Clinical trial NCT06034678: Evaluation of The Food Allergy Mastery Program
Official title: Evaluation of a Behavioral Intervention to Promote Food Allergy Self-Management Among Early Adolescents: The Food Allergy Mastery Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Food Allergy in Children
Keywords: food allergy
knowledge
management
adolescents
caregivers
social support
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Northwestern University
name: Rhode Island Hospital
First posted: 2023-09-13
Enrollment: 240
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Food Allergy Knowledge
timeFrame: Change in Food Allergy Knowledge from Baseline to 6 Month Follow Up
measure: Food Allergy Knowledge
timeFrame: Change in Food Allergy Knowledge from Baseline to 12 Month Follow Up
measure: Food Allergy Knowledge
timeFrame: Change in Food Allergy Knowledge from Baseline to 18 Month Follow Up
measure: Food Allergy Management Skills- Label Reading
timeFrame: Change in Food Allergy Management Skills- Label Reading from Baseline to 6 Month Follow Up
measure: Food Allergy Management Skills- Label Reading
timeFrame: Change in Food Allergy Management Skills- Label Reading from Baseline to 12 Month Follow Up
measure: Food Allergy Management Skills- Label Reading
timeFrame: Change in Food Allergy Management Skills- Label Reading from Baseline to 18 Month Follow Up
measure: Food Allergy Management Skills- Epinephrine Auto-Injector Use
timeFrame: Change in Food Allergy Management Skills- Epinephrine Auto-Injector Use from Baseline to 6 Month Follow Up
measure: Food Allergy Management Skills- Epinephrine Auto-Injector Use
timeFrame: Change in Food Allergy Management Skills- Epinephrine Auto-Injector Use from Baseline to 12 Month Follow Up
measure: Food Allergy Management Skills- Epinephrine Auto-Injector Use
timeFrame: Change in Food Allergy Management Skills- Epinephrine Auto-Injector Use from Baseline to 18 Month Follow Up
measure: Food Allergy Management Behaviors
timeFrame: Change in Food Allergy Management Behaviors from Baseline to 6 Month Follow Up
measure: Food Allergy Management Behaviors
timeFrame: Change in Food Allergy Management Behaviors from Baseline to 12 Month Follow Up
measure: Food Allergy Management Behaviors
timeFrame: Change in Food Allergy Management Behaviors from Baseline to 18 Month Follow Up
measure: Food Allergy Quality of Life- Child Self Report
timeFrame: Change in Food Allergy Quality of Life- Child Self Report from Baseline to 6 Month Follow Up
measure: Food Allergy Quality of Life- Child Self-Report
timeFrame: Change in Food Allergy Quality of Life- Child Self Report from Baseline to 12 Month Follow Up
measure: Food Allergy Quality of Life- Child Self-Report
timeFrame: Change in Food Allergy Quality of Life- Child Self Report from Baseline to 18 Month Follow Up
measure: Food Allergy Quality of Life- Parent Proxy
timeFrame: Change in Food Allergy Quality of Life- Parent Proxy from Baseline to 6 Month Follow Up
measure: Food Allergy Quality of Life- Parent Proxy
timeFrame: Change in Food Allergy Quality of Life- Parent Proxy from Baseline to 12 Month Follow Up
measure: Food Allergy Quality of Life- Parent Proxy
timeFrame: Change in Food Allergy Quality of Life- Parent Proxy from Baseline to 18 Month Follow Up
measure: Food Allergy Impact
timeFrame: Change in Food Allergy Impact from Baseline to 6 Month Follow Up
measure: Food Allergy Impact
timeFrame: Change in Food Allergy Impact from Baseline to 12 Month Follow Up
measure: Food Allergy Impact
timeFrame: Change in Food Allergy Impact from Baseline to 18 Month Follow Up
measure: Frequency of Treatment for Allergic Reactions
timeFrame: Change in Frequency of Treatment for Allergic Reactions from Baseline to 6 Month Follow Up
measure: Frequency of Treatment for Allergic Reactions
timeFrame: Change in Frequency of Treatment for Allergic Reactions from Baseline to 12 Month Follow Up
measure: Frequency of Treatment for Allergic Reactions
timeFrame: Change in Frequency of Treatment for Allergic Reactions from Baseline to 18 Month Follow Up
measure: Frequency of Allergy Appointments
timeFrame: Change in Frequency of Allergy Appointments from Baseline to 6 Month Follow Up
measure: Frequency of Allergy Appointments
timeFrame: Change in Frequency of Allergy Appointments from Baseline to 12 Month Follow Up
measure: Frequency of Emergency Room/Urgent Care Visits for Allergic Reactions
timeFrame: Change in Frequency of Emergency Room/Urgent Care Visits for Allergy Reactions from Baseline to 6 Month Follow Up
measure: Frequency of Allergy Appointments
timeFrame: Change in Frequency of Allergy Appointments from Baseline to 18 Month Follow Up
measure: Frequency of Emergency Room/Urgent Care Visits for Allergic Reactions
timeFrame: Change in Frequency of Emergency Room/Urgent Care Visits for Allergy Reactions from Baseline to 12 Month Follow Up
measure: Frequency of Emergency Room/Urgent Care Visits for Allergic Reactions
timeFrame: Change in Frequency of Emergency Room/Urgent Care Visits for Allergy Reactions from Baseline to 18 Month Follow Up
Secondary outcomes:
measure: Social Support
timeFrame: Change in Social Support from Baseline to 6 Month Follow Up
measure: Social Support
timeFrame: Change in Social Support from Baseline to 12 Month Follow Up
measure: Social Support
timeFrame: Change in Social Support from Baseline to 18 Month Follow Up
measure: Food Allergy Self-Efficacy
timeFrame: Change in Food Allergy Self-Efficacy from Baseline to 6 Month Follow Up
measure: Food Allergy Self-Efficacy
timeFrame: Change in Food Allergy Self-Efficacy from Baseline to 12 Month Follow Up
measure: Food Allergy Self-Efficacy
timeFrame: Change in Food Allergy Self-Efficacy from Baseline to 18 Month Follow Up
measure: Food Allergy Anxiety
timeFrame: Change in Food Allergy Anxiety from Baseline to 6 Month Follow Up
measure: Food Allergy Anxiety
timeFrame: Change in Food Allergy Anxiety from Baseline to 12 Month Follow Up
measure: Food Allergy Anxiety
timeFrame: Change in Food Allergy Anxiety from Baseline to 18 Month Follow Up
Other outcomes:
Locations:
city: Washington
country: United States
facility: Childrens' National Hospital
state: District of Columbia
Study officials:
affiliation: Childrens National Hospital
name: Linda Herbert, PhD
role: PRINCIPAL_INVESTIGATOR
References: