New treatment option for Families With Infants
Official title HealthySteps + PlayReadVIP
ClinicalTrials.gov ID: NCT06941337
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 6. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Parent is able to willing to provide consent for their own and their child's participation.
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 6 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.