Recruiting

Food Allergy Intervention

Sponsor:

Children's National Research Institute

Code:

NCT06034678

Conditions

Food Allergy in Children

Eligibility Criteria

Sex: All

Age: 10 - 14

Healthy Volunteers: Not accepted

Interventions

Food Allergy Mastery Program

Study Details

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.

Conditions

Food Allergy in Children

Study ID

NCT06034678

Start date

Jun 26, 2023

Status verified date

Jul, 2025

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 14

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Food Allergy Mastery Program

Participants 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 Care

Participants will receive their usual allergy care.

Interventions

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.

Primary outcome measure

  • Food Allergy Knowledge [ Time Frame: Change in Food Allergy Knowledge from Baseline to 6 Month Follow Up ]
  • Food Allergy Knowledge [ Time Frame: Change in Food Allergy Knowledge from Baseline to 12 Month Follow Up ]
  • Food Allergy Knowledge [ Time Frame: Change in Food Allergy Knowledge from Baseline to 18 Month Follow Up ]
  • Food Allergy Management Skills- Label Reading [ Time Frame: Change in Food Allergy Management Skills- Label Reading from Baseline to 6 Month Follow Up ]
  • Food Allergy Management Skills- Label Reading [ Time Frame: Change in Food Allergy Management Skills- Label Reading from Baseline to 12 Month Follow Up ]
  • Food Allergy Management Skills- Label Reading [ Time Frame: Change in Food Allergy Management Skills- Label Reading from Baseline to 18 Month Follow Up ]
  • Food Allergy Management Skills- Epinephrine Auto-Injector Use [ Time Frame: Change in Food Allergy Management Skills- Epinephrine Auto-Injector Use from Baseline to 6 Month Follow Up ]
  • Food Allergy Management Skills- Epinephrine Auto-Injector Use [ Time Frame: Change in Food Allergy Management Skills- Epinephrine Auto-Injector Use from Baseline to 12 Month Follow Up ]
  • Food Allergy Management Skills- Epinephrine Auto-Injector Use [ Time Frame: Change in Food Allergy Management Skills- Epinephrine Auto-Injector Use from Baseline to 18 Month Follow Up ]
  • Food Allergy Management Behaviors [ Time Frame: Change in Food Allergy Management Behaviors from Baseline to 6 Month Follow Up ]
  • Food Allergy Management Behaviors [ Time Frame: Change in Food Allergy Management Behaviors from Baseline to 12 Month Follow Up ]
  • Food Allergy Management Behaviors [ Time Frame: Change in Food Allergy Management Behaviors from Baseline to 18 Month Follow Up ]
  • Food Allergy Quality of Life- Child Self Report [ Time Frame: Change in Food Allergy Quality of Life- Child Self Report from Baseline to 6 Month Follow Up ]
  • Food Allergy Quality of Life- Child Self-Report [ Time Frame: Change in Food Allergy Quality of Life- Child Self Report from Baseline to 12 Month Follow Up ]
  • Food Allergy Quality of Life- Child Self-Report [ Time Frame: Change in Food Allergy Quality of Life- Child Self Report from Baseline to 18 Month Follow Up ]
  • Food Allergy Quality of Life- Parent Proxy [ Time Frame: Change in Food Allergy Quality of Life- Parent Proxy from Baseline to 6 Month Follow Up ]
  • Food Allergy Quality of Life- Parent Proxy [ Time Frame: Change in Food Allergy Quality of Life- Parent Proxy from Baseline to 12 Month Follow Up ]
  • Food Allergy Quality of Life- Parent Proxy [ Time Frame: Change in Food Allergy Quality of Life- Parent Proxy from Baseline to 18 Month Follow Up ]
  • Food Allergy Impact [ Time Frame: Change in Food Allergy Impact from Baseline to 6 Month Follow Up ]
  • Food Allergy Impact [ Time Frame: Change in Food Allergy Impact from Baseline to 12 Month Follow Up ]
  • Food Allergy Impact [ Time Frame: Change in Food Allergy Impact from Baseline to 18 Month Follow Up ]
  • Frequency of Treatment for Allergic Reactions [ Time Frame: Change in Frequency of Treatment for Allergic Reactions from Baseline to 6 Month Follow Up ]
  • Frequency of Treatment for Allergic Reactions [ Time Frame: Change in Frequency of Treatment for Allergic Reactions from Baseline to 12 Month Follow Up ]
  • Frequency of Treatment for Allergic Reactions [ Time Frame: Change in Frequency of Treatment for Allergic Reactions from Baseline to 18 Month Follow Up ]
  • Frequency of Allergy Appointments [ Time Frame: Change in Frequency of Allergy Appointments from Baseline to 6 Month Follow Up ]
  • Frequency of Allergy Appointments [ Time Frame: Change in Frequency of Allergy Appointments from Baseline to 12 Month Follow Up ]
  • Frequency of Emergency Room/Urgent Care Visits for Allergic Reactions [ Time Frame: Change in Frequency of Emergency Room/Urgent Care Visits for Allergy Reactions from Baseline to 6 Month Follow Up ]
  • Frequency of Allergy Appointments [ Time Frame: Change in Frequency of Allergy Appointments from Baseline to 18 Month Follow Up ]
  • Frequency of Emergency Room/Urgent Care Visits for Allergic Reactions [ Time Frame: Change in Frequency of Emergency Room/Urgent Care Visits for Allergy Reactions from Baseline to 12 Month Follow Up ]
  • Frequency of Emergency Room/Urgent Care Visits for Allergic Reactions [ Time Frame: Change in Frequency of Emergency Room/Urgent Care Visits for Allergy Reactions from Baseline to 18 Month Follow Up ]

Central Contacts and Locations

Central contacts

Linda Herbert, PhD

2024764552lherbert@childrensnational.org

Locations

Childrens' National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Linda Herbert, PhD

202-476-4552lherbert@childrensnational.org

More Information

Sponsor

Children's National Research Institute

Last update posted

Jul 11, 2025

Last verified

Jul, 2025

Keywords

  • food allergy
  • knowledge
  • management
  • adolescents
  • caregivers
  • social support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2025-07-11.