Friends, Family & Food: Food Allergy App for Youth - II

NCT ID: NCT05111938

Last Updated: 2021-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-10
• Study Completion Date: 2017-05-19

Brief 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.

Conditions

Food Allergy in Children

Keywords

food allergy; intervention; virtual; pediatric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Arm A: Standard Care followed by F3A-App

The first portion of Arm A is a Standard Care (SC) office visit. Changes over time in Arm A represent a typical delivery channel in which a physician provides brief education and then encourages use of the F3A-App program. The SC intervention included a brief, structured office visit designed to replicate what would typically occur in a follow-up visit in an allergy clinic, and include provision standardized educational handouts available from the Food Allergy Research \& Education (FARE) website. The second phase of Arm A is use of the F3A-App.

Group Type: ACTIVE_COMPARATOR

Friends, Family, and Food App (F3A-App)

Intervention Type: BEHAVIORAL

Arm B: F3A-App followed by Standard Care

The first portion of Arm B is the use of the F3A-App for 2 weeks. Changes over time in Arm B represent an alternative delivery channel in which families use the F3A-App on their own and then have a follow-up office visit after using the self-guided program. The second phase of Arm B is the standard care office visit.

F3A-App efficacy vs. SC is evaluated after the first intervention period on primary outcomes.

Group Type: ACTIVE_COMPARATOR

Friends, Family, and Food App (F3A-App)

Intervention Type: BEHAVIORAL

Interventions

Friends, Family, and Food App (F3A-App)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. child must be 8-12

2. child must have an active diagnosis of FA, confirmed by a physician

3. child and parent must speak and read English

4. child must have access to a computer with internet access

5. child must have access to a smartphone or table

Exclusion Criteria

any chronic health condition requiring substantial dietary self-management (e.g., diabetes)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virtually Better, Inc.

INDUSTRY

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathy Mann-Koepke, PhD

Role: STUDY_CHAIR

Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)

References

Jandasek BN, Kopel SJ, Esteban CA, Rudders SA, Spitalnick JS, Larsen MA, Cushman GK, McQuaid EL. Friends, Family, and Food: Development of a Food Allergy Intervention, F3-App, for Children. Clin Pract Pediatr Psychol. 2024 Jun;12(2):143-156. doi: 10.1037/cpp0000513. Epub 2024 Jan 8.

Reference Type: DERIVED

PMID: 39045229 (View on PubMed)

Other Identifiers

R42HD075524

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R42 HD075524 (RCT)

Identifier Type: -

Identifier Source: org_study_id