Clinical trial NCT04677647: OurChild: A Health IT Solution to Reduce Minority Health Disparities
Official title: OurChild: A Health IT Solution to Reduce Minority Health Disparities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health
Keywords: Health Information Technology
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2020-12-21
Enrollment: 264
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chinese American immigrant families are a fast-growing immigrant group with unmet early childhood mental health needs. The team proposes to design, build, and implement OurChild, an integrated mHealth/EHR solution to increase access to early childhood mental health knowledge and mental health services and resources for Chinese American children ages 2-6 years old and their parents in the Sunset Park Brooklyn.

Detailed description: The goal of this study is to reduce health disparities by designing a digital solution (OurChild) that facilitates connection and bidirectional exchange of information across the cultural, contextual, language, and setting differences that are key barriers to early childhood mental health knowledge and care access for the Chinese American community in Sunset Park, Brooklyn. The first study aim is to iteratively design, build, and test OurChild. To do this, the team will 1) collaborate with family, clinical, and community stakeholders to conduct an early childhood mental health context/needs analysis and participatory design and discovery activities; 2) build a digital library of early childhood mental health resources accessible from OurChild; and 3) pilot and assess the usability and acceptability of a beta version of OurChild in a mixed-methods, cross-sectional cohort of 12 Chinese American parents and their 2- to 6-year-old children (N=24) who receive care at the Sunset Park 7th Avenue Family Health Center; and 5) optimize the design, features, and performance to create OurChild 1.0. The second study aim is to evaluate the reach, effectiveness, adoption, implementation and maintenance of OurChild 1.0 through an implementation cohort study with 120 parent/child dyads (N=240). A mixed-methods approach using metadata collected with the OurChild app, parent-reported data from the app, EHR data, and post-implementation key informant interviews with providers and other stakeholders to determine whether use of OurChild increases referrals of young children for a mental health consultation or evaluation (Primary Aim) will be used. The secondary aims include examining whether use of OurChild increases 1) parent self-efficacy; 2) parent-provider engagement; and 3) linkage with community early childhood resources.

Eligibility criteria: Inclusion Criteria:

* Child must be 24 to 72 months old
* Child must have been receiving pediatric primary care at the 7th Ave FHC for at least 6 months
* Child must be identified as Chinese and/or preferred language is Chinese in EHR
* Parents must be at least 18 years old
* Parents must be the child's parent/legal guardian
* Parents must be able and willing to provide informed consent

Exclusion Criteria:

* Siblings and parents of previously enrolled children
* Parents who do not have access to an iOS or Android smartphone

Primary outcomes:
measure: Change in Number of Referrals
timeFrame: Month 18, Month 45
Secondary outcomes:
measure: Change in Score on Parental Self-Efficacy Scale
timeFrame: Month 25, Month 45
measure: Change in Amount of parent-provider engagement
timeFrame: Month 18, Month 45
measure: Change in accessing resources on App
timeFrame: Month 25, Month 45
measure: Score on Betz Physician Confidence Scale
timeFrame: Month 48
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Simona Kwon, DrPH
role: PRINCIPAL_INVESTIGATOR
References: