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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HD106547-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The current study examines the impact of ParentCorps in high-poverty district schools in New York City (NYC). The study is conducted within the context of the NYC Department of Education (DOE) Pre-K Thrive initiative. As part of this initiative, the Center for Early Childhood Health and Development (CEHD) at NYU Langone Health is implementing services to strengthen family engagement and support parents and teachers in creating safe, nurturing and predictable environments for young children. All parents of Pre-K students in the 81 district schools will be invited for them and their Pre-K children to participate in the study, which includes 2 school-based assessments in Pre-K over a 10-month period and 1 school-based assessment at the end of Kindergarten, and teacher ratings of children in Pre-K and Kindergarten. Additionally, parents will be invited to consent to the use of their children's NYC DOE administrative records from Pre-K through grade 5 for the purposes of this study. Parents will also be invited to participate by completing surveys with NYU study staff. Parents will be consented to complete two surveys when their child is in Pre-K. Parents may be randomly selected to complete a third survey when their child is in Kindergarten or to participate in a focus group with other parents.
This randomized controlled trial is an evaluation of Thrive Professional Learning plus ParentCorps compared to the Thrive and Inspire Professional Learning tracks in 81 district schools. The study will include families of Pre-K students and Pre-K students. Forty-one (41) district schools are participating in Thrive Professional Learning, delivered by NYU Langone-based staff; 20 of these schools are randomly assigned to implement ParentCorps (in addition to Thrive Professional Learning). Forty (40 district schools) are participating in Inspire Professional Learning and will not implement ParentCorps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thrive Professional Learning plus ParentCorps | Experimental | Parents with a child enrolled at a participating school with teachers who received the thrive professional learning plus ParentCorps. |
|
| Thrive Professional Learning only | Experimental | Parents with a child enrolled at a participating school with teachers who received the thrive professional learning only. |
|
| Inspire Professional Learning | Experimental | Parents with a child enrolled at a participating school with teachers who received the inspire professional learning only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrive Professional Learning plus ParentCorps | Behavioral | led by the NYC Department of Education. Professional Learning sessions are tailored to the needs of pre-K teachers and leaders, and include topics aligned with the district's quality standards that support child instructional goals. |
| Measure | Description | Time Frame |
|---|---|---|
| NIH Toolbox Emotion Battery Test Anger Subscale Score | Parents report on the Anger subscale from the NIH Toolbox Emotion Battery. This measure was designed for children ages 3 - 7. The Anger subscale includes 9 items which measure attitudes of hostility and cynicism often associated with experiences of frustration impeding goal-directed behavior. Parents are asked to respond to items on a three-point scale ranging from "Never True" to "Often True". The NIH Toolbox uses a T-score metric where a score of 50 is the mean and 10 is the standard deviation. A higher T-score indicates higher anger. | End of Kindergarten, on average 22 months |
| Pediatric Symptom Checklist (PSC) Score | Parents report on Attention Problems on the PSC. Tis 5-item subscale screens psychosocial functioning in children 4-18 years of age. Parents are asked to rate the frequency of each symptom on a three-point scale ranging from "Never" (0) to "Often" (2). Scores are summed and range from 0-10, with higher scores indicating high attention problems. | End of Kindergarten, on average 22 months |
| Social Competence Scale - Parent Version Score | Parents report on two subscales, Prosocial/Communication Skills and Emotional Regulation Skills, on the Social Competence Scale. This 12-item measure assesses a child's prosocial behaviors, communication skills, and self-control. Parents respond to items on a five-point scale ranging from "Not at All" to "Very well". Scores are summed on both subscales for a total scale score, scores range from 0 to 48. Higher scores reflect higher parent-reported social competence. | End of Kindergarten, on average 22 months |
| The Parental Engagement of Families Questionnaire (PEFL) Score | Parents report on the Foundational Education sub-scale of the Parental Engagement of Families Questionnaire (PEFL). This measure captures parental engagement designed for and validated with Latino Head Start families. The 20-item Foundational Education sub-scale reflects parents' efforts to teach their children "the basics". Parents respond to each item using a 4-point rating scale ranging from 1 (Never) to 4 (Frequently). Raw summed scores are converted to T-scores where a score of 50 is the mean and 10 is the standard deviation. Higher scores indicates higher parent-reported social competence. |
| Measure | Description | Time Frame |
|---|---|---|
| NIH Toolbox Emotion Battery Test Score | Parents report on three sub-scales from the NIH Toolbox Emotion Battery. This measure was designed for children ages 3 - 7. The Fear-Over Anxious subscale includes 6 items measuring symptoms of anxiety that reflect autonomic arousal and perceptions of threat. The Fear-Separation Anxiety subscale includes 7 items measuring symptoms of anxiety that reflect autonomic arousal and perceptions of threat. The Sadness subscale includes 7 items measuring low levels of positive affect. Parents are asked to respond to items on a three-point scale ranging from "Never True" to "Often True". All subscales are summed for a total score. The NIH Toolbox uses a T-score metric where a score of 50 is the mean and 10 is the standard deviation. The average of the three sub-scales is calculated. A higher T-score indicates higher anxiety, separation anxiety and sadness. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurie Brotman, PhD | New York Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Requests should be directed to Andrea.Troxel@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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The Protocol Enrollment, Number Started and Completed reflected dyads.
