An interventional study of Food Allergy Superheroes Training (FAST) Program and Food Allergy Knowledge Intervention in Allergy;Food, Adherence, Treatment and Child, Only, sponsored by Kent State University. Terminated at 1 site in United States. Open to participants aged 6 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Kent State University · Not applicable, Interventional, and Prevention
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.
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.
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's enrollment of 22 is below the median of 60 across 246 interventional studies indexed under Food Hypersensitivity.
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Exclusion Criteria:
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
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
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
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
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.
Time frame: 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.
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 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.
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)
Food Allergy Knowledge Test (FAKT)
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. The FAKT will be used as a process measure designed to ensure that basic educational material is received. This outcome measure is a change score (end of treatment minus baseline) with higher scores representing greater improvement in food allergy knowledge.
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)
Food Allergy Quality of Life - Parent Burden (FAQL-PB)
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. This outcome measure is a change score (end of treatment minus baseline) with higher scores representing greater improvement in quality of life.
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)
Food Allergy Management and Adaptation Scale (FAMAS)
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. The outcome measure is a change score with higher scores representing greater change in a family's food allergy management.
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)
Food Allergy Impact Scale (FAIS)
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. Outcome measures represents a change score (i.e., final assessment - initial assessment) with smaller (negative) scores indicating a reduction in the impact of food allergy on the family.
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)
Child Behavior Checklist (CBCL)
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.
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)
| Milestone | Food Allergy Superheroes Training (FAST) Program | Food Allergy Knowledge (FAK) Intervention |
|---|---|---|
| Started | 0 | 3 |
| Completed | 0 | 3 |
| Not completed | 0 | 0 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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. The FAKT will be used as a process measure designed to ensure that basic educational material is received. This outcome measure is a change score (end of treatment minus baseline) with higher scores representing greater improvement in food allergy knowledge.
No measurements were reported for this outcome.
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. This outcome measure is a change score (end of treatment minus baseline) with higher scores representing greater improvement in quality of life.
No measurements were reported for this outcome.
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. The outcome measure is a change score with higher scores representing greater change in a family's food allergy management.
No measurements were reported for this outcome.
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. Outcome measures represents a change score (i.e., final assessment - initial assessment) with smaller (negative) scores indicating a reduction in the impact of food allergy on the family.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over Adverse event data were collected for participants from baseline to completion of the participant's role in this study (i.e., baseline to follow-up assessment). This time frame amounts to approximately 6 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Food Allergy Superheroes Training (FAST) Program | — | — | — |
| Food Allergy Knowledge (FAK) Intervention | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
As noted in previous sections, randomization occurred after completion of all pre-intervention assessments and prior to the child's first intervention session. Due to a loss in funding, multiple families withdrew from the study. The numbers reflected here are those families who remained part of the study, after loss of funding, and were randomized to an intervention condition.
| Age, Categorical(Participants) | Food Allergy Superheroes Training (FAST) Program | Food Allergy Knowledge (FAK) Intervention | Total |
|---|---|---|---|
| <=18 years | — | 3 | 3 |
| Between 18 and 65 years | — | 0 | 0 |
| >=65 years | — | 0 | 0 |
| Sex: Female, Male(Participants) | Food Allergy Superheroes Training (FAST) Program | Food Allergy Knowledge (FAK) Intervention | Total |
|---|---|---|---|
| Female | — | 0 | 0 |
| Male | — | 3 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Food Allergy Superheroes Training (FAST) Program | Food Allergy Knowledge (FAK) Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | — | 0 | 0 |
| Not Hispanic or Latino | — | 3 | 3 |
| Unknown or Not Reported | — | 0 | 0 |
| Race (NIH/OMB)(Participants) | Food Allergy Superheroes Training (FAST) Program | Food Allergy Knowledge (FAK) Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | — | 0 | 0 |
| Asian | — | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | — | 0 | 0 |
| Black or African American | — | 0 | 0 |
| White | — | 3 | 3 |
| More than one race | — | 0 | 0 |
| Unknown or Not Reported | — | 0 | 0 |
| Food Allergy Knowledge Test (FAKT)(Units on a scale) | Food Allergy Superheroes Training (FAST) Program | Food Allergy Knowledge (FAK) Intervention | Total |
|---|---|---|---|
| Mean | — | 48.7 ± 2.5 | 48.7 ± 2.5 |
| Change in In Situ Food Assessment Score(units on a scale) | Food Allergy Superheroes Training (FAST) Program | Food Allergy Knowledge (FAK) Intervention | Total |
|---|---|---|---|
| Mean | — | 2 (1 to 3) | 2 (1 to 3) |
| Change in Role-Play Assessment Score(units on a scale) | Food Allergy Superheroes Training (FAST) Program | Food Allergy Knowledge (FAK) Intervention | Total |
|---|---|---|---|
| Mean | — | 3.5 (3 to 4) | 3.5 (3 to 4) |
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