RecruitingNot ApplicableNCT06941337

HealthySteps + PlayReadVIP

HEALTHYSTEPS + PLAYREADVIP EFFECTS ON PARENTING AND CHILD DEVELOPMENT: A RANDOMIZED IMPLEMENTATION EFFECTIVENESS TRIAL


Sponsor

NYU Langone Health

Enrollment

1,000 participants

Start Date

Jun 9, 2025

Study Type

INTERVENTIONAL

Conditions

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: HealthySteps (HS), which provides parenting support, and PlayReadVIP, which promotes relational health through video coaching. Families will be randomized to receive either the integrated HS + PlayReadVIP model or traditional HS, and investigators will examine impacts on parenting, parent-child relationships, and child development, as well as feasibility, acceptability, and appropriateness of the integrated intervention.


Eligibility

Max Age: 6 Months

Inclusion Criteria5

  • 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 Criteria5

  • 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

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Interventions

BEHAVIORALHealthySteps (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.

BEHAVIORALPlayReadVIP

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.


Locations(1)

NYU Langone Health

New York, New York, United States

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NCT06941337