Anxiety About Casual Exposure to Food Allergens
| Status: | Completed |
|---|---|
| Conditions: | Allergy, Allergy, Food Studies, Neurology |
| Therapuetic Areas: | Neurology, Otolaryngology, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/23/2019 |
| Start Date: | November 15, 2017 |
| End Date: | June 13, 2018 |
Trial To Reduce Food Allergy Anxiety by Holding the Allergen (TOUCH Study)
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.
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.
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.
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.
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.
We found this trial at
1
site
1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
Principal Investigator: Scott Sicherer, MD
Phone: 212-241-1371
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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