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OpenTrials
Completed

NCT Number: NCT03349047

Anxiety About Casual Exposure to Food Allergens

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.

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Key information

Conditions

Food Allergy Anxiety Disorders Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Mental Disorders Nut Hypersensitivity Nut and Peanut Hypersensitivity Peanut Hypersensitivity

Age range

108 month–210 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral Intervention Group

Behavioral

Patients will hold the peanut or tree nut in a cup and will be asked to touch the nut with their finger.

Education

Behavioral

The group will be educated about what can occur with contact with or being in proximity of peanuts or tree nuts.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Trial To Reduce Food Allergy Anxiety by Holding the Allergen (TOUCH Study)

Acronym: TOUCH

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 21, 2017
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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