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

NCT05111938 | Completed DMC

• 2 other identifiers: R42 HD075524 (RCT)R42HD075524
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Food Allergy in Children

Keywords

food allergy; intervention; virtual; pediatric

Outcome Measures

Primary Outcomes (5)

• Change in Food Allergy Management Assessment Scale (FAMAS) scores

  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 various elements of FA management (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)

• Change in scores on the Food Allergy Independent Measure (FAIM)

  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 FA-related anxiety (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)

• Change in scores on the Food Allergy Self-Efficacy

  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.

  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)

• Change in Food Allergy Knowledge scores

  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 FA-related knowledge (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)

• Change in Parent-Child Communication related to Food Allergy

  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 amount of parent-child discussion related to FA (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)

Other Outcomes (4)

• Acceptability of the Friends, Family and Food App (F3-App): Technology Post-Trial Impressions Questionnaire

  Follow up (after use of the F3-App; approximately 8 week after baseline)

• Credibility of the F3-App: Technology Post-Trial Impressions Questionnaire

  Follow up (after use of the F3-App; approximately 8 week after baseline)

• Adherence to the use of the F3-App during study

  Follow up (after use of the F3-App; approximately 8 week after baseline)

Study Arms (2)

Arm A: Standard Care followed by F3A-App

ACTIVE COMPARATOR

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.

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

Arm B: F3A-App followed by Standard Care

ACTIVE COMPARATOR

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.

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

Interventions

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

Arm A: Standard Care followed by F3A-App; Arm B: F3A-App followed by Standard Care

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Virtually Better, Inc.: collaborator

Related Publications (1)

• 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.

  PMID: 39045229 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kathy Mann-Koepke, PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants were masked to treatment condition
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: AB/BA crossover: participants were randomized to Arm A (Standard Care (SC) then F3A-App), or Arm B (F3A-App then SC)

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 8, 2021
• Study Start: March 10, 2016
• Primary Completion: May 15, 2017
• Study Completion: May 19, 2017
• Last Updated: November 8, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share