The Psychosocial Outcomes in Caregivers of Children With Food Allergy

NCT04512924 | Completed Results

• 1 other identifier: 00100789
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Food Allergy in Children; Caregiver Burnout; Psychosocial Problem; Family Research

Outcome Measures

Primary Outcomes (12)

• Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System Fatigue Short Form: PROMIS Short Form 6a

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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?

  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?

  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

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Behavioral: Enhanced mobile app with standard of care and education

Group 2

EXPERIMENTAL

Behavioral: Enhanced mobile app with standard of care, education and support resources

Interventions

Enhanced mobile app with standard of care and education BEHAVIORAL

Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.

Group 1

Enhanced mobile app with standard of care, education and support resources BEHAVIORAL

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.

Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (2)

• Broome SB, Williams KW, Hendrix KH. App providing psychosocial and educational supports benefits caregivers of children with newly diagnosed food allergies. J Food Allergy. 2022 Dec 1;4(3):163-171. doi: 10.2500/jfa.2022.4.220035. eCollection 2022 Dec.

  PMID: 39036772 DERIVED

• Broome B, Madisetti M, Prentice M, Williams KW, Kelechi T. Food Allergy Symptom Self-Management With Technology (FASST) mHealth Intervention to Address Psychosocial Outcomes in Caregivers of Children With Newly Diagnosed Food Allergy: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2021 Mar 3;10(3):e25805. doi: 10.2196/25805.

  PMID: 33656448 DERIVED

MeSH Terms

Conditions

Caregiver Burden

Interventions

Standard of Care; Educational Status

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Dr. Brantlee Broome
• Organization: Medical University of South Carolina

broomeb@musc.edu

843-792-3370

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: December 8, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: August 11, 2025
• Results First Posted: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)