Clinical trial Recruiting at 1 site Interventional Ages 10 to 14

Program to help children manage food allergies

Official title: Evaluation of a Behavioral Intervention to Promote Food Allergy Self-Management Among Early Adolescents: The Food Allergy Mastery Program

Run by Children's National Research Institute · NCT06034678 · Data updated 2026-11-12

This study is testing a program to help early teens with food allergies and their caregivers learn how to manage allergies better and feel more confident.

Quick facts

Study typeInterventional
Ages10 Years to 14 Years
SexAll
Enrollment240 (estimated)
SponsorChildren's National Research Institute
Academic / other
Locations1 site (Washington D.C., District of Columbia)
StatusRecruiting
StartedJune 26, 2023
Main results expectedNovember 30, 2026
Study endsNovember 30, 2027
Registry record updatedJuly 11, 2025
Trial IDNCT06034678 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adolescents aged 10-14 years with a physician-diagnosed IgE-mediated food allergy and a food allergy knowledge score below 80%.

Probably not a fit

Patients with non-IgE-mediated food allergies, food intolerances, or cognitive limitations may not benefit from this program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates a behavioral intervention called the Food Allergy Mastery (FAM) program, designed for early adolescents with food allergies and their caregivers. The program consists of six sessions focusing on food allergy education, skill-building in problem-solving, communication, assertiveness, and anxiety management, along with peer support. The study aims to assess the program's effectiveness in improving food allergy knowledge, self-management skills, and psychosocial functioning, while also exploring how race/ethnicity may influence treatment outcomes.

Why it matters

Potential benefit: If successful, this program could significantly enhance the self-management skills and quality of life for adolescents with food allergies.

How similar studies have gone: Other studies have shown promise in behavioral interventions for food allergies, indicating potential for success with this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. age 10-14 years
2. 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
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 Knowledge Test (FAKT) or a food allergy impact score of ≥3 on the Food Allergy Independent Measure (FAIM).

Exclusion Criteria:

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

Where it's running

  • Childrens' National Hospital
    Washington D.C., District of Columbia, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.