OurChild: A Health IT Solution to Reduce Minority Health Disparities

Mental Health Clinical Trial

Official title:

OurChild: A Health IT Solution to Reduce Minority Health Disparities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04677647
• Other study ID #: 20-01468
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: Simona Kwon, DrPH
• Phone: 646-847-3479
• Email: simona.kwon[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: November 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health

Intervention

Other:
• OurChild mHealth Digital Platform
The intervention being created and tested in this study is OurChild an integrated mHealth/EHR app, initially designed for the Chinese American community in Sunset Park, Brooklyn. All participants will be assigned to either beta versions undergoing development, or to version 1.0.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Number of Referrals	Change in number of referrals to NYU Langone Child Psychiatry or Developmental Pediatrics	Month 18, Month 45
Secondary	Change in Score on Parental Self-Efficacy Scale	The General Self-Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life.	Month 25, Month 45
Secondary	Change in Amount of parent-provider engagement	Engagement defined as at least one interaction or messaging exchange between parent and provider through OurChild messaging portal	Month 18, Month 45
Secondary	Change in accessing resources on App	Access to clinical and community early childhood and family services and resources; access defined as click through on resources library tab in OurChild app	Month 25, Month 45
Secondary	Score on Betz Physician Confidence Scale	The Betz Scale is a collection of 11 statements describing the provider's perceived barriers to the identification and management of child mental health issues. Responses to each statement consist of Strongly Agree (0), Agree, Uncertain, Disagree, and Strongly Disagree (5). The total range of score is 0-55, with a higher score indicating higher physician confidence in assessing and treating mental health disorders.	Month 48