HealthySteps plus PlayReadVIP parenting and video coaching program

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

This program tries adding PlayReadVIP video coaching to HealthySteps to see if it helps parents of infants (≤6 months) improve parenting, parent-child relationships, and early child development.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: N/A to 6 Months
• Sex: All
• Sponsor: NYU Langone Health (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06941337 on ClinicalTrials.gov

What this trial studies

This randomized intervention enrolls families identified as higher-need (Tier 3) within pediatric primary care and assigns them to either the integrated HealthySteps + PlayReadVIP model or to usual HealthySteps. HealthySteps provides in-clinic parenting support while PlayReadVIP adds relational health video coaching delivered alongside routine care. Investigators will measure effects on parenting behaviors, parent-child relationship quality, and early child developmental outcomes, and will collect implementation outcomes such as feasibility, acceptability, and appropriateness. The study is conducted in English and Spanish at NYU Langone Health clinics.

Who should consider this trial

Good fit: Parents or legal guardians aged 18 or older who speak English or Spanish and have an infant ≤6 months old identified as a Tier 3 HealthySteps participant and planning to continue care at NYU are ideal candidates.

Not a fit: Families with non-singleton infants, parents who cannot consent, those with severe medical or psychiatric impairments that interfere with participation, non-English/Spanish speakers, or those planning to leave NYU care are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the integrated model could strengthen parenting support and parent-child relationships and improve early developmental outcomes while being workable within pediatric primary care.

How similar studies have performed: Components like HealthySteps and relational video coaching have prior evidence supporting benefits for parenting and early development, but combining them into an integrated primary care model is a newer approach with limited direct trial evidence.

Eligibility criteria

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

Where this trial is running

New York, New York

• NYU Langone Health — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Caitlin Canfield — NYU Langone Health
• Study coordinator: Caitlin Canfield

Conditions: Families With Infants