Burnout, CaregiverNCT05310201
Impact of the Be Well Care Well Program on Early Care Education Teachers
A study testing Be Well Care Well in people with Burnout, Caregiver, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burnout, Caregiver
- What is being tested?
- Be Well Care Well
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
MUSC Department of Psychiatry
Charleston, South Carolina, 29425
About this study
Official title: 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.
- Conditions
- Burnout, Caregiver
- Being tested
- Be Well Care Well
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Be Well Care WellBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Be Well Care Well | Experimental | Not described Receives: Behavioral: Be Well Care Well |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start15 Jan 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Burnout, CaregiverStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- University of Delaware, National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310201
- Sponsor's protocol ID
- 00105341
- Other IDs
- U54GM104941
- Status last verified
- Sep 2025
- First submitted
- 25 Mar 2022
- Last updated
- 14 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Teacher Stress and Well-being to Improve Child Outcomes: Impact of the Be Well Care Well Program
- ClinicalTrials.gov ID
- NCT05310201
- Acronym / sponsor ID
- 00105341
- Conditions
- Burnout, Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- University of Delaware, National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Posted 14 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Be Well Care Well | Experimental | Behavioral: Be Well Care Well |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Be Well Care WellBe 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. | Behavioural | Be Well Care Well |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Be Well Care Well in people with Burnout, Caregiver, run by Medical University of South Carolina 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 5 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 14 Oct 2025. 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?
Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Score of Child Worker Job Stress Inventory (time frame: Baseline and 1 year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2025.