Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MD018597 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HealthySteps + PlayReadVIP | Experimental | Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, plus PlayReadVIP, which promotes relational health through video coaching. |
|
| Standard HealthySteps | Active Comparator | Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caitlin Canfield | Contact | 2125622522 | Caitlin.canfield@nyulangone.org | |
| Janae Kuttamperoor | Contact | Janae.kuttamperoor@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Caitlin Canfield | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 |
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 |