Mental HealthNCT04677647
OurChild: A Health IT Solution to Reduce Minority Health Disparities
A study testing OurChild mHealth Digital Platform in people with Mental Health, run by NYU Langone Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- OurChild mHealth Digital Platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2023to 22 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Siblings and parents of previously enrolled children
- Parents who do not have access to an iOS or Android smartphone
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mental Health
- Being tested
- OurChild mHealth Digital Platform
- Keywords
- Health Information Technology
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OurChild mHealth Digital PlatformOther
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.
| Study group | Role | What they receive |
|---|---|---|
| OurChild | Experimental | Not described Receives: Other: OurChild mHealth Digital Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Referrals
Change in number of referrals to NYU Langone Child Psychiatry or Developmental Pediatrics
Measured: Month 18, Month 45
Secondary outcomes (4)
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.
Measured: Month 25, Month 45
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
Measured: Month 18, Month 45
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
Measured: Month 25, Month 45
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.
Measured: Month 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start25 Jul 2023
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Simona Kwon, DrPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677647
- Sponsor's protocol ID
- 20-01468
- Status last verified
- Jun 2026
- First submitted
- 17 Dec 2020
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OurChild: A Health IT Solution to Reduce Minority Health Disparities
- ClinicalTrials.gov ID
- NCT04677647
- Acronym / sponsor ID
- 20-01468
- Conditions
- Mental Health
- Keywords
- Health Information Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OurChild | Experimental | Other: OurChild mHealth Digital Platform |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Siblings and parents of previously enrolled children
- Parents who do not have access to an iOS or Android smartphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OurChild mHealth Digital PlatformThe 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. | Other | OurChild |
Primary outcome
Change in Number of Referrals
Time frame: Month 18, Month 45
Change in number of referrals to NYU Langone Child Psychiatry or Developmental Pediatrics
4 secondary outcomes
Change in Score on Parental Self-Efficacy Scale
Time frame: Month 25, Month 45
Change in Amount of parent-provider engagement
Time frame: Month 18, Month 45
Change in accessing resources on App
Time frame: Month 25, Month 45
Score on Betz Physician Confidence Scale
Time frame: Month 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simona Kwon, DrPH principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OurChild mHealth Digital Platform in people with Mental Health, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Number of Referrals (time frame: Month 18, Month 45). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.