The Food Allergy Superheroes Training (FAST) Program
Condition: Allergy;Food; Adherence, Treatment; Child, Only
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional

Summary: 
      Among children with a food allergy, strict avoidance (e.g., elimination of allergenic foods
      from one's diet) is the only intervention capable of preventing potentially devastating
      health-related sequelae including anaphylaxis and death. Youths from low-income backgrounds
      are particularly impacted by food allergies and may be the population most apt to benefit
      from a brief, portable, and engaging skills-based intervention designed to teach young
      children the skills needed to remain adherent to food allergy safety guidelines. Data
      collected as part of the proposed project will lay the groundwork for a line of
      federally-funded intervention research broadly examining how to promote adherence to food
      allergy safety guidelines among young children from low-income backgrounds through
      implementation of a robust, efficient, and portable intervention.
    

Detailed description: 
      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 behavioral skills training
      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.
    

Intervention name(s): Food Allergy Superheroes Training (FAST) Program; Food Allergy Knowledge Intervention
Intervention type(s): Behavioral; Other
Intervention description(s): The primary aim of the FAST intervention is to 1) increase the young child's understanding of food allergies (FA) and 2) promote-adherence to FA safety guidelines through active skills training. We will achieve this aim through the use of educational materials (session 1) and a developmentally-tailored skills training intervention (session 2-5). Core components embedded within each skill straining session include instructions, modeling, rehearsal, and reinforcement/corrective feedback. The young child and their parent/caregiver will be present for the entirety of all sessions; however, all intervention materials (i.e., educational content, skills training components) are designed with the young child as the primary focal point of interest. All children will be rewarded with a small toy (<$5 value) at the end of each successfully completed session.; The primary aim of the FAK intervention is to increase the young child's understanding of FAs including prevalence, symptoms, and management strategies among other topics. We will achieve this aim through the use of educational materials targeting knowledge acquisition through a variety of didactic materials made freely available through the Food Allergy Research Education (FARE) website (www.foodallergy.org). More specifically, we will employ information embedded within the "Food Allergy 101" segment of the FARE website. The young child and their parent/caregiver will be present for the entirety of all sessions; however, all intervention materials are designed with the young child as the primary focal point of interest. All children will be rewarded with a small toy (<$5 value) at the end of each successfully completed session. All FAK sessions will occur within the child's home and will include informational handouts relevant to the day's session.
Other intervention name(s): FAST Program; FAK intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants enrolled via the open-trial portion of this study will all receive a 5-session skills training intervention (n = 5 participants). All participants enrolled in the randomized trial portion of this study (n = 50 participants) will be randomly assigned to either a 5-session skills training or 5-session food allergy education intervention
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Food Allergy; Adherence; Skills training; Child