Evaluation of The Food Allergy Mastery Program
Part of paid clinical trials in Washington D.C., District of Columbia.
- Sponsor
- Children's National Research Institute
- Study ID
- NCT06034678
- Status
- Recruiting
Conditions
- Food Allergy in Children
Eligibility Criteria
- Sex
- ALL
- Age
- 10 Years - 14 Years
- Healthy Volunteers
- Not accepted
Interventions
- Food Allergy Mastery Program — BEHAVIORALFood Allergy Mastery Program sessions will be delivered by masters-level counselors as 6 45-minute biweekly telehealth or in-person sessions over a period of 3 months. Session 1 will include both youth and caregiver, Session 2 will be a group session with 5-6 youth, Session 3 will include both youth and caregiver, Sessions 4-5 will be individual youth sessions, and Session 6 will include both youth and caregiver. Sessions will incorporate a variety of formats, each based on the needs of the session content.
Study Details
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.
Key Dates
- Start date
- Jun 26, 2023
- Status verified
- Jul 2025
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2027
Study Design
- Enrollment
- 240 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Food Allergy Mastery ProgramParticipants randomized to the Food Allergy Mastery Program arm will participate in 6 telehealth intervention sessions with a trained mental health provider pertaining to food allergy education, food allergy management, anxiety and stress management, social situations, and self-efficacy. One of the 6 sessions is a group session with peers.
- No Intervention: Usual CareParticipants will receive their usual allergy care.
Primary Outcome Measure
Food Allergy Knowledge [ Time Frame: Change in Food Allergy Knowledge from Baseline to 6 Month Follow Up ]
Central Contacts
- Linda Herbert, PhD2024764552
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Childrens' National Hospital | Washington D.C. | District of Columbia | 20010 |
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