HealthySteps + PlayReadVIP

NCT06941337 | Recruiting DMC

• 2 other identifiers: 24-019881R01MD018597
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Families With Infants

Outcome Measures

Primary Outcomes (8)

• Adult-Child Relationship Scale Score

  13-item assessment of parent-child relationship quality. Each item is rated on a Likert 5 scale from 1 (definitely not) to 5 (definitely). The total score is the average of item responses and ranges from 1-5; higher scores indicate a stronger and more positive relationship between the child and parent.

  Month 12

• Adult-Child Relationship Scale Score

  13-item assessment of parent-child relationship quality. Each item is rated on a Likert 5 scale from 1 (definitely not) to 5 (definitely). The total score is the average of item responses and ranges from 1-5; higher scores indicate a stronger and more positive relationship between the child and parent.

  Month 24

• Stimulation Questionnaire (StimQ) Core: Reading, Teaching, Verbal Responsivity Score

  The StimQ is a parent-report measure of the cognitive home environment, designed to assess the level of cognitive stimulation children receive at home. Items include dichotomous (yes or no) and Likert-style responses ranging from 0-4. The total score is the sum of item responses and ranges from 0 to 43; higher scores are correlated with better parental behavior.

  Month 12

• Stimulation Questionnaire (StimQ) Core: Reading, Teaching, Verbal Responsivity Score

  The StimQ is a parent-report measure of the cognitive home environment, designed to assess the level of cognitive stimulation children receive at home. Items include dichotomous (yes or no) and Likert-style responses ranging from 0-4. The total score is the sum of item responses and ranges from 0 to 43; higher scores are correlated with better parental behavior.

  Month 24

• Infant Behavior Questionnaire Score

  36-item parent-report questionnaire used to measure the temperament of an infant (3-12 months old). Each item is rated on a scale from 1 (never) to 7 (always); the total score is the average of responses and ranges from 1-7; higher scores indicating greater frequency of behaviors.

  Month 12

• Brief Infant Toddler Social-Emotional Assessment (BITSEA) Score: Competence

  BITSEA measures socioemotional development in toddlerhood. 11 of the items cover competence. Each item is rated on a scale from 0-2. The total BITSEA Competence Score is the sum of responses and ranges from 0-22; higher scores indicate greater functioning.

  Month 12

• Brief Infant Toddler Social-Emotional Assessment (BITSEA) Score: Problems

  BITSEA measures socioemotional development in toddlerhood. 31 of the items cover problems. Each item is rated on a scale from 0-2. The total BITSEA Problems Score is the sum of responses and ranges from 0-62; higher scores indicate poorer functioning.

  Month 12

• Child Behavior Checklist Score

  100-item questionnaire identifying problem behavior in children. Each item is rated on a scale from 0 (absent) to 2 (often occurs). The raw score is the sum of responses and is transformed into a final t-score ranging from 0-100 with a mean of 50 and standard deviation of 10. T-scores below 60 indicate non-clinical symptoms; t-scores between 60 and 64 indicate that the child is at risk for problem behaviors; and t-scores above 65 indicate clinical symptoms.

  Month 24

Secondary Outcomes (21)

• Edinburgh Depression Scale (EPDS) Score

  Baseline

• Edinburgh Depression Scale (EPDS) Score

  Month 12

• Edinburgh Depression Scale (EPDS) Score

  Month 24

• Perceived Stress Scale (PSS) Score

  Baseline

• Perceived Stress Scale (PSS) Score

  Month 12

Study Arms (2)

HealthySteps + PlayReadVIP

EXPERIMENTAL

Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, plus PlayReadVIP, which promotes relational health through video coaching.

Behavioral: HealthySteps (HS); Behavioral: PlayReadVIP

Standard HealthySteps

ACTIVE COMPARATOR

Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, only.

Behavioral: HealthySteps (HS)

Interventions

HealthySteps (HS) BEHAVIORAL

Evidence-based program that focuses on addressing Adverse Childhood Experiences (ACEs) and family stressors. The program provides parenting guidance, mental health support, and care coordination. The program is delivered during well-child visits by an HS specialist.

HealthySteps + PlayReadVIP; Standard HealthySteps

PlayReadVIP BEHAVIORAL

Evidence-based program that promotes Positive Childhood Experiences (PCEs) and strengthens parent-child interactions. The program involves recording and reviewing videos of parents engaging with their child to provide feedback and encourage positive practices. Families receive toys, books, and guides to extend activities at home.

HealthySteps + PlayReadVIP

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify 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 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.

You may not qualify 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

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Study Officials

• Caitlin Canfield

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitlin Canfield

CONTACT

2125622522; Caitlin.canfield@nyulangone.org

Janae Kuttamperoor

CONTACT

Janae.kuttamperoor@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 23, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to caitlin.canfield@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

Locations

US (1)