Parents of pre-K students were invited to participate in the study in Fall 2019. The parent of the pre-K student provided consent for participation for both their pre-K child and themselves, only the parents provided consent. 81 district schools with Pre-K programs were selected for the study in late Spring 2017 by the NYC DOE. 20 schools were randomized to Thrive Professional Learning plus ParentCorps, 21 schools to Thrive Professional Learning only, 40 schools to Inspire Professional Learning.
| ID | Title | Description |
|---|---|---|
| FG000 | Thrive Professional Learning Plus ParentCorps | Parents with a child enrolled at a participating school with teachers who received the thrive professional learning plus ParentCorps. |
| FG001 | Thrive Professional Learning Only | Parents with a child enrolled at a participating school with teachers who received the thrive professional learning only. |
| FG002 | Inspire Professional Learning | Parents with a child enrolled at a participating school with teachers who received the inspire professional learning only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Baseline characteristics is reported for the Pre-K students, baseline characteristics were not collected for the Parents/Caregivers.
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| ID | Title | Description |
|---|---|---|
| BG000 | Thrive Professional Learning Plus ParentCorps | Parents with a child enrolled at a participating school with teachers who received the thrive professional learning plus ParentCorps. |
| BG001 | Thrive Professional Learning Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | NIH Toolbox Emotion Battery Test Anger Subscale Score | Parents report on the Anger subscale from the NIH Toolbox Emotion Battery. This measure was designed for children ages 3 - 7. The Anger subscale includes 9 items which measure attitudes of hostility and cynicism often associated with experiences of frustration impeding goal-directed behavior. Parents are asked to respond to items on a three-point scale ranging from "Never True" to "Often True". The NIH Toolbox uses a T-score metric where a score of 50 is the mean and 10 is the standard deviation. A higher T-score indicates higher anger. | Out of the 81 in the Thrive Professional Learning (PL) plus ParentCorps, 41 did not complete the measure at the end of Kindergarten. Out of the 85 participants in the Thrive PL, 42 did not complete this measure at the end of Kindergarten. Out of the 156 participants in the Inspire Professional Learning, 75 did not complete the measure at the end of Kindergarten. | Posted | Mean | Standard Deviation | T-score | End of Kindergarten, on average 22 months |
|
AE, SAE, and all cause mortality data were collected from the time the participant was consented until their final study visit (on average 22 months during the course of the 2 years of data collection)
Systematic assessment was conducted at each data collection point (baseline, end of pre-Kindergarten, start of Kindergarten, end of Kindergarten). We evaluated adverse events and participants' experience on a weekly basis during data collection, through meetings and review of data collected with staff conducting the interviews with parents. Adverse event data was collected for the dyads (parent + student).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thrive Professional Learning Plus ParentCorps | Parents with a child enrolled at a participating school with teachers who received the thrive professional learning plus ParentCorps. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laurie Miller Brotman, Ph.D. | NYU Langone Health | 646-754-4999 | laurie.brotman@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2020 | Oct 17, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 25, 2019 | Oct 17, 2025 | ICF_001.pdf |
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|
| Thrive Professional Learning only | Behavioral | Part of the Professional Learning Track system for all Pre-K for All teachers and leaders. The NYC DOE schedules Thrive Professional Learning training days for staff on non-attendance days. Teachers attend four Professional Learning days annually, and leaders attend three days annually, over a two-year period. |
|
| Inspire Professional Learning | Behavioral | Delivered to leaders in groups of 20 - 40 three times a year over the same two-year period. Content covers best practices in Family Engagement and Social Emotional Learning and includes an experiential approach to behavior change that asks learners to take the perspective of others and consider their own beliefs and assumptions about students, families, teachers and leaders |
|
| End of Pre-Kindergarten, on average 9 months |
| End of Kindergarten, on average 22 months |
| PROMIS-4 Sleep Disturbance Questionnaire Score | Parents report on the Patient-Reported Outcomes Measurement Information System (PROMIS) -4 sleep disturbance questionnaire. This 4-item questionnaire assesses child's sleep disturbances. Parents report on a 5-point scale ranging from "Never" to "Always". Scores are converted to a T-score, where a score of 50 is the mean and 10 is the standard deviation. Higher T-scores reflect high sleep disturbance. | End of Kindergarten, on average 22 months |
| Parent Evidence-Based Strategies Scale | Parents report on the Parent Evidence-Based Strategies Scale, which is adapted from the Parent Practices Interview (PPI). This 6-item scale assesses the frequency in which parents apply a range of evidence-based parenting strategies (e.g., behavioral management, promotion strategies). Parents report on a 5-point scale, ranging from 1 (Never) to 5 (Very Often). Items are scored for a total score, scores range from 6-30. Higher scores reflect higher frequency of evidence-based strategies in parenting. | End of Pre-Kindergarten, on average 9 months |
| Daily Living Routines Subscale of the Child Routines Inventory (CRI) Score | Parents report on the Daily Living Routines subscale of the Child Routines Inventory (CRI). This measures commonly occurring routines in school-aged children. This 11-item subscale consists of routines around activities of daily living, such as morning routine and bedtime routine. Parents report on a 5-point scale, ranging from "Almost Never" to "Nearly Always". Scores are summed and range from 0-44, with high scores reflecting higher frequency of routines related to daily activities. | End of Kindergarten, on average 22 months |
Parents with a child enrolled at a participating school with teachers who received the thrive professional learning only.
| BG002 | Inspire Professional Learning | Parents with a child enrolled at a participating school with teachers who received the inspire professional learning only. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Thrive Professional Learning Plus ParentCorps |
Parents with a child enrolled at a participating school with teachers who received the inspire professional learning only. |
| OG001 | Thrive Professional Learning Only | Parents with a child enrolled at a participating school with teachers who received the thrive professional learning only. |
| OG002 | Inspire Professional Learning | Parents with a child enrolled at a participating school with teachers who received the inspire professional learning only. |
|
|
| Primary | Pediatric Symptom Checklist (PSC) Score | Parents report on Attention Problems on the PSC. Tis 5-item subscale screens psychosocial functioning in children 4-18 years of age. Parents are asked to rate the frequency of each symptom on a three-point scale ranging from "Never" (0) to "Often" (2). Scores are summed and range from 0-10, with higher scores indicating high attention problems. | Out of the 81 in the Thrive Professional Learning plus ParentCorps, 41 did not complete the measure at the end of Kindergarten. Out of the 85 participants in the Thrive PL, 36 did not complete this measure at the end of Kindergarten. Out of the 156 participants in the Inspire Professional Learning, 76 did not complete the measure at the end of Kindergarten. | Posted | Mean | Standard Deviation | units on a scale | End of Kindergarten, on average 22 months |
|
|
|
| Primary | Social Competence Scale - Parent Version Score | Parents report on two subscales, Prosocial/Communication Skills and Emotional Regulation Skills, on the Social Competence Scale. This 12-item measure assesses a child's prosocial behaviors, communication skills, and self-control. Parents respond to items on a five-point scale ranging from "Not at All" to "Very well". Scores are summed on both subscales for a total scale score, scores range from 0 to 48. Higher scores reflect higher parent-reported social competence. | Out of the 81 in the Thrive Professional Learning plus ParentCorps, 41 did not complete the measure at the end of Kindergarten. Out of the 85 participants in the Thrive PL, 36 did not complete this measure at the end of Kindergarten. Out of the 156 participants in the Inspire Professional Learning, 76 did not complete the measure at the end of Kindergarten. | Posted | Mean | Standard Deviation | units on a scale | End of Kindergarten, on average 22 months |
|
|
|
| Primary | The Parental Engagement of Families Questionnaire (PEFL) Score | Parents report on the Foundational Education sub-scale of the Parental Engagement of Families Questionnaire (PEFL). This measure captures parental engagement designed for and validated with Latino Head Start families. The 20-item Foundational Education sub-scale reflects parents' efforts to teach their children "the basics". Parents respond to each item using a 4-point rating scale ranging from 1 (Never) to 4 (Frequently). Raw summed scores are converted to T-scores where a score of 50 is the mean and 10 is the standard deviation. Higher scores indicates higher parent-reported social competence. | Out of the 81 in the Thrive Professional Learning plus ParentCorps, 23 did not complete the measure at the end of pre-Kindergarten. Out of the 85 participants in the Thrive PL, 30 did not complete this measure at the end of pre-Kindergarten. Out of the 156 participants in the Inspire Professional Learning, 52 did not complete the measure at the end of pre-Kindergarten. | Posted | Mean | Standard Deviation | T-score | End of Pre-Kindergarten, on average 9 months |
|
|
|
| Secondary | NIH Toolbox Emotion Battery Test Score | Parents report on three sub-scales from the NIH Toolbox Emotion Battery. This measure was designed for children ages 3 - 7. The Fear-Over Anxious subscale includes 6 items measuring symptoms of anxiety that reflect autonomic arousal and perceptions of threat. The Fear-Separation Anxiety subscale includes 7 items measuring symptoms of anxiety that reflect autonomic arousal and perceptions of threat. The Sadness subscale includes 7 items measuring low levels of positive affect. Parents are asked to respond to items on a three-point scale ranging from "Never True" to "Often True". All subscales are summed for a total score. The NIH Toolbox uses a T-score metric where a score of 50 is the mean and 10 is the standard deviation. The average of the three sub-scales is calculated. A higher T-score indicates higher anxiety, separation anxiety and sadness. | Out of the 81 in the Thrive Professional Learning plus ParentCorps, 41 did not complete the measure at the end of Kindergarten. Out of the 85 participants in the Thrive PL, 42 did not complete this measure at the end of Kindergarten. Out of the 156 participants in the Inspire Professional Learning, 75 did not complete the measure at the end of Kindergarten. | Posted | Mean | Standard Deviation | T-score | End of Kindergarten, on average 22 months |
|
|
|
| Secondary | PROMIS-4 Sleep Disturbance Questionnaire Score | Parents report on the Patient-Reported Outcomes Measurement Information System (PROMIS) -4 sleep disturbance questionnaire. This 4-item questionnaire assesses child's sleep disturbances. Parents report on a 5-point scale ranging from "Never" to "Always". Scores are converted to a T-score, where a score of 50 is the mean and 10 is the standard deviation. Higher T-scores reflect high sleep disturbance. | Out of the 81 in the Thrive Professional Learning plus ParentCorps, 41 did not complete the measure at the end of Kindergarten. Out of the 85 participants in the Thrive PL, 36 did not complete this measure at the end of Kindergarten. Out of the 156 participants in the Inspire Professional Learning, 75 did not complete the measure at the end of Kindergarten. | Posted | Mean | Standard Deviation | T-score | End of Kindergarten, on average 22 months |
|
|
|
| Secondary | Parent Evidence-Based Strategies Scale | Parents report on the Parent Evidence-Based Strategies Scale, which is adapted from the Parent Practices Interview (PPI). This 6-item scale assesses the frequency in which parents apply a range of evidence-based parenting strategies (e.g., behavioral management, promotion strategies). Parents report on a 5-point scale, ranging from 1 (Never) to 5 (Very Often). Items are scored for a total score, scores range from 6-30. Higher scores reflect higher frequency of evidence-based strategies in parenting. | Out of the 81 in the Thrive Professional Learning plus ParentCorps, 24 did not complete the measure at the end of pre-Kindergarten. Out of the 85 participants in the Thrive PL, 33 did not complete this measure at the end of pre-Kindergarten. Out of the 156 participants in the Inspire Professional Learning, 55 did not complete the measure at the end of pre-Kindergarten. | Posted | Mean | Standard Deviation | units on a scale | End of Pre-Kindergarten, on average 9 months |
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|
|
| Secondary | Daily Living Routines Subscale of the Child Routines Inventory (CRI) Score | Parents report on the Daily Living Routines subscale of the Child Routines Inventory (CRI). This measures commonly occurring routines in school-aged children. This 11-item subscale consists of routines around activities of daily living, such as morning routine and bedtime routine. Parents report on a 5-point scale, ranging from "Almost Never" to "Nearly Always". Scores are summed and range from 0-44, with high scores reflecting higher frequency of routines related to daily activities. | Out of the 81 in the Thrive Professional Learning plus ParentCorps, 41 did not complete the measure at the end of Kindergarten. Out of the 85 participants in the Thrive PL, 36 did not complete this measure at the end of Kindergarten. Out of the 156 participants in the Inspire Professional Learning, 75 did not complete the measure at the end of Kindergarten. | Posted | Mean | Standard Deviation | units on a scale | End of Kindergarten, on average 22 months |
|
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| 0 |
| 81 |
| EG001 | Thrive Professional Learning Only | Parents with a child enrolled at a participating school with teachers who received the thrive professional learning only. | 0 | 85 | 0 | 85 | 0 | 85 |
| EG002 | Inspire Professional Learning | Parents with a child enrolled at a participating school with teachers who received the inspire professional learning only. | 0 | 156 | 0 | 156 | 0 | 156 |
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