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The Psychosocial Outcomes in Caregivers of Children With Food Allergy

NCT04512924 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-11

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-08
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04512924 on ClinicalTrials.gov