Evaluation of the CHIME Intervention for Improving Early Head Start/Head Start Educator Well-being

Study Overview
=================
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.

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

Conditions
-----------------
Health, Subjective, Work Related Stress, Compassion, Social Skills

Intervention / Treatment
-----------------
* Behavioral: Cultivating Healthy Intentional Mindful Educators


Participation Criteria
=================
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Receives CHIME<br>Half of the educators participating in the trial will be assigned to this condition. CHIME is an 8-week, mindfulness and self-compassion based intervention that teaches educators strategies to enhance socioemotional learning in the classroom. The primary endpoints are: educator mindfulness and self-compassion, educator emotional regulation, educator heart rate variability, educator wellbeing and socio-emotional learning, and educator responsiveness, support, and sensitivity in the classroom. The secondary endpoints are: child self-regulation and social skills and family-school relationships. | Behavioral: Cultivating Healthy Intentional Mindful Educators<br>* The 8-week, manualized, CHIME intervention consists of a 2-hour overview and seven weekly sessions, each lasting 90 minutes. Each CHIME session focuses on a specific mindfulness technique, such as mindful breathing, mindful listening and bringing attention to current states and surroundings to support optimal responsiveness, emotion regulation, and compassion. Social emotional learning is promoted by focusing on five broad competencies: self-awareness, social awareness, responsible decision-making, self-management, and relationship skills and these competencies are practiced and developed through small group discussions, storytelling, journal reflections, modeling, and guided awareness (e.g., meditations), and implementation activities (e.g., gratitude necklace).<br>|
| No Intervention: Wait-listed comparison<br>Half of the HS/EHS educators will be assigned to a waitlisted control group. Specifically, these educators will be scheduled to receive the intervention after a 6-month waiting period. During the interim period, they will complete the same assessments as Arm 1, but will continue to receive 'business as usual' support and professional development through typical Head Start/EHS programming. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Teacher Emotion Regulation Difficulties from baseline to post assessments | Difficulties in Emotion Regulation Scale | Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months. | 
| Change in Teacher Adaptive Emotion Regulation from baseline to post assessments | Emotion Regulation Questionnaire - Reappraisal scale | Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months. | 
| Change in Teacher Self-Compassion from baseline to post assessments | Self-Compassion Scale | Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months. | 
| Change in Teacher Workplace Stress from baseline to post assessments | NIOSH Worker Wellbeing Questionnaire | Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months. | 
| Change in Teacher Mental Well-Being from baseline to post assessments | Warkwick-Edinburgh Mental Wellbeing Scale measures perceptions of overall mental well-being | Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months. | 
| Change in Educator heart rate variability from baseline to post assessments | Actihearts worn in the classroom | Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months. | 
| Change in Teacher Depressive Symptoms from baseline to post assessments | Center for Epidemiological Depression - Short From measuring depressive symptoms | Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months. | 
| Change Teaching Practices from baseline to post assessments | Educator scores on the CLASS Observation Emotional Support Scale measuring the teachers emotional support for all the children in the classroom | Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months. | 
| Change in Teaching Practices from baseline to post assessments | Caregiver Interaction Scale that measures the interactions between the participating educator and a target child in the classroom. | Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Child Social Skills from baseline to post assessments | Child Social Skills Improvement System Socio-Emotional Learning Brief that measures social-emotional competencies | Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months. | 
| Change in Child Self-Regulation Skills from baseline to post assessments | child self-regulation task scores from a puppet task administered with a trained researcher | Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months. | 
| Change in Perceived Family and Teacher Relationships from baseline to post assessments | a measure of tahe quality of the relationship between the main primary caregiver and the teacher/educator) (Family and Provider Relationship Quality; Kim, 2012) | Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months. | 
| Change in Child Social Skills from baseline to post assessments | Devereux Early Childhood Assessment which is a behavior rating scale that is completed by parents and/or caregivers or teachers which provides an assessment of within-child protective factors central to social and emotional health and resilience. | Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mindfulness, Social-emotional learning, Self-compassion, Early care and education, Teacher well-being, Head Start