Actively Recruiting
Evaluation of a Behavioral Intervention to Promote Food Allergy Self-Management Among Early Adolescents: The Food Allergy Mastery Program
Led by Children's National Research Institute · Updated on 2025-07-11
240
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Children's National Research Institute
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new behavioral program called the Food Allergy Mastery (FAM) program designed to help early adolescents with food allergies improve their self-management skills and adjustment. This program focuses on food allergy education, problem-solving, communication, anxiety management, and peer support to assist youth and their caregivers. The study aims to understand how this intervention affects food allergy knowledge, behavior, psychosocial functioning, and healthcare use, including examining if race or ethnicity influences these outcomes. The FAM program includes six 45-minute sessions delivered biweekly over three months by trained counselors via telehealth or in person. Sessions involve both youth and caregivers, with a group session for peers, individual youth sessions, and combined youth-caregiver sessions. Participants randomized to this program receive these sessions alongside their usual allergy care, while others receive only their usual care. Participants will be assessed through surveys and tests measuring changes in food allergy knowledge, management skills such as label reading and epinephrine use, quality of life, anxiety, social support, and healthcare visits at baseline and follow-ups at 6, 12, and 18 months. The study tracks improvements in self-management behaviors and healthcare use, aiming to reduce emergency visits and improve quality of life. The total study duration includes these follow-ups, supporting long-term monitoring of outcomes.
CONDITIONS
Brief Title
Evaluation of The Food Allergy Mastery Program
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 10 to 14 years
- Physician diagnosis of at least one of the 9 common IgE-mediated food allergies (peanut, tree nut, cow's milk, egg, soy, wheat, shellfish, fish, sesame) for at least 1 year
- Prescribed allergen avoidance by an allergist
- Fluent in English
- Access to a device with internet
- Food allergy knowledge score below 80% on Food Allergy Knowledge Test or food allergy impact score of 3 or higher on Food Allergy Independent Measure
You will not qualify if you...
- Diagnosis of a non-IgE-mediated food allergy or food intolerance
- Presence of non-atopic chronic illness or pervasive developmental disorder/cognitive limitation
- Current participation in psychotherapy with a therapist experienced in food allergy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - 3 months
Participants in the Food Allergy Mastery Program engage in 6 behavioral intervention sessions focused on food allergy education, management skills, anxiety and stress management, social skills, and peer support.
6 sessions delivered biweekly via telehealth or in-person
Duration - Up to 18 months after treatment
Participants are followed to assess changes in food allergy knowledge, self-management skills, psychosocial functioning, and healthcare utilization.
Assessment visits at 6, 12, and 18 months post-baseline
Trial Site Locations
Total: 1 location
1
Childrens' National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
Research Team
L
Linda Herbert, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here