- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05310201
Impact of the Be Well Care Well Program on Early Care Education Teachers
September 24, 2025 updated by: Medical University of South Carolina
Targeting Teacher Stress and Well-being to Improve Child Outcomes: Impact of the Be Well Care Well Program
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
244
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- MUSC Department of Psychiatry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Teachers that meet the following criteria will be included:
- currently employed as a teacher or assistant teacher at a participating ECE center;
- ages 18 or older;
- men or women;
- able to speak, read, and write English.
Exclusion Criteria:
None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Score of Child Worker Job Stress Inventory
Time Frame: Baseline and 1 year follow-up
|
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
Time Frame: Baseline and 1-year follow-up
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Score on the Lifestyle Questionnaire
Time Frame: Baseline and 1-year follow-up
|
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
Time Frame: Baseline and 1-year follow-up
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2021
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
March 25, 2022
First Submitted That Met QC Criteria
March 25, 2022
First Posted (Actual)
April 4, 2022
Study Record Updates
Last Update Posted (Estimated)
October 14, 2025
Last Update Submitted That Met QC Criteria
September 24, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00105341
- U54GM104941 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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