Recruiting

HS & PlayReadVIP

Sponsor:

NYU Langone Health

Code:

NCT06941337

Conditions

Families With Infants

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

HealthySteps (HS)

PlayReadVIP

Study Details

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: 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.

Conditions

Families With Infants

Study ID

NCT06941337

Start date

Jun 9, 2025

Status verified date

Apr, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Adult-Child Relationship Scale Score [ Time Frame: Month 12 ]
  • Adult-Child Relationship Scale Score [ Time Frame: Month 24 ]
  • Stimulation Questionnaire (StimQ) Core: Reading, Teaching, Verbal Responsivity Score [ Time Frame: Month 12 ]
  • Stimulation Questionnaire (StimQ) Core: Reading, Teaching, Verbal Responsivity Score [ Time Frame: Month 24 ]
  • Infant Behavior Questionnaire Score [ Time Frame: Month 12 ]
  • Brief Infant Toddler Social-Emotional Assessment (BITSEA) Score: Competence [ Time Frame: Month 12 ]
  • Brief Infant Toddler Social-Emotional Assessment (BITSEA) Score: Problems [ Time Frame: Month 12 ]
  • Child Behavior Checklist Score [ Time Frame: Month 24 ]

Central Contacts and Locations

Central contacts

Caitlin Canfield

2125622522Caitlin.canfield@nyulangone.org

Janae Kuttamperoor

Janae.kuttamperoor@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-05-04.