Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2025-06-09
2028-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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HealthySteps + PlayReadVIP
Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, plus PlayReadVIP, which promotes relational health through video coaching.
HealthySteps (HS)
Evidence-based program that focuses on addressing Adverse Childhood Experiences (ACEs) and family stressors. The program provides parenting guidance, mental health support, and care coordination. The program is delivered during well-child visits by an HS specialist.
PlayReadVIP
Evidence-based program that promotes Positive Childhood Experiences (PCEs) and strengthens parent-child interactions. The program involves recording and reviewing videos of parents engaging with their child to provide feedback and encourage positive practices. Families receive toys, books, and guides to extend activities at home.
Standard HealthySteps
Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, only.
HealthySteps (HS)
Evidence-based program that focuses on addressing Adverse Childhood Experiences (ACEs) and family stressors. The program provides parenting guidance, mental health support, and care coordination. The program is delivered during well-child visits by an HS specialist.
Interventions
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HealthySteps (HS)
Evidence-based program that focuses on addressing Adverse Childhood Experiences (ACEs) and family stressors. The program provides parenting guidance, mental health support, and care coordination. The program is delivered during well-child visits by an HS specialist.
PlayReadVIP
Evidence-based program that promotes Positive Childhood Experiences (PCEs) and strengthens parent-child interactions. The program involves recording and reviewing videos of parents engaging with their child to provide feedback and encourage positive practices. Families receive toys, books, and guides to extend activities at home.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
6 Months
ALL
Yes
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Caitlin Caitlin
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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24-01988
Identifier Type: -
Identifier Source: org_study_id
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