search
Back to results

Evaluation of The Food Allergy Mastery Program

Primary Purpose

Food Allergy in Children

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food Allergy Mastery Program
Sponsored by
Children's National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Food Allergy in Children focused on measuring food allergy, knowledge, management, adolescents, caregivers, social support

Eligibility Criteria

10 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age 10-14 years physician diagnosis (i.e., history of a reaction to the food and/or recent positive skin prick test or IgE-specific testing) of at least 1 of the 9 most common IgE-mediated food allergies (peanut, tree nut, cow's milk, egg, soy, wheat, shellfish, fish, sesame) for ≥1 year, with accompanying allergen avoidance prescribed by an allergist English fluency access to a device with internet access either a food allergy knowledge score of <80% correct on the Food Allergy Knowledge Test (FAKT) or a food allergy impact score of ≥3 on the Food Allergy Independent Measure (FAIM). Exclusion Criteria: diagnosis of a non-IgE-mediated food allergy or food intolerance, a non-atopic chronic illness or pervasive developmental disorder/cognitive limitation Current participation in psychotherapy with a therapist with food allergy expertise

Sites / Locations

  • Childrens' National HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Food Allergy Mastery Program

Usual Care

Arm Description

Participants randomized to the Food Allergy Mastery Program arm will participate in 6 telehealth intervention sessions with a trained mental health provider pertaining to food allergy education, food allergy management, anxiety and stress management, social situations, and self-efficacy. One of the 6 sessions is a group session with peers.

Participants will receive their usual allergy care.

Outcomes

Primary Outcome Measures

Food Allergy Knowledge
Early adolescents and caregivers will complete the Food Allergy Knowledge Test (FAKT), a -item measure of food allergy knowledge, including general clinical food allergy knowledge, avoiding exposure (i.e., cross-contact, reading labels), epinephrine auto-injector use, and signs, symptoms, and treatment of anaphylaxis. Items are scored as correct/incorrect, and a sum score is generated. Higher scores indicate greater food allergy knowledge. The FAKT was found to be highly reliable with validity analyses revealing positive score correlations with parent age, education, insurance status, access to food allergy information, and epinephrine auto-injector use.
Food Allergy Knowledge
Early adolescents and caregivers will complete the Food Allergy Knowledge Test (FAKT), a -item measure of food allergy knowledge, including general clinical food allergy knowledge, avoiding exposure (i.e., cross-contact, reading labels), epinephrine auto-injector use, and signs, symptoms, and treatment of anaphylaxis. Items are scored as correct/incorrect, and a sum score is generated. Higher scores indicate greater food allergy knowledge. The FAKT was found to be highly reliable with validity analyses revealing positive score correlations with parent age, education, insurance status, access to food allergy information, and epinephrine auto-injector use.
Food Allergy Knowledge
Early adolescents and caregivers will complete the Food Allergy Knowledge Test (FAKT), a -item measure of food allergy knowledge, including general clinical food allergy knowledge, avoiding exposure (i.e., cross-contact, reading labels), epinephrine auto-injector use, and signs, symptoms, and treatment of anaphylaxis. Items are scored as correct/incorrect, and a sum score is generated. Higher scores indicate greater food allergy knowledge. The FAKT was found to be highly reliable with validity analyses revealing positive score correlations with parent age, education, insurance status, access to food allergy information, and epinephrine auto-injector use.
Food Allergy Management Skills- Label Reading
Early adolescents' and caregivers' food allergy management skills will be independently assessed via direct observation of their ability to correctly read food labels and use an epinephrine auto-injector trainer. Participants will be asked to review 5 food labels for safety for themselves/their child, of which 3 food labels will not be safe and 2 food labels will be safe. A percentage correct score based on the number of labels that they correctly identify as containing or not containing allergen(s) will be calculated.
Food Allergy Management Skills- Label Reading
Early adolescents' and caregivers' food allergy management skills will be independently assessed via direct observation of their ability to correctly read food labels and use an epinephrine auto-injector trainer. Participants will be asked to review 5 food labels for safety for themselves/their child, of which 3 food labels will not be safe and 2 food labels will be safe. A percentage correct score based on the number of labels that they correctly identify as containing or not containing allergen(s) will be calculated.
Food Allergy Management Skills- Label Reading
Early adolescents' and caregivers' food allergy management skills will be independently assessed via direct observation of their ability to correctly read food labels and use an epinephrine auto-injector trainer. Participants will be asked to review 5 food labels for safety for themselves/their child, of which 3 food labels will not be safe and 2 food labels will be safe. A percentage correct score based on the number of labels that they correctly identify as containing or not containing allergen(s) will be calculated.
Food Allergy Management Skills- Epinephrine Auto-Injector Use
Participants will be asked to demonstrate how to use the epinephrine auto-injector trainer for which they have a prescription (i.e., EpiPen, AuviQ, or generic). Participants will receive a point for each of the following: removing the cap, holding it correctly, positioning it correctly on the outer thigh, "injecting" it properly, and then holding it against the thigh for the appropriate amount of time. A percentage correct score will be calculated.
Food Allergy Management Skills- Epinephrine Auto-Injector Use
Participants will be asked to demonstrate how to use the epinephrine auto-injector trainer for which they have a prescription (i.e., EpiPen, AuviQ, or generic). Participants will receive a point for each of the following: removing the cap, holding it correctly, positioning it correctly on the outer thigh, "injecting" it properly, and then holding it against the thigh for the appropriate amount of time. A percentage correct score will be calculated.
Food Allergy Management Skills- Epinephrine Auto-Injector Use
Participants will be asked to demonstrate how to use the epinephrine auto-injector trainer for which they have a prescription (i.e., EpiPen, AuviQ, or generic). Participants will receive a point for each of the following: removing the cap, holding it correctly, positioning it correctly on the outer thigh, "injecting" it properly, and then holding it against the thigh for the appropriate amount of time. A percentage correct score will be calculated.
Food Allergy Management Behaviors
Early adolescents will complete the Food Allergy Management 24-Hour Recall (FAM-24), a 24-hour recall interview facilitated by a research team member that asks a series of questions about each food they ate during the previous day. Participants report on the time of the meal/snack, where they ate (e.g., school, home, a restaurant), whether an adult was present, whether epinephrine was available, and if so, where it was located (e.g., on person, in another room). They also report if they had an allergic reaction. For each individual food eaten during the meal/snack, participants report what the food was, whether they ate it before, whether it was verified as allergen-free, how it was verified (e.g., prepared at home, read the label, asked about ingredients), and who verified it (e.g., child, parent, teacher, another adult). Participants can endorse multiple methods of allergen-free verification and multiple people who completed the verification.
Food Allergy Management Behaviors
Early adolescents will complete the Food Allergy Management 24-Hour Recall (FAM-24), a 24-hour recall interview facilitated by a research team member that asks a series of questions about each food they ate during the previous day. Participants report on the time of the meal/snack, where they ate (e.g., school, home, a restaurant), whether an adult was present, whether epinephrine was available, and if so, where it was located (e.g., on person, in another room). They also report if they had an allergic reaction. For each individual food eaten during the meal/snack, participants report what the food was, whether they ate it before, whether it was verified as allergen-free, how it was verified (e.g., prepared at home, read the label, asked about ingredients), and who verified it (e.g., child, parent, teacher, another adult). Participants can endorse multiple methods of allergen-free verification and multiple people who completed the verification.
Food Allergy Management Behaviors
Early adolescents will complete the Food Allergy Management 24-Hour Recall (FAM-24), a 24-hour recall interview facilitated by a research team member that asks a series of questions about each food they ate during the previous day. Participants report on the time of the meal/snack, where they ate (e.g., school, home, a restaurant), whether an adult was present, whether epinephrine was available, and if so, where it was located (e.g., on person, in another room). They also report if they had an allergic reaction. For each individual food eaten during the meal/snack, participants report what the food was, whether they ate it before, whether it was verified as allergen-free, how it was verified (e.g., prepared at home, read the label, asked about ingredients), and who verified it (e.g., child, parent, teacher, another adult). Participants can endorse multiple methods of allergen-free verification and multiple people who completed the verification.
Food Allergy Quality of Life- Child Self Report
Early adolescents will complete the Food Allergy Quality of Life Questionnaire - Child Form (8-12 years) (FAQLQ-CF), a validated 10-item measure, or the Food Allergy Quality of Life Questionnaire - Teenager Form (13-17 years) (FAQLQ-TF), a validated 10-item measure. Participants only complete the questionnaire appropriate for their age. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.
Food Allergy Quality of Life- Child Self-Report
Early adolescents will complete the Food Allergy Quality of Life Questionnaire - Child Form (8-12 years) (FAQLQ-CF), a validated 10-item measure, or the Food Allergy Quality of Life Questionnaire - Teenager Form (13-17 years) (FAQLQ-TF), a validated 10-item measure. Participants only complete the questionnaire appropriate for their age. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.
Food Allergy Quality of Life- Child Self-Report
Early adolescents will complete the Food Allergy Quality of Life Questionnaire - Child Form (8-12 years) (FAQLQ-CF), a validated 10-item measure, or the Food Allergy Quality of Life Questionnaire - Teenager Form (13-17 years) (FAQLQ-TF), a validated 10-item measure. Participants only complete the questionnaire appropriate for their age. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.
Food Allergy Quality of Life- Parent Proxy
Caregivers will complete the Food Allergy Quality of Life Questionnaire - Parent Form (FAQLQ-PF), a validated 10-item measure of parents' perceptions of their child's quality of life. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.
Food Allergy Quality of Life- Parent Proxy
Caregivers will complete the Food Allergy Quality of Life Questionnaire - Parent Form (FAQLQ-PF), a validated 10-item measure of parents' perceptions of their child's quality of life. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.
Food Allergy Quality of Life- Parent Proxy
Caregivers will complete the Food Allergy Quality of Life Questionnaire - Parent Form (FAQLQ-PF), a validated 10-item measure of parents' perceptions of their child's quality of life. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.
Food Allergy Impact
Children will complete the Food Allergy Independent Measure (FAIM), a 6-item measure of children's perceptions of risk of allergen exposure, chance of a severe reaction, chance of dying, and ability to engage in proper treatment, which generates a total score. Scores can range from 0-6; higher scores indicate more impact of food allergy on daily life.
Food Allergy Impact
Children will complete the Food Allergy Independent Measure (FAIM), a 6-item measure of children's perceptions of risk of allergen exposure, chance of a severe reaction, chance of dying, and ability to engage in proper treatment, which generates a total score. Scores can range from 0-6; higher scores indicate more impact of food allergy on daily life.
Food Allergy Impact
Children will complete the Food Allergy Independent Measure (FAIM), a 6-item measure of children's perceptions of risk of allergen exposure, chance of a severe reaction, chance of dying, and ability to engage in proper treatment, which generates a total score. Scores can range from 0-6; higher scores indicate more impact of food allergy on daily life.
Frequency of Treatment for Allergic Reactions
Participants will report on the frequency of treatment for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.
Frequency of Treatment for Allergic Reactions
Participants will report on the frequency of treatment for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.
Frequency of Treatment for Allergic Reactions
Participants will report on the frequency of treatment for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.
Frequency of Allergy Appointments
Participants will report on the frequency of allergy appointments in the past 6 months. This information will also be assessed by study staff via clinic chart review.
Frequency of Allergy Appointments
Participants will report on the frequency of allergy appointments in the past 6 months. This information will also be assessed by study staff via clinic chart review.
Frequency of Emergency Room/Urgent Care Visits for Allergic Reactions
Participants will report on the frequency of emergency room/urgent care visits for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.
Frequency of Allergy Appointments
Participants will report on the frequency of allergy appointments in the past 6 months. This information will also be assessed by study staff via clinic chart review.
Frequency of Emergency Room/Urgent Care Visits for Allergic Reactions
Participants will report on the frequency of emergency room/urgent care visits for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.
Frequency of Emergency Room/Urgent Care Visits for Allergic Reactions
Participants will report on the frequency of emergency room/urgent care visits for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.

Secondary Outcome Measures

Social Support
Early adolescents will complete the Multidimensional Scale of Perceived Social Support (MSPSS) to measure agreement with statements of general subjectively assessed social support from friends, family, and a significant other. The MSPSS consists of 12 items that assess perceived social support. Respondents elect responses on a Likert-type scale from 0 ("Very Strongly Disagree") to 6 ("Very Strongly Agree"). Total scores are computed by calculating the mean of all items, and higher scores indicate greater perceived social support. Score range is 0-6.
Social Support
Early adolescents will complete the Multidimensional Scale of Perceived Social Support (MSPSS) to measure agreement with statements of general subjectively assessed social support from friends, family, and a significant other. The MSPSS consists of 12 items that assess perceived social support. Respondents elect responses on a Likert-type scale from 0 ("Very Strongly Disagree") to 6 ("Very Strongly Agree"). Total scores are computed by calculating the mean of all items, and higher scores indicate greater perceived social support. Score range is 0-6.
Social Support
Early adolescents will complete the Multidimensional Scale of Perceived Social Support (MSPSS) to measure agreement with statements of general subjectively assessed social support from friends, family, and a significant other. The MSPSS consists of 12 items that assess perceived social support. Respondents elect responses on a Likert-type scale from 0 ("Very Strongly Disagree") to 6 ("Very Strongly Agree"). Total scores are computed by calculating the mean of all items, and higher scores indicate greater perceived social support. Score range is 0-6.
Food Allergy Self-Efficacy
Early adolescents and caregivers will each complete the Food Allergy Self-Efficacy Scale (FASE), a 21-item measure that uses a 100-point visual analog scale. Higher scores indicate a greater degree of confidence in one's ability to manage food allergies. Score range is 0-100. The FASE is valid and reliable among parents.
Food Allergy Self-Efficacy
Early adolescents and caregivers will each complete the Food Allergy Self-Efficacy Scale (FASE), a 21-item measure that uses a 100-point visual analog scale. Higher scores indicate a greater degree of confidence in one's ability to manage food allergies. Score range is 0-100. The FASE is valid and reliable among parents.
Food Allergy Self-Efficacy
Early adolescents and caregivers will each complete the Food Allergy Self-Efficacy Scale (FASE), a 21-item measure that uses a 100-point visual analog scale. Higher scores indicate a greater degree of confidence in one's ability to manage food allergies. Score range is 0-100. The FASE is valid and reliable among parents.
Food Allergy Anxiety
Early adolescents and caregivers will each complete the Scale of Food Allergy Anxiety (SOFAA), a 21-item measure that uses a Likert scale (0=Never to 4=Almost Always). Higher scores indicate more food allergy anxiety. Score range is 0-84. The SOFAA is valid and reliable among parents.
Food Allergy Anxiety
Early adolescents and caregivers will each complete the Scale of Food Allergy Anxiety (SOFAA), a 21-item measure that uses a Likert scale (0=Never to 4=Almost Always). Higher scores indicate more food allergy anxiety. Score range is 0-84. The SOFAA is valid and reliable among parents.
Food Allergy Anxiety
Early adolescents and caregivers will each complete the Scale of Food Allergy Anxiety (SOFAA), a 21-item measure that uses a Likert scale (0=Never to 4=Almost Always). Higher scores indicate more food allergy anxiety. Score range is 0-84. The SOFAA is valid and reliable among parents.

