NCT03349047

Anxiety About Casual Exposure to Food Allergens

Trial To Reduce Food Allergy Anxiety by Holding the Allergen (TOUCH Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 108 Months – 210 Months
• Healthy volunteers: Not accepted

Summary

Living with food allergy may result in anxiety and reduced quality of life. Food allergic patients and their families are often concerned about casual exposure with the offending allergen through skin contact or being near the offending food, which is actually very low risk. This concern can limit social activities and increase stress. The aim of this study is to provide a behavioral intervention consisting of having peanut/tree nut allergic patients hold a cup with a peanut or tree nut to which the patient is allergic to and touching it. The goal is to reduce anxiety about casual exposure to food allergens and improve quality of life for patients with food allergies and their families.

Detailed description

The purpose of the present study is to determine if having patients (ages 9-17) who are peanut and/or tree nut allergic, and endorse anxiety/discomfort about non-ingestion exposure, hold and touch their offending allergen in addition to education leads to reduced discomfort for both patient and caregiver compared to education alone. The primary outcome measure is immediate differences in the score obtained on a child-reported scale in response to a question assessing how worried the patient is about the thought of being near or touching peanut or tree nut from pre-intervention to immediate post-intervention when compared between an intervention (education and touching) and a control group (education only). Secondary outcome measures include: difference between and within groups of child-reported scales regarding questions assessing patients worry regarding casual exposure immediately and one month post intervention within and between groups, differences between and within groups on a parent-reported scale regarding parental worry about casual exposure to food allergen immediately and one month post intervention within and between groups, differences between and within groups on a parent-proxy measures regarding child worry about casual exposure to food allergen immediately and one month post intervention within and between groups, improvement in child anxiety and parent-proxy measures of anxiety from pre-intervention to one month post-intervention within and between groups and improvement in parent-proxy measures of quality of life from pre-intervention to one month post-intervention within and between groups.

Conditions

• Food Allergy

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral intervention group	Patients will hold the peanut or tree nut in a cup and will be asked to touch the nut with their finger.
BEHAVIORAL	Education	The group will be educated about what can occur with contact with or being in proximity of peanuts or tree nuts.

Timeline

• Start date: 2017-11-15
• Primary completion: 2018-06-13
• Completion: 2018-06-13
• First posted: 2017-11-21
• Last updated: 2019-02-21

Locations

1 site across 1 country: United States