NCT04815252

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

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

August 27, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

2.7 years

First QC Date

August 27, 2020

Last Update Submit

June 6, 2023

Conditions

Keywords

MindfulnessEarly childhood educatorInterventionBurnout

Outcome Measures

Primary Outcomes (13)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Other Outcomes (2)

  • Child self-regulation task

    Week 1

  • Behavioral Rating Inventory of Executive Function - Preschool

    Week 1

Study Arms (2)

CHIME Intervention

EXPERIMENTAL

Participants will complete an 8-week compassion and mindfulness-based intervention with a group facilitator. The curriculum focuses on providing mindfulness-based stress reduction techniques for use in the early childhood education environment.

Behavioral: CHIME

Waitlist control

NO INTERVENTION

Participants are placed on a wait-list to receive the intervention.

Interventions

CHIMEBEHAVIORAL

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.

CHIME Intervention

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • years of age or older.

You may not qualify if:

  • \*Not participating/enrolled to participate in CHIME

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska-Lincoln

Lincoln, Nebraska, 68588, United States

Location

Related Publications (18)

  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 24324528BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 6481620BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 12916575BACKGROUND
  • 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.

    PMID: 28503022BACKGROUND
  • 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

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

    BACKGROUND
  • 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

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

    BACKGROUND
  • 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.

    PMID: 27156042BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 14759692BACKGROUND
  • 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.

    PMID: 19228398BACKGROUND
  • Carlson SM. Developmentally sensitive measures of executive function in preschool children. Dev Neuropsychol. 2005;28(2):595-616. doi: 10.1207/s15326942dn2802_3.

    PMID: 16144429BACKGROUND

MeSH Terms

Conditions

Stress, PsychologicalBurnout, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Caron Clark

    UNL

    PRINCIPAL INVESTIGATOR
  • Holly Hatton-Bowers

    UNL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are assigned, based on childcare center, to the intervention or waitlist control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2020

First Posted

March 24, 2021

Study Start

September 1, 2020

Primary Completion

April 30, 2023

Study Completion

May 1, 2023

Last Updated

June 8, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Scored and de-identified data that is stripped of any information that could be used to identify participants may be shared. Data will not be shared if there is any possibility that participants or childcare centers may be identifiable (e.g., based on geographic region).

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After publication of the data.
Access Criteria
Researchers may contact the study team to obtain information.

Locations