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NCT Number: NCT06941337

HealthySteps + PlayReadVIP

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.

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Key information

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Adult-Child Relationship Scale Score

    Time frame: Month 12

    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.

  2. Adult-Child Relationship Scale Score

    Time frame: Month 24

    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.

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

    Time frame: Month 12

    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.

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

    Time frame: Month 24

    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.

  5. Infant Behavior Questionnaire Score

    Time frame: Month 12

    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.

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

    Time frame: Month 12

    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.

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

    Time frame: Month 12

    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.

  8. Child Behavior Checklist Score

    Time frame: Month 24

    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.

Secondary outcomes

  1. Edinburgh Depression Scale (EPDS) Score

    Time frame: Baseline

    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.

  2. Edinburgh Depression Scale (EPDS) Score

    Time frame: Month 12

    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.

  3. Edinburgh Depression Scale (EPDS) Score

    Time frame: Month 24

    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.

  4. Perceived Stress Scale (PSS) Score

    Time frame: Baseline

    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.

  5. Perceived Stress Scale (PSS) Score

    Time frame: Month 12

    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.

  6. Perceived Stress Scale (PSS) Score

    Time frame: Month 24

    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.

  7. Parenting Self-Agency Measure

    Time frame: Baseline

    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.

  8. Parenting Self-Agency Measure

    Time frame: Month 12

    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.

  9. Parenting Self-Agency Measure

    Time frame: Month 24

    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.

  10. Patient-Reported Outcomes Measurement Information System (PROMIS): General Life Satisfaction Scale Score

    Time frame: Baseline

    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.

  11. PROMIS: General Life Satisfaction Scale Score

    Time frame: Month 12

    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.

  12. PROMIS: General Life Satisfaction Scale Score

    Time frame: Month 24

    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.

  13. Dyadic Adjustment Scale Score

    Time frame: Baseline

    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.

  14. Dyadic Adjustment Scale Score

    Time frame: Month 12

    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.

  15. Dyadic Adjustment Scale Score

    Time frame: Month 24

    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.

  16. Socolar Discipline Survey Score

    Time frame: Month 12

    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.

  17. Socolar Discipline Survey Score

    Time frame: Month 24

    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.

  18. Early Social Communication Scale (ESCS) Score

    Time frame: Month 12

    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.

  19. Early Social Communication Scale (ESCS) Score

    Time frame: Month 24

    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.

  20. MacArthur-Bates Communicative Development Inventory (CDI) Score

    Time frame: Month 12

    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.

  21. MacArthur-Bates Communicative Development Inventory (CDI) Score

    Time frame: Month 24

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caitlin Canfield

CONTACT

[email protected]

2125622522

Janae Kuttamperoor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 23, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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