NCT03349047

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2018

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

November 17, 2017

Last Update Submit

February 20, 2019

Conditions

Food Allergy

Keywords

Food AllergyAnxietyCasual ExposurePeanut HypersensitivityTree nut HypersensitivityAdolescents

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and approximately 10 minutes

Secondary Outcomes (4)

  • Parent worry about casual exposure

    Baseline and one month

  • Food Allergy Quality of Life-Parental Burden (FAQL-PB) Questionnaire

    One month

  • The Screen for Child Anxiety Related Disorders (SCARED)

    Baseline and one month

  • SCARED - parent version

    Baseline and one month

Study Arms (2)

Behavioral Intervention

ACTIVE COMPARATOR

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

Behavioral: Behavioral intervention groupBehavioral: Education

Control

PLACEBO COMPARATOR

Education regarding nut allergy

Behavioral: Education

Interventions

Behavioral intervention groupBEHAVIORAL

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

Behavioral Intervention
EducationBEHAVIORAL

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

Behavioral InterventionControl

Eligibility Criteria

Age108 Months - 210 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Food HypersensitivityAnxiety DisordersPeanut HypersensitivityNut Hypersensitivity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System DiseasesMental DisordersNut and Peanut Hypersensitivity

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Scott Sicherer, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 21, 2017

Study Start

November 15, 2017

Primary Completion

June 13, 2018

Study Completion

June 13, 2018

Last Updated

February 21, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)