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Stress, PsychologicalCHIMENCT04815252

Mindfulness Intervention for Early Childhood Educators

A study testing CHIME in people with Stress, Psychological and Stress, Physiological, run by University of Nebraska Lincoln at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Stress, Psychological, Stress, Physiological
What is being tested?
CHIME
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
1 Sep 2020to 1 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 14Show fewer
  • 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.

Who cannot join

  • Not participating/enrolled to participate in CHIME

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Nebraska-Lincoln

    Lincoln, Nebraska, 68588

Other trials in United States

About this study

Official title: Testing the Initial Efficacy of a Mindfulness Compassion-based Intervention to Support Wellbeing Amongst Early Childhood Professionals

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.

Read the detailed 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.

Being tested
CHIME
Keywords
Mindfulness, Early childhood educator, Intervention, Burnout
Medical subject headings
Stress, Psychological, Burnout, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHIMEBehavioural

    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.

Study groups in NCT04815252
Study groupRoleWhat they receive
CHIME InterventionExperimentalParticipants 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.
Receives: Behavioral: CHIME
Waitlist controlNo interventionParticipants are placed on a wait-list to receive the intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 1, week 9

  2. 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.

    Measured: Week 1, Week 9

  3. 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.

    Measured: Week 1, Week 9

  4. 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.

    Measured: Week 1, Week 9

  5. 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.

    Measured: Week 1, Week 9

  6. 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.

    Measured: Week 1, Week 9

  7. 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.

    Measured: Week 1, Week 9

  8. 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.

    Measured: Week 1, week 9

  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.

    Measured: Week 1, week 9

  10. 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.

    Measured: Week 1, week 9

  11. 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.

    Measured: Week 1, week 9

  12. 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.

    Measured: Week 1, Week 9

  13. 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.

    Measured: Week 1, week 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2021
  2. Study start1 Sep 2020
  3. Primary completion30 Apr 2023
  4. Study completion1 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Participants are assigned, based on childcare center, to the intervention or waitlist control group.
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04815252
Sponsor's protocol ID
20336
Acronym
CHIME
Status last verified
Jun 2023
First submitted
27 Aug 2020
Last updated
8 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • 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.

    PubMed 24324528

  • 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.

    PubMed 6481620

  • 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.

    PubMed 12916575

  • 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.

    PubMed 28503022

  • 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.

    PubMed 27156042

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing CHIME in people with Stress, Psychological and Stress, Physiological, run by University of Nebraska Lincoln at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change on the Cognitive and Affective Mindfulness Scale Revised (time frame: Week 1, week 9). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04815252, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.

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Mindfulness Intervention for Early Childhood Educators | AzTrials