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Behavioral Intervention

Food Allergy Mastery Program for Food Allergies

N/A

Recruiting

Led By Linda Herbert, PhD

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 10-14 years

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in social support from baseline to 18 month follow up

Awards & highlights

Study Summary

This trial will examine a new program to help teens with food allergies learn how to manage their condition, with education, problem-solving, communication, and peer support.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this program focuses on behavioral intervention rather than medication, traditional side effects like those seen with drugs are not expected. However, participants may experience emotional discomfort when discussing allergies or learning new coping strategies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 10 and 14 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in social support from baseline to 18 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in social support from baseline to 18 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in social support from baseline to 18 month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Food Allergy Impact

Food Allergy Knowledge

Food Allergy Management Behaviors

+8 more

Secondary outcome measures

Food Allergy Anxiety

Food Allergy Self-Efficacy

Social Support

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Food Allergy Mastery ProgramExperimental Treatment1 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 CareActive Control1 Intervention

Participants will receive their usual allergy care.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rhode Island HospitalOTHER

260 Previous Clinical Trials

66,767 Total Patients Enrolled

Children's National Research InstituteLead Sponsor

211 Previous Clinical Trials

207,917 Total Patients Enrolled

National Institute of Allergy and Infectious Diseases (NIAID)NIH

3,270 Previous Clinical Trials

5,484,997 Total Patients Enrolled

12 Trials studying Food Allergy

12,258 Patients Enrolled for Food Allergy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment currently accept volunteers?

"Yes, clinicaltrials.gov confirms that recruitment for this study is currently ongoing; it was first posted on June 26th 2023 and the most recent update occurred on September 5th of the same year. The trial seeks 240 volunteers from one medical centre."

Answered by AI

What is the scope of participants in this research project?

"Yes, according to the records found on clinicaltrials.gov this trial is actively recruiting patients. It was first listed on June 26th 2023 and has since been updated twice with its latest edit taking place of September 5th 2023. The study seeks a total of 240 participants from 1 site."

Answered by AI

Is this research trial open to geriatric patients?

"This clinical trial's eligibility requirements state that 10 is the least permissible age to join while 14 years old marks the upper limit."

Answered by AI

What criteria should be met for optimal participation in this clinical trial?

"To partake in this clinical trial, participants must have a confirmed food allergy and are restricted by age to those between 10 and 14. A total of 240 individuals will be accepted into the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of The Food Allergy Mastery Program

2023. "Evaluation of The Food Allergy Mastery Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06034678.

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