The Quality of Life of Mothers of Children With IgE-mediated Food Allergy
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ClinicalTrials.gov Identifier: NCT04740632 |
Recruitment Status :
Recruiting
First Posted : February 5, 2021
Last Update Posted : February 5, 2021
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Condition or disease | Intervention/treatment |
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Food Allergy | Behavioral: Assessment of the quality of life of mothers of children with IgE-mediated food allergy |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Impact of a Multidisciplinary Team on the Quality of Life of Mothers of Children With IgE-mediated Food Allergy |
Actual Study Start Date : | January 10, 2021 |
Actual Primary Completion Date : | January 26, 2021 |
Estimated Study Completion Date : | January 10, 2023 |

Group/Cohort | Intervention/treatment |
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Mothers of children with IgE-mediated food allergy diagnosed by a multidisciplinary team
Mothers of children with IgE-mediated FA diagnosed for at least 6 months who plan to visit a specialized level III center for the management of pediatric FA for the first time
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Behavioral: Assessment of the quality of life of mothers of children with IgE-mediated food allergy
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Mothers of children with IgE-mediated food allergy diagnosed by a non-multidisciplinary team
Mothers of children with IgE-mediated AA diagnosed for at least 6 months who plan to undergo a follow-up visit at a specialized level III center for the management of FA in pediatric age which they have already been followed for at least 6 months
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- Validate the Italian version of the food allergy self-efficacy scale for parents (FASE-P) [ Time Frame: 6 months ]The transversal validation of the Italian version of the scale will be evaluated by calculating the correlation between PHASE-P and FAQLQ-PF. The internal consistency will be evaluated by calculating Cronbach's α, identifying, on the basis of the literature, an acceptable correlation score <70%.
- Validate the Italian version of the Food Allergy Quality of Life - Parental Burden Questionnaire (FAQL-PB) [ Time Frame: 6 months ]
The cross-validation of the Italian version of the scale will be evaluated by calculating the correlation between FAQL-PB and FAQLQ-PF.
The internal consistency will be assessed by calculating Cronbach's α, identifying, on the basis of the literature, an acceptable correlation score <70%.
- Explore potential differences in the quality of life of mothers of children with IgE-mediated food allergy diagnosed by a multidisciplinary team or diagnosed by a non-multidisciplinary team [ Time Frame: 6 months ]The difference in QoL in the two cohorts will be evaluated by comparing the mean total scores of the three specific questionnaires for food allergies administered to the patient's mother (PHASE-P, FAQL-PB and FAQLQ-PF) and stratifying according to variables evaluated in the questionnaires and clinical data and demographics present in the patient's medical record.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Adult mother of a patient <12 years of age diagnosed with IgE-mediated FA
Exclusion Criteria:
- Mother's age <18 years
- Mother unable to understand Italian
- Mother suffering from chronic diseases
- Mother suffering from epilepsy
- Mother suffering from neoplasms
- Mother suffering from immunodeficiencies
- Mother suffering from chronic infections
- Mother suffering from autoimmune diseases
- Mother suffering from inflammatory bowel diseases
- Mother suffering from functional gastrointestinal disorders
- Mother suffering from celiac disease
- Mother suffering from genetic-metabolic diseases
- Mother suffering from tuberculosis
- Mother suffering from congenital heart disease
- Mother suffering from tuberculosis
- Mother suffering from cystic fibrosis
- Mother suffering from other chronic pulmonary diseases
- Mother suffering from major malformations
- Mother suffering from previous surgery of the cardiovascular / respiratory / gastrointestinal tract
- Mother suffering from diabetes
- Mother suffering from neuropsychiatric and neurological disorders
- Mother suffering from eosinophilic disorders of the gastrointestinal tract
- Mother not living with her child with FA
- Concomitant presence in the child with FA of chronic diseases
- Concomitant presence in the child with FA of epilepsy
- Concomitant presence in the child with FA of neoplasms
- Concomitant presence in the child with FA of immunodeficiencies
- Concomitant presence in the child with FA of chronic infections
- Concomitant presence in the child with FA of autoimmune diseases
- Concomitant presence in the child with FA of inflammatory bowel diseases
- Concomitant presence in the child with FA of functional gastrointestinal disorders
- Concomitant presence in the child with FA of celiac disease
- Concomitant presence in the child with FA of genetic-metabolic diseases
- Concomitant presence in the child with FA of tuberculosis
- Concomitant presence in the child with FA of congenital heart disease
- Concomitant presence in the child with FA of tuberculosis
- Concomitant presence in the child with FA of cystic fibrosis
- Concomitant presence in the child with FA of other chronic lung diseases
- Concomitant presence in the child with FA of major malformations
- Concomitant presence in the child with FA of previous surgeries of the cardiovascular / respiratory / gastrointestinal tract
- Concomitant presence in the child with FA of diabetes
- Concomitant presence in the child with FA of neuropsychiatric and neurological disorders
- Concomitant presence in the child with FA of eosinophilic diseases of the gastrointestinal tract
- Concomitant presence in the child with FA of allergic diseases other than FA.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04740632
Contact: Roberto Berni Canani, MD, PhD | 0817462680 | berni@unina.it |
Italy | |
Department of Traslational Medical Science - University of Naples Federico II | Recruiting |
Naples, Italy, 80131 | |
Contact: Roberto Berni Canani, MD, PhD 0817462680 berni@unina.it |
Responsible Party: | Roberto Berni Canani, Associate professor- Chief of the Pediatric Allergy Program at the Department of Traslational Medical Science, Federico II University |
ClinicalTrials.gov Identifier: | NCT04740632 |
Other Study ID Numbers: |
283/20 |
First Posted: | February 5, 2021 Key Record Dates |
Last Update Posted: | February 5, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypersensitivity Food Hypersensitivity Immune System Diseases Hypersensitivity, Immediate |