Early Head Start ParticipationBabyFACES18NCT04897789
The Early Head Start Family and Child Experiences Survey (Baby FACES 2018)
An observational study of Early Head Start Participation, run by Mathematica Policy Research, Inc. at 1 site in United States.
Trial summary
Early Head Start (EHS) Family and Child Experiences Survey - 2018 (Baby FACES 2018) will answer new questions about EHS programs, staff, and families that can guide program technical assistance, management, and policy. Read more about this study
- Who is it for?
- Ages Up to 4 years
- Conditions the study is for
- Early Head Start Participation
- How many people
- 6,723 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 1 Mar 2023
- Phase
- Observational
- 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 Up to 4 years
- All sexes
- No healthy volunteers
- Child
Study population: Early Head Start pregnant women and Early Heat Start infants and toddlers (and their families), Early Head Start programs, Early Head Start centers, Early Head Start home visitors, Early Head Start classrooms/teachers
Who may be able to join
- The Early Head Start programs participating in Baby FACES 2018 are a probability sample selected from among study-eligible programs on the 2016-2017 Head Start Program Information Report (PIR). To be eligible for the study, a program had to be
- In one of the 50 states or the District of Columbia
- Providing services directly to pregnant women or children up to preschool age.
- Not be in imminent danger of losing its grantee status.
Who cannot join
- American Indian and Alaska Native Head Start programs (Region XI) or Migrant and Seasonal Worker Head Start programs (Region XII) were not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mathematica Policy Research
Princeton, New Jersey, 08540
About this study
Early Head Start (EHS) Family and Child Experiences Survey - 2018 (Baby FACES 2018) will answer new questions about EHS programs, staff, and families that can guide program technical assistance, management, and policy. It will provide information about EHS programs in the context of the adoption of the new Head Start Early Learning Outcomes Framework. Baby FACES 2018 will consist of two nationally representative cross-sectional samples of programs, centers, classrooms, home visitors, and children and families. It will include surveys of program directors, center directors, teachers, home visitors, and parents; conduct observations of classrooms and home visits, and ask staff and parents to report on children's development.
Read the detailed description
The overarching purpose of the Baby FACES studies is to provide knowledge about Early Head Start children and families, and the EHS programs and staff who serve them. The ongoing series of Baby FACES data collections is aimed at maintaining up-to-date core information on EHS over time while also focusing on different areas of interest. The Baby FACES studies began with Baby FACES 2009, a longitudinal descriptive study that followed two cohorts of children and families through participation in the program and focused on program services and participation, and child and family wellbeing and outcomes over time. Baby FACES 2018 (and a future round in 2022) have been redesigned to provide cross-sectional descriptive information and a point in time picture of EHS. The present study will focus on understanding the processes in EHS core services (classrooms and home visits) that support infant and toddler development; namely, nurturing and responsive relationships between children and caregivers. With this new focus, Baby FACES 2018 will take a more in depth look at classrooms while a future study, Baby FACES 2022, will take a more in depth look at home visiting.
The Baby FACES team will carry out a descriptive study that includes a nationally representative sample of EHS programs, centers, classrooms, teachers, home visitors, and children and families (including pregnant women) and answers new questions about how EHS programs function. The study is guided by a comprehensive conceptual framework that illustrates how EHS program processes and activities are expected to lead to high quality service delivery and enhanced family and infant/toddler outcomes for the program overall. The overarching research question for Baby FACES 2018 is: How do EHS services support infant/toddler growth and development in the context of nurturing, responsive relationships? The study will address this question through the collection of rich information using interviews, self-administered questionnaires, classroom observations, and administrative data sources. This approach will allow the Administration for Children and Families to capture important information about EHS services, families, and children across all service options (e.g., center-based, home-based, or those providing both service options), as well as in depth information about how EHS classrooms and teacher-child relationships support infant/toddler development.
- Conditions
- Early Head Start Participation
- Keywords
- child care, child development, child health, child nutrition, child rearing, children, early childhood education, Early Head Start, families, parenting skills, parents, relationships
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| children/pregnant women | children/pregnant women (2,310) | |
| parents | parents (2,310) | |
| classrooms/teachers | classrooms/teachers (840) | |
| home visitors | home visitors (630) | |
| center directors | center directors (493) | |
| program directors | program directors (140) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classroom quality/teacher-child interactions
Indicators of classroom quality were assessed using the Classroom Assessment Scoring System, Infant version (CLASS-I), depending on the ages of children in the classroom. The CLASS assesses the quality of interactions between teachers and children in classrooms. Please see the Baby FACES User's Manual (Cannon et al. 2020) for more information on scores and technical properties.
