跳至主要内容
临床试验/NCT03349047
NCT03349047已完成不适用

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

Icahn School of Medicine at Mount Sinai2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Child worry about casual exposure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
108 Months 至 210 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Behavioral Intervention

Active Comparator

Behavioral Intervention Group - Education regarding nut allergy and will also have contact with nut.

干预措施: Behavioral intervention group (Behavioral)

Behavioral Intervention

Active Comparator

Behavioral Intervention Group - Education regarding nut allergy and will also have contact with nut.

干预措施: Education (Behavioral)

Control

Placebo Comparator

Education regarding nut allergy

干预措施: Education (Behavioral)

结局指标

主要结局

Child worry about casual exposure

时间窗: 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.

次要结局

  • Food Allergy Quality of Life-Parental Burden (FAQL-PB) Questionnaire(One month)
  • The Screen for Child Anxiety Related Disorders (SCARED)(Baseline and one month)
  • Parent worry about casual exposure(Baseline and one month)
  • SCARED - parent version(Baseline and one month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验