Friends, Family and Food: Interactive Virtual Environments for Children With Food Allergies - II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Change in Food Allergy Management Assessment Scale (FAMAS) scores
研究概览
简要总结
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.
详细描述
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:
- To refine the F3A-App based on the user feedback and data collected in Phase I.
- 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).
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research assistants were masked to treatment condition
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child must be 8-12
- •child must have an active diagnosis of FA, confirmed by a physician
- •child and parent must speak and read English
- •child must have access to a computer with internet access
- •child must have access to a smartphone or table
排除标准
- •any chronic health condition requiring substantial dietary self-management (e.g., diabetes)
结局指标
主要结局
Change in Food Allergy Management Assessment Scale (FAMAS) scores
时间窗: Change in various elements of FA management (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)
Semi-structured interview assessing various elements of food allergy (FA) management (caregiver and youth report). Domains of the scale are: FA knowledge, symptom assessment, family/child response to allergic reactions, family/child food avoidance, medication availability, alternate caregivers, parent/child anxiety related to FA, balanced integration of FA and family life. Higher scores on all scales indicate more optimal FA management. Klinnert, M.D., et al., Children's food allergies (FA): Development of the Food Allergy Management and Adaptation Scale (FAMAS). Journal of Allergy and Clinical Immunology, 2012. 129(AB299).
Change in Parent-Child Communication related to Food Allergy
时间窗: Change in amount of parent-child discussion related to FA (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)
This measure was adapted from a parent-child communication assessment used to evaluate communication about sexual health. The Food Allergy adaptation evaluates the number of times parent and child discussed each of 6 FA management topics in prior week (e.g., using epinephrine) (caregiver and youth report). Huston, R.L. and L.J. Martin, Effect of a program to facilitate parent-chld communication about sex. Clinical Pediatrics, 1990. 29(11): p. 626-633. 45. Schuster, M.A., et al., Evaluation of talking parents, healthy teens, a new worksite based parenting programme to promote parent-adolescent communication about sexual health: randomised controlled data. BMJ, 2008. 337(a308).
Change in scores on the Food Allergy Independent Measure (FAIM)
时间窗: Change in FA-related anxiety (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)
The FAIM is a 4-item measure of anxiety related to the child's food allergy. Higher scores indicate a higher degree of anxiety. van der Velde J. L., Flokstra-de Blok B. M. J., Vlieg-Boerstra B. J., Oude Elberink G., DunnGalvin A., Hourihane J. B., Dubois A. E. J. (2010). Development validity and reliability of food allergy independent measure (FAIM). Allergy, 65, 630-635. doi: 10.1111/j.1398-9995.2009.02216.x
Change in Food Allergy Knowledge scores
时间窗: Change in FA-related knowledge (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)
An assessment of the level of food allergy-related knowledge (youth report). Higher scores indicate better knowledge of FA. Sicherer, S.H., et al., Development and validation of educational materials for food allergy. Journal of Pediatrics, 2012. 160(4): p. 651-656.
Change in scores on the Food Allergy Self-Efficacy
时间窗: Change in self-efficacy related to self-tx of FA (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)
Self-efficacy related to self-treatment of Food Allergy (youth report). Higher scores indicate a higher level of self-efficacy. Bursch, B., et al., Construction and validation of four childhood asthma self-management scales: parent barriers, child and parent self-efficacy, and parent belief in treatment efficacy. J Asthma, 1999. 36(1): p. 115-28.
次要结局
未报告次要终点