Friends, Family & Food: Food Allergy App for Youth - II
Condition: Food Allergy in Children
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional

Summary: 
      Objective: This Phase II STTR grant incorporated user feedback collected in an earlier
      development project to build interactive, web-based software that helps children with food
      allergies learn about their condition and gain self-management skills. This highly
      interactive game allows children to progress through virtual scenes to help them learn about
      food avoidance, symptom detection, and reaction management. In addition, this project built
      gaming complexity, with more levels and game options, of the two interactive games "Label
      Learning: Like it or Lose it!" and "Reaction Action!." Research Procedures: The researchers
      elicited input from 8 families of children (ages 8-12) with food allergies and their parents
      by presenting some of preliminary intervention materials (e.g., storyboards of a child in a
      family gathering involving food) in a focus group format. After that, up to 40 families of
      children with food allergies (ages 8-12) were recruited to participate in an "open trial".
      Families were asked to use the software for two weeks and provide feedback on the software.
      Up to 100 families of children with food allergies (ages 8-12) were then recruited to
      participate in a Randomized Clinical Trial (RCT) to assess the efficacy of the F3A-App vs.
      Standard Care (brief office visit and educational handouts). Families in the clinical trial
      were asked to use the software for two weeks and complete a standard care allergy office
      visit. This design enabled the investigators to evaluate combined effects of Standard Care
      and the F3A-App through typical treatment channels (e.g., is the greatest efficacy found
      after a physician refers family to use the App after an office visit?). Gains in families'
      knowledge and confidence in food allergy management were evaluated, and interviews with
      families were conducted to gain further input regarding the software's credibility,
      usability, and acceptability.

      This entry describes only the RCT portion of this Phase II STTR project.
    

Detailed description: 
      The central goal of this project was to develop an interactive, game-based application (App)
      for school-aged children (aged 8-12) with food allergies (FA) that would increase knowledge,
      improve behavioral skills for disease management, and ultimately reduce risk of negative
      outcomes. An effective FA intervention for children should target content areas of food
      avoidance and reaction management, and across these areas facilitate knowledge acquisition,
      develop behavioral skills, and provide practice using these skills in social contexts. The
      "Friends, Family, and Food App (F3A-App)", consists of four related parts: (a) an
      interactive, game-based application that is the core of the program, (b) the experiential
      scenarios in interactive environments (e.g., school cafeteria vignette) that target knowledge
      and behavioral skills practice in social contexts, (c) two engaging multi-level games to
      build skills in food avoidance (Label Learning: Like it or Lose it!) and symptom assessment
      (Reaction Action!), and (d) a multi-tiered reward system that uses token economy-based
      reinforcement to enhance motivation and engagement (SeaLife Spectacular). From a user
      perspective, the interactive, game-based application provides opportunities to practice
      behavioral skills (e.g. negotiating pressures to accept trigger foods, requesting assistance
      from adults, responding to teasing/bullying) in role-play situations with immediate feedback
      and reinforcement.

      In this Phase II project, the investigators proposed to produce a fully-developed version of
      the F3A-App, including added content and enhanced features, and evaluate the final product in
      a randomized clinical trial.

      The specific aims of Phase II were:

        1. To refine the F3A-App based on the user feedback and data collected in Phase I.

        2. To develop and field test additional content, including two additional interactive
           environments (family gathering, school pot-luck); and to increase gaming complexity
           (i.e., more levels and options) in Label Learning: Like it or Lose it! and Reaction
           Action! A small open trial was conducted, in which 40 children with FA, ages 8-12, used
           selected segments containing the newly developed content. Children used the application
           for 2 weeks on their home computer or tablet. Feedback about device preference and usage
           was used to determine the focus of the Evaluation Stage (Aim 3).

        3. To assess the efficacy of the F3A-App vs. Standard Care (brief office visit and
           educational handouts) in a randomized clinical trial with 100 children with FA, ages
           8-12. The investigators expected the F3A-App would improve children's FA knowledge and
           self-efficacy to manage FA (primary outcomes) and would increase parent-child
           communication regarding FA management relative to Standard Care (secondary outcome). The
           study's crossover design also made it possible to evaluate combined effects of Standard
           Care and the F3A-App through typical treatment channels (e.g., is the greatest efficacy
           found after a physician refers family to use the App after an office visit?) This Phase
           II STTR targeted pediatric FA, a critical public health problem of increasing
           prevalence. The approach was innovative by incorporating an emphasis on behavioral
           skills practice using a platform that is engaging, interactive, affordable, and has high
           potential for broad dissemination. The researchers envision that the F3A-App will
           ultimately serve as a template for interactive, game-based applications for children
           with other chronic conditions requiring self-management, such as asthma, diabetes, and
           celiac disease.

      This entry describes only the RCT portion of this Phase II STTR project.
    

Intervention name(s): Friends, Family, and Food App (F3A-App)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: AB/BA crossover: participants were randomized to Arm A (Standard Care (SC) then F3A-App), or Arm B (F3A-App then SC)
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: food allergy; intervention; virtual; pediatric