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

Medical University of South Carolina (MUSC)

Status: Completed

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04512924

00100789

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Group 1

Active Comparator group

Treatment:

Behavioral: Enhanced mobile app with standard of care and education

Group 2

Experimental group

Treatment:

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