Food Allergies (FA) are a growing health crisis affecting approximately 2.0 million young children (i.e., < 8
years of age) in the United States. Strict avoidance (e.g., elimination of allergenic foods from one’s diet) is the
only intervention capable of preventing potentially devasting health-related sequelae including anaphylaxis and
death. Adhering to recommendations for strict avoidance (i.e., not ingesting, touching, or playing with
potentially allergenic food) is challenging for young children. Youths from disadvantaged backgrounds (i.e., low
socioeconomic status) are particularly impacted by FAs (i.e., greater financial burden, increased risk of
complications); thus, it is critical that adherence-promoting interventions take into account SES-related
disparities. Behavioral Skills Training (BST) is a brief (i.e., <5 sessions, 15-20 min/session), portable, skills-
based, and engaging intervention designed to educate, reinforce through modeling, provide praise/corrective
feedback, and practice (i.e., rehearsal) the skills necessary for children to remain adherent to safety-related
behaviors. Prior research has shown BST superior to education alone. The primary aim of this R21 proposal is
to test the efficacy of a 5-session intervention designed to increase adherence to FA safety guidelines among
low-income, young children (6-8 years of age) with FAs. This intervention, the Food Allergy Superheroes
Training (FAST) Program, will be developed and refined across Phases 1a and 1b to target skills beneficial to
promote adherence to FA guidelines (i.e., food avoidance). During Phase 1a, we will recruit a parent-child
advisory board to aide in integrating principles of BST within the FAST Program manual. We will then examine
the initial acceptability and feasibility of the FAST Program in an open trial with 10 low-income, young children
with FAs to further refine the intervention’s content. During Phase 1b, we will randomize 50 young children with
a FA who are from a low-income background to receive either the FAST Program or FA knowledge. We will
employ developmentally relevant FA assessments (i.e., child-report, role-play, in situ) before, after, and one-
month post-intervention as our primary outcomes. Aim 1: Determine feasibility and acceptability of the FAST
intervention. We will evaluate the feasibility and acceptability of this intervention with 60 participants (n=10 in
pilot trial [Phase 1a] and n=50 in a preliminary randomized trial [Phase 1b]). Aim 2: Estimate the effect size of
the FAST intervention relative to FA knowledge alone. Adherence will be measured via a multi-modal, FA
assessment including child-report, role-play, and in situ assessment. This form of naturalistic, FA assessment
will be designed to measure the child’s behavior (i.e., ingest food, touch or play with food, etc.) in a safe yet
realistic manner. This study will contribute to the field’s knowledge of efficacious interventions for promoting
adherence among young children with FAs.
