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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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Food Allergy Impact

Food Allergy Knowledge

Food Allergy Management Behaviors

+8 more

Secondary study objectives

Food Allergy Anxiety

Food Allergy Self-Efficacy

Social Support

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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