Food Allergy in ChildrenF3A-AppNCT05093114
Friends, Family & Food: Food Allergy App for Youth ( F3A-App )
An observational study of Food Allergy in Children, run by Rhode Island Hospital.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Food Allergy in Children
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 18 May 2015to 2 Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Child
Study population: Children with food allergy to one of the four most common FAs that may cause anaphylaxis (peanut, tree nut, milk, and egg)
Who may be able to join
- 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
Who cannot join
- Any chronic health condition requiring substantial dietary self-management (e.g., diabetes).
About this study
Official title: Friends, Family and Food: Interactive Virtual Environments for Children With Food Allergies
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!".
Read the 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. 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.
- Conditions
- Food Allergy in Children
- Keywords
- Food Allergy, Intervention, Virtual, Pediatric
- Medical subject headings
- Food Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Feedback interviews
A semi-structured interview assessing child participants' opinions and feedback regarding game segments.
Measured: Session 2, about 5 weeks after Session 1 and post-intervention
Secondary outcomes (4)
Food Allergy Knowledge Questionnaire
Child report
Measured: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
Food Allergy Management Efficacy
Child report
Measured: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
Food Allergy Independent Measure
Parent/Caregiver report
Measured: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
Food Allergy Caregiver-Child Communication
Parent/Caregiver report
Measured: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start18 May 2015
- Primary completion2 Feb 2016
- Study completion2 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathy Mann-Koepke, PhD, Study chair, Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093114
- Sponsor's protocol ID
- R42 HD075524 (Open Trial)
- Other IDs
- R42HD075524
- Acronym
- F3A-App
- Status last verified
- May 2021
- First submitted
- 7 Oct 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Friends, Family and Food: Interactive Virtual Environments for Children With Food Allergies
- ClinicalTrials.gov ID
- NCT05093114
- Acronym / sponsor ID
- F3A-App / R42 HD075524 (Open Trial)
- Conditions
- Food Allergy in Children
- Keywords
- Food Allergy, Intervention, Virtual, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 18 May 2015 (actual)
- Primary completion
- 2 Feb 2016 (actual)
- Study completion
- 2 Feb 2016 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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!".
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. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Children with food allergy to one of the four most common FAs that may cause anaphylaxis (peanut, tree nut, milk, and egg)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Any chronic health condition requiring substantial dietary self-management (e.g., diabetes).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feedback interviews
Time frame: Session 2, about 5 weeks after Session 1 and post-intervention
A semi-structured interview assessing child participants' opinions and feedback regarding game segments.
4 secondary outcomes
Food Allergy Knowledge Questionnaire
Time frame: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
Food Allergy Management Efficacy
Time frame: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
Food Allergy Independent Measure
Time frame: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
Food Allergy Caregiver-Child Communication
Time frame: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathy Mann-Koepke, PhD study chair
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy in Children, run by Rhode Island Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feedback interviews (time frame: Session 2, about 5 weeks after Session 1 and post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.