Food Allergy in Children Clinical Trial
Official title:
Evaluation of a Behavioral Intervention to Promote Food Allergy Self-Management Among Early Adolescents: The Food Allergy Mastery Program
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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | November 30, 2027 |
Est. primary completion date | November 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 14 Years |
Eligibility | Inclusion Criteria: 1. age 10-14 years 2. 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 3. English fluency 4. access to a device with internet access 5. 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: 1. diagnosis of a non-IgE-mediated food allergy or food intolerance, a non-atopic chronic illness or pervasive developmental disorder/cognitive limitation 2. Current participation in psychotherapy with a therapist with food allergy expertise |
Country | Name | City | State |
---|---|---|---|
United States | Childrens' National Hospital | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Children's National Research Institute | National Institute of Allergy and Infectious Diseases (NIAID), Northwestern University, Rhode Island Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Change in Food Allergy Knowledge from Baseline to 6 Month Follow Up | |
Primary | 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. | Change in Food Allergy Knowledge from Baseline to 12 Month Follow Up | |
Primary | 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. | Change in Food Allergy Knowledge from Baseline to 18 Month Follow Up | |
Primary | 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. | Change in Food Allergy Management Skills- Label Reading from Baseline to 6 Month Follow Up | |
Primary | 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. | Change in Food Allergy Management Skills- Label Reading from Baseline to 12 Month Follow Up | |
Primary | 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. | Change in Food Allergy Management Skills- Label Reading from Baseline to 18 Month Follow Up | |
Primary | 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. | Change in Food Allergy Management Skills- Epinephrine Auto-Injector Use from Baseline to 6 Month Follow Up | |
Primary | 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. | Change in Food Allergy Management Skills- Epinephrine Auto-Injector Use from Baseline to 12 Month Follow Up | |
Primary | 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. | Change in Food Allergy Management Skills- Epinephrine Auto-Injector Use from Baseline to 18 Month Follow Up | |
Primary | 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. | Change in Food Allergy Management Behaviors from Baseline to 6 Month Follow Up | |
Primary | 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. | Change in Food Allergy Management Behaviors from Baseline to 12 Month Follow Up | |
Primary | 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. | Change in Food Allergy Management Behaviors from Baseline to 18 Month Follow Up | |
Primary | 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. | Change in Food Allergy Quality of Life- Child Self Report from Baseline to 6 Month Follow Up | |
Primary | 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. | Change in Food Allergy Quality of Life- Child Self Report from Baseline to 12 Month Follow Up | |
Primary | 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. | Change in Food Allergy Quality of Life- Child Self Report from Baseline to 18 Month Follow Up | |
Primary | 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. | Change in Food Allergy Quality of Life- Parent Proxy from Baseline to 6 Month Follow Up | |
Primary | 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. | Change in Food Allergy Quality of Life- Parent Proxy from Baseline to 12 Month Follow Up | |
Primary | 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. | Change in Food Allergy Quality of Life- Parent Proxy from Baseline to 18 Month Follow Up | |
Primary | 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. | Change in Food Allergy Impact from Baseline to 6 Month Follow Up | |
Primary | 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. | Change in Food Allergy Impact from Baseline to 12 Month Follow Up | |
Primary | 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. | Change in Food Allergy Impact from Baseline to 18 Month Follow Up | |
Primary | 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. | Change in Frequency of Treatment for Allergic Reactions from Baseline to 6 Month Follow Up | |
Primary | 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. | Change in Frequency of Treatment for Allergic Reactions from Baseline to 12 Month Follow Up | |
Primary | 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. | Change in Frequency of Treatment for Allergic Reactions from Baseline to 18 Month Follow Up | |
Primary | 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. | Change in Frequency of Allergy Appointments from Baseline to 6 Month Follow Up | |
Primary | 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. | Change in Frequency of Allergy Appointments from Baseline to 12 Month Follow Up | |
Primary | 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. | Change in Frequency of Emergency Room/Urgent Care Visits for Allergy Reactions from Baseline to 6 Month Follow Up | |
Primary | 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. | Change in Frequency of Allergy Appointments from Baseline to 18 Month Follow Up | |
Primary | 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. | Change in Frequency of Emergency Room/Urgent Care Visits for Allergy Reactions from Baseline to 12 Month Follow Up | |
Primary | 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. | Change in Frequency of Emergency Room/Urgent Care Visits for Allergy Reactions from Baseline to 18 Month Follow Up | |
Secondary | 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. | Change in Social Support from Baseline to 6 Month Follow Up | |
Secondary | 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. | Change in Social Support from Baseline to 12 Month Follow Up | |
Secondary | 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. | Change in Social Support from Baseline to 18 Month Follow Up | |
Secondary | 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. | Change in Food Allergy Self-Efficacy from Baseline to 6 Month Follow Up | |
Secondary | 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. | Change in Food Allergy Self-Efficacy from Baseline to 12 Month Follow Up | |
Secondary | 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. | Change in Food Allergy Self-Efficacy from Baseline to 18 Month Follow Up | |
Secondary | 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. | Change in Food Allergy Anxiety from Baseline to 6 Month Follow Up | |
Secondary | 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. | Change in Food Allergy Anxiety from Baseline to 12 Month Follow Up | |
Secondary | 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. | Change in Food Allergy Anxiety from Baseline to 18 Month Follow Up |
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