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Anxiety About Casual Exposure to Food Allergens (TOUCH)

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ClinicalTrials.gov Identifier: NCT03349047
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Food Allergy Behavioral: Behavioral intervention group Behavioral: Education Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial To Reduce Food Allergy Anxiety by Holding the Allergen (TOUCH Study)
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : November 13, 2018
Estimated Study Completion Date : November 13, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Child worry about casual exposure [ Time Frame: Baseline and approximately 10 minutes ]
    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 :
  1. Parent worry about casual exposure [ Time Frame: Baseline and one month ]
    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.

  2. Food Allergy Quality of Life-Parental Burden (FAQL-PB) Questionnaire [ Time Frame: One month ]
    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.

  3. The Screen for Child Anxiety Related Disorders (SCARED) [ Time Frame: Baseline and one month ]
    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).

  4. SCARED - parent version [ Time Frame: Baseline and one month ]
    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).



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Ages Eligible for Study:   108 Months to 210 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349047


Contacts
Contact: Tamar Weinberger, MD 212-241-1371 tamar.weinberger@mountsinai.org
Contact: Scott Sicherer, MD 212-241-5538 scott.sicherer@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Tamar Weinberger, MD    212-241-1371    tamar.weinberger@mountsinai.org   
Contact: Christopher Knight       Christopher.knight@mountsinai.org   
Principal Investigator: Scott Sicherer, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Scott Sicherer, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03349047     History of Changes
Other Study ID Numbers: GCO 17-1957
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
Food Allergy
Anxiety
Casual Exposure
Peanut Hypersensitivity
Tree nut Hypersensitivity
Adolescents

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate