Brantlee Broome

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

Background: Approximately 2.4 million children in the United States suffer from food-induced anaphylaxis, a condition that is annually responsible for over 200 deaths and 200,000 emergency room visits. As a result, caregivers of children newly diagnosed with severe and life-threatening food allergic reactions experience clinically significant symptoms of psychological distress, including fatigue, anxiety, depressed mood, social isolation, and substantially reduced quality of life. Despite this recognition, there is a lack of caregiver-centered self-management interventions to address these concerns. Objective: In this protocol, we propose to develop and conduct feasibility testing of a technology-enhanced, self-management, mobile health, smartphone app intervention called Food Allergy Symptom Self-Management with Technology for Caregivers (FASST) designed to meet the psychosocial health needs of caregivers of children with a new diagnosis of food allergy. Methods: This pilot study uses qualitative work (Phase I) to inform a 4-week longitudinal randomized controlled trial (Phase II). In Phase I, 10 caregivers of children (≤18 years old) with established food allergy (≥1 year from diagnosis) will participate in semistructured interviews to inform the development of the FASST app. In Phase II, 30 caregivers of children (≤18 years old) with a newly diagnosed food allergy (≤90 days from diagnosis) will be randomized 2:1 to receive the FASST intervention (n=20) or control condition (basic app with educational resources; n=10). Process measures include feasibility, caregiver acceptability, adherence, and satisfaction. Outcome measures include caregiver fatigue, anxiety, depression, sleep, self-efficacy, and quality of life measured at baseline, week 4, and 3 months post study completion. Results: Phase I study activities have been completed, and Phase II participant enrollment into the randomized controlled trial is expected to commence in 2021. Conclusions: With limited readily available resources at their disposal, the results from this study have the potential to provide caregivers of children with a newly diagnosed food allergy a tool to help them self-manage and mitigate negative psychosocial factors during a critical time period in the caregiving/condition trajectory. Trial Registration: ClinicalTrials.gov Identifier NCT04512924: https://clinicaltrials.gov/ct2/show/NCT04512924 International Registered Report Identifier (IRRID): DERR1-10.2196/25805

BACKGROUND Approximately 2.4 million children in the United States suffer from food-induced anaphylaxis, a condition that is annually responsible for over 200 deaths and 200,000 emergency room visits. As a result, caregivers of children newly diagnosed with severe and life-threatening food allergic reactions experience clinically significant symptoms of psychological distress, including fatigue, anxiety, depressed mood, social isolation, and substantially reduced quality of life. Despite this recognition, there is a lack of caregiver-centered self-management interventions to address these concerns. OBJECTIVE In this protocol, we propose to develop and conduct feasibility testing of a technology-enhanced, self-management, mobile health, smartphone app intervention called Food Allergy Symptom Self-Management with Technology for Caregivers (FASST) designed to meet the psychosocial health needs of caregivers of children with a new diagnosis of food allergy. METHODS This pilot study uses qualitative work (Phase I) to inform a 4-week longitudinal randomized controlled trial (Phase II). In Phase I, 10 caregivers of children (≤18 years old) with established food allergy (≥1 year from diagnosis) will participate in semistructured interviews to inform the development of the FASST app. In Phase II, 30 caregivers of children (≤18 years old) with a newly diagnosed food allergy (≤90 days from diagnosis) will be randomized 2:1 to receive the FASST intervention (n=20) or control condition (basic app with educational resources; n=10). Process measures include feasibility, caregiver acceptability, adherence, and satisfaction. Outcome measures include caregiver fatigue, anxiety, depression, sleep, self-efficacy, and quality of life measured at baseline, week 4, and 3 months post study completion. RESULTS Phase I study activities have been completed, and Phase II participant enrollment into the randomized controlled trial is expected to commence in 2021. CONCLUSIONS With limited readily available resources at their disposal, the results from this study have the potential to provide caregivers of children with a newly diagnosed food allergy a tool to help them self-manage and mitigate negative psychosocial factors during a critical time period in the caregiving/condition trajectory. CLINICALTRIAL ClinicalTrials.gov Identifier NCT04512924: https://clinicaltrials.gov/ct2/show/NCT04512924 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/25805