The Psychosocial Outcomes in Caregivers of Children With Food Allergy (FASST)

August 7, 2025 updated by: Medical University of South Carolina

Food Allergy Symptom Self-management With Technology (FASST) for Caregivers: An mHealth Intervention to Address Psychosocial Outcomes in Caregivers of Children With Newly Diagnosed Food Allergy

The purpose of this study is to evaluate use of a mobile application (also commonly referred to as an app) designed to support caregivers of children with newly diagnosed food allergy. This study has 2 phases. In Phase 1, the researchers obtained feedback regarding use of mobile apps from caregivers who have been managing their child's food allergy for one year or more. The researchers then used this feedback to build a mobile app for caregivers of children with newly diagnosed food allergy. In Phase 2, the researchers will evaluate the mobile app during a 4-week evaluation period with a group of caregivers of children newly diagnosed with food allergy. The data obtained from this study will hopefully benefit caregivers of children with newly diagnosed food allergy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Caregiver of child less than or equal to 18 years of age who are newly diagnosed (less than or equal to 90 days from diagnosis) with food allergy(ies).

Exclusion Criteria:

  • Caregiver with cognitive impairment/deficit and/or observed lack of understanding during the informed consent process

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1
Behavioral: Enhanced mobile app with standard of care and education
Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.
Experimental: Group 2
Behavioral: Enhanced mobile app with standard of care, education and support resources
Group 2 will download an enhanced mobile app that will include education and support resources related to food allergy and its management, a symptom monitoring and tracking system that allows mobile app users to log symptoms they may experience as caregivers of children newly diagnosed with food allergy, e.g. fatigue and anxiety, and symptom based interventions (recommendations) that may improve a caregiver's ability to self-manage experienced symptoms.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System Fatigue Short Form: PROMIS Short Form 6a
Time Frame: 30 days
The PROMISED Interference (Short Form 6a) instrument measures the self-reported consequences of fatigue across aspects of life including social, cognitive, emotional, physical and recreational activities; this instrument refers to the past seven days. This validated scale has five response options, with scores ranging from one to five. Scores are converted to t-scores, and higher t-scores indicate greater pain interference. Higher scores represent greater degrees of fatigue. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe fatigue. Fatigue T-scores measured by PROMIS Fatigue Short Form 6a. This 6-item instrument assesses a patient's a patient's level of fatigue over a 7-day recall period. Respondents report fatigue on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 33.4 to 76.8. Lower T-scores represent better outcomes.
30 days
Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System Fatigue Short Form. PROMIS Short Form 6a
Time Frame: 4 months
The Patient-Reported Outcomes Measurement Information System Fatigue item banks assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe fatigue. Fatigue T-scores measured by PROMIS Fatigue Short Form 6a. This 6-item instrument assesses a patient's a patient's level of fatigue over a 7-day recall period. Respondents report fatigue on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 33.4 to 76.8. Lower T-scores represent better outcomes.
4 months
Sleep Disturbance as Assessed by Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form. PROMIS Sleep Disturbance Short Form 6a
Time Frame: 30 days
Change in mean sleep disturbance score measured with PROMIS Sleep Disturbance short form 6a, 6 individual items allow for different responses which are scored separately to provide specific information about self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. The lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the worse or the greater the individual's sleep is disturbed compared to individuals with chronic conditions. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe sleep disturbance.
30 days
Sleep Disturbance as Assessed by Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form. PROMIS Sleep Disturbance Short Form 76a
Time Frame: 4 months
The Patient-Reported Outcomes Measurement Information System Sleep Disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. A low score indicates low sleep disturbance; high score indicates high sleep disturbance. Scores less than 55 are "within normal limits," 55-60 are "mild," 60-70 are "moderate," and greater than 70 are "severe." Raw scores on the survey are converted to T scores, which are standardized scores based on the average in the population; a score of 50 would indicate meeting the T score for the average quality of sleep in the reference general population, with a standard deviation of 10. Higher T scores reflect greater sleep disturbance, and thus worse outcomes. The means reported are the mean T scores at the indicated timepoint.
4 months
Depression as Assessed by Patient-Reported Outcomes Measurement Information System Depression Short Form. PROMIS Depression Short Form 6a
Time Frame: 30 days
The Patient-Reported Outcomes Measurement Information System Depression item banks assess self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Higher scores indicate negative mood; lower scores indicate more positive mode. Six items are rated on a 5 point scale that assess caregiver depression; 1=Never to 5=Always. To find the total raw score, sum the values of the response to each question. Higher scores indicate greater severity in depression. Scores less than 55 are "within normal limits," 55-60 are "mild," 60-70 are "moderate," and greater than 70 are "severe." T-score range 38 to 81; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.
30 days
Depression as Assessed by Patient-Reported Outcomes Measurement Information System Depression Short Form. PROMIS Depression Short Form 6a
Time Frame: 4 months
The Patient-Reported Outcomes Measurement Information System Depression item banks assess self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Higher scores indicate negative mood; lower scores indicate more positive mode. Six items are rated on a 5 point scale that assess caregiver depression; 1=Never to 5=Always. To find the total raw score, sum the values of the response to each question. Higher scores indicate greater severity in depression. Scores less than 55 are "within normal limits," 55-60 are "mild," 60-70 are "moderate," and greater than 70 are "severe." T-score range 38 to 81; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.
4 months
Anxiety as Assessed by Patient-Reported Outcomes Measurement Information System Anxiety Short Form. PROMIS Anxiety Short Form 6a
Time Frame: 30 days
The Patient-Reported Outcomes Measurement Information System Anxiety item banks assess self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). The anxiety measure is universal rather than disease-specific. Higher scores indicate higher levels of anxiety; lower scores indicate lower levels of anxiety. Six items are rated on a 5 point scale that assess caregiver anxiety; 1=Never to 5=Always. To find the total raw score, sum the values of the response to each question. Higher scores indicate a greater severity in anxiety. Scores less than 55 are "within normal limits", 55-60 are "mild", 60-70 are "moderate", and greater than 70 are "severe". The raw score is converted to a T-score ranging from 31.7 to 76.1. 50 indicates the population mean with a standard deviation of 10. Higher T-scores indicate greater anxiety disturbance.
30 days
Anxiety as Assessed by Patient-Reported Outcomes Measurement Information System Anxiety Short Form. PROMIS Anxiety Short Form 6a
Time Frame: 4 months
The Patient-Reported Outcomes Measurement Information System Anxiety item assess self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness) . The anxiety measure is universal rather than disease-specific. Higher scores indicate higher levels of anxiety; lower scores indicate lower levels of anxiety. Six items are rated on a 5 point scale that assess caregiver anxiety; 1=Never to 5=Always. To find the total raw score, sum the values of the response to each question. Higher scores indicate a greater severity in anxiety. Scores less than 55 are "within normal limits", 55-60 are "mild", 60-70 are "moderate", and greater than 70 are "severe". The raw score is converted to a T-score ranging from 31.7 to 76.1, 50 indicates the population mean with a standard deviation of 10 Higher T-scores indicate greater anxiety disturbance.
4 months
Caregiver Self-efficacy Related to Managing Food Allergy in Child as Assessed by the Food Allergy Self-Efficacy Scale for Parents:(FASE-P): Treat my Child if They Had an Allergic Reaction
Time Frame: 30 days
Food Allergy Self Efficacy Scale for Parents (FASE-P) The FASE-P measures parental confidence in their ability to manage their child's FA. Subdomains include managing social activities, precaution and prevention, allergic treatment, food allergen identification, and seeking information about FA. Each item is rated from 0-100 and a mean score is calculated. Higher scores indicate greater FA-related self-efficacy. The FASE-P offers excellent reliability over time in a general FA population.
30 days
Caregiver Self-efficacy Related to Managing Food Allergy in Child as Assessed by the Food Allergy Self-Efficacy Scale for Parents (FASE-P):Treat my Child if They Had an Allergic Reaction
Time Frame: 4 months
Food Allergy Self Efficacy Scale for Parents (FASE-P) The FASE-P measures parental confidence in their ability to manage their child's FA. Subdomains include managing social activities, precaution and prevention, allergic treatment, food allergen identification, and seeking information about FA. Each item is rated from 0-100 and a mean score is calculated. Higher scores indicate greater FA-related self-efficacy. The FASE-P offers excellent reliability over time in a general FA population.
4 months
Change in Caregiver Quality of Life-parental Burden as Assessed by the Food Allergy Quality of Life-Parental Burden (FAQoL-PB): How Limited Would Your Ability to Participate in Social Activities That Involve Food be Because of Your Child's Food Allergy?
Time Frame: Baseline and 30 days
The FAQL-PB is a 17-item questionnaire designed to capture caregiver HRQoL in children ages 0-12 years with FA. Items are rated on a 7-point Likert scale (0=not limited/troubled to 6=extremely limited/troubled); a mean score is calculated with higher scores indicating poorer HRQoL.
Baseline and 30 days
Change in Caregiver Quality of Life-parental Burden as Assessed by the Food Allergy Quality of Life-Parental Burden (FAQoL-PB):How Limited Would Your Ability to Participate in Social Activities That Involve Food be Because of Your Child's Food Allergy?
Time Frame: Baseline and 4 months
The FAQL-PB is a 17-item questionnaire designed to capture caregiver HRQoL in children ages 0-12 years with FA. Items are rated on a 7-point Likert scale (0=not limited/troubled to 6=extremely limited/troubled); a mean score is calculated with higher scores indicating poorer HRQoL.
Baseline and 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00100789

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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