Head Start ParticipationNCT06510218
The 2021-2022 Study of Family and Staff Well-Being in Head Start AIAN FACES Programs
An observational study of Head Start Participation, run by Mathematica Policy Research, Inc. at 1 site in United States.
Trial summary
The 2021-2022 Study of Family and Staff Experiences in American Indian and Alaska Native Head Start Family and Child Experiences Survey Programs (the 2021-2022 Study) builds on AIAN FACES 2019, a national study of children and families participating in Head Start programs funded through grants to federally recognized… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Head Start Participation
- How many people
- 560 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2021to 31 Jul 2022
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Region XI Head Start children (and their families), Region XI Head Start programs, Region XI Head Start centers, Region XI Head Start classrooms/teachers.
Inclusion Criteria: The Head Start programs participating in the 2021-2022 Study were a probability sample selected from among 146 study-eligible programs on the 2016-2017 Head Start Program Information Report (PIR). To be eligible for the study, a program had to be
- providing services directly to children ages 3 to 5
- The Head Start Program Performance Standards require that children turn 3 by date used to determine eligibility for public school in the community in which the Head Start program is located. Therefore, some study children were 2 years old at the time of sampling if sampling occurred before the date used for public school eligibility.
- not be in imminent danger of losing its grantee status. Probability samples of centers were selected within each program, teachers within each center, and children within each teacher. Further, the programs that participated in the 2019-2020 study had to have participated in AIAN FACES 2019-2020.
Exclusion Criteria: Head Start programs in Regions I through X and Migrant and Seasonal Head Start (Region XII) were not eligible for the 2021-2022 Study. Programs that did not participate in AIAN FACES 2019-2020 were also not eligible for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mathematica
Washington D.C., District of Columbia, 20002
About this study
The 2021-2022 Study of Family and Staff Experiences in American Indian and Alaska Native Head Start Family and Child Experiences Survey Programs (the 2021-2022 Study) builds on AIAN FACES 2019, a national study of children and families participating in Head Start programs funded through grants to federally recognized tribes and consortia. In the year following the start of the COVID-19 pandemic, there was a need to understand how children, families, and Head Start staff were faring. The 2021-2022 Study explores this with some of the programs that participated in AIAN FACES 2019.
Read the detailed description
The American Indian and Alaska Native Head Start Family and Child Experiences Survey (AIAN FACES) provides information about children and families enrolled in Head Start programs operated by federally recognized tribes (known as Region XI AIAN Head Start). Nationally representative studies were conducted in the 2015-2016 and 2019-2020 program years (entered as NCT03842111 and NCT04046965, respectively).
The motivation and goals of the 2021-2022 Study of Family and Staff Experiences in AIAN FACES Programs came from a need to learn about children's, families', and teachers' experiences as the COVID-19 pandemic continued affecting Region XI Head Start families' and staff's lives into another program year-and from recognizing the disproportionate impact of the pandemic on AIAN communities. The Office of Planning, Research, and Evaluation in the Administration for Children and Families (ACF), U.S. Department of Health and Human Services, funded Mathematica to conduct a new data collection effort, the 2021-2022 Study, for the fall and spring of the 2021-2022 program year. The goals were to provide data on the characteristics and needs of Region XI children, families, and staff starting 18 months into the COVID-19 pandemic, and to provide information to help better understand staff retention and turnover.
The 2021-2022 Study includes data from a multistage sample of Region XI Head Start programs (based on the AIAN FACES 2019 sample), centers, teachers, and families from across the United States. Data from the 2021-2022 Study provide a window into the experiences of a small number of Region XI children, their families, and staff who were able to participate in data collection between October 2021 and July 2022. The data do not represent all Region XI Head Start children, their families, and staff nationally. They provide a snapshot of the experiences of children in Region XI Head Start children, their families, and staff during this difficult time.
