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临床试验/NCT07019389
NCT07019389Enrolling By Invitation不适用

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

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2023年7月13日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
105
试验地点
1
主要终点
Internal Consistency of the Turkish Version of the SOFAA-C and SOFAA-P

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: 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

时间窗: 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

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hilal Gungor

Medical Doctor, Clinical Fellow in Pediatric Allergy and Immunology

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

研究点 (1)

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