Evaluation of The Food Allergy Mastery Program

NCT06034678 | Recruiting DMC

• 2 other identifiers: 30007544R01AI168090
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed research project will evaluate a novel behavioral intervention that promotes early adolescent food allergy self-management and adjustment through 1) food allergy education, 2) problem-solving, communication, assertiveness, and anxiety management skill building, and 3) peer support.

Conditions

Food Allergy in Children

Keywords

food allergy; knowledge; management; adolescents; caregivers; social support

Outcome Measures

Primary Outcomes (30)

• Food Allergy Knowledge

  Early adolescents and caregivers will complete the Food Allergy Knowledge Test (FAKT), a -item measure of food allergy knowledge, including general clinical food allergy knowledge, avoiding exposure (i.e., cross-contact, reading labels), epinephrine auto-injector use, and signs, symptoms, and treatment of anaphylaxis. Items are scored as correct/incorrect, and a sum score is generated. Higher scores indicate greater food allergy knowledge. The FAKT was found to be highly reliable with validity analyses revealing positive score correlations with parent age, education, insurance status, access to food allergy information, and epinephrine auto-injector use.

  Change in Food Allergy Knowledge from Baseline to 6 Month Follow Up

• Food Allergy Knowledge

  Early adolescents and caregivers will complete the Food Allergy Knowledge Test (FAKT), a -item measure of food allergy knowledge, including general clinical food allergy knowledge, avoiding exposure (i.e., cross-contact, reading labels), epinephrine auto-injector use, and signs, symptoms, and treatment of anaphylaxis. Items are scored as correct/incorrect, and a sum score is generated. Higher scores indicate greater food allergy knowledge. The FAKT was found to be highly reliable with validity analyses revealing positive score correlations with parent age, education, insurance status, access to food allergy information, and epinephrine auto-injector use.

  Change in Food Allergy Knowledge from Baseline to 12 Month Follow Up

• Food Allergy Knowledge

  Early adolescents and caregivers will complete the Food Allergy Knowledge Test (FAKT), a -item measure of food allergy knowledge, including general clinical food allergy knowledge, avoiding exposure (i.e., cross-contact, reading labels), epinephrine auto-injector use, and signs, symptoms, and treatment of anaphylaxis. Items are scored as correct/incorrect, and a sum score is generated. Higher scores indicate greater food allergy knowledge. The FAKT was found to be highly reliable with validity analyses revealing positive score correlations with parent age, education, insurance status, access to food allergy information, and epinephrine auto-injector use.

  Change in Food Allergy Knowledge from Baseline to 18 Month Follow Up

• Food Allergy Management Skills- Label Reading

  Early adolescents' and caregivers' food allergy management skills will be independently assessed via direct observation of their ability to correctly read food labels and use an epinephrine auto-injector trainer. Participants will be asked to review 5 food labels for safety for themselves/their child, of which 3 food labels will not be safe and 2 food labels will be safe. A percentage correct score based on the number of labels that they correctly identify as containing or not containing allergen(s) will be calculated.

  Change in Food Allergy Management Skills- Label Reading from Baseline to 6 Month Follow Up

• Food Allergy Management Skills- Label Reading

  Early adolescents' and caregivers' food allergy management skills will be independently assessed via direct observation of their ability to correctly read food labels and use an epinephrine auto-injector trainer. Participants will be asked to review 5 food labels for safety for themselves/their child, of which 3 food labels will not be safe and 2 food labels will be safe. A percentage correct score based on the number of labels that they correctly identify as containing or not containing allergen(s) will be calculated.

  Change in Food Allergy Management Skills- Label Reading from Baseline to 12 Month Follow Up

• Food Allergy Management Skills- Label Reading

  Early adolescents' and caregivers' food allergy management skills will be independently assessed via direct observation of their ability to correctly read food labels and use an epinephrine auto-injector trainer. Participants will be asked to review 5 food labels for safety for themselves/their child, of which 3 food labels will not be safe and 2 food labels will be safe. A percentage correct score based on the number of labels that they correctly identify as containing or not containing allergen(s) will be calculated.

