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| ID | Type | Description | Link |
|---|---|---|---|
| U54GM104941 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Delaware | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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The study will address the following specific aims: (1) assess the impact of the BWCW program on teacher stress and physical activity, (2) Examine feasibility of collecting cortisol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Be Well Care Well | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Be Well Care Well | Behavioral | Be Well Care Well addresses teacher well-being through activities implemented in the classroom aimed at reducing teacher stress and improving physical activity. A subset of teachers involved in the program will complete classroom observations and cortisol testing to examine additional measures of stress. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score of Child Worker Job Stress Inventory | The Child Worker Job Stress Inventory is a survey used to measure job stress via questionnaire that the childcare worker completes. This survey measure contains 22 items that range from 22 (low levels of stress) to 110 (High Levels of Stress). A higher score on each item represents higher child worker stress. The total score is utilized in this study with higher total score representing higher reported child worker job stress. | Baseline and 1 year follow-up |
| Change in Score on the Devereux Adult Resilience Survey | The Devereux Adult Resilience Survey (DARS) is a 23-item self-report measure assessing personal strengths and resilience. Each item is scored from 0 (Not Yet) to 2 (Almost Always), yielding a raw total score range of 0-46. In this study, subscale scores (e.g., relationships, internal beliefs, professional skills) may be combined or analyzed separately. If a composite score is used, the method of combination (e.g., summing across subscales) will be specified in the analysis plan. | Baseline and 1-year follow-up |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Score on the Lifestyle Questionnaire | The lifestyle questionnaire measured health and functioning. The physical activity subscale was used in this study, which had 18 items and ranged from 0-4 with higher scores representing more physical activity. | Baseline and 1-year follow-up |
| Change in Score on the Early Childhood Job Satisfaction Survey |
Inclusion Criteria:
Teachers that meet the following criteria will be included:
Exclusion Criteria:
None
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUSC Department of Psychiatry | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Be Well Care Well | Be Well Care Well: Be Well Care Well addresses teacher well-being through activities implemented in the classroom aimed at reducing teacher stress and improving physical activity. A subset of teachers involved in the program will complete classroom observations and cortisol testing to examine additional measures of stress. |
| FG001 | Control | Teacher attention toward well-being as usual. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No different from assignment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Be Well Care Well | Be Well Care Well: Be Well Care Well addresses teacher well-being through activities implemented in the classroom aimed at reducing teacher stress and improving physical activity. A subset of teachers involved in the program will complete classroom observations and cortisol testing to examine additional measures of stress. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Score of Child Worker Job Stress Inventory | The Child Worker Job Stress Inventory is a survey used to measure job stress via questionnaire that the childcare worker completes. This survey measure contains 22 items that range from 22 (low levels of stress) to 110 (High Levels of Stress). A higher score on each item represents higher child worker stress. The total score is utilized in this study with higher total score representing higher reported child worker job stress. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 year follow-up |
|
1 year
There were no adverse events in the current study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Be Well Care Well | There were no adverse events reported in the Be Well Care Well group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Moreland, PhD | Medical University of South Carolina | 8437928209 | moreland@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol | Jul 15, 2021 | Mar 12, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 18, 2022 | Mar 14, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
The Early Childhood Job Satisfaction Survey measures work satisfaction regarding co-worker relations, supervisor support, nature of the work itself, working conditions, and pay and promotion opportunities. The total score is used in this study and contains 55 items that range from 1-5. Higher scores on this scale represent higher job satisfaction. |
| Baseline and 1-year follow-up |
| BG001 |
| Control |
Teacher well-being addressed as usual |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
The control group included the centers that did not receive the intervention (Be Well Care Well).
|
|
| Primary | Change in Score on the Devereux Adult Resilience Survey | The Devereux Adult Resilience Survey (DARS) is a 23-item self-report measure assessing personal strengths and resilience. Each item is scored from 0 (Not Yet) to 2 (Almost Always), yielding a raw total score range of 0-46. In this study, subscale scores (e.g., relationships, internal beliefs, professional skills) may be combined or analyzed separately. If a composite score is used, the method of combination (e.g., summing across subscales) will be specified in the analysis plan. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1-year follow-up |
|
|
|
| Other Pre-specified | Change in Score on the Lifestyle Questionnaire | The lifestyle questionnaire measured health and functioning. The physical activity subscale was used in this study, which had 18 items and ranged from 0-4 with higher scores representing more physical activity. | Not Posted | Baseline and 1-year follow-up | Participants |
| Other Pre-specified | Change in Score on the Early Childhood Job Satisfaction Survey | The Early Childhood Job Satisfaction Survey measures work satisfaction regarding co-worker relations, supervisor support, nature of the work itself, working conditions, and pay and promotion opportunities. The total score is used in this study and contains 55 items that range from 1-5. Higher scores on this scale represent higher job satisfaction. | Not Posted | Baseline and 1-year follow-up | Participants |
| 0 |
| 115 |
| 0 |
| 115 |
| 0 |
| 115 |
| EG001 | Control | There were not adverse events reported in the control group. | 0 | 67 | 0 | 67 | 0 | 67 |
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