HealthySteps + PlayReadVIP

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

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.

Study Overview

• Status: Recruiting
• Conditions: Families With Infants
• Intervention / Treatment: Behavioral: HealthySteps (HS); Behavioral: PlayReadVIP

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Janae Kuttamperoor; Email: Janae.kuttamperoor@nyulangone.org
• Study Contact Backup: Name: Caitlin Canfield; Phone Number: 2125622522; Email: Caitlin.canfield@nyulangone.org

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HealthySteps + PlayReadVIP; 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); 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.; Behavioral: PlayReadVIP; 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.
Active Comparator: Standard HealthySteps; Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, only.	Behavioral: HealthySteps (HS); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh Depression Scale (EPDS) Score	10-item screening tool used to assess symptoms of depression in pregnant and postpartum women. The total score is determined by adding together the scores for each of the 10 items and ranges from 0-30; higher scores indicate greater severity of depression.	Baseline
Edinburgh Depression Scale (EPDS) Score	10-item screening tool used to assess symptoms of depression in pregnant and postpartum women. The total score is determined by adding together the scores for each of the 10 items and ranges from 0-30; higher scores indicate greater severity of depression.	Month 12
Edinburgh Depression Scale (EPDS) Score	10-item screening tool used to assess symptoms of depression in pregnant and postpartum women. The total score is determined by adding together the scores for each of the 10 items and ranges from 0-30; higher scores indicate greater severity of depression.	Month 24
Perceived Stress Scale (PSS) Score	10-item assessment of stress over the past month. Each item is rated on a scale from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0-40; higher scores indicate more severe stress.	Baseline
Perceived Stress Scale (PSS) Score	10-item assessment of stress over the past month. Each item is rated on a scale from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0-40; higher scores indicate more severe stress.	Month 12
Perceived Stress Scale (PSS) Score	10-item assessment of stress over the past month. Each item is rated on a scale from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0-40; higher scores indicate more severe stress.	Month 24
Parenting Self-Agency Measure	5-item assessment of thoughts and feelings about being a parent. Each item is rated on a scale from 1 (almost never or never) to 5 (almost always or always). The total score ranges from 5-25; higher scores indicate greater parenting self-agency.	Baseline
Parenting Self-Agency Measure	5-item assessment of thoughts and feelings about being a parent. Each item is rated on a scale from 1 (almost never or never) to 5 (almost always or always). The total score ranges from 5-25; higher scores indicate greater parenting self-agency.	Month 12
Parenting Self-Agency Measure	5-item assessment of thoughts and feelings about being a parent. Each item is rated on a scale from 1 (almost never or never) to 5 (almost always or always). The total score ranges from 5-25; higher scores indicate greater parenting self-agency.	Month 24
Patient-Reported Outcomes Measurement Information System (PROMIS): General Life Satisfaction Scale Score	5-item questionnaire of life satisfaction. Responses are scored on a Likert scale and then converted to a T-score with a mean of 50 and a standard deviation of 10, where higher scores indicate greater satisfaction.	Baseline
PROMIS: General Life Satisfaction Scale Score	5-item questionnaire of life satisfaction. Responses are scored on a Likert scale and then converted to a T-score with a mean of 50 and a standard deviation of 10, where higher scores indicate greater satisfaction.	Month 12
PROMIS: General Life Satisfaction Scale Score	5-item questionnaire of life satisfaction. Responses are scored on a Likert scale and then converted to a T-score with a mean of 50 and a standard deviation of 10, where higher scores indicate greater satisfaction.	Month 24
Dyadic Adjustment Scale Score	32-item assessment of relationship quality of intact couples. Each item is rated on a scale; the total score is the sum of responses. Scores range from 0 to 151, with higher scores indicating greater relationship satisfaction and lower scores suggesting more distress.	Baseline
Dyadic Adjustment Scale Score	32-item assessment of relationship quality of intact couples. Each item is rated on a scale; the total score is the sum of responses. Scores range from 0 to 151, with higher scores indicating greater relationship satisfaction and lower scores suggesting more distress.	Month 12
Dyadic Adjustment Scale Score	32-item assessment of relationship quality of intact couples. Each item is rated on a scale; the total score is the sum of responses. Scores range from 0 to 151, with higher scores indicating greater relationship satisfaction and lower scores suggesting more distress.	Month 24
Socolar Discipline Survey Score	34-item questionnaire assessing how a parent handles their problems with their children's behavior over the past 3 months. Each item is rated on a scale from 1 (never) to 6 (always). The total score is the sum of responses and ranges from 34 to 204; higher scores indicate greater frequency of harsher discipline.	Month 12
Socolar Discipline Survey Score	34-item questionnaire assessing how a parent handles their problems with their children's behavior over the past 3 months. Each item is rated on a scale from 1 (never) to 6 (always). The total score is the sum of responses and ranges from 34 to 204; higher scores indicate greater frequency of harsher discipline.	Month 24
Early Social Communication Scale (ESCS) Score	The ESCS is a videotaped, structured observation measure designed to assess nonverbal communication skills in children. Frequency scores for initiation of joint attention (IJA) are derived from behavioral observations during a series of tasks. IJA score ranges from 0 to 100 where a higher value indicates greater initiation of joint attention.	Month 12
Early Social Communication Scale (ESCS) Score	The ESCS is a videotaped, structured observation measure designed to assess nonverbal communication skills in children. Frequency scores for initiation of joint attention (IJA) are derived from behavioral observations during a series of tasks. IJA score ranges from 0 to 100 where a higher value indicates greater initiation of joint attention.	Month 24
MacArthur-Bates Communicative Development Inventory (CDI) Score	Parent report instrument that measures early language development, including productive vocabulary. Parents mark each example of words that their child says. The total score is the total number of words marked.	Month 12
MacArthur-Bates Communicative Development Inventory (CDI) Score	Parent report instrument that measures early language development, including productive vocabulary. Parents mark each example of words that their child says. The total score is the total number of words marked.	Month 24

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Caitlin Canfield, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 24-01988; 1R01MD018597 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: caitlin.canfield@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No