- Conditions
- Head Start Participation
- Keywords
- child care, child development, child health, child rearing, children, curriculum, early childhood education, families, Head Start, parenting, parents, parent well-being, teacher well-being, early childhood workforce, school readiness
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 |
|---|---|---|
| Head Start children and families | Children (261) Parents (261) Teachers (88) Program directors (18) Center directors (43) |
What is being measured
The primary outcome is the main question the study is designed to answer.
General health status
Indicators of physical well-being were assessed by parent report to a survey item on if child's health is excellent, very good, good, fair, or poor
Measured: October 2021-January 2022; April-July 2022
Social-emotional development
Indicators of social-emotional development were assessed using teacher report of several items on children's positive and problem behaviors. Please see the 2021-2022 Study User's Manual (Reid et al. 2024) for more information on the scores and technical information.
Measured: November 2021-January 2022; April-July 2022
Social-emotional development - Approaches to learning
Indicators of social-emotional development were assessed using teacher and parent report of approaches to learning using the Early Childhood Longitudinal Study - Kindergarten Class of 1998 (ECLS-K). The items assess a child's motivation, attention, organization, persistence, and independence in learning. Please see U.S. Department of Education 2002 for more information on the scores and technical properties.
Measured: October 2021-January 2022; April-July 2022
Parents' depressive symptoms
Parents' levels of depressive symptoms were measured using the short form of the Center for Epidemiologic Studies-Depression Scale (CES-D). Please see Radloff 1977 for more information.
Measured: October 2021-January 2022; April-July 2022
Teachers' depressive symptoms
Teachers' levels of depressive symptoms were measured using the short form of the Center for Epidemiologic Studies-Depression Scale (CES-D). Please see Radloff 1977 for more information.
Measured: November 2021-January 2022; April-July 2022
Program directors' depressive symptoms
Program directors' levels of depressive symptoms were measured using the short form of the Center for Epidemiologic Studies-Depression Scale (CES-D). Please see Radloff 1977 for more information.
Measured: April-July 2022
Center directors' depressive symptoms
Center directors' levels of depressive symptoms were measured using the short form of the Center for Epidemiologic Studies-Depression Scale (CES-D). Please see Radloff 1977 for more information.
Measured: April-July 2022
Parents' anxiety
Parents' and caregivers' anxiety levels were measured using items from the General Anxiety Disorder-7 (GAD-7). Please see Spitzer et al. 2006 for more information.
Measured: October 2021-January 2022; April-July 2022
Teachers' anxiety
Teachers' anxiety levels were measured using items from the General Anxiety Disorder-7 (GAD-7). Please see Spitzer et al. 2006 for more information.
Measured: November 2021-January 2022; April-July 2022
Program directors' anxiety
Program directors' anxiety levels were measured using items from the General Anxiety Disorder-7 (GAD-7). Please see Spitzer et al. 2006 for more information.
Measured: April-July 2022
Center directors' anxiety
Center directors' anxiety levels were measured using items from the General Anxiety Disorder-7 (GAD-7). Please see Spitzer et al. 2006 for more information.
Measured: April-July 2022
Staffing challenges
Staffing challenges were measured by summarizing center director survey items about the extent to which staff turnover has been a problem in terms of maintaining consistency in operations and care of children, and about finding classroom coverage and having enough staff to operate at full capacity.
Measured: April-July 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start2 Aug 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, Office of Planning, Research & Evaluation
- Responsible party
- Sponsor
- Investigators
- Sara Bernstein, Ph.D., Study director, Mathematica Policy Research, Inc.Nikki Aikens, Ph.D., Principal investigator, Mathematica Policy Research, Inc.Louisa Tarullo, Ed.D., Principal investigator, Mathematica Policy Research, Inc.Ashley Kopack Klein, M.A., Study director, Mathematica Policy Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510218
- Sponsor's protocol ID
- 51307-B
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In the future, the 2021-2022 Study of Family and Staff Experiences in AIAN Head Start FACES Programs archived data will be available for access.
Publications
Radloff, L. "The CES-D Scale: A Self-Report Depression Scale for Research in the General Population." Applied Psychological Measurement, vol. 1, no. 3, 1977, pp. 385-401.
Reid, M., A. Kopack Klein, E. Doran, B. Lepidus Carlson, J. Cannon, N. Aikens, N. Reid, S. Skidmore, K. Gonzalez, X. Li, L. Malone, S. Bernstein. "2021-2022 Study of Family and Staff Experiences in AIAN Head Start FACES Programs (2021-2022 Study): User's Manual." Washington, DC: Mathematica, 2024.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171U.S. Department of Education, National Center for Education Statistics. Early Childhood Longitudinal Study-Kindergarten Class of 1998-99 (ECLS-K), Psychometric Report for Kindergarten through First Grade. NCES 2002-05. Washington, DC: National Center for Education Statistics, Institute of Education Sciences, U.S. Department of Education, 2002.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 2021-2022 Study of Family and Staff Well-Being in Head Start AIAN FACES Programs
- ClinicalTrials.gov ID
- NCT06510218
- Acronym / sponsor ID
- 51307-B
- Conditions
- Head Start Participation
- Keywords
- child care, child development, child health, child rearing, children, curriculum, early childhood education, families
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- Department of Health and Human Services, Office of Planning, Research & Evaluation
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 19 Jul 2024 (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 2021-2022 Study of Family and Staff Experiences in American Indian and Alaska Native Head Start Family and Child Experiences Survey Programs (the 2021-2022 Study) builds on AIAN FACES 2019, a national study of children and families participating in Head Start programs funded through grants to federally recognized tribes and consortia. In the year following the start of the COVID-19 pandemic, there was a need to understand how children, families, and Head Start staff were faring. The 2021-2022 Study explores this with some of the programs that participated in AIAN FACES 2019.
Detailed description
The American Indian and Alaska Native Head Start Family and Child Experiences Survey (AIAN FACES) provides information about children and families enrolled in Head Start programs operated by federally recognized tribes (known as Region XI AIAN Head Start). Nationally representative studies were conducted in the 2015-2016 and 2019-2020 program years (entered as NCT03842111 and NCT04046965, respectively).
The motivation and goals of the 2021-2022 Study of Family and Staff Experiences in AIAN FACES Programs came from a need to learn about children's, families', and teachers' experiences as the COVID-19 pandemic continued affecting Region XI Head Start families' and staff's lives into another program year-and from recognizing the disproportionate impact of the pandemic on AIAN communities. The Office of Planning, Research, and Evaluation in the Administration for Children and Families (ACF), U.S. Department of Health and Human Services, funded Mathematica to conduct a new data collection effort, the 2021-2022 Study, for the fall and spring of the 2021-2022 program year. The goals were to provide data on the characteristics and needs of Region XI children, families, and staff starting 18 months into the COVID-19 pandemic, and to provide information to help better understand staff retention and turnover.
The 2021-2022 Study includes data from a multistage sample of Region XI Head Start programs (based on the AIAN FACES 2019 sample), centers, teachers, and families from across the United States. Data from the 2021-2022 Study provide a window into the experiences of a small number of Region XI children, their families, and staff who were able to participate in data collection between October 2021 and July 2022. The data do not represent all Region XI Head Start children, their families, and staff nationally. They provide a snapshot of the experiences of children in Region XI Head Start children, their families, and staff during this difficult time.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head Start children and families | – | –Children (261) Parents (261) Teachers (88) Program directors (18) Center directors (43) |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Region XI Head Start children (and their families), Region XI Head Start programs, Region XI Head Start centers, Region XI Head Start classrooms/teachers.
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
General health status
Time frame: October 2021-January 2022; April-July 2022
Indicators of physical well-being were assessed by parent report to a survey item on if child's health is excellent, very good, good, fair, or poor
Social-emotional development
Time frame: November 2021-January 2022; April-July 2022
Indicators of social-emotional development were assessed using teacher report of several items on children's positive and problem behaviors. Please see the 2021-2022 Study User's Manual (Reid et al. 2024) for more information on the scores and technical information.
Social-emotional development - Approaches to learning
Time frame: October 2021-January 2022; April-July 2022
Indicators of social-emotional development were assessed using teacher and parent report of approaches to learning using the Early Childhood Longitudinal Study - Kindergarten Class of 1998 (ECLS-K). The items assess a child's motivation, attention, organization, persistence, and independence in learning. Please see U.S. Department of Education 2002 for more information on the scores and technical properties.
Parents' depressive symptoms
Time frame: October 2021-January 2022; April-July 2022
Parents' levels of depressive symptoms were measured using the short form of the Center for Epidemiologic Studies-Depression Scale (CES-D). Please see Radloff 1977 for more information.
Teachers' depressive symptoms
Time frame: November 2021-January 2022; April-July 2022
Teachers' levels of depressive symptoms were measured using the short form of the Center for Epidemiologic Studies-Depression Scale (CES-D). Please see Radloff 1977 for more information.
Program directors' depressive symptoms
Time frame: April-July 2022
Program directors' levels of depressive symptoms were measured using the short form of the Center for Epidemiologic Studies-Depression Scale (CES-D). Please see Radloff 1977 for more information.
Center directors' depressive symptoms
Time frame: April-July 2022
Center directors' levels of depressive symptoms were measured using the short form of the Center for Epidemiologic Studies-Depression Scale (CES-D). Please see Radloff 1977 for more information.
Parents' anxiety
Time frame: October 2021-January 2022; April-July 2022
Parents' and caregivers' anxiety levels were measured using items from the General Anxiety Disorder-7 (GAD-7). Please see Spitzer et al. 2006 for more information.
Teachers' anxiety
Time frame: November 2021-January 2022; April-July 2022
Teachers' anxiety levels were measured using items from the General Anxiety Disorder-7 (GAD-7). Please see Spitzer et al. 2006 for more information.
Program directors' anxiety
Time frame: April-July 2022
Program directors' anxiety levels were measured using items from the General Anxiety Disorder-7 (GAD-7). Please see Spitzer et al. 2006 for more information.
Center directors' anxiety
Time frame: April-July 2022
Center directors' anxiety levels were measured using items from the General Anxiety Disorder-7 (GAD-7). Please see Spitzer et al. 2006 for more information.
Staffing challenges
Time frame: April-July 2022
Staffing challenges were measured by summarizing center director survey items about the extent to which staff turnover has been a problem in terms of maintaining consistency in operations and care of children, and about finding classroom coverage and having enough staff to operate at full capacity.
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 22 Jul 2024.
- BackgroundRadloff, L. "The CES-D Scale: A Self-Report Depression Scale for Research in the General Population." Applied Psychological Measurement, vol. 1, no. 3, 1977, pp. 385-401.
- BackgroundReid, M., A. Kopack Klein, E. Doran, B. Lepidus Carlson, J. Cannon, N. Aikens, N. Reid, S. Skidmore, K. Gonzalez, X. Li, L. Malone, S. Bernstein. "2021-2022 Study of Family and Staff Experiences in AIAN Head Start FACES Programs (2021-2022 Study): User's Manual." Washington, DC: Mathematica, 2024.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- BackgroundU.S. Department of Education, National Center for Education Statistics. Early Childhood Longitudinal Study-Kindergarten Class of 1998-99 (ECLS-K), Psychometric Report for Kindergarten through First Grade. NCES 2002-05. Washington, DC: National Center for Education Statistics, Institute of Education Sciences, U.S. Department of Education, 2002.
- Individual participant dataSharing planned: Yes. In the future, the 2021-2022 Study of Family and Staff Experiences in AIAN Head Start FACES Programs 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.
Sara Bernstein, Ph.D. study director
Mathematica Policy Research, Inc.
Nikki Aikens, Ph.D. principal investigator
Mathematica Policy Research, Inc.
Louisa Tarullo, Ed.D. principal investigator
Mathematica Policy Research, Inc.
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 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?
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 22 Jul 2024. 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?
General health status (time frame: October 2021-January 2022; April-July 2022). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06510218, which also lists 4 linked publications.
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 22 Jul 2024.