Stress, Psychological Clinical Trial
— CHIMEOfficial title:
Testing the Initial Efficacy of a Mindfulness Compassion-based Intervention to Support Wellbeing Amongst Early Childhood Professionals
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 |
Verified date | June 2023 |
Source | University of Nebraska Lincoln |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska-Lincoln | Lincoln | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska Lincoln | Department of Health and Human Services |
United States,
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* Note: There are 18 references in all — Click here to view all references
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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