The Food Allergy Superheroes Training (FAST) Program (FAST Program)

Kent State University

Status: Completed

Conditions: Allergy;Food; Child, Only; Adherence, Treatment

Treatments: Behavioral: Food Allergy Superheroes Training (FAST) Program; Other: Food Allergy Knowledge Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04400214

19-121

19-118 (Other Identifier)

Details and patient eligibility

About

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.

Full description

The primary aim of this R21 proposal is to test the efficacy of a 5-session intervention designed to increase adherence to FA safety guidelines among low-income, young children (6-8 years of age) with FAs. This intervention, the Food Allergy Superheroes Training (FAST) Program, will be developed and refined across Phases 1a and 1b to target skills beneficial to promote adherence to FA guidelines (i.e., food avoidance). During Phase 1a, we will recruit a parent-child advisory board to aide in integrating principles of behavioral skills training within the FAST Program manual. We will then examine the initial acceptability and feasibility of the FAST Program in an open trial with 10 low-income, young children with FAs to further refine the intervention's content. During Phase 1b, we will randomize 50 young children with a FA who are from a low-income background to receive either the FAST Program or FA knowledge. We will employ developmentally relevant FA assessments (i.e., child-report, role-play, in situ) before, after, and one-month post-intervention as our primary outcomes. Aim 1: Determine feasibility and acceptability of the FAST intervention. We will evaluate the feasibility and acceptability of this intervention with 60 participants (n=10 in pilot trial [Phase 1a] and n=50 in a preliminary randomized trial [Phase 1b]). Aim 2: Estimate the effect size of the FAST intervention relative to FA knowledge alone. Adherence will be measured via a multi-modal, FA assessment including child-report, role-play, and in situ assessment. This form of naturalistic, FA assessment will be designed to measure the child's behavior (i.e., ingest food, touch or play with food, etc.) in a safe yet realistic manner. This study will contribute to the field's knowledge of efficacious interventions for promoting adherence among young children with FAs.

Enrollment: 37 patients

Sex: All

Ages: 6 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 6-8 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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 2 patient groups

Food Allergy Superheroes Training (FAST) Program

Experimental group

Description:

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.

Treatment:

Behavioral: Food Allergy Superheroes Training (FAST) Program

Food Allergy Knowledge (FAK) Intervention

Active Comparator group

Description:

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.

Treatment:

Other: Food Allergy Knowledge Intervention