Anxiety About Casual Exposure to Food Allergens (TOUCH)

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.

Study Overview

• Status: Completed
• Conditions: Food Allergy
• Intervention / Treatment: Behavioral: Behavioral intervention group; Behavioral: Education

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Behavioral Intervention; Behavioral Intervention Group - Education regarding nut allergy and will also have contact with nut.	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.
Placebo Comparator: Control; Education regarding nut allergy	Behavioral: Education; The group will be educated about what can occur with contact with or being in proximity of peanuts or tree nuts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child worry about casual exposure	Change in a child-reported 10-point likert scale assessing how worried the child is about the thought of being near or touching peanut or tree nut, where 0 is not worried at all and 10 is extremely worried pre-intervention compared to immediately post-intervention.	Baseline and approximately 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent worry about casual exposure	Parent-proxy reported scale in response to additional questions assessing how worried the child is about the thought of being near or touching peanut or tree nut, where 0 is not worried at all and 10 is extremely worried, at one month compared to baseline.	Baseline and one month
Food Allergy Quality of Life-Parental Burden (FAQL-PB) Questionnaire	The score obtained on a parent-reported quality of life questionnaire (QOL). QOL is measured on a standardized FAQL-PB questionnaire which consists of 17 questions and responses are measured on a 6-point likert scale where 0 is not limited and 6 is very limited with total from 0 to 102.	One month
The Screen for Child Anxiety Related Disorders (SCARED)	Change in child anxiety at one month compared to baseline.The SCARED consists of 17 items, rated on a 3 point Likert-type scale. Total score range from 0 (not anxious) to 34 (very anxious).	Baseline and one month
SCARED - parent version	Change in parent-proxy measures of child anxiety on parent reported SCARED at one month compared to baseline. 17 items, rated on a 3 point Likert-type scale. Total score range from 0 (not anxious) to 34 (very anxious).	Baseline and one month

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): June 13, 2018
• Study Completion (Actual): June 13, 2018

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Adolescents; Anxiety; Food Allergy; Peanut Hypersensitivity; Casual Exposure; Tree nut Hypersensitivity
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: GCO 17-1957

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No