Food Allergy Mastery Program for Food Allergies

Overseen By Linda Herbert, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Disqualifiers: Non-IgE food allergy, Intolerance, Non-atopic illness, Pervasive developmental disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

240 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Food Allergy Mastery Program treatment for food allergies?

Educational programs, like the Food Allergy Mastery Program, can improve the quality of life for children with food allergies and their parents. Studies suggest that educational interventions, along with medical treatments, help reduce stress and anxiety related to food allergies. ^{1 2 3 4 5}

Is the Food Allergy Mastery Program safe for humans?

The available research focuses on managing food allergies and preventing allergic reactions, but it does not provide specific safety data for the Food Allergy Mastery Program itself. The studies emphasize the importance of education, allergen avoidance, and having an action plan for allergic reactions, which are general safety measures for managing food allergies. ^{6 7 8 9 10}

How is the Food Allergy Mastery Program different from other treatments for food allergies?

The Food Allergy Mastery Program is unique because it focuses on comprehensive education and mastery of allergen avoidance and emergency care, which is crucial for managing food allergies effectively. Unlike standard treatments that may focus solely on medical interventions, this program emphasizes improving the quality of life through education and support for both patients and their families. ^{4 11 12 13 14}

Research Team

Linda Herbert, PhD

Principal Investigator

Childrens National Hospital

Eligibility Criteria

This trial is for early adolescents aged 10-14 with a physician-diagnosed IgE-mediated food allergy (like peanuts or shellfish) for over a year, who speak English and have internet access. They should either lack some knowledge about their allergy or feel it impacts their life significantly. Those with non-IgE allergies, other chronic illnesses, cognitive issues, or currently in specialized therapy are excluded.

Inclusion Criteria

You have access to a device with an internet connection.

You possess fluency in the English language.

A physician has diagnosed you with one of the nine most common IgE-mediated food allergies (peanut, tree nut, cow's milk, egg, soy, wheat, shellfish, fish or sesame) for at least 1 year and recommended avoidance measures.

Exclusion Criteria

I am currently seeing a therapist who specializes in food allergies.

You have a non-IgE-mediated food allergy or food intolerance, a chronic illness that is not related to allergies, or a developmental disorder or cognitive limitation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Food Allergy Mastery Program, a 6-session telehealth intervention focusing on food allergy education, management, and peer support

6 weeks

6 telehealth sessions

Follow-up

Participants are monitored for changes in food allergy management skills, quality of life, and healthcare utilization

18 months

Treatment Details

Interventions

• Food Allergy Mastery Program

Trial Overview The Food Allergy Mastery Program is being tested to see if it helps young people manage their food allergies better. It includes education on food allergies, skills training for problem-solving and anxiety management, and peer support to improve self-care and adjustment.

Participant Groups

Group I: Food Allergy Mastery Program Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 Intervention

Participants will receive their usual allergy care.

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Rhode Island Hospital

Collaborator

Trials

275

Recruited

71,400+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Findings from Research

Food allergies are becoming more common globally, and they significantly impact the quality of life (QOL) for affected children and their caregivers due to stress and anxiety from allergen avoidance and the risk of anaphylaxis.

Recent studies indicate that interventions like oral food challenges and oral immunotherapy can improve the quality of life for food allergy patients and their caregivers, suggesting that these treatments may help alleviate some of the associated stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Life Among Food Allergic Patients and Their Caregivers. Warren, CM., Otto, AK., Walkner, MM., et al.[2022]

The Food Allergy Quality of Life Questionnaire-Parent Form (FAQLQ-PF) demonstrated high reliability and discrimination in assessing quality of life for children with peanut allergies undergoing epicutaneous immunotherapy, based on data from the phase 3 PEPITES study involving children aged 4-11 years.

The psychometric analysis confirmed that the FAQLQ-PF is suitable for longitudinal measurements in food allergy treatment trials, indicating its effectiveness as a patient-reported outcome measure in clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric parameters of food allergy quality of life during an allergen immunotherapy trial. Lins de Holanda Coelho, G., DunnGalvin, A., Greenhawt, M., et al.[2023]

Clinical trials for food allergy treatments often prioritize outcomes that are more relevant to researchers and investors, such as reactivity thresholds and immunologic changes, rather than focusing on what matters most to patients and their families.

