Food AllergyTOUCHNCT03349047
Anxiety About Casual Exposure to Food Allergens
A study testing Behavioral intervention group and Education in people with Food Allergy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 108 to 210 months
- Conditions the study is for
- Food Allergy
- What is being tested?
- Behavioral intervention group and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 13 Jun 2018
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 108 to 210 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Trial To Reduce Food Allergy Anxiety by Holding the Allergen (TOUCH Study)
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.
Read the 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.
- Conditions
- Food Allergy
- Being tested
- Behavioral intervention group, Education
- Keywords
- Food Allergy, Anxiety, Casual Exposure, Peanut Hypersensitivity, Tree nut Hypersensitivity, Adolescents
- Medical subject headings
- Food Hypersensitivity, Anxiety Disorders, Peanut Hypersensitivity, Nut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral intervention groupBehavioural
Patients will hold the peanut or tree nut in a cup and will be asked to touch the nut with their finger.
EducationBehavioural
The group will be educated about what can occur with contact with or being in proximity of peanuts or tree nuts.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Intervention | Active comparator | Behavioral Intervention Group - Education regarding nut allergy and will also have contact with nut. Receives: Behavioral: Behavioral intervention group; Behavioral: Education |
| Control | Placebo comparator | Education regarding nut allergy Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and approximately 10 minutes
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline and one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start15 Nov 2017
- Primary completion13 Jun 2018
- Study completion13 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Sicherer, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349047
- Sponsor's protocol ID
- GCO 17-1957
- Acronym
- TOUCH
- Status last verified
- Feb 2019
- First submitted
- 17 Nov 2017
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No