Anxiety About Casual Exposure to Food Allergens

NCT ID: NCT03349047

Last Updated: 2019-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-15
• Study Completion Date: 2018-06-13

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavioral Intervention

Behavioral Intervention Group - Education regarding nut allergy and will also have contact with nut.

Group Type: ACTIVE_COMPARATOR

Behavioral intervention group

Intervention Type: BEHAVIORAL

Patients will hold the peanut or tree nut in a cup and will be asked to touch the nut with their finger.

Education

Intervention Type: BEHAVIORAL

The group will be educated about what can occur with contact with or being in proximity of peanuts or tree nuts.

Control

Education regarding nut allergy

Group Type: PLACEBO_COMPARATOR

Education

Intervention Type: BEHAVIORAL

The group will be educated about what can occur with contact with or being in proximity of peanuts or tree nuts.

Interventions

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.

Intervention Type: BEHAVIORAL

Education

The group will be educated about what can occur with contact with or being in proximity of peanuts or tree nuts.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age: 9 years to 17.5 years
• Patient seen in the outpatient clinic (no inpatients).
• Patient and or caretaker endorses anxiety about being in proximity with or touching peanut
• Patients must have been diagnosed with a peanut and or tree nut allergy

Exclusion Criteria

• Patients and caregiver(s) without ability to understand the study, as determined by either: a previously diagnosed cognitive disability or inability to repeat the study protocol at the time of consent.

• Minimum Eligible Age: 108 Months
• Maximum Eligible Age: 210 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Sicherer, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

GCO 17-1957

Identifier Type: -

Identifier Source: org_study_id