Evaluation of The Food Allergy Mastery Program

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 sess

Первичные конечные точки

• Food Allergy Knowledge [Срок оценки: Change in Food Allergy Knowledge from Baseline to 6 Month Follow Up]
• Food Allergy Knowledge [Срок оценки: Change in Food Allergy Knowledge from Baseline to 12 Month Follow Up]
• Food Allergy Knowledge [Срок оценки: Change in Food Allergy Knowledge from Baseline to 18 Month Follow Up]
• Food Allergy Management Skills- Label Reading [Срок оценки: Change in Food Allergy Management Skills- Label Reading from Baseline to 6 Month Follow Up]
• Food Allergy Management Skills- Label Reading [Срок оценки: Change in Food Allergy Management Skills- Label Reading from Baseline to 12 Month Follow Up]
• Food Allergy Management Skills- Label Reading [Срок оценки: Change in Food Allergy Management Skills- Label Reading from Baseline to 18 Month Follow Up]
• Food Allergy Management Skills- Epinephrine Auto-Injector Use [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Change in Food Allergy Management Skills- Epinephrine Auto-Injector Use from Baseline to 18 Month Follow Up]
• Food Allergy Management Behaviors [Срок оценки: Change in Food Allergy Management Behaviors from Baseline to 6 Month Follow Up]

Вторичные конечные точки (9)

• Social Support [Срок оценки: Change in Social Support from Baseline to 6 Month Follow Up]
• Social Support [Срок оценки: Change in Social Support from Baseline to 12 Month Follow Up]
• Social Support [Срок оценки: Change in Social Support from Baseline to 18 Month Follow Up]
• Food Allergy Self-Efficacy [Срок оценки: Change in Food Allergy Self-Efficacy from Baseline to 6 Month Follow Up]
• Food Allergy Self-Efficacy [Срок оценки: Change in Food Allergy Self-Efficacy from Baseline to 12 Month Follow Up]
• Food Allergy Self-Efficacy [Срок оценки: Change in Food Allergy Self-Efficacy from Baseline to 18 Month Follow Up]
• Food Allergy Anxiety [Срок оценки: Change in Food Allergy Anxiety from Baseline to 6 Month Follow Up]
• Food Allergy Anxiety [Срок оценки: Change in Food Allergy Anxiety from Baseline to 12 Month Follow Up]
• Food Allergy Anxiety [Срок оценки: Change in Food Allergy Anxiety from Baseline to 18 Month Follow Up]

Критерии участия

Критерии включения

• age 10-14 years
• 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
• English fluency
• access to a device with internet access
• 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).

Критерии исключения

• diagnosis of a non-IgE-mediated food allergy or food intolerance, a non-atopic chronic illness or pervasive developmental disorder/cognitive limitation
• Current participation in psychotherapy with a therapist with food allergy expertise

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Childrens' National Hospital — Washington D.C.

Идентификаторы

NCT: NCT06034678 · 30007544 · R01AI168090

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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