- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04677647
OurChild: A Health IT Solution to Reduce Minority Health Disparities
August 4, 2025 updated by: NYU Langone Health
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
254
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Simona Kwon, DrPH
- Phone Number: 646-847-3479
- Email: simona.kwon@nyulangone.org
Study Contact Backup
- Name: Yi-Ling Tan, MPH
- Phone Number: 646-501-3489
- Email: yi-ling.tan@nyulangone.org
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- Recruiting
- NYU Langone Health
-
Contact:
- Simona Kwon, DrPH
- Phone Number: 646-501-3479
- Email: simona.kwon@nyulangone.org
-
Principal Investigator:
- Simona Kwon, DrPh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: OurChild
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Number of Referrals
Time Frame: Month 18, Month 45
|
Change in number of referrals to NYU Langone Child Psychiatry or Developmental Pediatrics
|
Month 18, Month 45
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Score on Parental Self-Efficacy Scale
Time Frame: Month 25, Month 45
|
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
|
|
Change in Amount of parent-provider engagement
Time Frame: Month 18, Month 45
|
Engagement defined as at least one interaction or messaging exchange between parent and provider through OurChild messaging portal
|
Month 18, Month 45
|
|
Change in accessing resources on App
Time Frame: Month 25, Month 45
|
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
|
|
Score on Betz Physician Confidence Scale
Time Frame: Month 48
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Simona Kwon, DrPH, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 25, 2023
Primary Completion (Estimated)
December 30, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
December 17, 2020
First Submitted That Met QC Criteria
December 17, 2020
First Posted (Actual)
December 21, 2020
Study Record Updates
Last Update Posted (Actual)
August 6, 2025
Last Update Submitted That Met QC Criteria
August 4, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20-01468
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will have access to the data upon reasonable request.
Requests should be directed to helen.egger@nyulangone.org.
To gain access, data requestors will need to sign a data access agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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