App providing psychosocial and educational supports benefits caregivers of children with newly diagnosed food allergies.

Background: Approximately 6 million children in the United States have a diagnosed food allergy, and 32% of caregivers experience significant psychological distress due to the diagnosis. Despite substantial impacts on psychosocial health and quality of life, few interventions aim to help caregivers of newly diagnosed children. There is a clear, unmet need for interventions to address caregiver distress, especially after the initial diagnosis. Objective: We developed a mobile psychosocial health intervention, the Food Allergy Symptom Self-Management with Technology (FASST) app. Primary end points were to determine the app's feasibility and caregiver satisfaction. Methods: This was a phase II, randomized controlled, implementation study (4-week duration) in caregivers (N = 30) of children ≤ 18 years of age who were newly diagnosed with a food allergy (≤90 days after the diagnosis). Caregivers (n = 20) were randomized to use the FASST app (intervention group) with access to individualized, self-help symptom relief interventions and food allergy support, and educational resources; or to use a limited app with a basic FASST interface and links to a few educational resources (control group [n = 10]). Ten participants (intervention group, n = 5; control group, n = 5) participated in semistructured interviews at week 4. Results: Both groups found the app relatively easy to use. The intervention group scores for safety preparedness during social activities increased by 24%, whereas those in the control group experienced a 1% decline. The intervention group participants increased the use of websites to find food allergy information by 17% at week 4 compared with 4% for the control group. Although the intervention group participants showed greater gains than did those in the control group in their confidence to prepare for and prevent allergic reactions, and greater declines in perceived social limitations, more participants in the control group endorsed confidence in their ability to recognize (11% versus 5%, respectively) and treat (10% versus 6%, respectively) allergic reactions. Conclusion: Analysis of our results suggests that the FASST app may provide a feasible means of delivering psychosocial and educational supports to caregivers of children recently diagnosed with a food allergy.Clinical trial NCT04512924, www.clinicaltrials.gov.