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 — BEHAVIORAL
    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.

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 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.

Primary Outcome Measure

Food Allergy Knowledge [ Time Frame: Change in Food Allergy Knowledge from Baseline to 6 Month Follow Up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Childrens' National HospitalWashington D.C.District of Columbia20010
Linda Herbert, PhD
202-476-4552

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