- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05791825
Evaluation of the CHIME Intervention for Improving Early Head Start/Head Start Educator Well-being (CHIME)
Cultivating Healthy Intentional Mindful Educators (CHIME): The Use of Mindfulness and Compassion to Promote Early Head Start/Head Start Education Staffs Well-Being
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Holly Hatton, PhD
- Phone Number: 4025983879
- Email: hattonb@unl.edu
Study Contact Backup
- Name: Jaci Foged, MA
- Email: jaci.foged@unl.edu
Study Locations
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68588
- Recruiting
- University of Nebraska-Lincoln
-
Contact:
- Holly Hatton
- Phone Number: 402-598-3879
- Email: hattonb@unl.edu
-
Contact:
- Jaci Foged
- Email: jaci.foged@unl.edu
-
Principal Investigator:
- Holly Hatton-Bowers, PhD
-
Sub-Investigator:
- Carrie Clark, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Receives CHIME
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.
|
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).
|
No Intervention: Wait-listed comparison
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
Time Frame: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.
|
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
Time Frame: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.
|
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
Time Frame: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.
|
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
Time Frame: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.
|
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
Time Frame: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.
|
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
Time Frame: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.
|
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
Time Frame: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.
|
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
Time Frame: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.
|
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
Time Frame: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.
|
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
Time Frame: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.
|
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
Time Frame: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.
|
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.
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Change in Perceived Family and Teacher Relationships 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.
|
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
Time Frame: Baseline, a post-assessment 8 weeks after the intervention or waitlist period, and a follow-up assessment after 3 months.
|
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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Holly Hatton-Bowers, PhD, University of Nebraska Lincoln
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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
- Schmitt, T. A. (2011). Current methodological considerations in exploratory and confirmatory factor analysis. Journal of Psychoeducational Assessment, 29, 4, 304-321.
- 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
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22130
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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