Trial Outcomes & Findings for The Food Allergy Superheroes Training (FAST) Program (NCT NCT04400214)

Twenty two participants were consented for the randomized trial. Eighteen participants withdrew due to a loss in funding (prior to completing the pre-intervention, primary outcome assessment). One family withdrew after completing the primary outcome assessment but before randomization to an intervention condition. This rate of attrition and randomization resulted in 3 remaining participants. All of these participants had been assigned to the FAK intervention.

Due to an error in data collection, data from one participant was missing.

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.

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.

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.

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.

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.

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.

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.

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.