Measured: One-day observation in March-May 2018
Classroom quality/teacher-child interactions
Indicators of classroom quality were assessed using the Classroom Assessment Scoring System, Toddler version (CLASS-T), depending on the ages of children in the classroom. The CLASS assesses the quality of interactions between teachers and children in classrooms. Please see the Baby FACES User's Manual (Cannon et al. 2020) for more information on scores and technical properties.
Measured: One-day observation in March-May 2018
Classroom quality/teacher-child interactions
Indicators of classroom quality were assessed using the Quality of Caregiver Child Interactions for Infants and Toddlers (Q-CCIIT). The Q-CCIIT assesses the quality of interactions between teachers and children in classrooms. Please see the Baby FACES User's Manual (Cannon et al. 2020) for more information on scores and technical properties.
Measured: One-day observation in March-May 2018
Child expressive and receptive vocabulary
Teachers and parents independently reported on words the child understands and says, using the MacArthur Communicative Development Inventories (CDI). Please see the Baby FACES User's Manual (Cannon et al. 2020) for more information on scores and technical properties.
Measured: 1 week
Child social-emotional/behavioral development
Teachers and parents independently reported on children's social competence and problem behaviors using the Brief Infant Toddler Social Emotional Assessment. Please see the Baby FACES User's Manual (Cannon et al. 2020) for more information on scores and technical properties.
Measured: 1 week
Secondary outcomes (3)
Teacher-child relationships
Teachers report on their relationship with children using the Student-Teacher Relationship, Short Form. Please see the Baby FACES 2018 User's Manual (Cannon et al. 2020) for more information on the scores and technical properties.
Measured: 1 week
Parent-child relationships
Parent-child relationships were assessed with the Child-Parent Relationship Scale, Short Form. Please see the Baby FACES 2018 User's Manual (Cannon et al. 2020) for more information on the scores and technical properties.
Measured: 1 week
Parent-child relationships
Parent-child relationships were assessed with the Healthy Families Parenting Inventory. Please see the Baby FACES 2018 User's Manual (Cannon et al. 2020) for more information on the scores and technical properties.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Oct 2017
- Primary completion30 Jun 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Head Start ParticipationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 6,723 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Office of Planning, Research & Evaluation, Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Cheri Vogel, Ph.D., Study director, Mathematica Policy ResearchSally Atkins-Burnett, Ph.D., Principal investigator, Mathematica Policy ResearchYange Xue, Ph.D., Principal investigator, Mathematica Policy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897789
- Sponsor's protocol ID
- 50193
- Acronym
- BabyFACES18
- Status last verified
- May 2021
- First submitted
- 17 May 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In the future, Baby FACES archived data will be available for access
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Early Head Start Family and Child Experiences Survey (Baby FACES 2018)
- ClinicalTrials.gov ID
- NCT04897789
- Acronym / sponsor ID
- BabyFACES18 / 50193
- Conditions
- Early Head Start Participation
- Keywords
- child care, child development, child health, child nutrition, child rearing, children, early childhood education, Early Head Start
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,723 participants (estimated)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- Office of Planning, Research & Evaluation, Department of Health and Human Services
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 24 May 2021 (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.
Early Head Start (EHS) Family and Child Experiences Survey - 2018 (Baby FACES 2018) will answer new questions about EHS programs, staff, and families that can guide program technical assistance, management, and policy. It will provide information about EHS programs in the context of the adoption of the new Head Start Early Learning Outcomes Framework. Baby FACES 2018 will consist of two nationally representative cross-sectional samples of programs, centers, classrooms, home visitors, and children and families. It will include surveys of program directors, center directors, teachers, home visitors, and parents; conduct observations of classrooms and home visits, and ask staff and parents to report on children's development.
Detailed description
The overarching purpose of the Baby FACES studies is to provide knowledge about Early Head Start children and families, and the EHS programs and staff who serve them. The ongoing series of Baby FACES data collections is aimed at maintaining up-to-date core information on EHS over time while also focusing on different areas of interest. The Baby FACES studies began with Baby FACES 2009, a longitudinal descriptive study that followed two cohorts of children and families through participation in the program and focused on program services and participation, and child and family wellbeing and outcomes over time. Baby FACES 2018 (and a future round in 2022) have been redesigned to provide cross-sectional descriptive information and a point in time picture of EHS. The present study will focus on understanding the processes in EHS core services (classrooms and home visits) that support infant and toddler development; namely, nurturing and responsive relationships between children and caregivers. With this new focus, Baby FACES 2018 will take a more in depth look at classrooms while a future study, Baby FACES 2022, will take a more in depth look at home visiting.
