RECRUITING

HealthySteps + PlayReadVIP

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Conditions

Families With Infants

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-09
Study Completion:2028-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06941337

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 6 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Parent is a biological parent or legal guardian and at least 18 years of age
  2. * Infants must be ≤6 months old at the time of enrollment.
  3. * Parents/guardians must speak either English or Spanish to ensure they can fully engage with the intervention and assessments.
  4. * 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.
  5. * Parent is able to willing to provide consent for their own and their child's participation.
  1. * Non-singleton child
  2. * Parent is unable to provide consent
  3. * Parent does not speak English or Spanish, as study materials (e.g., questionnaires) are available in those languages
  4. * Parent has a severe medical or psychiatric impairment (e.g., intellectual disability, psychosis) that would interfere with study participation
  5. * Parent has plans to discontinue care at NYU Langone Health - Sunset Park Family Health Centers

Contacts and Locations

Study Contact

Caitlin Caitlin
CONTACT
2125622522
Caitlin.canfield@nyulangone.org
Janae Kuttamperoor
CONTACT
Janae.kuttamperoor@nyulangone.org

Principal Investigator

Caitlin Caitlin
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Caitlin Caitlin, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-09
Study Completion Date2028-11

Study Record Updates

Study Start Date2025-06-09
Study Completion Date2028-11

Terms related to this study

Additional Relevant MeSH Terms

  • Families With Infants