- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04400214
The Food Allergy Superheroes Training (FAST) Program (FAST Program)
October 27, 2023 updated by: Christopher Flessner, Kent State University
The Food Allergy Superheroes Training (FAST) Program: Increasing Adherence to Food Allergy Safety Guidelines
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christopher A Flessner, Ph.D.
- Phone Number: 330-672-2236
- Email: cflessne@kent.edu
Study Contact Backup
- Name: Ashley Lahoud, B.A.
- Phone Number: 330-672-4888
- Email: alahoud1@kent.edu
Study Locations
-
-
Ohio
-
Kent, Ohio, United States, 44242
- Kent State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 8 years (Child)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Food Allergy Superheroes Training (FAST) Program
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.
|
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.
Other Names:
|
Active Comparator: Food Allergy Knowledge (FAK) Intervention
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in in situ food assessment score
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)
|
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.
Study Independent Evaluation (IE) will introduce themselves as a visitor seeking to learn more about working with kids.
IE will ask the parent for an empty room to setup their materials.
After setup, the child will be asked to complete a simple task (e.g., choose a game or toy to play) whereby the child will come into contact with an unknown food-item (e.g., cookie laying on top of a coloring book).
IE will provide minimal response to the child's behavior (e.g., eating food).
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 in situ 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)
|
Change in role-play food assessment
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)
|
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 IE 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.
|
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
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)
|
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 IE 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food Allergy Knowledge Test (FAKT)
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)
|
The FAKT is a 39 question, parent-report measure designed to assess knowledge about food allergies across five domains: General clinical food allergy knowledge, avoiding exposure, epinephrine auto-injector, anaphylaxis, and symptoms.
Questions are multiple choice, true/false, or multiple-item (i.e., indicate whether each item is a symptom of a food allergy) formats.
The scale yields a total of 59 items that can be scored.
Higher scores indicate a great degree of food allergy knowledge.
The scale demonstrates strong internal consistency and construct validity with criterion measures of parent educational status, access to food allergy information, insurance status, and epinephrine use.
For purposes of the present study, the FAKT will be used as a process measure designed to ensure that basic educational material is received.
Higher scores indicate greater overall food allergy knowledge.
|
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)
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)
|
The FAQL-PB is designed to assess the health-related quality of life among parents of children, 0-12 years of age, with a food allergy.
Higher scores indicate greater perceived burden.
The scale has demonstrated excellent internal consistency and temporal stability and good construct validity.
|
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)
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)
|
The FAMAS is a semi-structured interviewed designed to assess variety of domains related to a family's psychosocial adjustment to a child's food allergy.
The interview includes a myriad of subscales related to this broader construct including food allergy knowledge, medication availability, symptoms of food allergy, child and family food avoidance, family and child response readiness, and parent and child anxiety among other domains.
Evidence suggests that the FAMAS demonstrates excellent inter-rater reliability and strong construct validity.
Higher scores indicate greater overall (better) food allergy management.
|
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)
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)
|
The FAIS is a 32-item scale designed to measure the impact of a child's food allergies on day-to-day activities within the home including meal preparation, social activities, etc. Higher scores indicate increasing level of impact on family functioning.
Prior research suggests that the FAIS demonstrates adequate internal consistency.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child Behavior Checklist (CBCL)
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)
|
The CBCL is a 112-item parent-report scale assessing child symptoms across several domains including social skills, school functioning, and emotional and behavioral problems.
Prior research utilizing the CBCL demonstrates strong reliability and validity amongst youth populations.
Although multiple versions of the CBCL exist, we will employ the parent-report (6-18 year old) version.
For the purposes of the proposed study, we will employ the CBCL as a post hoc measure to assess potential predictors of intervention response.
Higher scores on CBCL subscales indicate a greater presence of corresponding behavioral symptoms.
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
May 14, 2020
First Submitted That Met QC Criteria
May 19, 2020
First Posted (Actual)
May 22, 2020
Study Record Updates
Last Update Posted (Actual)
October 30, 2023
Last Update Submitted That Met QC Criteria
October 27, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-121
- 19-118 (Other Identifier: Kent State University)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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