Both arms are given identical treatment instructions at their first clinic visit, including practical strategies for taking doses and managing symptoms. Families are given comprehensive instructions for recognizing life-threatening symptoms and administering epinephrine when appropriate. However, information about the implications of non-life-threatening symptoms differs between arms. At the first clinic visit, families are given verbal (e.g., provider explanations) and written information (e.g., brochures on symptom management) informing them about symptoms in different ways. In this arm, families are informed that these non-life-threatening symptoms are an unfortunate part of treatment that must be endured, similar to side effects from common medications.

Both arms are given identical treatment instructions at their first clinic visit, including practical strategies for taking doses and managing symptoms. Families are given comprehensive instructions for recognizing life-threatening symptoms and administering epinephrine when appropriate. However, information about the implications of non-life-threatening symptoms differs between arms. At the first clinic visit, families are given verbal (e.g., provider explanations) and written information (e.g., brochures on symptom management) informing them about symptoms in different ways. In this arm, families are informed that symptoms are a sign that that their bodies are gradually increasing desensitization, similar to having sore muscles after a difficult workout.

Peanut Allergy

In this intervention, both arms receive the same strategies for managing symptoms and receive the same level of support regarding symptoms. However, Symptoms as Positive Signals Mindset families are additionally encouraged to think of symptoms as a positive signal that their immune system is becoming increasingly desensitized to their allergen. For each arm, four families (six to seven patients per group) meet monthly for eight months in the clinic with at least two members of the patient support team. These visits are an opportunity for families to harness peer support and ask questions, and include a variety of activities that depict symptoms in different ways.

Symptoms as Positive Signals Mindset

In this intervention, both arms receive the same strategies for managing symptoms and receive the same level of support regarding symptoms. For each arm, four families (six to seven patients per group) meet monthly for eight months in the clinic with at least two members of the patient support team. These visits are an opportunity for families to harness peer support and ask questions, and include a variety of activities that depict symptoms in different ways.

Symptoms as Side Effects Mindset

Allergy Experience Study

Changing Mindsets About Oral Immunotherapy for Peanut Allergies Via Informing Patients That Symptoms Are a Sign of Treatment Efficacy: A Randomized Controlled Trial

Measured through daily REDCap surveys and monthly in clinic surveys; measured through parent contacting staff with concerns about symptoms

Number of patients who complete within 2 weeks of the target end date

Number of doses skipped or reduced because of anxiety

Two blood samples assayed for IgG4 levels; one pre-treatment and one post-treatment

Two blood samples assayed for IgE levels; one pre-treatment and one post-treatment

If made publicly available, all data will be de-identified and the anonymous data will be shared with researchers on the Open Science Framework

Alia Crum

Assistant Professor of Psychology

Stanford University

Challenge Group: Children with positive skin prick testing to peanut who are avoiding peanut will undergo a double-blind placebo-controlled peanut challenge (gold standard for peanut allergy diagnosis) if their allergy evaluation suggests that they have a good chance of not being allergic to peanut. Children who pass the challenge are not allergic to peanut. Children who react during the challenge are allergic to peanut and will continue to avoid peanut.

Comparison Group: Children with positive skin prick testing to peanut who are eating and tolerating peanut are not clinically allergic to peanut and may continue eating peanut.

Blood for immunological markers of peanut allergy

Allergy to Peanut

Children who are avoiding peanut will be gradually introduced to smoothies containing and not containing peanut, to see if they are able to tolerate eating peanut. This challenge does not change a child's ability to tolerate peanut, but will determine which children avoiding peanut are allergic to peanut and which children are not allergic and may begin eating peanut.

Double-blind placebo-controlled peanut challenge

Predictors of Persistent Peanut Allergy at Age 5 Years

Early Life Origins of the Food Allergy Epidemic: Predictors of Persistent Peanut Allergy at Age 5 Years

Clinical tolerance to peanut (passing a peanut challenge and eating peanut regularly)

Elinor Simons

Dr. Elinor Simons, Assistant Professor

University of Manitoba

University of British Columbia

The Hospital for Sick Children

McGill University

Double Blind Placebo Controlled Food Challenge 5 gram peanut challenge
17 doses of peanut will be administered. Dose will be increased every 20-30 minutes. All doses listed are in g of peanut flour.
0.1 0.25 0.5 0.75
1 2.5 5 10 25 50 100 250 500 750 1000 2500 5000

Double Blind Placebo Controlled Food Challenge (No peanut - placebo only)

All participants will undergo Double Blind Placebo Controlled Food Challenge. Participants will be randomized to receive either Peanut on Day 1, Placebo on Day 2, or vice versa.
For 'Peanut' arm, participants will be fed increasing doses of peanut until mild objective allergic reaction is observed.
Doses will be increased every 20-30 minutes. All doses are listed in g peanut flour
0.1 0.25 0.5 0.75
1 2.5 5 10 25 50 100 250 500 750 1000 2500 5000
For "Placebo" arm, participants will be fed increasing amounts of food matrix without peanut flour.

peanut hypersensitivity/erbrechen

Allergy Experience Study

Predictors of Persistent Peanut Allergy at Age 5 Years

Canadian Peanut Thresholds Study

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