There is a critical need to develop core outcome sets for food allergy trials to ensure that future studies measure and report outcomes that reflect the experiences and concerns of both patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes for clinical trials of food allergy treatments. Sim, K., Mijakoski, D., Stoleski, S., et al.[2020]

A systematic review of 2351 articles identified only 9 studies that met the criteria for evaluating educational interventions for children with food allergies and their parents, highlighting a significant gap in available resources.

Among the studies reviewed, only 2 demonstrated significant improvements in quality of life through educational support, indicating that while education is crucial, more effective programs need to be developed and implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of educational interventions for quality of life of parents and children with food allergy: A systematic review. Cheon, J., Cho, CM., Kim, HJ., et al.[2022]

A systematic review of 15 studies found that while interventions for caregivers of children with food allergies (FA) generally had high acceptability, the overall quality of research was poor to moderate, indicating a need for better studies.

Some evidence suggests that cognitive behavioral interventions may help mothers of children with FA, and educational interventions can improve knowledge about food allergies, but more rigorous research is needed to confirm these benefits across different caregiver populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for caregivers of children with food allergy: A systematic review. Sugunasingha, N., Jones, FW., Jones, CJ.[2021]

Eliminating allergens from a child's diet is crucial for preventing accidents related to food allergies, and families can effectively identify these allergens through careful label reading and communication with restaurants.

Patient education is essential, including understanding a personalized action plan for managing allergic reactions and knowing how to administer necessary medications, with the Individualized Care Project serving as a key resource in schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Managing the risks of accident in child with food allergy]. Benoist, G., Orcel, MC.[2019]

A project developed age-specific, evidence-based handouts for managing food allergies, which were reviewed by 57 caregivers and 2 young adults, ensuring the content was relevant and practical for different developmental stages.

The majority of participants found the handouts to be clear and useful, with 79% rating the information as 'just right' and 63% indicating they would be 'very likely' to use them, suggesting these resources could effectively support families in food allergy management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of Age-Based Food Allergy Educational Handouts for Caregivers and Patients: A Work Group Report of the AAAAI Adverse Reactions to Foods Committee. LeBovidge, JS., Herbert, LJ., Ramos, A., et al.[2023]

The study developed a program to improve the management of food allergies in hospitals, allowing for better communication among medical staff and dieticians regarding patients' allergies.

After implementing the program, there was a measurable increase in the number of allergic prescriptions for inpatients, indicating enhanced safety and efficacy in meal delivery for patients with food allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction of a Program to Improve the Information Sharing System of Food Allergy Patients. Ha, JS., Kim, SH., Lim, SH., et al.[2019]

In a study of 314 patients with food-induced anaphylaxis (FIA), 160 infants (50.9%) were identified, with cow's milk being the most common trigger (51.4%), highlighting the need for awareness of specific allergens in this age group.

Infants exhibited different symptoms compared to older children, with gastrointestinal and neurologic symptoms being more prevalent, and a significant portion (40.6%) received adrenaline, indicating a need for prompt treatment in emergencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food-induced anaphylaxis in infants, as compared to toddlers and preschool children in Turkey. Kahveci, M., Akarsu, A., Koken, G., et al.[2021]

The EAACI guidelines emphasize the importance of educating children and caregivers about food allergen avoidance and the prompt recognition and management of allergic reactions to reduce the risk of anaphylaxis in community settings.

Provision and education on the use of adrenaline auto-injectors are critical components of managing food allergies, highlighting the need for collaboration between families, schools, and food service providers to ensure safety and prevent accidental exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EAACI food allergy and anaphylaxis guidelines: managing patients with food allergy in the community. Muraro, A., Agache, I., Clark, A., et al.[2022]

The Thai versions of the Food Allergy Quality of Life Questionnaire (FAQLQ-AF) and Food Allergy Independent Measure (FAIM-AF) have been successfully translated and validated for use in Thai adults with food allergies, demonstrating strong reliability with intraclass correlation coefficients of 0.83 and 0.85, respectively.

