An interventional study of Behavioral intervention group and Education in Food Allergy, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 108 Months to 210 Months. Per ClinicalTrials.gov, last updated 2019-02-21.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
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.
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.
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 246 interventional studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
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Exclusion Criteria:
Behavioral Intervention Group - Education regarding nut allergy and will also have contact with nut.
Behavioral: Behavioral intervention group · Behavioral: Education
Education regarding nut allergy
Behavioral: Education
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.
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.
Time frame: Baseline and approximately 10 minutes
Parent worry about casual exposure
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.
Time frame: Baseline and one month
Food Allergy Quality of Life-Parental Burden (FAQL-PB) Questionnaire
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.
Time frame: One month
The Screen for Child Anxiety Related Disorders (SCARED)
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).
Time frame: Baseline and one month
SCARED - parent version
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).
Time frame: Baseline and one month
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Jun 2018, 6 months.
Of 81 non-industry interventional studies with no phase under Food Hypersensitivity, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 50. This study's 6 months is below that.
Counting every sponsor, half of 84 studies reached it within 29 months; a quarter within 13 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai →