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| ID | Type | Description | Link |
|---|---|---|---|
| 19-118 | Other Identifier | Kent State University |
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Funding for study was removed prior to reaching recruitment goals
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| Name | Class |
|---|---|
| Rhode Island Hospital | OTHER |
| University of Memphis | OTHER |
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Among children with a food allergy, strict avoidance (e.g., elimination of allergenic foods from one's diet) is the only intervention capable of preventing potentially devastating health-related sequelae including anaphylaxis and death. Youths from low-income backgrounds are particularly impacted by food allergies and may be the population most apt to benefit from a brief, portable, and engaging skills-based intervention designed to teach young children the skills needed to remain adherent to food allergy safety guidelines. Data collected as part of the proposed project will lay the groundwork for a line of federally-funded intervention research broadly examining how to promote adherence to food allergy safety guidelines among young children from low-income backgrounds through implementation of a robust, efficient, and portable intervention.
The primary aim of this R21 proposal is to test the efficacy of a 5-session intervention designed to increase adherence to FA safety guidelines among low-income, young children (6-8 years of age) with FAs. This intervention, the Food Allergy Superheroes Training (FAST) Program, will be developed and refined across Phases 1a and 1b to target skills beneficial to promote adherence to FA guidelines (i.e., food avoidance). During Phase 1a, we will recruit a parent-child advisory board to aide in integrating principles of behavioral skills training within the FAST Program manual. We will then examine the initial acceptability and feasibility of the FAST Program in an open trial with 10 low-income, young children with FAs to further refine the intervention's content. During Phase 1b, we will randomize 50 young children with a FA who are from a low-income background to receive either the FAST Program or FA knowledge. We will employ developmentally relevant FA assessments (i.e., child-report, role-play, in situ) before, after, and one-month post-intervention as our primary outcomes. Aim 1: Determine feasibility and acceptability of the FAST intervention. We will evaluate the feasibility and acceptability of this intervention with 60 participants (n=10 in pilot trial [Phase 1a] and n=50 in a preliminary randomized trial [Phase 1b]). Aim 2: Estimate the effect size of the FAST intervention relative to FA knowledge alone. Adherence will be measured via a multi-modal, FA assessment including child-report, role-play, and in situ assessment. This form of naturalistic, FA assessment will be designed to measure the child's behavior (i.e., ingest food, touch or play with food, etc.) in a safe yet realistic manner. This study will contribute to the field's knowledge of efficacious interventions for promoting adherence among young children with FAs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Food Allergy Superheroes Training (FAST) Program | Experimental | Participants enrolled in this arm of the study will receive 5, 20 minutes skills training sessions designed to promote adherence to food allergy safety guidelines. These sessions will occur over the period of <2 weeks. All sessions will occur at the PIs laboratory or within the participant's home. |
|
| Food Allergy Knowledge (FAK) Intervention | Active Comparator | Participants enrolled in this arm of the study will receive 5, 20 minutes educational training sessions designed to increase knowledge pertaining to food allergies. These sessions will occur over the period of <2 weeks. All sessions will occur at the PIs laboratory or within the participant's home. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food Allergy Superheroes Training (FAST) Program | Behavioral | The primary aim of the FAST intervention is to 1) increase the young child's understanding of food allergies (FA) and 2) promote-adherence to FA safety guidelines through active skills training. We will achieve this aim through the use of educational materials (session 1) and a developmentally-tailored skills training intervention (session 2-5). Core components embedded within each skill straining session include instructions, modeling, rehearsal, and reinforcement/corrective feedback. The young child and their parent/caregiver will be present for the entirety of all sessions; however, all intervention materials (i.e., educational content, skills training components) are designed with the young child as the primary focal point of interest. All children will be rewarded with a small toy (<$5 value) at the end of each successfully completed session. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in in Situ Food Assessment Score | Designed to provide an objective measure of a child's behavior to an unknown food-item in the real world. Modeled after similar methodology employed in prior skills training research. Child's response coded (see Research Strategy), based upon video assessment. Higher scores (ranging from 0 to 4) indicate greater adherence. Scores represent change from pre-intervention to one-month follow-up assessment. | Planned time frame: pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks). |
| Change in Role-play Food Assessment | The role-play assessment will occur immediately following the in situ assessment and is modeled upon similar methodology employed in prior skills training research. The study independent evaluator verbally presents the young child with a hypothetical scenario. For example, "Let's pretend that you are in your living room and your mom asks you to pick up your toys. While you are picking up your toys, you find candy. What would you do?" The IE will design each scenario so that the physical layout of the room permits the child to exhibit behavior congruent with the described situation. The child?s response will be coded (see Research Strategy), based upon videotaped assessment made possible via a camera placed in the room. Higher scores (ranging from 0 to 3) indicate greater adherence. Inter-rater reliability will be obtained on 30% of role-play food assessments.Scores represent change from pre-intervention to one-month follow-up assessment. | pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks) |
| Change in Child-report Food Assessment | The child-report food assessment will occur immediately following the role-play assessment. The study IE presents a scenario in which a child finds a food-item (e.g., playing at a friend's home). The independent evaluator will ask the child to state what he/she would do, if that situation happened to them. The child's response will be coded (see Research Strategy), based upon videotaped assessment made possible via a camera placed in the room. Higher scores (ranging from 0 to 3) indicate greater adherence. Inter-rater reliability will be obtained on 30% of child-report food assessments. |
| Measure | Description | Time Frame |
|---|---|---|
| Food Allergy Knowledge Test (FAKT) | The FAKT is a 39 question, parent-report measure designed to assess knowledge about food allergies across five domains: General clinical food allergy knowledge, avoiding exposure, epinephrine auto-injector, anaphylaxis, and symptoms. Questions are multiple choice, true/false, or multiple-item (i.e., indicate whether each item is a symptom of a food allergy) formats. The scale yields a total of 59 items that can be scored. Higher scores indicate a great degree of food allergy knowledge. The scale demonstrates strong internal consistency and construct validity with criterion measures of parent educational status, access to food allergy information, insurance status, and epinephrine use. The FAKT will be used as a process measure designed to ensure that basic educational material is received. This outcome measure is a change score (end of treatment minus baseline) with higher scores representing greater improvement in food allergy knowledge. |
| Measure | Description | Time Frame |
|---|---|---|
| Child Behavior Checklist (CBCL) | The CBCL is a 112-item parent-report scale assessing child symptoms across several domains including social skills, school functioning, and emotional and behavioral problems. Prior research utilizing the CBCL demonstrates strong reliability and validity amongst youth populations. Although multiple versions of the CBCL exist, we will employ the parent-report (6-18 year old) version. For the purposes of the proposed study, we will employ the CBCL as a post hoc measure to assess potential predictors of intervention response. Higher scores on CBCL subscales indicate a greater presence of corresponding behavioral symptoms. |
Inclusion Criteria:
Exclusion Criteria:
• Neurodevelopmental disorder (i.e., autism spectrum disorder), cognitive delays, or psychiatric disorder, based upon parent-report.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher A Flessner | Kent State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kent State University | Kent | Ohio | 44242 | United States |
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| Label | URL |
|---|---|
| PI's laboratory webpage with greater detail about the study and related projects | View source |
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Twenty two participants were consented for the randomized trial. Eighteen participants withdrew due to a loss in funding (prior to completing the pre-intervention, primary outcome assessment). One family withdrew after completing the primary outcome assessment but before randomization to an intervention condition. This rate of attrition and randomization resulted in 3 remaining participants. All of these participants had been assigned to the FAK intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Food Allergy Superheroes Training (FAST) Program | Participants enrolled in this arm of the study were to receive 5, 20 minutes skills virtual training sessions designed to promote adherence to food allergy safety guidelines. All sessions were to occur virtually at the child's home. Food Allergy Superheroes Training (FAST) Program: The primary aim of the FAST intervention was to 1) increase the young child's understanding of food allergy (FA) and 2) promote-adherence to FA safety guidelines through active skills training. The FAST Program intervention included educational materials (session 1) and a developmentally-tailored skills training intervention (session 2-5). Core components embedded within each skill straining session included instructions, modeling, rehearsal, and reinforcement/corrective feedback. The young child and their parent/caregiver were present for all sessions; however, all intervention materials (i.e., educational content, skills training components) were designed with the young child as the primary focal point of interest. |
| FG001 | Food Allergy Knowledge (FAK) Intervention | Participants enrolled in this arm of the study received 5, 20 minutes educational virtual training sessions designed to increase knowledge pertaining to food allergy. All sessions occurred virtually at the child's home. The primary aim of the FAK intervention was to increase the young child's understanding of FAs including prevalence, symptoms, and management strategies among other topics. The FAK intervention achieved this through the use of educational materials targeting knowledge acquisition through a variety of didactic materials made freely available through the Food Allergy Research Education (FARE) website (www.foodallergy.org). More specifically, we employed information embedded within the "Food Allergy 101" segment of the FARE website. The young child and their parent/caregiver were present for all sessions; however, all intervention materials were designed with the young child as the primary focal point of interest. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
As noted in previous sections, randomization occurred after completion of all pre-intervention assessments and prior to the child's first intervention session. Due to a loss in funding, multiple families withdrew from the study. The numbers reflected here are those families who remained part of the study, after loss of funding, and were randomized to an intervention condition.
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| ID | Title | Description |
|---|---|---|
| BG000 | Food Allergy Superheroes Training (FAST) Program | Participants enrolled in this arm of the study were to receive 5, 20 minutes skills virtual training sessions designed to promote adherence to food allergy safety guidelines. All sessions were to occur virtually at the child's home. Food Allergy Superheroes Training (FAST) Program: The primary aim of the FAST intervention was to 1) increase the young child's understanding of food allergies (FA) and 2) promote-adherence to FA safety guidelines through active skills training. The FAST Program intervention included educational materials (session 1) and a developmentally-tailored skills training intervention (session 2-5). Core components embedded within each skill straining session include instructions, modeling, rehearsal, and reinforcement/corrective feedback. The young child and their parent/caregiver were present for all sessions; however, all intervention materials (i.e., educational content, skills training components) were designed with the young child as the primary focal point of interest. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in in Situ Food Assessment Score | Designed to provide an objective measure of a child's behavior to an unknown food-item in the real world. Modeled after similar methodology employed in prior skills training research. Child's response coded (see Research Strategy), based upon video assessment. Higher scores (ranging from 0 to 4) indicate greater adherence. Scores represent change from pre-intervention to one-month follow-up assessment. | Data missing/Data collection error. In total, three participants were randomized to an intervention condition. One participant did not attend their post-intervention assessment; thus, no data are available for said participant. The remaining two participants data are missing due to video not being uploaded properly; thus, no data are available for the two remaining participants. | Posted | Planned time frame: pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks). |
|
Adverse event data were collected for participants from baseline to completion of the participant's role in this study (i.e., baseline to follow-up assessment). This time frame amounts to approximately 6 weeks.
No adverse events were reported to the study team by any participants during the course of this project.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Food Allergy Superheroes Training (FAST) Program | Participants enrolled in this arm of the study were to receive 5, 20 minutes skills virtual training sessions designed to promote adherence to food allergy safety guidelines. All sessions were to occur virtually at the child's home. Food Allergy Superheroes Training (FAST) Program: The primary aim of the FAST intervention was to 1) increase the young child's understanding of food allergies (FA) and 2) promote-adherence to FA safety guidelines through active skills training. The FAST Program intervention included educational materials (session 1) and a developmentally-tailored skills training intervention (session 2-5). Core components embedded within each skill straining session include instructions, modeling, rehearsal, and reinforcement/corrective feedback. The young child and their parent/caregiver were present for all sessions; however, all intervention materials (i.e., educational content, skills training components) were designed with the young child as the primary focal point of interest. |
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The goal of this study was to develop and refine a tailored skills training intervention to promote adherence to food allergy (FA) safety guidelines. Recruitment prior to onset of the pandemic was ahead of schedule (i.e., advisory board phase). Recruitment was hindered thereafter. Modifications to inclusion criteria reinvigorated recruitment but was too late. We hope future researchers will learn from this and develop innovative strategies for increasing adherence to FA safety guidelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher A. Flessner, Ph.D., Professor of Psychological Sciences | Kent State University | 330-672-2236 | cflessne@kent.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2023 | Oct 21, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2019 | Oct 21, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D015438 | Health Behavior |
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Participants enrolled via the open-trial portion of this study will all receive a 5-session skills training intervention (n = 5 participants). All participants enrolled in the randomized trial portion of this study (n = 50 participants) will be randomly assigned to either a 5-session skills training or 5-session food allergy education intervention
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Independent evaluators will assess pre-, post-, and follow-up naturalistic, food allergy assessment outcomes. These evaluators will have no knowledge as to the intervention participants received via their participation in this study.
|
|
| Food Allergy Knowledge Intervention | Other | The primary aim of the FAK intervention is to increase the young child's understanding of FAs including prevalence, symptoms, and management strategies among other topics. We will achieve this aim through the use of educational materials targeting knowledge acquisition through a variety of didactic materials made freely available through the Food Allergy Research Education (FARE) website (www.foodallergy.org). More specifically, we will employ information embedded within the "Food Allergy 101" segment of the FARE website. The young child and their parent/caregiver will be present for the entirety of all sessions; however, all intervention materials are designed with the young child as the primary focal point of interest. All children will be rewarded with a small toy (<$5 value) at the end of each successfully completed session. All FAK sessions will occur within the child's home and will include informational handouts relevant to the day's session. |
|
|
| pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks) |
| pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks) |
| Food Allergy Quality of Life - Parent Burden (FAQL-PB) | The FAQL-PB is designed to assess the health-related quality of life among parents of children, 0-12 years of age, with a food allergy. Higher scores indicate greater perceived burden. The scale has demonstrated excellent internal consistency and temporal stability and good construct validity. This outcome measure is a change score (end of treatment minus baseline) with higher scores representing greater improvement in quality of life. | pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks) |
| Food Allergy Management and Adaptation Scale (FAMAS) | The FAMAS is a semi-structured interviewed designed to assess variety of domains related to a family's psychosocial adjustment to a child's food allergy. The interview includes a myriad of subscales related to this broader construct including food allergy knowledge, medication availability, symptoms of food allergy, child and family food avoidance, family and child response readiness, and parent and child anxiety among other domains. Evidence suggests that the FAMAS demonstrates excellent inter-rater reliability and strong construct validity. Higher scores indicate greater overall (better) food allergy management. The outcome measure is a change score with higher scores representing greater change in a family's food allergy management. | pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks) |
| Food Allergy Impact Scale (FAIS) | The FAIS is a 32-item scale designed to measure the impact of a child's food allergies on day-to-day activities within the home including meal preparation, social activities, etc. Higher scores indicate increasing level of impact on family functioning. Prior research suggests that the FAIS demonstrates adequate internal consistency. Outcome measures represents a change score (i.e., final assessment - initial assessment) with smaller (negative) scores indicating a reduction in the impact of food allergy on the family. | pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks) |
| pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks) |
| BG001 | Food Allergy Knowledge (FAK) Intervention | Participants enrolled in this arm of the study received 5, 20 minutes educational virtual training sessions designed to increase knowledge pertaining to food allergies. All sessions occurred virtually at the child's home. Food Allergy Knowledge Intervention: The primary aim of the FAK intervention was to increase the young child's understanding of FAs including prevalence, symptoms, and management strategies among other topics. The FAK intervention achieved this through the use of educational materials targeting knowledge acquisition through a variety of didactic materials made freely available through the Food Allergy Research Education (FARE) website (www.foodallergy.org). More specifically, we employed information embedded within the "Food Allergy 101" segment of the FARE website. The young child and their parent/caregiver were present for all sessions; however, all intervention materials were designed with the young child as the primary focal point of interest. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Food Allergy Knowledge Test (FAKT) | The FAKT is a 39 question, parent-report measure designed to assess knowledge about food allergies across five domains: General clinical food allergy knowledge, avoiding exposure, epinephrine auto-injector, anaphylaxis, and symptoms. Questions are multiple choice, true/false, or multiple-item (i.e., indicate whether each item is a symptom of a food allergy) formats. The scale yields a total of 59 items that can be scored with possible scores ranging from 0 to 59. Higher scores indicate a great degree of food allergy knowledge. This scale demonstrates strong psychometric properties. | Mean | Standard Deviation | Units on a scale |
|
| Change in In Situ Food Assessment Score | Designed to provide an objective measure of a child's behavior to an unknown food-item in the real world. Modeled after similar methodology employed in prior skills training research. Child's response coded (see Research Strategy), based upon video assessment. Higher scores (ranging from 0 to 4) indicate greater adherence. Baseline data represent pre-intervention score. | Due to an error in data collection, data from one participant was missing. | Mean | Full Range | units on a scale |
|
| Change in Role-Play Assessment Score | Designed to present a young child with a hypothetical scenario in which they might come into contact with a novel food item. The child's response is coded (see Research Strategy), based upon videotaped assessment made possible via a camera placed in the room. Higher scores (ranging from 0 to 4) indicate greater adherence. Baseline scores represent data from the pre-intervention assessment. | Due to an error in data collection, data is missing from one participant. | Mean | Full Range | units on a scale |
|
| Food Allergy Superheroes Training (FAST) Program |
Participants enrolled in this arm of the study were to receive 5, 20 minutes skills virtual training sessions designed to promote adherence to food allergy safety guidelines. All sessions were to occur virtually at the child's home. Food Allergy Superheroes Training (FAST) Program: The primary aim of the FAST intervention was to 1) increase the young child's understanding of food allergies (FA) and 2) promote-adherence to FA safety guidelines through active skills training. The FAST Program intervention included educational materials (session 1) and a developmentally-tailored skills training intervention (session 2-5). Core components embedded within each skill straining session include instructions, modeling, rehearsal, and reinforcement/corrective feedback. The young child and their parent/caregiver were present for all sessions; however, all intervention materials (i.e., educational content, skills training components) were designed with the young child as the primary focal point of interest. |
| OG001 | Food Allergy Knowledge (FAK) Intervention | Participants enrolled in this arm of the study received 5, 20 minutes educational virtual training sessions designed to increase knowledge pertaining to food allergies. All sessions occurred virtually at the child's home. Food Allergy Knowledge Intervention: The primary aim of the FAK intervention was to increase the young child's understanding of FAs including prevalence, symptoms, and management strategies among other topics. The FAK intervention achieved this through the use of educational materials targeting knowledge acquisition through a variety of didactic materials made freely available through the Food Allergy Research Education (FARE) website (www.foodallergy.org). More specifically, we employed information embedded within the "Food Allergy 101" segment of the FARE website. The young child and their parent/caregiver were present for all sessions; however, all intervention materials were designed with the young child as the primary focal point of interest. |
|
| Primary | Change in Role-play Food Assessment | The role-play assessment will occur immediately following the in situ assessment and is modeled upon similar methodology employed in prior skills training research. The study independent evaluator verbally presents the young child with a hypothetical scenario. For example, "Let's pretend that you are in your living room and your mom asks you to pick up your toys. While you are picking up your toys, you find candy. What would you do?" The IE will design each scenario so that the physical layout of the room permits the child to exhibit behavior congruent with the described situation. The child?s response will be coded (see Research Strategy), based upon videotaped assessment made possible via a camera placed in the room. Higher scores (ranging from 0 to 3) indicate greater adherence. Inter-rater reliability will be obtained on 30% of role-play food assessments.Scores represent change from pre-intervention to one-month follow-up assessment. | Data missing/Data collection error. In total, three participants were randomized to an intervention condition. One participant did not attend their post-intervention assessment; thus, no data are available for said participant. The remaining two participants data are missing due to video not being uploaded properly; thus, no data are available for the two remaining participants. | Posted | pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks) |
|
|
| Primary | Change in Child-report Food Assessment | The child-report food assessment will occur immediately following the role-play assessment. The study IE presents a scenario in which a child finds a food-item (e.g., playing at a friend's home). The independent evaluator will ask the child to state what he/she would do, if that situation happened to them. The child's response will be coded (see Research Strategy), based upon videotaped assessment made possible via a camera placed in the room. Higher scores (ranging from 0 to 3) indicate greater adherence. Inter-rater reliability will be obtained on 30% of child-report food assessments. | Data missing/Data collection error. In total, three participants were randomized to an intervention condition. One participant did not attend their post-intervention assessment; thus, no data are available for said participant. The remaining two participants data are missing due to video not being uploaded properly; thus, no data are available for the two remaining participants. | Posted | pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks) |
|
|
| Secondary | Food Allergy Knowledge Test (FAKT) | The FAKT is a 39 question, parent-report measure designed to assess knowledge about food allergies across five domains: General clinical food allergy knowledge, avoiding exposure, epinephrine auto-injector, anaphylaxis, and symptoms. Questions are multiple choice, true/false, or multiple-item (i.e., indicate whether each item is a symptom of a food allergy) formats. The scale yields a total of 59 items that can be scored. Higher scores indicate a great degree of food allergy knowledge. The scale demonstrates strong internal consistency and construct validity with criterion measures of parent educational status, access to food allergy information, insurance status, and epinephrine use. The FAKT will be used as a process measure designed to ensure that basic educational material is received. This outcome measure is a change score (end of treatment minus baseline) with higher scores representing greater improvement in food allergy knowledge. | Data missing/Data collection error. In total, three participants were randomized to an intervention condition. One participant did not attend their post-intervention assessment; thus, no data are available for said participant. The remaining two participants data are missing due to the participants either not responding to (or receiving) the post-intervention survey link; thus, no data are available for the two remaining participants. | Posted | pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks) |
|
|
| Secondary | Food Allergy Quality of Life - Parent Burden (FAQL-PB) | The FAQL-PB is designed to assess the health-related quality of life among parents of children, 0-12 years of age, with a food allergy. Higher scores indicate greater perceived burden. The scale has demonstrated excellent internal consistency and temporal stability and good construct validity. This outcome measure is a change score (end of treatment minus baseline) with higher scores representing greater improvement in quality of life. | Data missing/Data collection error. In total, three participants were randomized to an intervention condition. One participant did not attend their post-intervention assessment; thus, no data are available for said participant. The remaining two participants data are missing due to the participants either not responding to (or receiving) the post-intervention survey link; thus, no data are available for the two remaining participants. | Posted | pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks) |
|
|
| Secondary | Food Allergy Management and Adaptation Scale (FAMAS) | The FAMAS is a semi-structured interviewed designed to assess variety of domains related to a family's psychosocial adjustment to a child's food allergy. The interview includes a myriad of subscales related to this broader construct including food allergy knowledge, medication availability, symptoms of food allergy, child and family food avoidance, family and child response readiness, and parent and child anxiety among other domains. Evidence suggests that the FAMAS demonstrates excellent inter-rater reliability and strong construct validity. Higher scores indicate greater overall (better) food allergy management. The outcome measure is a change score with higher scores representing greater change in a family's food allergy management. | Data missing/Data collection error. In total, three participants were randomized to an intervention condition. One participant did not attend their post-intervention assessment; thus, no data are available for said participant. The remaining two participants data are missing due to the participants either not responding to (or receiving) the post-intervention survey link; thus, no data are available for the two remaining participants. | Posted | pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks) |
|
|
| Secondary | Food Allergy Impact Scale (FAIS) | The FAIS is a 32-item scale designed to measure the impact of a child's food allergies on day-to-day activities within the home including meal preparation, social activities, etc. Higher scores indicate increasing level of impact on family functioning. Prior research suggests that the FAIS demonstrates adequate internal consistency. Outcome measures represents a change score (i.e., final assessment - initial assessment) with smaller (negative) scores indicating a reduction in the impact of food allergy on the family. | Data missing/Data collection error. In total, three participants were randomized to an intervention condition. One participant did not attend their post-intervention assessment; thus, no data are available for said participant. The remaining two participants data are missing due to the participants either not responding to (or receiving) the post-intervention survey link; thus, no data are available for the two remaining participants. | Posted | pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks) |
|
|
| Other Pre-specified | Child Behavior Checklist (CBCL) | The CBCL is a 112-item parent-report scale assessing child symptoms across several domains including social skills, school functioning, and emotional and behavioral problems. Prior research utilizing the CBCL demonstrates strong reliability and validity amongst youth populations. Although multiple versions of the CBCL exist, we will employ the parent-report (6-18 year old) version. For the purposes of the proposed study, we will employ the CBCL as a post hoc measure to assess potential predictors of intervention response. Higher scores on CBCL subscales indicate a greater presence of corresponding behavioral symptoms. | Data missing/Data collection error. In total, three participants were randomized to an intervention condition. One participant did not attend their post-intervention assessment; thus, no data are available for said participant. The remaining two participants data are missing due to the participants either not responding to (or receiving) the post-intervention survey link; thus, no data are available for the two remaining participants. | Posted | pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks) |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Food Allergy Knowledge (FAK) Intervention | Participants enrolled in this arm of the study received 5, 20 minutes educational virtual training sessions designed to increase knowledge pertaining to food allergies. All sessions occurred virtually at the child's home. Food Allergy Knowledge Intervention: The primary aim of the FAK intervention was to increase the young child's understanding of FAs including prevalence, symptoms, and management strategies among other topics. The FAK intervention achieved this through the use of educational materials targeting knowledge acquisition through a variety of didactic materials made freely available through the Food Allergy Research Education (FARE) website (www.foodallergy.org). More specifically, we employed information embedded within the "Food Allergy 101" segment of the FARE website. The young child and their parent/caregiver were present for all sessions; however, all intervention materials were designed with the young child as the primary focal point of interest. | 0 | 3 | 0 | 3 | 0 | 3 |
Not provided
Not provided
| D001519 |
| Behavior |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|