Status:
RECRUITING
HealthySteps + PlayReadVIP
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Conditions:
Families With Infants
Eligibility:
All Genders
Up to 6 years
Phase:
NA
Brief Summary
This study aims to investigate the effectiveness and implementation outcomes for the integration of two evidence-based practices and interventions (EBPIs) within pediatric primary care settings: Healt...
Eligibility Criteria
Inclusion
- Parent is a biological parent or legal guardian and at least 18 years of age
- Infants must be ≤6 months old at the time of enrollment.
- Parents/guardians must speak either English or Spanish to ensure they can fully engage with the intervention and assessments.
- Families must be identified as Tier 3 HealthySteps participants, indicating higher levels of need based on clinic screening for factors such as:Adverse Childhood Experiences (ACEs) and parenting challenges or vulnerabilities.
- Parent is able to willing to provide consent for their own and their child's participation.
Exclusion
- Non-singleton child
- Parent is unable to provide consent
- Parent does not speak English or Spanish, as study materials (e.g., questionnaires) are available in those languages
- Parent has a severe medical or psychiatric impairment (e.g., intellectual disability, psychosis) that would interfere with study participation
- Parent has plans to discontinue care at NYU Langone Health - Sunset Park Family Health Centers
Key Trial Info
Start Date :
June 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06941337
Start Date
June 9 2025
End Date
November 1 2028
Last Update
June 10 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016