- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05093114
Friends, Family & Food: Food Allergy App for Youth ( F3A-App ) (F3A-App)
Friends, Family and Food: Interactive Virtual Environments for Children With Food Allergies
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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:
- 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! 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).
- 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.
Tipo di studio
Iscrizione (Effettivo)
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Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- child must be 8 -12 years of age
- child must have an active diagnosis of food allergy (FA), specifically one or more of the four most common FAs that may cause anaphylaxis (peanut, tree nut, milk, and egg), confirmed by a physician within the past two years
- 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 tablet
Exclusion Criteria:
- Any chronic health condition requiring substantial dietary self-management (e.g., diabetes).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Feedback interviews
Lasso di tempo: Session 2, about 5 weeks after Session 1 and post-intervention
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A semi-structured interview assessing child participants' opinions and feedback regarding game segments.
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Session 2, about 5 weeks after Session 1 and post-intervention
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Food Allergy Knowledge Questionnaire
Lasso di tempo: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
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Child report
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Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
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Food Allergy Management Efficacy
Lasso di tempo: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
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Child report
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Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
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Food Allergy Independent Measure
Lasso di tempo: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
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Parent/Caregiver report
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Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
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Food Allergy Caregiver-Child Communication
Lasso di tempo: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
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Parent/Caregiver report
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Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
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Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Kathy Mann-Koepke, PhD, Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Studiare le date dei record
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R42 HD075524 (Open Trial)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Allergia alimentare nei bambini
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Ebbing LautenbachUniversity of UtahReclutamentoNeoplasie ematologiche | Beta Lactam AllergyStati Uniti