HealthySteps + PlayReadVIP

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06941337
Status
Recruiting

Conditions

  • Families With Infants

Eligibility Criteria

Sex
ALL
Age
N/A - 6 Months
Healthy Volunteers
Accepted

Interventions

  • HealthySteps (HS) — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 9, 2025
Status verified
Apr 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: HealthySteps + PlayReadVIP
    Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, plus PlayReadVIP, which promotes relational health through video coaching.
  • Active Comparator: Standard HealthySteps
    Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, only.

Primary Outcome Measure

Adult-Child Relationship Scale Score [ Time Frame: Month 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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