| NCT ID | NCT06941337 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Families With Infants |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-06-09 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2025-06-09 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Caitlin Canfield
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06941337 clinical trial?
This trial is open to participants of all sexes, up to 6 Months, studying Families With Infants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06941337 currently recruiting?
Yes, NCT06941337 is actively recruiting participants. Contact the research team at Caitlin.canfield@nyulangone.org for enrollment information.
Where is the NCT06941337 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06941337 clinical trial?
NCT06941337 is sponsored by NYU Langone Health. The principal investigator is Caitlin Canfield at NYU Langone Health. The trial plans to enroll 1,000 participants.