HealthySteps + PlayReadVIP

NYU Langone Health

Status: Enrolling

Conditions: Families With Infants

Treatments: Behavioral: HealthySteps (HS); Behavioral: PlayReadVIP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06941337

1R01MD018597 (U.S. NIH Grant/Contract)

24-01988

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups

HealthySteps + PlayReadVIP

Experimental group

Description:

Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, plus PlayReadVIP, which promotes relational health through video coaching.

Treatment:

Behavioral: PlayReadVIP

Behavioral: HealthySteps (HS)

Standard HealthySteps

Active Comparator group

Description:

Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, only.

Treatment:

Behavioral: HealthySteps (HS)