N/A
Completed N=30
The Psychosocial Outcomes in Caregivers of Children With Food Allergy
Food Allergy in Children · Caregiver Burnout · Psychosocial Problem · Family Research
Source: ClinicalTrials.gov NCT04512924 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System Fatigue Short Form: PROMIS Short Form 6a — 50.6; 53 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System Fatigue Short Form: PROMIS Short Form 6a |
50.6; 53 | — |
| PRIMARY Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System Fatigue Short Form. PROMIS Short Form 6a |
52.2; 49.5 | — |
| PRIMARY Sleep Disturbance as Assessed by Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form. PROMIS Sleep Disturbance Short Form 6a |
59.9; 58.8 | — |
| PRIMARY Sleep Disturbance as Assessed by Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form. PROMIS Sleep Disturbance Short Form 76a |
59.3; 59.7 | — |
| PRIMARY Depression as Assessed by Patient-Reported Outcomes Measurement Information System Depression Short Form. PROMIS Depression Short Form 6a |
44.1; 45.6 | — |
| PRIMARY Anxiety as Assessed by Patient-Reported Outcomes Measurement Information System Anxiety Short Form. PROMIS Anxiety Short Form 6a |
51.2; 52.3 | — |
| PRIMARY 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 |
78.7; 87.2 | — |
| PRIMARY 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 |
86.5; 92.6 | — |
| PRIMARY 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? |
2.9; 2.8 | — |
| PRIMARY 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? |
2.3; 1.7 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04512924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.