Clinical trial NCT05791825: Evaluation of the CHIME Intervention for Improving Early Head Start/Head Start Educator Well-being
Official title: Cultivating Healthy Intentional Mindful Educators (CHIME): The Use of Mindfulness and Compassion to Promote Early Head Start/Head Start Education Staffs Well-Being
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health, Subjective
Work Related Stress
Compassion
Social Skills
Keywords: Mindfulness
Social-emotional learning
Self-compassion
Early care and education
Teacher well-being
Head Start
Lead sponsor: University of Nebraska Lincoln
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2023-03-30
Enrollment: 860
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study employs a cluster-randomized design with two study arms, one of which will receive the intervention and the other of which will act as the control group. The study will employ repeated measures at pre- (baseline/time 1 assessment), post-intervention (time 2), and 3-month (time 3) follow-up points. The counterfactual will be a waitlisted control comparison condition and randomization to the intervention/control group will occur at the classroom level.
Primary purpose: OTHER

Brief 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.

Detailed description: To address the critical need of supporting Early Head Start/Head Start (EHS/HS) education staff well-being, investigators are collaborating with EHS/HS programs to co-refine and adapt a new mindfulness-based intervention (MBI), Cultivating Healthy Intentional Mindful Educators (CHIME-HS), to make the intervention effective and internally sustainable for EHS/HS programs. Small studies with CHIME in general early care and education settings provide a proof of concept of its effectiveness, with educators reporting enhanced well-being and reduced workplace burnout. However, CHIME has not been adapted for or rigorously tested in EHS/HS settings. Building on promising evidence for the efficacy of CHIME, investigators partnered with EHS/HS programs to gather feedback from EHS and HS staff and families about how to refine CHIME to best address their needs, and determine CHIME's feasibility, acceptability, and fidelity within the EHS/HS context. In this way, investigators will maximize CHIME's acceptability, feasibility, and sustainability specifically for the unique needs of the HS/EHS start community. Investigators draw upon tenets of community-engaged research to co-refine and adapt the program to address EHS/HS education staff's well-being more effectively, and with sustainability in mind. After investigators refine CHIME in phase 1, investigators will work with EHS/HS partners to coordinate a rigorous, multi-method approach to evaluate the efficacy of CHIME with 120 EHS/HS education staff and 730 children/families (Phase 2). Investigators will also interview 10 directors and assistant EHS/HS directors to identify barriers and facilitators to implementation and to put in place effective mechanisms to support the sustainability of CHIME-HS (Phase 3). Through the iterative development and refinement of the facilitator training, investigators will determine if trained EHS/HS staff can effectively implement CHIME with fidelity for promoting EHS/HS education staff emotional well-being and workplace engagement, decreasing their physiological and emotional reactivity, promoting positive teaching practices, strengthening family partnerships, and promoting young children's social skills and self-regulation. Additionally, investigators will engage with other Early Head Start/Head Start University Partnership (HSUP) grantees during the yearly grantee workshop to share lessons learned, identify opportunities for collaborative analyses, and create shared dissemination products. A variety of dissemination efforts will be utilized to make findings from the study accessible to multiple audiences invested in EHS and HS populations. Dissemination products will include the CHIME-HS intervention, its promise for improving education staff well-being, outcomes, and lessons learned about implementation, including usability, feasibility, and cost. Investigators will work cooperatively with the consortium to disseminate policy findings recognizing that collective presentation and publication of findings can concentrate the impact.

Eligibility criteria: 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 than 19 years of age

Parents

* Not a parent/legal guardian of a child in an EHS/HS classroom
* younger than 19 years of age Children NA, although children less than 3 years will not complete the self-regulation tasks These exclusion criteria are essential to the design of the study. The population of interest is EHS/HS education staff (e.g., teachers) working within centers that have agreed to participate in the evaluation of CHIME. The legal age of majority in Nebraska is age 19 years.

Primary outcomes:
measure: 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.
measure: 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.
measure: 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.
measure: 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.
measure: 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.
measure: Change in Educator heart rate variability 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.
measure: Change in Teacher Depressive Symptoms 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.
measure: Change Teaching Practices 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.
measure: Change in Teaching Practices 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.
Secondary outcomes:
measure: Change in Child Social Skills 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.
measure: Change in Child Self-Regulation Skills 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.
measure: Change in Perceived Family and Teacher Relationships 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.
measure: Change in Child Social Skills 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.
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: University of Nebraska-Lincoln
state: Nebraska
Study officials:
affiliation: University of Nebraska Lincoln
name: Holly Hatton-Bowers, PhD
role: PRINCIPAL_INVESTIGATOR
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