Child Mental HealthNCT04276363
Families, Children and Teachers Thriving Together
A study testing Thrive Professional Learning plus ParentCorps, Thrive Professional Learning only and Inspire Professional Learning in people with Child Mental Health, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Mental Health
- What is being tested?
- Thrive Professional Learning plus ParentCorps, Thrive Professional Learning only and Inspire Professional Learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2019to 6 Sep 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pre-K students and families who attend one of the 81 district schools in 2019-2020.
- Only parents and students who are English or Spanish speaking will be eligible for participation in the study.
Who cannot join
- Families in sites other than the 81 district schools randomized to this study are excluded.
- Parents or students who do not speak English and/or Spanish will not be eligible to participate.
- Teachers and principals from the 81 sites are not considered participants in the study of student and family outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Child Mental Health
- Being tested
- Thrive Professional Learning plus ParentCorps, Thrive Professional Learning only, Inspire Professional Learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrive Professional Learning plus ParentCorpsBehavioural
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.
Thrive Professional Learning onlyBehavioural
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 LearningBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: 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. Receives: Behavioral: 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. Receives: Behavioral: Inspire Professional Learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of Pre-Kindergarten, on average 9 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of Kindergarten, on average 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start14 Nov 2019
- Primary completion6 Sep 2021
- Study completion6 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Child Mental HealthStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Laurie Brotman, PhD, Principal investigator, New York Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276363
- Sponsor's protocol ID
- 19-00707
- Other IDs
- 5R01HD106547-04
- Status last verified
- Apr 2026
- First submitted
- 2 Oct 2019
- Last updated
- 7 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).