Clinical trial NCT03349047: Anxiety About Casual Exposure to Food Allergens
Official title: Trial To Reduce Food Allergy Anxiety by Holding the Allergen (TOUCH Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy
Keywords: Food Allergy
Anxiety
Casual Exposure
Peanut Hypersensitivity
Tree nut Hypersensitivity
Adolescents
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 108
Maximum age (years): 210
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Child worry about casual exposure
timeFrame: Baseline and approximately 10 minutes
Secondary outcomes:
measure: Parent worry about casual exposure
timeFrame: Baseline and one month
measure: Food Allergy Quality of Life-Parental Burden (FAQL-PB) Questionnaire
timeFrame: One month
measure: The Screen for Child Anxiety Related Disorders (SCARED)
timeFrame: Baseline and one month
measure: SCARED - parent version
timeFrame: Baseline and one month
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Scott Sicherer, MD
role: PRINCIPAL_INVESTIGATOR
References: