Caregiver Beliefs and Psychosocial Experiences Related to Emerging Treatment Options for Children with Food Allergy

/ ABSTRACT The goals of this R03 Award are to 1) identify food allergy beliefs and perceived treatment benefits/burdens among caregivers of children who pursue Xolair food allergy treatment and 2) determine the relationship of the uptake of Xolair food allergy treatment and caregivers’ psychosocial functioning. Food allergy affects up to 8% of children in the United States, with 45% of these children diagnosed with multiple food allergies.1,2 Over a third of children with food allergy experience >1 food allergic reaction a year.3 Caregivers consistently report experiencing intense fear about the chance of life-threatening food-induced anaphylaxis and food allergy anxiety,4–8 and have long advocated for a food allergy treatment that prevents anaphylaxis.9 A promising new form of food allergy treatment that may increase allergic reaction threshold for multiple food allergies, omalizumab, was FDA approved in February 2024.9 In a recent clinical trial, 67% of children with diagnosed food allergies who received Xolair via subcutaneous injection for 16 weeks demonstrated an increased reaction threshold to peanut and multiple other food allergens, meaning they may be protected against allergic reactions in response to accidental food allergen exposure.10 The clinical trial assessed caregiver food allergy-related quality of life, an important measure of overall food allergy well-being, but not the impact of Xolair food allergy treatment on fear of allergic reactions or food allergy anxiety,11 two critical factors to understand because they are factors that caregivers report motivate them to participate in food allergy treatment9,12,13—and therefore could greatly affect their decisions to pursue or abandon treatment. This new treatment also presents new decision points which require thoughtful shared decision-making with allergy care providers and may lead to unique food allergy-related stress and anxiety.14 We will augment the clinical trial’s quality of life findings and address crucial information gaps about caregiver fear of allergic reactions, food allergy anxiety, and decision-making using a behavioral health research framework guided by the Health Belief Model and the Shared Decision Making model. We will characterize food allergy beliefs, perceived treatment benefits/burdens, the decision-making process, and the relationship of Xolair treatment with food allergy-related fear, anxiety, and quality of life among 30 caregivers of children ages 5-11 years. We anticipate using data from this pilot study to inform a larger scale, multi-site trial in order to determine if patterns that emerge at our food allergy clinics are comparable with other food allergy clinics. Additionally, these data will provide crucial early-stage information about caregivers who pursue new food allergy treatment options, how they make treatment decisions, and the relationship of treatment with their food allergy-related fear and anxiety. We will use our data to inform the development of clinical and educational resources that will support families during the decision-making process. Our data will also clarify if behavioral interventions should be developed to support families while they undergo new food allergy treatments. Project Number: 1R03AI190490-01A1 | Fiscal Year: 2026 | NIH Institute/Center: National Institute of Allergy and Infectious Diseases (NIAID) | Principal Investigator: Linda Herbert | Institution: CHILDREN'S RESEARCH INSTITUTE, WASHINGTON, DC | Award Amount: $182,000 | Activity Code: R03 | Study Section: Lifestyle Change and Behavioral Health Study Section[LCBH] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R03AI19049001A1