AzTrials
AzTrials

Health, SubjectiveCHIMENCT05791825

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

A study testing Cultivating Healthy Intentional Mindful Educators in people with Health, Subjective and Work Related Stress, run by University of Nebraska Lincoln at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Cultivating Healthy Intentional Mindful Educators
Could I receive a placebo?
No, everyone receives an active treatment
How many people
571 participants
Where
1 siteUnited States
Study dates
13 Mar 2023to 31 Oct 2025
Phase
Interventional
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • 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
Show all 18Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Nebraska-Lincoln

    Lincoln, Nebraska, 68588

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Cultivating Healthy Intentional Mindful Educators
Keywords
Mindfulness, Social-emotional learning, Self-compassion, Early care and education, Teacher well-being, Head Start
Medical subject headings
Occupational Stress, Social Skills

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cultivating Healthy Intentional Mindful EducatorsBehavioural

    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).

Study groups in NCT05791825
Study groupRoleWhat they receive
Receives CHIMEExperimentalHalf 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.
Receives: Behavioral: Cultivating Healthy Intentional Mindful Educators
Wait-listed comparisonNo interventionHalf 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Teacher Emotion Regulation Difficulties from baseline to post assessments

    Difficulties in Emotion Regulation Scale

    Measured: 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

    Emotion Regulation Questionnaire - Reappraisal scale

    Measured: 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

    Self-Compassion Scale

    Measured: 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

    NIOSH Worker Wellbeing Questionnaire

    Measured: 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

    Warkwick-Edinburgh Mental Wellbeing Scale measures perceptions of overall mental well-being

    Measured: 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

    Actihearts worn in the classroom

    Measured: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.

  7. Change in Teacher Depressive Symptoms from baseline to post assessments

    Center for Epidemiological Depression - Short From measuring depressive symptoms

    Measured: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.

  8. 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

    Measured: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.

  9. 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.

    Measured: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.

Secondary outcomes (4)
  1. Change in Child Social Skills from baseline to post assessments

    Child Social Skills Improvement System Socio-Emotional Learning Brief that measures social-emotional competencies

    Measured: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.

  2. 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

    Measured: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.

  3. 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)

    Measured: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.

  4. 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.

    Measured: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2023
  2. Study start13 Mar 2023
  3. Primary completion31 Oct 2025
  4. Study completion31 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
571 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05791825
Sponsor's protocol ID
22130
Acronym
CHIME
Status last verified
Jan 2026
First submitted
13 Feb 2023
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Publications

  • Alvares GA, Quintana DS, Hickie IB, Guastella AJ. Autonomic nervous system dysfunction in psychiatric disorders and the impact of psychotropic medications: a systematic review and meta-analysis. J Psychiatry Neurosci. 2016 Mar;41(2):89-104. doi: 10.1503/jpn.140217.

    PubMed 26447819
  • Beauchaine TP. Respiratory Sinus Arrhythmia: A Transdiagnostic Biomarker of Emotion Dysregulation and Psychopathology. Curr Opin Psychol. 2015 Jun 1;3:43-47. doi: 10.1016/j.copsyc.2015.01.017.

    PubMed 25866835
  • Brody GH, Dorsey S, Forehand R, Armistead L. Unique and protective contributions of parenting and classroom processes to the adjustment of African American children living in single-parent families. Child Dev. 2002 Jan-Feb;73(1):274-86. doi: 10.1111/1467-8624.00405.

    PubMed 14717257
  • Chari R, Chang CC, Sauter SL, Petrun Sayers EL, Cerully JL, Schulte P, Schill AL, Uscher-Pines L. Expanding the Paradigm of Occupational Safety and Health: A New Framework for Worker Well-Being. J Occup Environ Med. 2018 Jul;60(7):589-593. doi: 10.1097/JOM.0000000000001330.

    PubMed 29608542
  • Dewhirst, C., & Goldman, J. (2018). Launching motivation for mindfulness: Introducing mindfulness to early childhood preservice teachers. Early Child Development and Care, 1-14, Advance online publication.. https://doi.org/10.1080/03004430.2018.1531853.

  • Hamre BK, Pianta RC. Can instructional and emotional support in the first-grade classroom make a difference for children at risk of school failure? Child Dev. 2005 Sep-Oct;76(5):949-67. doi: 10.1111/j.1467-8624.2005.00889.x.

    PubMed 16149994
  • Hatton-Bowers H, Clark C, Parra G, Calvi J, Bird MY, Avari P, Foged J, Smith J. Promising Findings that the Cultivating Healthy Intentional Mindful Educators' Program (CHIME) Strengthens Early Childhood Teachers' Emotional Resources: An Iterative Study. Early Child Educ J. 2022 Aug 8:1-14. doi: 10.1007/s10643-022-01386-3. Online ahead of print.

    PubMed 35967911
  • Hays RD, Schalet BD, Spritzer KL, Cella D. Two-item PROMIS(R) global physical and mental health scales. J Patient Rep Outcomes. 2017;1(1):2. doi: 10.1186/s41687-017-0003-8. Epub 2017 Sep 12.

    PubMed 29757325
  • Holmes C, Levy M, Smith A, Pinne S, Neese P. A Model for Creating a Supportive Trauma-Informed Culture for Children in Preschool Settings. J Child Fam Stud. 2015;24(6):1650-1659. doi: 10.1007/s10826-014-9968-6.

    PubMed 25972726
  • Lomas T, Medina JC, Ivtzan I, Rupprecht S, Eiroa-Orosa FJ. A systematic review of the impact of mindfulness on the well-being of healthcare professionals. J Clin Psychol. 2018 Mar;74(3):319-355. doi: 10.1002/jclp.22515. Epub 2017 Jul 28.

    PubMed 28752554
  • Mackrain, M., LeBuffe, P. A., & Powell, G. (2007). The Devereux Early Childhood Assessment for Infants and Toddlers (DECA-I/T) assessment, technical manual, and user's guide. Lewisville, NC: Kaplan.

  • Neff, K. D. (2003). The development and validation of a scale to measure self-compassion. Self and Identity, 2, 223-250. https://doi.org/10.1080/15298860309027

  • Paniccia M, Paniccia D, Thomas S, Taha T, Reed N. Clinical and non-clinical depression and anxiety in young people: A scoping review on heart rate variability. Auton Neurosci. 2017 Dec;208:1-14. doi: 10.1016/j.autneu.2017.08.008. Epub 2017 Aug 26.

    PubMed 28870754
  • Perry, D., Allen, M. D., Brennan, E. M., & Bradley, J. R. (2010). The evidence base for mental health consultation in early childhood settings: A research synthesis addressing children's behavioral outcomes. Early Education & Development, 21, 795-824.

  • Pianta, R. C. (2001). The Student-Teacher Relationship Scale. Lutz, FL: PAR.

Questions about this trial

What is this clinical trial studying?

A study testing Cultivating Healthy Intentional Mindful Educators in people with Health, Subjective and Work Related Stress, run by University of Nebraska Lincoln 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?

The sponsor lists 18 inclusion and 7 exclusion criteria. 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 27 Jan 2026. 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?

Change in Teacher Emotion Regulation Difficulties from baseline to post assessments (time frame: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.). The study lists 9 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 NCT05791825, which also lists 25 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 27 Jan 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in