Evaluation of the CHIME Intervention for Improving Early Head Start/Head Start Educator Well-being (NCT05791825) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the CHIME Intervention for Improving Early Head Start/Head Start Educator Well-being
United States571 participantsStarted 2023-03-13
Plain-language summary
This study will test how well a mindfulness-based intervention called CHIME improves the emotional well-being of educators in Early Head Start and Head Start (EHS/HS) settings. The study also will examine if there are any benefits to young children's social emotional health as a result of the CHIME program. Researchers will compare educators who participate in CHIME to educators who are asked to participate at a later time to see if there are benefits to their emotional health and teaching practices.
Who can participate
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:
There are 3 types of participants included in this study: Early Head Start/Head Start education staff who work at one of the partner sites; parents of children attending EHS or HS; children attending EHS or HS and enrolled in the classroom of a participating EHS/HS educator.
Inclusion criteria for each of these groups are as follows:
Early Head Start and Head Start Educators:
* Provision of signed and dated informed consent form in Docusign
* Currently employed as a lead or assistant educator for \>20 hours per week in a participating Head Start or Early Head Start center
* Stated intention to participate in the CHIME intervention
* All genders; age 19 and older
* Able to complete activities in English
Parents
* Provision of electronically (in Docusign) /manually signed informed consent form
* All genders
* Age 19 and older
* is Parent or legal guardian of child enrolled in the classroom of a EHS/HS educator participating in the study
* Able to complete activities
Children
* Provision of electronically signed informed consent form by parent/legal guardian
* All genders; aged \< 6 years
* Enrolled in the classroom of a EHS/HS educator participating in the study
* If \> 3 years, ability to complete study activities in English or with translation support
Exclusion Criteria:
Exclusion criteria for each of the study groups are as follows:
Early Head Start and Head Start Educators:
* Does not currently work at a participating HS/EHS center
* younger …
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
Change in Teacher Emotion Regulation Difficulties from baseline to post assessments
Timeframe: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.
2
Change in Teacher Adaptive Emotion Regulation from baseline to post assessments
Timeframe: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.
3
Change in Teacher Self-Compassion from baseline to post assessments
Timeframe: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.
4
Change in Teacher Workplace Stress from baseline to post assessments
Timeframe: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.
5
Change in Teacher Mental Well-Being from baseline to post assessments
Timeframe: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.
6
Change in Educator heart rate variability from baseline to post assessments