Full Information

First Posted
July 18, 2023
Last Updated
September 5, 2023
Sponsor
Children's National Research Institute
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Northwestern University, Rhode Island Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT06034678
Brief Title
Evaluation of The Food Allergy Mastery Program
Official Title
Evaluation of a Behavioral Intervention to Promote Food Allergy Self-Management Among Early Adolescents: The Food Allergy Mastery Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
November 30, 2026 (Anticipated)
Study Completion Date
November 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's National Research Institute
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Northwestern University, Rhode Island Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The proposed research project will evaluate a novel behavioral intervention that promotes early adolescent food allergy self-management and adjustment through 1) food allergy education, 2) problem-solving, communication, assertiveness, and anxiety management skill building, and 3) peer support.
Detailed Description
The proposed research project will evaluate a novel behavioral intervention that promotes early adolescent food allergy self-management and adjustment through 1) food allergy education, 2) problem-solving, communication, assertiveness, and anxiety management skill building, and 3) peer support. The Food Allergy Mastery (FAM) program is a 6-session food allergy self-management program that will be delivered to early adolescents with food allergy, a high-risk population that is growing in size, and a primary caregiver by a trained interventionist. The specific aims are: 1) To evaluate the intervention's impact on food allergy knowledge and self-management skills, 2) To determine the intervention's impact on food allergy self-management behavior and psychosocial functioning and healthcare utilization, and as an exploratory aim 3) to determine if early adolescents' race/ethnicity moderates response to treatment, including food allergy knowledge, skills, self-management behavior, psychosocial functioning, and healthcare utilization. The study has the potential to positively impact the health care utilization of youth with food allergy by evaluating a scalable behavioral intervention for adolescents and their caregivers. The intervention will equip youth with food allergy knowledge and self-management skills by bolstering their food allergy-related knowledge and problem-solving, social skills, and social support and attenuating food allergy anxiety. Successful development and implementation of the FAM Program that promotes the attainment of integration of food allergy into daily life has the potential to decrease health care utilization reducing emergency visits and improve food allergy-related quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy in Children
Keywords
food allergy, knowledge, management, adolescents, caregivers, social support

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Food Allergy Mastery Program
Arm Type
Experimental
Arm Description
Participants randomized to the Food Allergy Mastery Program arm will participate in 6 telehealth intervention sessions with a trained mental health provider pertaining to food allergy education, food allergy management, anxiety and stress management, social situations, and self-efficacy. One of the 6 sessions is a group session with peers.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants will receive their usual allergy care.
Intervention Type
Behavioral
Intervention Name(s)
Food Allergy Mastery Program
Intervention Description
Food Allergy Mastery Program sessions will be delivered by masters-level counselors as 6 45-minute biweekly telehealth or in-person sessions over a period of 3 months. Session 1 will include both youth and caregiver, Session 2 will be a group session with 5-6 youth, Session 3 will include both youth and caregiver, Sessions 4-5 will be individual youth sessions, and Session 6 will include both youth and caregiver. Sessions will incorporate a variety of formats, each based on the needs of the session content.
Primary Outcome Measure Information:
Title
Food Allergy Knowledge
Description
Early adolescents and caregivers will complete the Food Allergy Knowledge Test (FAKT), a -item measure of food allergy knowledge, including general clinical food allergy knowledge, avoiding exposure (i.e., cross-contact, reading labels), epinephrine auto-injector use, and signs, symptoms, and treatment of anaphylaxis. Items are scored as correct/incorrect, and a sum score is generated. Higher scores indicate greater food allergy knowledge. The FAKT was found to be highly reliable with validity analyses revealing positive score correlations with parent age, education, insurance status, access to food allergy information, and epinephrine auto-injector use.
Time Frame
Change in Food Allergy Knowledge from Baseline to 6 Month Follow Up
Title
Food Allergy Knowledge
Description
Early adolescents and caregivers will complete the Food Allergy Knowledge Test (FAKT), a -item measure of food allergy knowledge, including general clinical food allergy knowledge, avoiding exposure (i.e., cross-contact, reading labels), epinephrine auto-injector use, and signs, symptoms, and treatment of anaphylaxis. Items are scored as correct/incorrect, and a sum score is generated. Higher scores indicate greater food allergy knowledge. The FAKT was found to be highly reliable with validity analyses revealing positive score correlations with parent age, education, insurance status, access to food allergy information, and epinephrine auto-injector use.
Time Frame
Change in Food Allergy Knowledge from Baseline to 12 Month Follow Up
Title
Food Allergy Knowledge
Description
Early adolescents and caregivers will complete the Food Allergy Knowledge Test (FAKT), a -item measure of food allergy knowledge, including general clinical food allergy knowledge, avoiding exposure (i.e., cross-contact, reading labels), epinephrine auto-injector use, and signs, symptoms, and treatment of anaphylaxis. Items are scored as correct/incorrect, and a sum score is generated. Higher scores indicate greater food allergy knowledge. The FAKT was found to be highly reliable with validity analyses revealing positive score correlations with parent age, education, insurance status, access to food allergy information, and epinephrine auto-injector use.
Time Frame
Change in Food Allergy Knowledge from Baseline to 18 Month Follow Up
Title
Food Allergy Management Skills- Label Reading
Description
Early adolescents' and caregivers' food allergy management skills will be independently assessed via direct observation of their ability to correctly read food labels and use an epinephrine auto-injector trainer. Participants will be asked to review 5 food labels for safety for themselves/their child, of which 3 food labels will not be safe and 2 food labels will be safe. A percentage correct score based on the number of labels that they correctly identify as containing or not containing allergen(s) will be calculated.
Time Frame
Change in Food Allergy Management Skills- Label Reading from Baseline to 6 Month Follow Up
Title
Food Allergy Management Skills- Label Reading
Description
Early adolescents' and caregivers' food allergy management skills will be independently assessed via direct observation of their ability to correctly read food labels and use an epinephrine auto-injector trainer. Participants will be asked to review 5 food labels for safety for themselves/their child, of which 3 food labels will not be safe and 2 food labels will be safe. A percentage correct score based on the number of labels that they correctly identify as containing or not containing allergen(s) will be calculated.
Time Frame
Change in Food Allergy Management Skills- Label Reading from Baseline to 12 Month Follow Up
Title
Food Allergy Management Skills- Label Reading
Description
Early adolescents' and caregivers' food allergy management skills will be independently assessed via direct observation of their ability to correctly read food labels and use an epinephrine auto-injector trainer. Participants will be asked to review 5 food labels for safety for themselves/their child, of which 3 food labels will not be safe and 2 food labels will be safe. A percentage correct score based on the number of labels that they correctly identify as containing or not containing allergen(s) will be calculated.
Time Frame
Change in Food Allergy Management Skills- Label Reading from Baseline to 18 Month Follow Up
Title
Food Allergy Management Skills- Epinephrine Auto-Injector Use
Description
Participants will be asked to demonstrate how to use the epinephrine auto-injector trainer for which they have a prescription (i.e., EpiPen, AuviQ, or generic). Participants will receive a point for each of the following: removing the cap, holding it correctly, positioning it correctly on the outer thigh, "injecting" it properly, and then holding it against the thigh for the appropriate amount of time. A percentage correct score will be calculated.
