NCT06034678 Evaluation of The Food Allergy Mastery Program
| NCT ID | NCT06034678 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's National Research Institute |
| Condition | Food Allergy in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-06-26 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2023-06-26 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Linda Herbert, PhD
PRINCIPAL INVESTIGATOR
Childrens National Hospital
Frequently Asked Questions
Who can join the NCT06034678 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 14 Years, studying Food Allergy in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06034678 currently recruiting?
Yes, NCT06034678 is actively recruiting participants. Contact the research team at lherbert@childrensnational.org for enrollment information.
Where is the NCT06034678 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT06034678 clinical trial?
NCT06034678 is sponsored by Children's National Research Institute. The principal investigator is Linda Herbert, PhD at Childrens National Hospital. The trial plans to enroll 240 participants.