NCT05791825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
571

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

March 13, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

February 13, 2023

Last Update Submit

January 23, 2026

Conditions

Keywords

MindfulnessSocial-emotional learningSelf-compassionEarly care and educationTeacher well-beingHead Start

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (4)

  • Change in Child Social Skills from baseline to post assessments

    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

    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

    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

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

Study Arms (2)

Receives CHIME

EXPERIMENTAL

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

Wait-listed comparison

NO INTERVENTION

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.

Interventions

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).

Receives CHIME

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +3 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska-Lincoln

Lincoln, Nebraska, 68588, United States

Location

Related Publications (25)

  • 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.

    PMID: 26447819BACKGROUND
  • 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.

    PMID: 25866835BACKGROUND
  • 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.

    PMID: 14717257BACKGROUND
  • 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.

    PMID: 29608542BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 16149994BACKGROUND
  • 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.

    PMID: 35967911BACKGROUND
  • 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.

    PMID: 29757325BACKGROUND
  • 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.

    PMID: 25972726BACKGROUND
  • 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.

    PMID: 28752554BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 28870754BACKGROUND
  • 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.

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

    BACKGROUND
  • Pianta, R. C., Clifford, R., Burchinal, M., Bryant, D., Clifford, R., Early, D., & Barbarin, O. A. (2005). Features of pre-kindergarten programs, classrooms, and teachers: Do they predict observed classroom quality and child-teacher interactions. Applied Developmental Science, 9, 144-159. https://doi.org/10.1207/s1532480xads0903

    BACKGROUND
  • Porges, S. W., & Lewis, G. F. (2010). The polyvagal hypothesis: Common mechanisms mediating autonomic regulation, vocalizations and listening. In S. M. Burdzynski (Ed.), Handbook of Behavioral Neuroscience (Vol. 19, pp. 255-264). https://doi.org/10.1016/B978-0-12-374593-4.00025-5

    BACKGROUND
  • Santor, D. a., & Coyne, J. C. (1997). Shortening the CES-D to improve its ability to detect cases of depression. Psychological Assessment, 9(3), 233-243. https://doi.org/10.1037/1040-3590.9.3.233

    BACKGROUND
  • Schmitt, T. A. (2011). Current methodological considerations in exploratory and confirmatory factor analysis. Journal of Psychoeducational Assessment, 29, 4, 304-321.

    BACKGROUND
  • Shearer, A., Hunt, M., Chowdhury, M., & Nicol, L. (2015). Effects of a brief mindfulness meditation intervention on student stress and heart rate variability. International Journal of Stress Management, 23, 232-254. https://doi.org/10.1037/a0039814

    BACKGROUND
  • Yin H, Huang S, Wang W. Work Environment Characteristics and Teacher Well-Being: The Mediation of Emotion Regulation Strategies. Int J Environ Res Public Health. 2016 Sep 13;13(9):907. doi: 10.3390/ijerph13090907.

    PMID: 27649216BACKGROUND
  • Zinsser KM, Christensen CG, Torres L. She's supporting them; who's supporting her? Preschool center-level social-emotional supports and teacher well-being. J Sch Psychol. 2016 Dec;59:55-66. doi: 10.1016/j.jsp.2016.09.001. Epub 2016 Oct 4.

    PMID: 27923441BACKGROUND
  • Williams JM, Mathews A, MacLeod C. The emotional Stroop task and psychopathology. Psychol Bull. 1996 Jul;120(1):3-24. doi: 10.1037/0033-2909.120.1.3.

    PMID: 8711015BACKGROUND
  • Ziv Y. Social information processing patterns, social skills, and school readiness in preschool children. J Exp Child Psychol. 2013 Feb;114(2):306-20. doi: 10.1016/j.jecp.2012.08.009. Epub 2012 Oct 6.

    PMID: 23046690BACKGROUND
  • Park G, Van Bavel JJ, Vasey MW, Thayer JF. Cardiac vagal tone predicts attentional engagement to and disengagement from fearful faces. Emotion. 2013 Aug;13(4):645-56. doi: 10.1037/a0032971.

    PMID: 23914769BACKGROUND

MeSH Terms

Conditions

Occupational StressSocial Skills

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Holly Hatton-Bowers, PhD

    University of Nebraska Lincoln

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2023

First Posted

March 30, 2023

Study Start

March 13, 2023

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 3 months and ending 36 months following article publication.
Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations