Anxiety About Casual Exposure to Food Allergens (TOUCH)
Primary Purpose
Food Allergy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral intervention group
Education
Sponsored by
About this trial
This is an interventional treatment trial for Food Allergy focused on measuring Food Allergy, Anxiety, Casual Exposure, Peanut Hypersensitivity, Tree nut Hypersensitivity, Adolescents
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.
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Behavioral Intervention
Control
Arm Description
Behavioral Intervention Group - Education regarding nut allergy and will also have contact with nut.
Education regarding nut allergy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
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).
Full Information
NCT ID
NCT03349047
First Posted
November 17, 2017
Last Updated
February 20, 2019
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT03349047
Brief Title
Anxiety About Casual Exposure to Food Allergens
Acronym
TOUCH
Official Title
Trial To Reduce Food Allergy Anxiety by Holding the Allergen (TOUCH Study)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
June 13, 2018 (Actual)
Study Completion Date
June 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy
Keywords
Food Allergy, Anxiety, Casual Exposure, Peanut Hypersensitivity, Tree nut Hypersensitivity, Adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Intervention
Arm Type
Active Comparator
Arm Description
Behavioral Intervention Group - Education regarding nut allergy and will also have contact with nut.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Education regarding nut allergy
Intervention Type
Behavioral
Intervention Name(s)
Behavioral intervention group
Intervention Description
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
Intervention Name(s)
Education
Intervention Description
The group will be educated about what can occur with contact with or being in proximity of peanuts or tree nuts.
Primary Outcome Measure Information:
Title
Child worry about casual exposure
Description
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.
Time Frame
Baseline and approximately 10 minutes
Secondary Outcome Measure Information:
Title
Parent worry about casual exposure
Description
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.
Time Frame
Baseline and one month
Title
Food Allergy Quality of Life-Parental Burden (FAQL-PB) Questionnaire
Description
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.
Time Frame
One month
Title
The Screen for Child Anxiety Related Disorders (SCARED)
Description
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).
Time Frame
Baseline and one month
Title
SCARED - parent version
Description
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).
Time Frame
Baseline and one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
108 Months
Maximum Age & Unit of Time
210 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Sicherer, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Anxiety About Casual Exposure to Food Allergens
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