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

NCT05111938 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-11-08

No results posted yet for this study

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.

Conditions

  • Food Allergy in Children

Interventions

BEHAVIORAL

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

Sponsors & Collaborators

  • Virtually Better, Inc.

    collaborator INDUSTRY

  • Rhode Island Hospital

    lead OTHER

Principal Investigators

  • Kathy Mann-Koepke, PhD · Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-10
Primary Completion
2017-05-15
Completion
2017-05-19

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05111938 on ClinicalTrials.gov