The 2021-2022 Study of Family and Staff Well-Being in Head Start AIAN FACES Programs (NCT06510218) | Clinical Trial Compass
CompletedNot Applicable
The 2021-2022 Study of Family and Staff Well-Being in Head Start AIAN FACES Programs
United States560 participantsStarted 2021-08-02
Plain-language 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 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.
Who can participate
Age range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
o 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
General health status
Timeframe: October 2021-January 2022; April-July 2022
2
Social-emotional development
Timeframe: November 2021-January 2022; April-July 2022
3
Social-emotional development - Approaches to learning
Timeframe: October 2021-January 2022; April-July 2022
4
Parents' depressive symptoms
Timeframe: October 2021-January 2022; April-July 2022
5
Teachers' depressive symptoms
Timeframe: November 2021-January 2022; April-July 2022