The Food Allergy Superheroes Training (FAST) Program

NCT04400214 | Terminated Results DMC

• 2 other identifiers: 19-12119-118
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Among children with a food allergy, strict avoidance (e.g., elimination of allergenic foods from one's diet) is the only intervention capable of preventing potentially devastating health-related sequelae including anaphylaxis and death. Youths from low-income backgrounds are particularly impacted by food allergies and may be the population most apt to benefit from a brief, portable, and engaging skills-based intervention designed to teach young children the skills needed to remain adherent to food allergy safety guidelines. Data collected as part of the proposed project will lay the groundwork for a line of federally-funded intervention research broadly examining how to promote adherence to food allergy safety guidelines among young children from low-income backgrounds through implementation of a robust, efficient, and portable intervention.

Conditions

Allergy;Food; Adherence, Treatment; Child, Only

Keywords

Food Allergy; Adherence; Skills training; Child

Outcome Measures

Primary Outcomes (3)

• Change in in Situ Food Assessment Score

  Designed to provide an objective measure of a child's behavior to an unknown food-item in the real world. Modeled after similar methodology employed in prior skills training research. Child's response coded (see Research Strategy), based upon video assessment. Higher scores (ranging from 0 to 4) indicate greater adherence. Scores represent change from pre-intervention to one-month follow-up assessment.

  Planned time frame: pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks).

• Change in Role-play Food Assessment

  The role-play assessment will occur immediately following the in situ assessment and is modeled upon similar methodology employed in prior skills training research. The study independent evaluator verbally presents the young child with a hypothetical scenario. For example, "Let's pretend that you are in your living room and your mom asks you to pick up your toys. While you are picking up your toys, you find candy. What would you do?" The IE will design each scenario so that the physical layout of the room permits the child to exhibit behavior congruent with the described situation. The child?s response will be coded (see Research Strategy), based upon videotaped assessment made possible via a camera placed in the room. Higher scores (ranging from 0 to 3) indicate greater adherence. Inter-rater reliability will be obtained on 30% of role-play food assessments.Scores represent change from pre-intervention to one-month follow-up assessment.

  pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks)

• Change in Child-report Food Assessment

  The child-report food assessment will occur immediately following the role-play assessment. The study IE presents a scenario in which a child finds a food-item (e.g., playing at a friend's home). The independent evaluator will ask the child to state what he/she would do, if that situation happened to them. The child's response will be coded (see Research Strategy), based upon videotaped assessment made possible via a camera placed in the room. Higher scores (ranging from 0 to 3) indicate greater adherence. Inter-rater reliability will be obtained on 30% of child-report food assessments.

  pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks)

Secondary Outcomes (4)

• Food Allergy Knowledge Test (FAKT)

  pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks)

• Food Allergy Quality of Life - Parent Burden (FAQL-PB)

  pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks)

• Food Allergy Management and Adaptation Scale (FAMAS)

  pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks)

• Food Allergy Impact Scale (FAIS)

  pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks)

Other Outcomes (1)

• Child Behavior Checklist (CBCL)

  pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks)

Study Arms (2)

Food Allergy Superheroes Training (FAST) Program

EXPERIMENTAL

Participants enrolled in this arm of the study will receive 5, 20 minutes skills training sessions designed to promote adherence to food allergy safety guidelines. These sessions will occur over the period of \<2 weeks. All sessions will occur at the PIs laboratory or within the participant's home.

Behavioral: Food Allergy Superheroes Training (FAST) Program

Food Allergy Knowledge (FAK) Intervention

ACTIVE COMPARATOR

Participants enrolled in this arm of the study will receive 5, 20 minutes educational training sessions designed to increase knowledge pertaining to food allergies. These sessions will occur over the period of \<2 weeks. All sessions will occur at the PIs laboratory or within the participant's home.

Other: Food Allergy Knowledge Intervention

Interventions

Food Allergy Knowledge Intervention OTHER

The primary aim of the FAK intervention is to increase the young child's understanding of FAs including prevalence, symptoms, and management strategies among other topics. We will achieve this aim through the use of educational materials targeting knowledge acquisition through a variety of didactic materials made freely available through the Food Allergy Research Education (FARE) website (www.foodallergy.org). More specifically, we will employ information embedded within the "Food Allergy 101" segment of the FARE website. The young child and their parent/caregiver will be present for the entirety of all sessions; however, all intervention materials are designed with the young child as the primary focal point of interest. All children will be rewarded with a small toy (\<$5 value) at the end of each successfully completed session. All FAK sessions will occur within the child's home and will include informational handouts relevant to the day's session.

Also known as: FAK intervention

Food Allergy Knowledge (FAK) Intervention

Food Allergy Superheroes Training (FAST) Program BEHAVIORAL

The primary aim of the FAST intervention is to 1) increase the young child's understanding of food allergies (FA) and 2) promote-adherence to FA safety guidelines through active skills training. We will achieve this aim through the use of educational materials (session 1) and a developmentally-tailored skills training intervention (session 2-5). Core components embedded within each skill straining session include instructions, modeling, rehearsal, and reinforcement/corrective feedback. The young child and their parent/caregiver will be present for the entirety of all sessions; however, all intervention materials (i.e., educational content, skills training components) are designed with the young child as the primary focal point of interest. All children will be rewarded with a small toy (\<$5 value) at the end of each successfully completed session.

Also known as: FAST Program

Food Allergy Superheroes Training (FAST) Program

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years of age.
• Demonstrates a food allergy, based upon parent-report and confirmed diagnosis.
• Family considered low-income (income-to-needs ratio \<200% of Department of Health and Human Services Federal Poverty Threshold)
• English as child's primary language
• One English-speaking parent/guardian

You may not qualify if:

• Neurodevelopmental disorder (i.e., autism spectrum disorder), cognitive delays, or psychiatric disorder, based upon parent-report.

Sponsors & Collaborators

• Kent State University: lead
• Rhode Island Hospital: collaborator
• University of Memphis: collaborator

Study Sites (1)

Kent State University

Kent, Ohio, 44242, United States

Location

Related Links

• PI's laboratory webpage with greater detail about the study and related projects

MeSH Terms

Conditions

Food Hypersensitivity; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Health Behavior; Behavior

Limitations and Caveats

The goal of this study was to develop and refine a tailored skills training intervention to promote adherence to food allergy (FA) safety guidelines. Recruitment prior to onset of the pandemic was ahead of schedule (i.e., advisory board phase). Recruitment was hindered thereafter. Modifications to inclusion criteria reinvigorated recruitment but was too late. We hope future researchers will learn from this and develop innovative strategies for increasing adherence to FA safety guidelines.

Results Point of Contact

• Title: Christopher A. Flessner, Ph.D., Professor of Psychological Sciences
• Organization: Kent State University

cflessne@kent.edu

330-672-2236

Study Officials

• Christopher A Flessner

  Kent State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators will assess pre-, post-, and follow-up naturalistic, food allergy assessment outcomes. These evaluators will have no knowledge as to the intervention participants received via their participation in this study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychological Sciences

Model Details: Participants enrolled via the open-trial portion of this study will all receive a 5-session skills training intervention (n = 5 participants). All participants enrolled in the randomized trial portion of this study (n = 50 participants) will be randomly assigned to either a 5-session skills training or 5-session food allergy education intervention

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 22, 2020
• Study Start: July 1, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 23, 2026
• Results First Posted: April 23, 2026

Record last verified: 2026-04

Locations

US (1)