HealthySteps + PlayReadVIP
ConditionFamilies With Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 6
SponsorNYU Langone Health
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
HealthySteps (HS)
BehavioralEvidence-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
BehavioralEvidence-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.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: HealthySteps + PlayReadVIPExperimental treatment 2 interventions
Group B: Standard HealthyStepsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Month 122
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.
Time frame
Month 243
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.
Time frame
Month 124
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.
Time frame
Month 24Secondary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Month 123
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.
Time frame
Month 244
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.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov