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Search / Trial NCT06941337

HealthySteps + PlayReadVIP

Launched by NYU LANGONE HEALTH · Apr 16, 2025

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, called HealthySteps + PlayReadVIP, is exploring how effective a new program is for families with infants. The program combines two helpful approaches: HealthySteps, which offers parenting support, and PlayReadVIP, which uses video coaching to improve relationships between parents and their children. Families participating in the study will be randomly assigned to either the new combined program or the traditional HealthySteps support. The researchers will look at how this affects parenting, the relationship between parents and their children, and the overall development of the child, as well as how well the new program works and how families feel about it.

To be eligible for this trial, you need to be a biological parent or legal guardian, at least 18 years old, and have an infant who is 6 months old or younger. You also need to speak either English or Spanish to participate fully. Families must be identified as needing extra support based on specific screenings for challenges like parenting difficulties or past negative experiences. If you join the study, you’ll receive support to help with parenting and your child's development, and you will be contributing to important research that could help other families in the future.

Gender

ALL

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

About Nyu Langone Health

NYU Langone Health is a premier academic medical center located in New York City, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, NYU Langone Health integrates cutting-edge scientific inquiry with patient-centered care, striving to develop new therapies and improve health outcomes across a wide range of medical conditions. The institution is dedicated to fostering collaboration among researchers, clinicians, and patients, ensuring rigorous adherence to ethical standards and regulatory guidelines in all clinical research initiatives. By leveraging its extensive resources and expertise, NYU Langone Health aims to contribute significantly to the advancement of medical knowledge and the enhancement of patient care.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Caitlin Caitlin

Principal Investigator

NYU Langone Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported