NCT06034678

Evaluation of The Food Allergy Mastery Program

Evaluation of a Behavioral Intervention to Promote Food Allergy Self-Management Among Early Adolescents: The Food Allergy Mastery Program

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Children's National Research Institute · Academic / Other
• Sex: All
• Age: 10 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The Food Allergy Mastery (FAM) program is a 6-session food allergy self-management program that will be delivered to early adolescents with food allergy, a high-risk population that is growing in size, and a primary caregiver by a trained interventionist. The specific aims are: 1) To evaluate the intervention's impact on food allergy knowledge and self-management skills, 2) To determine the intervention's impact on food allergy self-management behavior and psychosocial functioning and healthcare utilization, and as an exploratory aim 3) to determine if early adolescents' race/ethnicity moderates response to treatment, including food allergy knowledge, skills, self-management behavior, psychosocial functioning, and healthcare utilization. The study has the potential to positively impact the health care utilization of youth with food allergy by evaluating a scalable behavioral intervention for adolescents and their caregivers. The intervention will equip youth with food allergy knowledge and self-management skills by bolstering their food allergy-related knowledge and problem-solving, social skills, and social support and attenuating food allergy anxiety. Successful development and implementation of the FAM Program that promotes the attainment of integration of food allergy into daily life has the potential to decrease health care utilization reducing emergency visits and improve food allergy-related quality of life.

Conditions

• Food Allergy in Children

Interventions

Type	Name	Description
BEHAVIORAL	Food Allergy Mastery Program	Food 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.

Timeline

• Start date: 2023-06-26
• Primary completion: 2026-11-30
• Completion: 2027-11-30
• First posted: 2023-09-13
• Last updated: 2025-07-11

Locations

1 site across 1 country: United States