Anxiety About Casual Exposure to Food Allergens
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional

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.
    

Intervention name(s): Behavioral intervention group; Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients will hold the peanut or tree nut in a cup and will be asked to touch the nut with their finger.; The group will be educated about what can occur with contact with or being in proximity of peanuts or tree nuts.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Food Allergy; Anxiety; Casual Exposure; Peanut Hypersensitivity; Tree nut Hypersensitivity; Adolescents