Both questionnaires showed excellent internal consistency, with Cronbach's α coefficients of 0.91 and 0.92, indicating they are effective tools for assessing quality of life specifically related to food allergies, rather than general health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity and reliability of the Thai version of Food Allergy Quality of Life Questionnaire - Adult Form (FAQLQ-AF) and Food Allergy Independent Measure - Adult Form (FAIM-AF). Tangwiwat, C., Sompornrattanaphan, M., Thongngarm, T., et al.[2023]

The Spanish version of the Food Allergy Quality of Life Questionnaire for Adults (S-FAQLQ-AF) has been validated and shows excellent reliability and internal consistency, making it a reliable tool for assessing the quality of life in patients with food allergies.

The S-FAQLQ-AF effectively discriminates between patients with different atopic phenotypes and correlates well with the Food Allergy Independent Measure, indicating its efficacy in evaluating the impact of IgE-mediated food allergies on quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Spanish Version of the Food Allergy Quality of Life Questionnaire-Adult Form (S-FAQLQ-AF). Antolin-Amerigo, D., Cerecedo Carballo I, ., Muriel, A., et al.[2019]

A focus group study with 36 parents of food allergic children highlighted the need for a comprehensive curriculum that covers essential topics like recognizing early symptoms, understanding cross-contamination, and proper use of self-injectable epinephrine.

Parents expressed that improving access to reliable educational resources could significantly reduce stress and anxiety related to managing food allergies, ultimately enhancing their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a food allergy curriculum for parents. Vargas, PA., Sicherer, SH., Christie, L., et al.[2021]

The German version of the Food Allergy Quality of Life Questionnaire - Adult Form (FAQLQ-AF) has been validated as a reliable tool for assessing health-related quality of life in adults with birch pollen-associated food allergies, showing excellent internal consistency (Cronbach's α = 0.98).

In a study of 73 patients, the most common food triggers were identified, with 30% experiencing only oral allergy syndrome (OAS) symptoms, while 64% had OAS combined with systemic symptoms, indicating the complexity of food allergies and their impact on quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of health-related quality of life in adult patients with birch pollen-associated food allergy. Beyer, S., Franke, A., Simon, JC., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Quality of Life Among Food Allergic Patients and Their Caregivers. [2022]

2. Denmark pubmed.ncbi.nlm.nih.gov

Psychometric parameters of food allergy quality of life during an allergen immunotherapy trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Outcomes for clinical trials of food allergy treatments. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of educational interventions for quality of life of parents and children with food allergy: A systematic review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Interventions for caregivers of children with food allergy: A systematic review. [2021]

6. France pubmed.ncbi.nlm.nih.gov

[Managing the risks of accident in child with food allergy]. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The Development of Age-Based Food Allergy Educational Handouts for Caregivers and Patients: A Work Group Report of the AAAAI Adverse Reactions to Foods Committee. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Introduction of a Program to Improve the Information Sharing System of Food Allergy Patients. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Food-induced anaphylaxis in infants, as compared to toddlers and preschool children in Turkey. [2021]

10. Denmark pubmed.ncbi.nlm.nih.gov

EAACI food allergy and anaphylaxis guidelines: managing patients with food allergy in the community. [2022]

11. Thailand pubmed.ncbi.nlm.nih.gov

Validity and reliability of the Thai version of Food Allergy Quality of Life Questionnaire - Adult Form (FAQLQ-AF) and Food Allergy Independent Measure - Adult Form (FAIM-AF). [2023]

12. Spain pubmed.ncbi.nlm.nih.gov

Validation of the Spanish Version of the Food Allergy Quality of Life Questionnaire-Adult Form (S-FAQLQ-AF). [2019]

13. England pubmed.ncbi.nlm.nih.gov

Developing a food allergy curriculum for parents. [2021]

14. Germany pubmed.ncbi.nlm.nih.gov

Measurement of health-related quality of life in adult patients with birch pollen-associated food allergy. [2019]