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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05791825
Other study ID # 22130
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 13, 2023
Est. completion date October 31, 2026

Study information

Verified date April 2024
Source University of Nebraska Lincoln
Contact Holly Hatton, PhD
Phone 4025983879
Email hattonb@unl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 860
Est. completion date October 31, 2026
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Behavioral:
Cultivating Healthy Intentional Mindful Educators
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).

Locations

Country Name City State
United States University of Nebraska-Lincoln Lincoln Nebraska

Sponsors (2)

Lead Sponsor Collaborator
University of Nebraska Lincoln Department of Health and Human Services

Country where clinical trial is conducted

United States, 

References & Publications (25)

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 25 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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 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.
Secondary 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.
Secondary 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.
Secondary 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.
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