Clinical trial NCT06941337: HealthySteps + PlayReadVIP
Official title: HEALTHYSTEPS + PLAYREADVIP EFFECTS ON PARENTING AND CHILD DEVELOPMENT: A RANDOMIZED IMPLEMENTATION EFFECTIVENESS TRIAL
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Families With Infants
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-04-23
Enrollment: 1000
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Primary outcomes:
measure: Adult-Child Relationship Scale Score
timeFrame: Month 12
measure: Adult-Child Relationship Scale Score
timeFrame: Month 24
measure: Stimulation Questionnaire (StimQ) Core: Reading, Teaching, Verbal Responsivity Score
timeFrame: Month 12
measure: Stimulation Questionnaire (StimQ) Core: Reading, Teaching, Verbal Responsivity Score
timeFrame: Month 24
measure: Infant Behavior Questionnaire Score
timeFrame: Month 12
measure: Brief Infant Toddler Social-Emotional Assessment (BITSEA) Score: Competence
timeFrame: Month 12
measure: Brief Infant Toddler Social-Emotional Assessment (BITSEA) Score: Problems
timeFrame: Month 12
measure: Child Behavior Checklist Score
timeFrame: Month 24
Secondary outcomes:
measure: Edinburgh Depression Scale (EPDS) Score
timeFrame: Baseline
measure: Edinburgh Depression Scale (EPDS) Score
timeFrame: Month 12
measure: Edinburgh Depression Scale (EPDS) Score
timeFrame: Month 24
measure: Perceived Stress Scale (PSS) Score
timeFrame: Baseline
measure: Perceived Stress Scale (PSS) Score
timeFrame: Month 12
measure: Perceived Stress Scale (PSS) Score
timeFrame: Month 24
measure: Parenting Self-Agency Measure
timeFrame: Baseline
measure: Parenting Self-Agency Measure
timeFrame: Month 12
measure: Parenting Self-Agency Measure
timeFrame: Month 24
measure: Patient-Reported Outcomes Measurement Information System (PROMIS): General Life Satisfaction Scale Score
timeFrame: Baseline
measure: PROMIS: General Life Satisfaction Scale Score
timeFrame: Month 12
measure: PROMIS: General Life Satisfaction Scale Score
timeFrame: Month 24
measure: Dyadic Adjustment Scale Score
timeFrame: Baseline
measure: Dyadic Adjustment Scale Score
timeFrame: Month 12
measure: Dyadic Adjustment Scale Score
timeFrame: Month 24
measure: Socolar Discipline Survey Score
timeFrame: Month 12
measure: Socolar Discipline Survey Score
timeFrame: Month 24
measure: Early Social Communication Scale (ESCS) Score
timeFrame: Month 12
measure: Early Social Communication Scale (ESCS) Score
timeFrame: Month 24
measure: MacArthur-Bates Communicative Development Inventory (CDI) Score
timeFrame: Month 12
measure: MacArthur-Bates Communicative Development Inventory (CDI) Score
timeFrame: Month 24
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Caitlin Caitlin
role: PRINCIPAL_INVESTIGATOR
References: