Clinical trial NCT04400214: The Food Allergy Superheroes Training (FAST) Program
Official title: The Food Allergy Superheroes Training (FAST) Program: Increasing Adherence to Food Allergy Safety Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy;Food
Adherence, Treatment
Child, Only
Keywords: Food Allergy
Adherence
Skills training
Child
Lead sponsor: Kent State University
Sponsor class: OTHER
Collaborators: name: Rhode Island Hospital
name: University of Memphis
First posted: 2020-05-22
Enrollment: 37
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in in situ food assessment score
timeFrame: 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)
measure: Change in role-play food assessment
timeFrame: 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)
measure: Change in child-report food assessment
timeFrame: 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:
measure: Food Allergy Knowledge Test (FAKT)
timeFrame: 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)
measure: Food Allergy Quality of Life - Parent Burden (FAQL-PB)
timeFrame: 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)
measure: Food Allergy Management and Adaptation Scale (FAMAS)
timeFrame: 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)
measure: Food Allergy Impact Scale (FAIS)
timeFrame: 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:
measure: Child Behavior Checklist (CBCL)
timeFrame: 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)
Locations:
city: Kent
country: United States
facility: Kent State University
state: Ohio
Study officials:
References: