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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04815252
Other study ID # 20336
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date May 1, 2023

Study information

Verified date June 2023
Source University of Nebraska Lincoln
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized trial of the 'Cultivating Healthy, intentional, Mindful Educators' (CHIME) intervention designed for early childhood educators. The intervention aims to enhance wellbeing, emotion regulation, and sensitive, responsive caregiving among educators by providing them with mindfulness, compassion-based techniques to alleviate stress and respond to emotional challenges in the classroom. The intervention ultimately aims to enhance children's self-regulation through sensitive, responsive caregiving. Measures of teachers' emotional regulation, wellbeing, and stress physiology will be collected pre- and post- the 8 week intervention and compared to a waitlist comparison group. Measures of child self-regulation also will be collected to assess the relation of teacher stress, wellbeing and emotion regulation to child self-regulation.


Description:

Across varied disciplines, the science is clear that early relationships and the quality of early care are central in achieving positive language, cognitive, and social development outcomes for young children and investments made in early childhood pay for themselves. Early childhood education is a critical context for fostering stimulating, responsive, and sensitive caregiving as a substantial number of children under the age of 5 years spend time in childcare settings, with 64% of children aged 3 to 5 years enrolled in non-relative care outside the home. While great efforts are made to improve the children's social emotional well-being in child care environments, less attention has been given to early childhood educators' (encompassing of early childhood teachers') own well-being. Research that has been conducted finds early childhood educators experience high levels of distress, including high levels of depression and burnout. Additionally, previous research finds school age teachers feeling overworked and overstressed show an altered hypothalamus-pituitary-adrenal (HPA) axis and higher levels of teacher burnout is related to elevated cortisol levels in elementary school students. The current study will test the efficacy of an 8-week compassion and mindfulness based stress reduction program for early childhood educators, as well as characterizing relations from early childhood educator wellbeing to child self-regulation. Teachers will be assigned at the center level to an intervention group or a wait-list comparison condition, with the wait-list group receiving the intervention after the 8-week study. Pre- intervention, teachers in both groups will complete survey measures of their wellbeing, mindfulness, and emotion regulation; emotion regulation tasks; and assessments of stress physiology in the classroom. Teacher-child interactions will be observed and children's self-regulation will be measured. Post-intervention, the same teacher measures will be collected.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date May 1, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: Teachers/educators: - Providing care to children aged birth through 6 years - Participating in, or are signed up to eventually participate in, the 8-week "Cultivating Healthy Intentional, Mindful Educators" (CHIME) intervention - English speakers - 19 years of age or older. Children: - Aged 3-6 years - Enrolled in a preschool setting with a teachers enrolled/signed up to participate in the CHIME study. - English or Spanish speakers Parents: - Have a child aged 3-6 who is enrolled in a preschool classroom of a teacher participating in the study. - Speak and read English or Spanish and - Legal guardian - 19 years of age or older. Exclusion Criteria: *Not participating/enrolled to participate in CHIME

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
CHIME
CHIME is a professional development program to provide knowledge and skills for nurturing early childhood educator mindfulness, compassion and socio-emotional learning. CHIME is a manualized curriculum delivered by a trained facilitator. The intervention consists of a 2-hour overview and seven weekly sessions, each lasting 90 minutes. Sessions can be delivered online or in-person.

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 (18)

Carlson SM. Developmentally sensitive measures of executive function in preschool children. Dev Neuropsychol. 2005;28(2):595-616. doi: 10.1207/s15326942dn2802_3. — View Citation

Cassidy, D. J., Lippard, C., King, E. K., & Lower, J. K. (2019). Improving the Lives of Teachers in the Early Care and Education Field to Better Support Children and Families. Family Relations. https://doi.org/10.1111/fare.12362

Curbow, B., Spratt, K., Ungaretti, A., McDonnell, K., & Breckler, S. (2000). Development of the child care worker job stress inventory. Early Childhood Research Quarterly, 15(4), 515-536. https://doi.org/10.1016/S0885-2006(01)00068-0

Feldman, G., Hayes, A., Kumar, S., Greeson, J., & Laurenceau, J. (2007). Mindfulness and Emotion Regulation: The Development and Initial Validation of the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Journal of Psychopathology and Behavioral Assesssment, 29, 177-190. https://doi.org/10.1007/s10862-006-9035-8

Flook L, Goldberg SB, Pinger L, Bonus K, Davidson RJ. Mindfulness for teachers: A pilot study to assess effects on stress, burnout and teaching efficacy. Mind Brain Educ. 2013 Sep;7(3):10.1111/mbe.12026. doi: 10.1111/mbe.12026. — View Citation

Gioia, G. A., Espy, K. A., & Isquith, P. K. (2003). BRIEF-P: Behavior Rating Inventory of Executive Function - Preschool Version. Lutz, FL: Psychological Assessment Resources.

Gotlib IH, McCann CD. Construct accessibility and depression: an examination of cognitive and affective factors. J Pers Soc Psychol. 1984 Aug;47(2):427-39. doi: 10.1037//0022-3514.47.2.427. — View Citation

Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation. Journal of Psychopathology and Behavioral Assessment, 26(1), 41-54. https://doi.org/10.1023/B:JOBA.0000007455.08539.94

Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348. — View Citation

Howard SJ, Melhuish E. An Early Years Toolbox for Assessing Early Executive Function, Language, Self-Regulation, and Social Development: Validity, Reliability, and Preliminary Norms. J Psychoeduc Assess. 2017 Jun;35(3):255-275. doi: 10.1177/0734282916633009. Epub 2016 Feb 28. — View Citation

Jeon, L., Buettner, C. K., Grant, A. A., Jeon, L., Buettner, C. K., & Early, A. A. G. (2018). Early Childhood Teachers' Psychological Well-Being: Exploring Potential Predictors of Depression , Stress , and Emotional Exhaustion Early Childhood Teachers ' Psychological Well-Being : Exploring. Early Education and Development, 29(1), 53-69. https://doi.org/10.1080/10409289.2017.1341806

Mamedova, S., & Redford, J. (2015). Early childhood program participation, From the National Household Education Surveys Program of 2012. Washington D.C.

McClelland, M. M., & Wanless, S. B. (2012). Growing up with assets and risks: The importance of self-regulation for academic achievement. Research in Human Development, 9(4), 278-297. https://doi.org/10.1080/15427609.2012.729907

Neff, K. D. (2003). Measure - Self-Compassion Scale (SCS). Self and Identity, 2, 223-250. https://doi.org/10.1080/15298860309027

Oberle E, Schonert-Reichl KA. Stress contagion in the classroom? The link between classroom teacher burnout and morning cortisol in elementary school students. Soc Sci Med. 2016 Jun;159:30-7. doi: 10.1016/j.socscimed.2016.04.031. Epub 2016 Apr 24. — View Citation

Roberts, A., LoCasale-Crouch, J., Hamre, B., & DeCoster, J. (2016). Exploring Teachers' Depressive Symptoms, Interaction Quality, and Children's Social-Emotional Development in Head Start. Early Education and Development, 27(5), 642-654. https://doi.org/10.1080/10409289.2016.1127088

Siegrist J, Starke D, Chandola T, Godin I, Marmot M, Niedhammer I, Peter R. The measurement of effort-reward imbalance at work: European comparisons. Soc Sci Med. 2004 Apr;58(8):1483-99. doi: 10.1016/S0277-9536(03)00351-4. — View Citation

Stewart-Brown S, Tennant A, Tennant R, Platt S, Parkinson J, Weich S. Internal construct validity of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS): a Rasch analysis using data from the Scottish Health Education Population Survey. Health Qual Life Outcomes. 2009 Feb 19;7:15. doi: 10.1186/1477-7525-7-15. — View Citation

