinical Fellow in Pediatric Allergy and Immunology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 35000731 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34265450 (View on PubMed)

Other Identifiers

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b.30.2.ODM.0.20.08/111

Identifier Type: -

Identifier Source: org_study_id

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