  Change in Food Allergy Management Skills- Label Reading from Baseline to 18 Month Follow Up

• Food Allergy Management Skills- Epinephrine Auto-Injector Use

  Participants will be asked to demonstrate how to use the epinephrine auto-injector trainer for which they have a prescription (i.e., EpiPen, AuviQ, or generic). Participants will receive a point for each of the following: removing the cap, holding it correctly, positioning it correctly on the outer thigh, "injecting" it properly, and then holding it against the thigh for the appropriate amount of time. A percentage correct score will be calculated.

  Change in Food Allergy Management Skills- Epinephrine Auto-Injector Use from Baseline to 6 Month Follow Up

• Food Allergy Management Skills- Epinephrine Auto-Injector Use

  Participants will be asked to demonstrate how to use the epinephrine auto-injector trainer for which they have a prescription (i.e., EpiPen, AuviQ, or generic). Participants will receive a point for each of the following: removing the cap, holding it correctly, positioning it correctly on the outer thigh, "injecting" it properly, and then holding it against the thigh for the appropriate amount of time. A percentage correct score will be calculated.

  Change in Food Allergy Management Skills- Epinephrine Auto-Injector Use from Baseline to 12 Month Follow Up

• Food Allergy Management Skills- Epinephrine Auto-Injector Use

  Participants will be asked to demonstrate how to use the epinephrine auto-injector trainer for which they have a prescription (i.e., EpiPen, AuviQ, or generic). Participants will receive a point for each of the following: removing the cap, holding it correctly, positioning it correctly on the outer thigh, "injecting" it properly, and then holding it against the thigh for the appropriate amount of time. A percentage correct score will be calculated.

  Change in Food Allergy Management Skills- Epinephrine Auto-Injector Use from Baseline to 18 Month Follow Up

• Food Allergy Management Behaviors

  Early adolescents will complete the Food Allergy Management 24-Hour Recall (FAM-24), a 24-hour recall interview facilitated by a research team member that asks a series of questions about each food they ate during the previous day. Participants report on the time of the meal/snack, where they ate (e.g., school, home, a restaurant), whether an adult was present, whether epinephrine was available, and if so, where it was located (e.g., on person, in another room). They also report if they had an allergic reaction. For each individual food eaten during the meal/snack, participants report what the food was, whether they ate it before, whether it was verified as allergen-free, how it was verified (e.g., prepared at home, read the label, asked about ingredients), and who verified it (e.g., child, parent, teacher, another adult). Participants can endorse multiple methods of allergen-free verification and multiple people who completed the verification.

  Change in Food Allergy Management Behaviors from Baseline to 6 Month Follow Up

• Food Allergy Management Behaviors

  Early adolescents will complete the Food Allergy Management 24-Hour Recall (FAM-24), a 24-hour recall interview facilitated by a research team member that asks a series of questions about each food they ate during the previous day. Participants report on the time of the meal/snack, where they ate (e.g., school, home, a restaurant), whether an adult was present, whether epinephrine was available, and if so, where it was located (e.g., on person, in another room). They also report if they had an allergic reaction. For each individual food eaten during the meal/snack, participants report what the food was, whether they ate it before, whether it was verified as allergen-free, how it was verified (e.g., prepared at home, read the label, asked about ingredients), and who verified it (e.g., child, parent, teacher, another adult). Participants can endorse multiple methods of allergen-free verification and multiple people who completed the verification.

  Change in Food Allergy Management Behaviors from Baseline to 12 Month Follow Up

• Food Allergy Management Behaviors

  Early adolescents will complete the Food Allergy Management 24-Hour Recall (FAM-24), a 24-hour recall interview facilitated by a research team member that asks a series of questions about each food they ate during the previous day. Participants report on the time of the meal/snack, where they ate (e.g., school, home, a restaurant), whether an adult was present, whether epinephrine was available, and if so, where it was located (e.g., on person, in another room). They also report if they had an allergic reaction. For each individual food eaten during the meal/snack, participants report what the food was, whether they ate it before, whether it was verified as allergen-free, how it was verified (e.g., prepared at home, read the label, asked about ingredients), and who verified it (e.g., child, parent, teacher, another adult). Participants can endorse multiple methods of allergen-free verification and multiple people who completed the verification.

  Change in Food Allergy Management Behaviors from Baseline to 18 Month Follow Up

• Food Allergy Quality of Life- Child Self Report

  Early adolescents will complete the Food Allergy Quality of Life Questionnaire - Child Form (8-12 years) (FAQLQ-CF), a validated 10-item measure, or the Food Allergy Quality of Life Questionnaire - Teenager Form (13-17 years) (FAQLQ-TF), a validated 10-item measure. Participants only complete the questionnaire appropriate for their age. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.

  Change in Food Allergy Quality of Life- Child Self Report from Baseline to 6 Month Follow Up

• Food Allergy Quality of Life- Child Self-Report

  Early adolescents will complete the Food Allergy Quality of Life Questionnaire - Child Form (8-12 years) (FAQLQ-CF), a validated 10-item measure, or the Food Allergy Quality of Life Questionnaire - Teenager Form (13-17 years) (FAQLQ-TF), a validated 10-item measure. Participants only complete the questionnaire appropriate for their age. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.

  Change in Food Allergy Quality of Life- Child Self Report from Baseline to 12 Month Follow Up

• Food Allergy Quality of Life- Child Self-Report

  Early adolescents will complete the Food Allergy Quality of Life Questionnaire - Child Form (8-12 years) (FAQLQ-CF), a validated 10-item measure, or the Food Allergy Quality of Life Questionnaire - Teenager Form (13-17 years) (FAQLQ-TF), a validated 10-item measure. Participants only complete the questionnaire appropriate for their age. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.

  Change in Food Allergy Quality of Life- Child Self Report from Baseline to 18 Month Follow Up

• Food Allergy Quality of Life- Parent Proxy

  Caregivers will complete the Food Allergy Quality of Life Questionnaire - Parent Form (FAQLQ-PF), a validated 10-item measure of parents' perceptions of their child's quality of life. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.

  Change in Food Allergy Quality of Life- Parent Proxy from Baseline to 6 Month Follow Up

• Food Allergy Quality of Life- Parent Proxy

  Caregivers will complete the Food Allergy Quality of Life Questionnaire - Parent Form (FAQLQ-PF), a validated 10-item measure of parents' perceptions of their child's quality of life. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.

  Change in Food Allergy Quality of Life- Parent Proxy from Baseline to 12 Month Follow Up

• Food Allergy Quality of Life- Parent Proxy

  Caregivers will complete the Food Allergy Quality of Life Questionnaire - Parent Form (FAQLQ-PF), a validated 10-item measure of parents' perceptions of their child's quality of life. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.

  Change in Food Allergy Quality of Life- Parent Proxy from Baseline to 18 Month Follow Up

• Food Allergy Impact

  Children will complete the Food Allergy Independent Measure (FAIM), a 6-item measure of children's perceptions of risk of allergen exposure, chance of a severe reaction, chance of dying, and ability to engage in proper treatment, which generates a total score. Scores can range from 0-6; higher scores indicate more impact of food allergy on daily life.

  Change in Food Allergy Impact from Baseline to 6 Month Follow Up

• Food Allergy Impact

  Children will complete the Food Allergy Independent Measure (FAIM), a 6-item measure of children's perceptions of risk of allergen exposure, chance of a severe reaction, chance of dying, and ability to engage in proper treatment, which generates a total score. Scores can range from 0-6; higher scores indicate more impact of food allergy on daily life.

  Change in Food Allergy Impact from Baseline to 12 Month Follow Up

• Food Allergy Impact

  Children will complete the Food Allergy Independent Measure (FAIM), a 6-item measure of children's perceptions of risk of allergen exposure, chance of a severe reaction, chance of dying, and ability to engage in proper treatment, which generates a total score. Scores can range from 0-6; higher scores indicate more impact of food allergy on daily life.

  Change in Food Allergy Impact from Baseline to 18 Month Follow Up

• Frequency of Treatment for Allergic Reactions

  Participants will report on the frequency of treatment for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.

  Change in Frequency of Treatment for Allergic Reactions from Baseline to 6 Month Follow Up

• Frequency of Treatment for Allergic Reactions

  Participants will report on the frequency of treatment for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.

  Change in Frequency of Treatment for Allergic Reactions from Baseline to 12 Month Follow Up

• Frequency of Treatment for Allergic Reactions

  Participants will report on the frequency of treatment for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.

