Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05093114 |
Other study ID # |
R42 HD075524 (Open Trial) |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 18, 2015 |
Est. completion date |
February 2, 2016 |
Study information
Verified date |
May 2021 |
Source |
Rhode Island Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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!".
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. Our
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, we 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! We conducted a small open trial 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 our focus in 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. We 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). Our crossover design also
enabled us 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. Our 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. We
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 record describes only the Open Trial portion of this Phase II STTR project.