* Note: There are 18 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Child self-regulation task This measure will be administered through 'Zoom.' Children are instructed to respond to directions from one puppet, but to inhibit their behavioral responses to another puppet. Scores range from 0-100, with higher scores indicating higher levels of self-regulation. Week 1
Other Behavioral Rating Inventory of Executive Function - Preschool This questionnaire measure will be completed by parent or legal guardians to assess children's self-regulation of emotion and behavior in everyday settings. The total score is rated on a t-score metric, with higher scores reflecting higher levels of difficulty in executive function. Week 1
Primary Change on the Cognitive and Affective Mindfulness Scale Revised Measures attention regulation, awareness, acceptance, and mindful focus on the present. The scale comprises 12 items rated on a 5-point scale. Scores on this scale range from 12-60, with higher scores indicating greater levels of mindfulness. Week 1, week 9
Primary Change on the Self Compassion Scale - Short Form Measures the tendency to treat oneself with compassion, mindfulness and feelings of isolation. The scale comprises 12 items, with scores ranging from 12-60. Higher scores indicate greater levels of self-compassion. Week 1, Week 9
Primary Change on the Emotion Regulation Questionnaire Measures the tendency to engage in cognitive reappraisal or suppression of negative emotions. The reappraisal scale comprises 6 items with scores ranging from 6-42. the suppression scale comprises 4 items with scores ranging from 4-28. Higher levels of reappraisal and lower levels of suppression are associated with better emotion regulation. Week 1, Week 9
Primary Change on the Difficulties in Emotion Regulation Scale Measures emotional awareness, clarity and strategy use, and impulse control. The scale comprises 36 items rated on a 5-point scale, with total scores ranging from 36-180. Higher scores indicate higher levels of difficulty regulating emotions. Week 1, Week 9
Primary Change on the Emotion Stroop Computerized task administered online that measures the ability to override attentional interference from emotion. A greater difference in the reaction times for emotional vs. neutral trials indicates greater in difficulty in over-riding attentional interference from emotion. Week 1, Week 9
Primary Change on the Modified Emotional Exogenous Cuing Paradigm Computerized task administered online that measures the ability to override attentional interference from emotion. Longer reaction times during incongruent emotional trials relative to neutral emotional trials indicate greater difficulty resisting attentional interference from emotion. Week 1, Week 9
Primary Change on the Short Warwick-Edinburgh Mental Wellbeing Measure A Rasch-validated questionnaire that captures feelings of happiness, social wellbeing and quality of life. Scores range from 14-70, with higher scores indicating higher levels of wellbeing. Week 1, Week 9
Primary Change on the The Early Childhood Job Attitude Survey A questionnaire that evaluates workplace satisfaction and supports and workload manageability. Scores range from 5-25, with higher scores indicating more negative workplace perceptions. Week 1, week 9
Primary Change on the Job Demands scale Taken from the Child Care Worker Job Stress Inventory, this questionnaire will provide a more detailed assessment of stress related to parent interactions and challenging child behavior. The scale comprises 16 items rated on a scale from 1-5. Total scores range from 16-80, with higher scores indicative of greater stress. Week 1, week 9
Primary Change on the The Effort/Reward imbalance scale This questionnaire measures the balance of effort relative to reward that people feel they are putting into their work. The effort-reward imbalance ratio is calculated as the effort score, which ranges from 5-25, divided by the reward score (ranging from 11-55) multiplied by a correction factor. The minimum score is 0 and values above 1 are less favorable and indicate a high level of effort relative to workplace reward. Week 1, week 9
Primary Change in Salivary Cortisol Measure of the reactivity of the hypothalamic pituitary-adrenal axis. Saliva will be collected by passive drool in the morning and in the afternoon for two consecutive days. Week 1, week 9
Primary Change in the Heart rate variability Teachers will wear an 'Actiheart' device to measure cardiac inter-beat intervals and motion for three consecutive days in the classroom. Root mean square of successive differences will be calculated as a measure of heart rate variability. Week 1, Week 9
Primary Change in Classroom Assessment Scoring System Emotional Support score Teacher behavior will be observed and coded using the Emotional Support scale from the Classroom Assessment Scoring System. The primary outcome is the Emotional Support scale, which centers on the teachers' capacity to create a sensitive and positive emotional climate in the classroom. Scores range from 0 to 7, with scores of 7 indicating higher levels emotional support. Week 1, week 9
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