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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
1,000
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, United States
RECRUITINGAdult-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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 24
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: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 24