Evaluation of The Food Allergy Mastery Program

Last updated: July 8, 2025
Sponsor: Children's National Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergies & Asthma

Allergy (Pediatric)

Allergy

Treatment

Food Allergy Mastery Program

Clinical Study ID

NCT06034678
30007544
R01AI168090
  • Ages 10-14
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. age 10-14 years

  2. physician diagnosis (i.e., history of a reaction to the food and/or recent positiveskin prick test or IgE-specific testing) of at least 1 of the 9 most commonIgE-mediated food allergies (peanut, tree nut, cow's milk, egg, soy, wheat,shellfish, fish, sesame) for ≥1 year, with accompanying allergen avoidanceprescribed by an allergist

  3. English fluency

  4. access to a device with internet access

  5. either a food allergy knowledge score of <80% correct on the Food Allergy KnowledgeTest (FAKT) or a food allergy impact score of ≥3 on the Food Allergy IndependentMeasure (FAIM).

Exclusion

Exclusion Criteria:

  1. diagnosis of a non-IgE-mediated food allergy or food intolerance, a non-atopicchronic illness or pervasive developmental disorder/cognitive limitation

  2. Current participation in psychotherapy with a therapist with food allergy expertise

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: Food Allergy Mastery Program
Phase:
Study Start date:
June 26, 2023
Estimated Completion Date:
November 30, 2027

Study Description

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. The Food Allergy Mastery (FAM) program is a 6-session food allergy self-management program that will be delivered to early adolescents with food allergy, a high-risk population that is growing in size, and a primary caregiver by a trained interventionist. The specific aims are: 1) To evaluate the intervention's impact on food allergy knowledge and self-management skills, 2) To determine the intervention's impact on food allergy self-management behavior and psychosocial functioning and healthcare utilization, and as an exploratory aim 3) to determine if early adolescents' race/ethnicity moderates response to treatment, including food allergy knowledge, skills, self-management behavior, psychosocial functioning, and healthcare utilization. The study has the potential to positively impact the health care utilization of youth with food allergy by evaluating a scalable behavioral intervention for adolescents and their caregivers. The intervention will equip youth with food allergy knowledge and self-management skills by bolstering their food allergy-related knowledge and problem-solving, social skills, and social support and attenuating food allergy anxiety. Successful development and implementation of the FAM Program that promotes the attainment of integration of food allergy into daily life has the potential to decrease health care utilization reducing emergency visits and improve food allergy-related quality of life.

Connect with a study center

  • Childrens' National Hospital

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

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