NCT06941337|RecruitingDMC
HealthySteps + PlayReadVIP
HEALTHYSTEPS + PLAYREADVIP EFFECTS ON PARENTING AND CHILD DEVELOPMENT: A RANDOMIZED IMPLEMENTATION EFFECTIVENESS TRIAL
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HEALTHYSTEPS + PLAYREADVIP EFFECTS ON PARENTING AND CHILD DEVELOPMENT: A RANDOMIZED IMPLEMENTATION EFFECTIVENESS TRIAL
Sponsor study identifier
Secondary identifiers
NIH
interventional
1,000
1 country
1
Study Start
June 9, 2025
Actual (reported)Primary Completion
January 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 16, 2025
Actual (reported)April 23, 2025
Actual (reported)June 9, 2025
Actual (reported)January 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, plus PlayReadVIP, which promotes relational health through video coaching.
Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, only.
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.
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.
NYU Langone Health
New York, New York, 10016, United States
Caitlin Canfield
NYU Langone Health
First Submitted
April 16, 2025
First Posted
April 23, 2025
Study Start
June 9, 2025
Actual (reported)Primary Completion
January 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Completion
January 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 4, 2026
Record last verified: 2026-04
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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