Time Frame
Change in Food Allergy Management Skills- Epinephrine Auto-Injector Use from Baseline to 6 Month Follow Up
Title
Food Allergy Management Skills- Epinephrine Auto-Injector Use
Description
Participants will be asked to demonstrate how to use the epinephrine auto-injector trainer for which they have a prescription (i.e., EpiPen, AuviQ, or generic). Participants will receive a point for each of the following: removing the cap, holding it correctly, positioning it correctly on the outer thigh, "injecting" it properly, and then holding it against the thigh for the appropriate amount of time. A percentage correct score will be calculated.
Time Frame
Change in Food Allergy Management Skills- Epinephrine Auto-Injector Use from Baseline to 12 Month Follow Up
Title
Food Allergy Management Skills- Epinephrine Auto-Injector Use
Description
Participants will be asked to demonstrate how to use the epinephrine auto-injector trainer for which they have a prescription (i.e., EpiPen, AuviQ, or generic). Participants will receive a point for each of the following: removing the cap, holding it correctly, positioning it correctly on the outer thigh, "injecting" it properly, and then holding it against the thigh for the appropriate amount of time. A percentage correct score will be calculated.
Time Frame
Change in Food Allergy Management Skills- Epinephrine Auto-Injector Use from Baseline to 18 Month Follow Up
Title
Food Allergy Management Behaviors
Description
Early adolescents will complete the Food Allergy Management 24-Hour Recall (FAM-24), a 24-hour recall interview facilitated by a research team member that asks a series of questions about each food they ate during the previous day. Participants report on the time of the meal/snack, where they ate (e.g., school, home, a restaurant), whether an adult was present, whether epinephrine was available, and if so, where it was located (e.g., on person, in another room). They also report if they had an allergic reaction. For each individual food eaten during the meal/snack, participants report what the food was, whether they ate it before, whether it was verified as allergen-free, how it was verified (e.g., prepared at home, read the label, asked about ingredients), and who verified it (e.g., child, parent, teacher, another adult). Participants can endorse multiple methods of allergen-free verification and multiple people who completed the verification.
Time Frame
Change in Food Allergy Management Behaviors from Baseline to 6 Month Follow Up
Title
Food Allergy Management Behaviors
Description
Early adolescents will complete the Food Allergy Management 24-Hour Recall (FAM-24), a 24-hour recall interview facilitated by a research team member that asks a series of questions about each food they ate during the previous day. Participants report on the time of the meal/snack, where they ate (e.g., school, home, a restaurant), whether an adult was present, whether epinephrine was available, and if so, where it was located (e.g., on person, in another room). They also report if they had an allergic reaction. For each individual food eaten during the meal/snack, participants report what the food was, whether they ate it before, whether it was verified as allergen-free, how it was verified (e.g., prepared at home, read the label, asked about ingredients), and who verified it (e.g., child, parent, teacher, another adult). Participants can endorse multiple methods of allergen-free verification and multiple people who completed the verification.
Time Frame
Change in Food Allergy Management Behaviors from Baseline to 12 Month Follow Up
Title
Food Allergy Management Behaviors
Description
Early adolescents will complete the Food Allergy Management 24-Hour Recall (FAM-24), a 24-hour recall interview facilitated by a research team member that asks a series of questions about each food they ate during the previous day. Participants report on the time of the meal/snack, where they ate (e.g., school, home, a restaurant), whether an adult was present, whether epinephrine was available, and if so, where it was located (e.g., on person, in another room). They also report if they had an allergic reaction. For each individual food eaten during the meal/snack, participants report what the food was, whether they ate it before, whether it was verified as allergen-free, how it was verified (e.g., prepared at home, read the label, asked about ingredients), and who verified it (e.g., child, parent, teacher, another adult). Participants can endorse multiple methods of allergen-free verification and multiple people who completed the verification.
Time Frame
Change in Food Allergy Management Behaviors from Baseline to 18 Month Follow Up
Title
Food Allergy Quality of Life- Child Self Report
Description
Early adolescents will complete the Food Allergy Quality of Life Questionnaire - Child Form (8-12 years) (FAQLQ-CF), a validated 10-item measure, or the Food Allergy Quality of Life Questionnaire - Teenager Form (13-17 years) (FAQLQ-TF), a validated 10-item measure. Participants only complete the questionnaire appropriate for their age. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.
Time Frame
Change in Food Allergy Quality of Life- Child Self Report from Baseline to 6 Month Follow Up
Title
Food Allergy Quality of Life- Child Self-Report
Description
Early adolescents will complete the Food Allergy Quality of Life Questionnaire - Child Form (8-12 years) (FAQLQ-CF), a validated 10-item measure, or the Food Allergy Quality of Life Questionnaire - Teenager Form (13-17 years) (FAQLQ-TF), a validated 10-item measure. Participants only complete the questionnaire appropriate for their age. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.
Time Frame
Change in Food Allergy Quality of Life- Child Self Report from Baseline to 12 Month Follow Up
Title
Food Allergy Quality of Life- Child Self-Report
Description
Early adolescents will complete the Food Allergy Quality of Life Questionnaire - Child Form (8-12 years) (FAQLQ-CF), a validated 10-item measure, or the Food Allergy Quality of Life Questionnaire - Teenager Form (13-17 years) (FAQLQ-TF), a validated 10-item measure. Participants only complete the questionnaire appropriate for their age. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.
Time Frame
Change in Food Allergy Quality of Life- Child Self Report from Baseline to 18 Month Follow Up
Title
Food Allergy Quality of Life- Parent Proxy
Description
Caregivers will complete the Food Allergy Quality of Life Questionnaire - Parent Form (FAQLQ-PF), a validated 10-item measure of parents' perceptions of their child's quality of life. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.
Time Frame
Change in Food Allergy Quality of Life- Parent Proxy from Baseline to 6 Month Follow Up
Title
Food Allergy Quality of Life- Parent Proxy
Description
Caregivers will complete the Food Allergy Quality of Life Questionnaire - Parent Form (FAQLQ-PF), a validated 10-item measure of parents' perceptions of their child's quality of life. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.
Time Frame
Change in Food Allergy Quality of Life- Parent Proxy from Baseline to 12 Month Follow Up
Title
Food Allergy Quality of Life- Parent Proxy
Description
Caregivers will complete the Food Allergy Quality of Life Questionnaire - Parent Form (FAQLQ-PF), a validated 10-item measure of parents' perceptions of their child's quality of life. Items for these scales are rated on a 7-point Likert scale; subscale and total scores are generated with higher scores indicating greater food allergy anxiety and impact of food allergy on quality of life. Score range is 0-60.
Time Frame
Change in Food Allergy Quality of Life- Parent Proxy from Baseline to 18 Month Follow Up
Title
Food Allergy Impact
Description
Children will complete the Food Allergy Independent Measure (FAIM), a 6-item measure of children's perceptions of risk of allergen exposure, chance of a severe reaction, chance of dying, and ability to engage in proper treatment, which generates a total score. Scores can range from 0-6; higher scores indicate more impact of food allergy on daily life.
Time Frame
Change in Food Allergy Impact from Baseline to 6 Month Follow Up
Title
Food Allergy Impact
Description
Children will complete the Food Allergy Independent Measure (FAIM), a 6-item measure of children's perceptions of risk of allergen exposure, chance of a severe reaction, chance of dying, and ability to engage in proper treatment, which generates a total score. Scores can range from 0-6; higher scores indicate more impact of food allergy on daily life.
Time Frame
Change in Food Allergy Impact from Baseline to 12 Month Follow Up
Title
Food Allergy Impact
Description
Children will complete the Food Allergy Independent Measure (FAIM), a 6-item measure of children's perceptions of risk of allergen exposure, chance of a severe reaction, chance of dying, and ability to engage in proper treatment, which generates a total score. Scores can range from 0-6; higher scores indicate more impact of food allergy on daily life.
Time Frame
Change in Food Allergy Impact from Baseline to 18 Month Follow Up
Title
Frequency of Treatment for Allergic Reactions
Description
Participants will report on the frequency of treatment for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.
Time Frame
Change in Frequency of Treatment for Allergic Reactions from Baseline to 6 Month Follow Up
Title
Frequency of Treatment for Allergic Reactions
Description
Participants will report on the frequency of treatment for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.
Time Frame
Change in Frequency of Treatment for Allergic Reactions from Baseline to 12 Month Follow Up
Title
Frequency of Treatment for Allergic Reactions
Description
Participants will report on the frequency of treatment for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.
Time Frame
Change in Frequency of Treatment for Allergic Reactions from Baseline to 18 Month Follow Up
Title
Frequency of Allergy Appointments
Description
Participants will report on the frequency of allergy appointments in the past 6 months. This information will also be assessed by study staff via clinic chart review.
Time Frame
Change in Frequency of Allergy Appointments from Baseline to 6 Month Follow Up
Title
Frequency of Allergy Appointments
Description
Participants will report on the frequency of allergy appointments in the past 6 months. This information will also be assessed by study staff via clinic chart review.
Time Frame
Change in Frequency of Allergy Appointments from Baseline to 12 Month Follow Up
Title
Frequency of Emergency Room/Urgent Care Visits for Allergic Reactions
Description
Participants will report on the frequency of emergency room/urgent care visits for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.
Time Frame
Change in Frequency of Emergency Room/Urgent Care Visits for Allergy Reactions from Baseline to 6 Month Follow Up
Title
Frequency of Allergy Appointments
Description
Participants will report on the frequency of allergy appointments in the past 6 months. This information will also be assessed by study staff via clinic chart review.
Time Frame
Change in Frequency of Allergy Appointments from Baseline to 18 Month Follow Up
Title
Frequency of Emergency Room/Urgent Care Visits for Allergic Reactions
Description
Participants will report on the frequency of emergency room/urgent care visits for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.
Time Frame
Change in Frequency of Emergency Room/Urgent Care Visits for Allergy Reactions from Baseline to 12 Month Follow Up
Title
Frequency of Emergency Room/Urgent Care Visits for Allergic Reactions
Description
Participants will report on the frequency of emergency room/urgent care visits for allergic reactions in the past 6 months. This information will also be assessed by study staff via clinic chart review.
Time Frame
Change in Frequency of Emergency Room/Urgent Care Visits for Allergy Reactions from Baseline to 18 Month Follow Up
Secondary Outcome Measure Information:
Title
Social Support
Description
Early adolescents will complete the Multidimensional Scale of Perceived Social Support (MSPSS) to measure agreement with statements of general subjectively assessed social support from friends, family, and a significant other. The MSPSS consists of 12 items that assess perceived social support. Respondents elect responses on a Likert-type scale from 0 ("Very Strongly Disagree") to 6 ("Very Strongly Agree"). Total scores are computed by calculating the mean of all items, and higher scores indicate greater perceived social support. Score range is 0-6.
Time Frame
Change in Social Support from Baseline to 6 Month Follow Up
Title
Social Support
Description
Early adolescents will complete the Multidimensional Scale of Perceived Social Support (MSPSS) to measure agreement with statements of general subjectively assessed social support from friends, family, and a significant other. The MSPSS consists of 12 items that assess perceived social support. Respondents elect responses on a Likert-type scale from 0 ("Very Strongly Disagree") to 6 ("Very Strongly Agree"). Total scores are computed by calculating the mean of all items, and higher scores indicate greater perceived social support. Score range is 0-6.
Time Frame
Change in Social Support from Baseline to 12 Month Follow Up
Title
Social Support
Description
Early adolescents will complete the Multidimensional Scale of Perceived Social Support (MSPSS) to measure agreement with statements of general subjectively assessed social support from friends, family, and a significant other. The MSPSS consists of 12 items that assess perceived social support. Respondents elect responses on a Likert-type scale from 0 ("Very Strongly Disagree") to 6 ("Very Strongly Agree"). Total scores are computed by calculating the mean of all items, and higher scores indicate greater perceived social support. Score range is 0-6.
Time Frame
Change in Social Support from Baseline to 18 Month Follow Up
Title
Food Allergy Self-Efficacy
Description
Early adolescents and caregivers will each complete the Food Allergy Self-Efficacy Scale (FASE), a 21-item measure that uses a 100-point visual analog scale. Higher scores indicate a greater degree of confidence in one's ability to manage food allergies. Score range is 0-100. The FASE is valid and reliable among parents.
Time Frame
Change in Food Allergy Self-Efficacy from Baseline to 6 Month Follow Up
Title
Food Allergy Self-Efficacy
Description
Early adolescents and caregivers will each complete the Food Allergy Self-Efficacy Scale (FASE), a 21-item measure that uses a 100-point visual analog scale. Higher scores indicate a greater degree of confidence in one's ability to manage food allergies. Score range is 0-100. The FASE is valid and reliable among parents.
Time Frame
Change in Food Allergy Self-Efficacy from Baseline to 12 Month Follow Up
Title
Food Allergy Self-Efficacy
Description
Early adolescents and caregivers will each complete the Food Allergy Self-Efficacy Scale (FASE), a 21-item measure that uses a 100-point visual analog scale. Higher scores indicate a greater degree of confidence in one's ability to manage food allergies. Score range is 0-100. The FASE is valid and reliable among parents.
Time Frame
Change in Food Allergy Self-Efficacy from Baseline to 18 Month Follow Up
Title
Food Allergy Anxiety
Description
Early adolescents and caregivers will each complete the Scale of Food Allergy Anxiety (SOFAA), a 21-item measure that uses a Likert scale (0=Never to 4=Almost Always). Higher scores indicate more food allergy anxiety. Score range is 0-84. The SOFAA is valid and reliable among parents.
Time Frame
Change in Food Allergy Anxiety from Baseline to 6 Month Follow Up
Title
Food Allergy Anxiety
Description
Early adolescents and caregivers will each complete the Scale of Food Allergy Anxiety (SOFAA), a 21-item measure that uses a Likert scale (0=Never to 4=Almost Always). Higher scores indicate more food allergy anxiety. Score range is 0-84. The SOFAA is valid and reliable among parents.
Time Frame
Change in Food Allergy Anxiety from Baseline to 12 Month Follow Up
Title
Food Allergy Anxiety
Description
Early adolescents and caregivers will each complete the Scale of Food Allergy Anxiety (SOFAA), a 21-item measure that uses a Likert scale (0=Never to 4=Almost Always). Higher scores indicate more food allergy anxiety. Score range is 0-84. The SOFAA is valid and reliable among parents.
Time Frame
Change in Food Allergy Anxiety from Baseline to 18 Month Follow Up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 10-14 years physician diagnosis (i.e., history of a reaction to the food and/or recent positive skin prick test or IgE-specific testing) of at least 1 of the 9 most common IgE-mediated food allergies (peanut, tree nut, cow's milk, egg, soy, wheat, shellfish, fish, sesame) for ≥1 year, with accompanying allergen avoidance prescribed by an allergist English fluency access to a device with internet access either a food allergy knowledge score of <80% correct on the Food Allergy Knowledge Test (FAKT) or a food allergy impact score of ≥3 on the Food Allergy Independent Measure (FAIM). Exclusion Criteria: diagnosis of a non-IgE-mediated food allergy or food intolerance, a non-atopic chronic illness or pervasive developmental disorder/cognitive limitation Current participation in psychotherapy with a therapist with food allergy expertise
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Herbert, PhD
Phone
2024764552
Email
lherbert@childrensnational.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Herbert, PhD
Organizational Affiliation
Childrens National Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens' National Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Herbert, PhD
Phone
202-476-4552
Email
lherbert@childrensnational.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of The Food Allergy Mastery Program

We'll reach out to this number within 24 hrs