Food HypersensitivityNCT07019389
Validation of Turkish Versions Child- and Parent-Rated Scales of Food Allergy Anxiety
An observational study of Food Hypersensitivity and Allergy, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Food Hypersensitivity, Allergy, Phobic Disorders
- What is being tested?
- Turkish Version of the Scale of Food Allergy Anxiety (SOFAA)
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jul 2023to 30 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged 8-18 with food allergy and their parents, recruited from pediatric allergy outpatient clinics in Turkey.
Who may be able to join
- Diagnosed with IgE-mediated food allergy
- At least one parent/caregiver willing to participate
- Fluent in Turkish
Who cannot join
- Major neurodevelopmental or psychiatric disorders that impair ability to complete scales
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Istanbul
About this study
Official title: Assessment of the Validity and Reliability of the Turkish Adaptation of the Child- and Parent-Rated Scales of Food Allergy Anxiety (SOFAA)
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
- Being tested
- Turkish Version of the Scale of Food Allergy Anxiety (SOFAA)
- Medical subject headings
- Food Hypersensitivity, Hypersensitivity, Phobic Disorders, Caregiver Burden, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: Other: Turkish Version of the Scale of Food Allergy Anxiety (SOFAA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Approximately 10-14 days after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start13 Jul 2023
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Food HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Gungor, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019389
- Sponsor's protocol ID
- b.30.2.ODM.0.20.08/111
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only aggregate results (e.g., internal consistency coefficients, summary statistics) will be shared. Individual participant data (IPD), even in de-identified form, will not be made publicly available. Access to data may be considered upon reasonable request and with appropriate ethical approvals.
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.
PubMed 35000731Dahlsgaard 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.
PubMed 34265450
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Validity and Reliability of the Turkish Adaptation of the Child- and Parent-Rated Scales of Food Allergy Anxiety (SOFAA)
- ClinicalTrials.gov ID
- NCT07019389
- Acronym / sponsor ID
- b.30.2.ODM.0.20.08/111
- Conditions
- Food Hypersensitivity, Allergy, Phobic Disorders, Caregiver Burden, Validation Study, Cross-Cultural Comparison
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Food Allergy | – | Other: Turkish Version of the Scale of Food Allergy Anxiety (SOFAA)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). |
| Parents of Children with Food Allergy | – | Other: Turkish Version of the Scale of Food Allergy Anxiety (SOFAA)Parents or primary caregivers of the participating children complete the parent version of the Turkish-translated Scale of Food Allergy Anxiety (SOFAA-P) |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged 8-18 with food allergy and their parents, recruited from pediatric allergy outpatient clinics in Turkey.
Key inclusion criteria (3 listed)
- Diagnosed with IgE-mediated food allergy
- At least one parent/caregiver willing to participate
- Fluent in Turkish
Key exclusion criteria (1 listed)
- Major neurodevelopmental or psychiatric disorders that impair ability to complete scales
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Children with Food Allergy, Parents of Children with Food Allergy |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Results publication: PubMed 35000731Protudjer 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.
- Results publication: PubMed 34265450Dahlsgaard 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.
- Individual participant dataSharing planned: Yes. Only aggregate results (e.g., internal consistency coefficients, summary statistics) will be shared. Individual participant data (IPD), even in de-identified form, will not be made publicly available. Access to data may be considered upon reasonable request and with appropriate ethical approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Hypersensitivity and Allergy, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal Consistency of the Turkish Version of the SOFAA-C and SOFAA-P (time frame: Within 1 week of initial administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07019389, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.