Program to help children manage food allergies
Evaluation of a Behavioral Intervention to Promote Food Allergy Self-Management Among Early Adolescents: The Food Allergy Mastery Program
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 10 Years to 14 Years |
| Sex | All |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06034678 on ClinicalTrials.gov |
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.
Who should consider this trial
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%.
Not a fit: Patients with non-IgE-mediated food allergies, food intolerances, or cognitive limitations may not benefit from this program.
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 performed: Other studies have shown promise in behavioral interventions for food allergies, indicating potential for success with this approach.
Eligibility criteria
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 this trial is running
Washington D.C., District of Columbia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.