Emotional StressNCT03524105
Promoting Success for Pre-K Teachers, Families and Children
A study testing Program for Parents (Parenting Program) and Thrive Professional Learning in people with Emotional Stress, run by NYU Langone Health at 1 site in United States.
Trial summary
The current study examines the impact of ParentCorps in high-poverty Early Education Centers 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 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Stress
- What is being tested?
- Program for Parents (Parenting Program) and Thrive Professional Learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Teachers who are teaching staff in the Pre-K classrooms in the 23 Centers.
Who cannot join
- Only Pre-K teachers from the 23 Centers will be invited to participate in the study. Leaders and other school staff from the Centers are excluded from the study.
- Family-level administrative data only on Pre-K families from the 12 Centers assigned to the Professional Learning plus ParentCorps condition will be obtained from the NYC DOE. Families in other sites are excluded from the request for family-level administrative data.
Trial locations and contacts
1 site in 1 country.
About this study
The current study examines the impact of ParentCorps in high-poverty Early Education Centers 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 building safe, nurturing and predictable environments for young children. Services include resources to support social emotional learning (SEL) and family engagement (FE) for all Pre-K for All (PKFA) programs and all PKFA families; Professional Learning to support the use of evidence-based SEL and FE practices for teachers and leaders from 350 PKFA programs; and ParentCorps programs for PKFA children and families in 50 PKFA programs (which is a subset of PKFA programs receiving Professional Learning). The current study evaluates the relative value of Thrive Professional Learning plus ParentCorps compared to Thrive Professional Learning.
This study will include 158 pre-K teachers (teachers and teaching assistants) across 23 Centers (12 Centers receiving Thrive Professional Learning plus ParentCorps, 11 Centers receiving Thrive Professional Learning only). All teachers in the 23 Centers will be invited to complete 2 self-report surveys over a two-year period. A sub-set of teachers will be randomly selected to participate in 2 interviews during this period. In addition, teachers in sites randomized to ParentCorps (12 Centers) will be invited to consent to the use of weekly implementation surveys, observational data and semi-structured interviews about experiences with implementation, collected as part of standard implementation practice of ParentCorps, for the purposes of this study.
- Conditions
- Emotional Stress
- Being tested
- Program for Parents (Parenting Program), Thrive Professional Learning
- Keywords
- Socio Economic Adversity, Child Development, Poverty, racial disparity, ethnic disparity
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program for Parents (Parenting Program)Behavioural
Program for Parents (Parenting Program) is implemented by a mental health professional and offered to groups of ~15 parents during the school day and during after school hours. The Program for Parents includes 2-hour sessions provided weekly over a 4-month period. The Program for Students (Friends School Social Emotional Learning Program) is implemented by classroom teachers in the classroom with 90 minute lessons and activities once a week for 14 weeks
Thrive Professional LearningBehavioural
Professional Learning is delivered to teachers in groups of 20-40 4 times a year over a two-year period. Professional Learning is delivered to leaders in groups of 20 - 40 three times a year over the same two-year period.
| Study group | Role | What they receive |
|---|---|---|
| Thrive Professional Learning plus ParentCorps | Active comparator | Not described Receives: Behavioral: Program for Parents (Parenting Program) |
| Thrive Professional Learning track | Active comparator | Not described Receives: Behavioral: Thrive Professional Learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Teacher's knowledge measured using self- report surveys
Measured: 15 Months
Teachers' social emotional competencies measured using the Emotion Regulation Questionnaire (ERQ)
The emotion regulation questionnaire is designed to assess individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression on a 5 point scale
Measured: 15 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start17 Sep 2018
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional StressStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurie Brotman, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524105
- Sponsor's protocol ID
- 17-01812
- Status last verified
- Jan 2021
- First submitted
- 11 Apr 2018
- Last updated
- 8 Jan 2021
- Results posted
- No
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Success for Pre-K Teachers, Families and Children
- ClinicalTrials.gov ID
- NCT03524105
- Acronym / sponsor ID
- 17-01812
- Conditions
- Emotional Stress
- Keywords
- Socio Economic Adversity, Child Development, Poverty, racial disparity, ethnic disparity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study examines the impact of ParentCorps in high-poverty Early Education Centers 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 building safe, nurturing and predictable environments for young children. Services include resources to support social emotional learning (SEL) and family engagement (FE) for all Pre-K for All (PKFA) programs and all PKFA families; Professional Learning to support the use of evidence-based SEL and FE practices for teachers and leaders from 350 PKFA programs; and ParentCorps programs for PKFA children and families in 50 PKFA programs (which is a subset of PKFA programs receiving Professional Learning). The current study evaluates the relative value of Thrive Professional Learning plus ParentCorps compared to Thrive Professional Learning.
This study will include 158 pre-K teachers (teachers and teaching assistants) across 23 Centers (12 Centers receiving Thrive Professional Learning plus ParentCorps, 11 Centers receiving Thrive Professional Learning only). All teachers in the 23 Centers will be invited to complete 2 self-report surveys over a two-year period. A sub-set of teachers will be randomly selected to participate in 2 interviews during this period. In addition, teachers in sites randomized to ParentCorps (12 Centers) will be invited to consent to the use of weekly implementation surveys, observational data and semi-structured interviews about experiences with implementation, collected as part of standard implementation practice of ParentCorps, for the purposes of this study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrive Professional Learning plus ParentCorps | Active comparator | Behavioral: Program for Parents (Parenting Program) |
| Thrive Professional Learning track | Active comparator | Behavioral: Thrive Professional Learning |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Teachers who are teaching staff in the Pre-K classrooms in the 23 Centers.
Key exclusion criteria (2 listed)
- Only Pre-K teachers from the 23 Centers will be invited to participate in the study. Leaders and other school staff from the Centers are excluded from the study.
- Family-level administrative data only on Pre-K families from the 12 Centers assigned to the Professional Learning plus ParentCorps condition will be obtained from the NYC DOE. Families in other sites are excluded from the request for family-level administrative data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Program for Parents (Parenting Program)Program for Parents (Parenting Program) is implemented by a mental health professional and offered to groups of ~15 parents during the school day and during after school hours. The Program for Parents includes 2-hour sessions provided weekly over a 4-month period. The Program for Students (Friends School Social Emotional Learning Program) is implemented by classroom teachers in the classroom with 90 minute lessons and activities once a week for 14 weeks | Behavioural | Thrive Professional Learning plus ParentCorps |
| Thrive Professional LearningProfessional Learning is delivered to teachers in groups of 20-40 4 times a year over a two-year period. Professional Learning is delivered to leaders in groups of 20 - 40 three times a year over the same two-year period. | Behavioural | Thrive Professional Learning track |
Primary outcome
Teacher's knowledge measured using self- report surveys
Time frame: 15 Months
Teachers' social emotional competencies measured using the Emotion Regulation Questionnaire (ERQ)
Time frame: 15 Months
The emotion regulation questionnaire is designed to assess individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression on a 5 point scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie Brotman, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program for Parents (Parenting Program) and Thrive Professional Learning in people with Emotional Stress, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Teacher's knowledge measured using self- report surveys (time frame: 15 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.