NCT04677647

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
254

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
2.6 years until next milestone

Study Start

First participant enrolled

July 25, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

2.4 years

First QC Date

December 17, 2020

Last Update Submit

August 4, 2025

Conditions

Keywords

Health Information Technology

Outcome Measures

Primary Outcomes (1)

  • Change in Number of Referrals

    Change in number of referrals to NYU Langone Child Psychiatry or Developmental Pediatrics

    Month 18, Month 45

Secondary Outcomes (4)

  • Change in Score on Parental Self-Efficacy Scale

    Month 25, Month 45

  • Change in Amount of parent-provider engagement

    Month 18, Month 45

  • Change in accessing resources on App

    Month 25, Month 45

  • Score on Betz Physician Confidence Scale

    Month 48

Study Arms (1)

OurChild

EXPERIMENTAL
Other: OurChild mHealth Digital Platform

Interventions

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.

OurChild

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Simona Kwon, DrPH

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2020

First Posted

December 21, 2020

Study Start

July 25, 2023

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

August 6, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP
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.
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.

Locations