The Baby FACES team will carry out a descriptive study that includes a nationally representative sample of EHS programs, centers, classrooms, teachers, home visitors, and children and families (including pregnant women) and answers new questions about how EHS programs function. The study is guided by a comprehensive conceptual framework that illustrates how EHS program processes and activities are expected to lead to high quality service delivery and enhanced family and infant/toddler outcomes for the program overall. The overarching research question for Baby FACES 2018 is: How do EHS services support infant/toddler growth and development in the context of nurturing, responsive relationships? The study will address this question through the collection of rich information using interviews, self-administered questionnaires, classroom observations, and administrative data sources. This approach will allow the Administration for Children and Families to capture important information about EHS services, families, and children across all service options (e.g., center-based, home-based, or those providing both service options), as well as in depth information about how EHS classrooms and teacher-child relationships support infant/toddler development.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| children/pregnant women | – | –children/pregnant women (2,310) |
| parents | – | –parents (2,310) |
| classrooms/teachers | – | –classrooms/teachers (840) |
| home visitors | – | –home visitors (630) |
| center directors | – | –center directors (493) |
| program directors | – | –program directors (140) |
Who may qualify
- Ages
- Up to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Early Head Start pregnant women and Early Heat Start infants and toddlers (and their families), Early Head Start programs, Early Head Start centers, Early Head Start home visitors, Early Head Start classrooms/teachers
Key inclusion criteria (4 listed)
- The Early Head Start programs participating in Baby FACES 2018 are a probability sample selected from among study-eligible programs on the 2016-2017 Head Start Program Information Report (PIR). To be eligible for the study, a program had to be
- In one of the 50 states or the District of Columbia
- Providing services directly to pregnant women or children up to preschool age.
- Not be in imminent danger of losing its grantee status.
Key exclusion criteria (1 listed)
- American Indian and Alaska Native Head Start programs (Region XI) or Migrant and Seasonal Worker Head Start programs (Region XII) were not eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Classroom quality/teacher-child interactions
Time frame: One-day observation in March-May 2018
Indicators of classroom quality were assessed using the Classroom Assessment Scoring System, Infant version (CLASS-I), depending on the ages of children in the classroom. The CLASS assesses the quality of interactions between teachers and children in classrooms. Please see the Baby FACES User's Manual (Cannon et al. 2020) for more information on scores and technical properties.
Classroom quality/teacher-child interactions
Time frame: One-day observation in March-May 2018
Indicators of classroom quality were assessed using the Classroom Assessment Scoring System, Toddler version (CLASS-T), depending on the ages of children in the classroom. The CLASS assesses the quality of interactions between teachers and children in classrooms. Please see the Baby FACES User's Manual (Cannon et al. 2020) for more information on scores and technical properties.
Classroom quality/teacher-child interactions
Time frame: One-day observation in March-May 2018
Indicators of classroom quality were assessed using the Quality of Caregiver Child Interactions for Infants and Toddlers (Q-CCIIT). The Q-CCIIT assesses the quality of interactions between teachers and children in classrooms. Please see the Baby FACES User's Manual (Cannon et al. 2020) for more information on scores and technical properties.
Child expressive and receptive vocabulary
Time frame: 1 week
Teachers and parents independently reported on words the child understands and says, using the MacArthur Communicative Development Inventories (CDI). Please see the Baby FACES User's Manual (Cannon et al. 2020) for more information on scores and technical properties.
Child social-emotional/behavioral development
Time frame: 1 week
Teachers and parents independently reported on children's social competence and problem behaviors using the Brief Infant Toddler Social Emotional Assessment. Please see the Baby FACES User's Manual (Cannon et al. 2020) for more information on scores and technical properties.
3 secondary outcomes
Teacher-child relationships
Time frame: 1 week
Parent-child relationships
Time frame: 1 week
Parent-child relationships
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Individual participant dataSharing planned: Yes. In the future, Baby FACES archived data will be available for access
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.
Cheri Vogel, Ph.D. study director
Mathematica Policy Research
Sally Atkins-Burnett, Ph.D. principal investigator
Mathematica Policy Research
Yange Xue, Ph.D. principal investigator
Mathematica Policy Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Head Start Participation, run by Mathematica Policy Research, Inc. 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 May 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?
Results are not available in the source record.
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?
Classroom quality/teacher-child interactions (time frame: One-day observation in March-May 2018). The study lists 5 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 24 May 2021.