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 type | Interventional |
|---|---|
| Ages | 10 Years to 14 Years |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Status | Recruiting |
| Started | June 26, 2023 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2027 |
| Registry record updated | July 11, 2025 |
| Trial ID | NCT06034678 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
- Principal investigator: Linda Herbert, PhD — Childrens National Hospital
- Study coordinator: Linda Herbert, PhD
- Email: lherbert@childrensnational.org
- Phone: 2024764552
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Peanut Oral Immunotherapy for Children in Hong Kong
This study tests whether peanut oral immunotherapy can desensitize children under 18 with peanut allergy in real-world Hong Kong settings compared with standard peanut avoidance.
-
Oral immunotherapy versus natural course for milk and egg allergy in children
This study will see if oral immunotherapy helps children aged 4–10 with cow's milk or hen's egg allergy become desensitized compared with natural evolution.
-
Nickel and LTP sensitization in children with functional gastrointestinal disorders
This research tests whether sensitization to non-specific lipid transfer proteins (LTPs) and to nickel is linked to functional gut symptoms in children aged 4 and older with dyspepsia or irritable bowel symptoms.
-
Rush versus conventional oral immunotherapy for cow's milk and hen's egg allergy in children
This test compares a faster 'rush' oral immunotherapy schedule with a conventional slower schedule to see which better helps children aged 6–16 with milk or egg allergy tolerate those foods.
-
Evaluating Omalizumab's Effect on Skin in Food Allergy Patients
This study is testing if the medication omalizumab can improve skin problems in people with food allergies and help reduce their allergic reactions.
-
Boiled cashew treatment for children with food allergies
This study is testing if giving boiled cashews to children with cashew allergies can help them safely eat cashews and possibly other tree nuts too.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.