  Change in Frequency of Treatment for Allergic Reactions from Baseline to 18 Month Follow Up

• Frequency of Allergy Appointments

  Participants will report on the frequency of allergy appointments in the past 6 months. This information will also be assessed by study staff via clinic chart review.

  Change in Frequency of Allergy Appointments from Baseline to 6 Month Follow Up

• Frequency of Allergy Appointments

  Participants will report on the frequency of allergy appointments in the past 6 months. This information will also be assessed by study staff via clinic chart review.

  Change in Frequency of Allergy Appointments from Baseline to 12 Month Follow Up

• Frequency of Emergency Room/Urgent Care Visits for Allergic Reactions

  Participants will report on the frequency of emergency room/urgent care visits for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.

  Change in Frequency of Emergency Room/Urgent Care Visits for Allergy Reactions from Baseline to 6 Month Follow Up

• Frequency of Allergy Appointments

  Participants will report on the frequency of allergy appointments in the past 6 months. This information will also be assessed by study staff via clinic chart review.

  Change in Frequency of Allergy Appointments from Baseline to 18 Month Follow Up

• Frequency of Emergency Room/Urgent Care Visits for Allergic Reactions

  Participants will report on the frequency of emergency room/urgent care visits for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.

  Change in Frequency of Emergency Room/Urgent Care Visits for Allergy Reactions from Baseline to 12 Month Follow Up

• Frequency of Emergency Room/Urgent Care Visits for Allergic Reactions

  Participants will report on the frequency of emergency room/urgent care visits for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.

  Change in Frequency of Emergency Room/Urgent Care Visits for Allergy Reactions from Baseline to 18 Month Follow Up

Secondary Outcomes (9)

• Social Support

  Change in Social Support from Baseline to 6 Month Follow Up

• Social Support

  Change in Social Support from Baseline to 12 Month Follow Up

• Social Support

  Change in Social Support from Baseline to 18 Month Follow Up

• Food Allergy Self-Efficacy

  Change in Food Allergy Self-Efficacy from Baseline to 6 Month Follow Up

• Food Allergy Self-Efficacy

  Change in Food Allergy Self-Efficacy from Baseline to 12 Month Follow Up

Study Arms (2)

Food Allergy Mastery Program

EXPERIMENTAL

Participants randomized to the Food Allergy Mastery Program arm will participate in 6 telehealth intervention sessions with a trained mental health provider pertaining to food allergy education, food allergy management, anxiety and stress management, social situations, and self-efficacy. One of the 6 sessions is a group session with peers.

Behavioral: Food Allergy Mastery Program

Usual Care

NO INTERVENTION

Participants will receive their usual allergy care.

Interventions

Food Allergy Mastery Program BEHAVIORAL

Food Allergy Mastery Program sessions will be delivered by masters-level counselors as 6 45-minute biweekly telehealth or in-person sessions over a period of 3 months. Session 1 will include both youth and caregiver, Session 2 will be a group session with 5-6 youth, Session 3 will include both youth and caregiver, Sessions 4-5 will be individual youth sessions, and Session 6 will include both youth and caregiver. Sessions will incorporate a variety of formats, each based on the needs of the session content.

Food Allergy Mastery Program

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 10-14 years
• physician diagnosis (i.e., history of a reaction to the food and/or recent positive skin prick test or IgE-specific testing) of at least 1 of the 9 most common IgE-mediated food allergies (peanut, tree nut, cow's milk, egg, soy, wheat, shellfish, fish, sesame) for ≥1 year, with accompanying allergen avoidance prescribed by an allergist
• English fluency
• access to a device with internet access
• either a food allergy knowledge score of \<80% correct on the Food Allergy Knowledge Test (FAKT) or a food allergy impact score of ≥3 on the Food Allergy Independent Measure (FAIM).

You may not qualify if:

• diagnosis of a non-IgE-mediated food allergy or food intolerance, a non-atopic chronic illness or pervasive developmental disorder/cognitive limitation
• Current participation in psychotherapy with a therapist with food allergy expertise

Sponsors & Collaborators

• Children's National Research Institute: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Northwestern University: collaborator
• Rhode Island Hospital: collaborator

Study Sites (1)

Childrens' National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Linda Herbert, PhD

  Childrens National Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Herbert, PhD

CONTACT

2024764552; lherbert@childrensnational.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: September 13, 2023
• Study Start: June 26, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)