ResilienceOnWARDNCT06919952
Comparing a Workplace Resilience and a Physical Activity Intervention on Early Childhood Educators Well-being
A study testing Resilience and Physical Activity in people with Resilience, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The goal of this 15-month cluster clinical trial is to compare a resilience and stress management program to a physical activity program for early childhood education (ECE) staff on change in well-being. It will also look to see if changes in well-being continue over time. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Resilience
- What is being tested?
- Resilience and Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2025to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Child Care Centers
- Licensed with no plans to close in the next 2 years
- Been in operation for at least 1 year
- Has at least 4 employees
- ECE Staff
- Must be at least 18 years old
Show all 9Show fewer
- Be able to read and speak English
- Must have access to an online resource (e.g., smartphone, tablet, computer)
- Must be willing to receive text messages
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UNC Center for Health Promotion and Disease Prevention
Chapel Hill, North Carolina, 27599-7426
Regan V Burney, PhD, 336-971-7459, reganb@email.unc.edu
Derek Hales, PhD
About this study
Official title: A Cluster-randomized Control Trial of a Workplace Resilience Intervention for Child Care Providers' Mental Health & Well-being
The goal of this 15-month cluster clinical trial is to compare a resilience and stress management program to a physical activity program for early childhood education (ECE) staff on change in well-being. It will also look to see if changes in well-being continue over time.
The study sample will include 80 child care centers. Including 80 ECE center directors and approximately 560 ECE center staff.
Read more
Some ECE centers will receive only the remotely delivered Resilience program. This program works with ECE staff and helps them recognize and strengthen their resilience assets and resources. Other ECE centers will receive only the remotely delivered Physical Activity program that will focus on staff physical activity habits and strength training.
There will be 3 months of active program participation and 12 months of a maintenance period where participants will only have access to program materials.
Read the detailed description
This study is two-group clustered randomized trial comparing two remotely delivered programs to early childhood education (ECE) center staff, a Resilience program and a Physical Activity program, on ECE center staff change in well-being. The investigators will randomized (by center 1:1 ratio) 80 ECE centers, including 640 ECE staff from these centers, to one of arms (Resilience or Physical Activity) for a 15 month trial (3 months active intervention and 12 months maintenance period). The specific aims are to 1) increase resilience assets and resources for ECE staff, 2) increase overall well-being and organizational assets and resources, and 3) maintain increases in resilience assets and resources, well-being, and organizational assets and resources for ECE staff over time.
Once randomized, all program tasks and activities will be remotely delivered, and guidance will be provided by a behavioral health counselor. Participants will complete their assigned program over four modules spanning 3 months (3 weeks per module). Activities will include an orientation, modules consisting of video lessons and resources, 3 webinars for all participants, text messages (3-5 per week), and 4 coaching calls for ECE center directors only.
Measures will be collected at four timepoints: baseline (0 months), post-intervention (3 months), and long-term maintenance (9 and 15 months). Secondary outcomes will include changes in overall mental health, negative and positive mental health indicators, social support, and organizational assets and resources. Additionally, potential moderators' (e.g., sociodemographic, social determinants of health) influence on treatment effects will be explored. The Reach Effectiveness-Adoption Implementation Maintenance (RE-AIM) Framework will be used to determine reach and representativeness, and potential for organizational level adoption, implementation, and maintenance of the SMART program.
Primary analyses will involve testing change in the total score from the Connor- Davidson Resilience Scale (CD-RISC) between Resilience and Physical Activity arms at 3 months. Using maximum likelihood methods, multi-level linear mixed models (PROC MIXED) that include random effect for cluster to account for covariance between participants within the same center as well as fixed effects for time (0, 3, 9, 15 months), trial arm (resilience or physical activity), time*arm interaction will be used. Similar analyses will be completed for secondary outcomes. Baseline variables including center and worker demographics and social determinants of health will be included as covariates to assess their potential moderating effect.
- Conditions
- Resilience
- Being tested
- Resilience, Physical Activity
- Keywords
- child care provider well-being, child care centers, early childhood education, physical activity, resilience, behavior change
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResilienceBehavioural
The Resilience program focuses on drawing on resilience assets and resources, both internal and external. Participants will have access to materials (e.g., lessons, videos, webinars, coaching calls) supporting the adoption of strategies for improving well-being. Behavior change strategies used are meant to increase intervention adherence and improve well-being and resilience.
Physical ActivityBehavioural
The Physical Activity program focuses on supporting physical activity health habits. Participants will have access to materials (e.g., lessons, videos, webinars, coaching calls) supporting the adoption of strategies of evidence-based strategies for physical activity goals. Behavior change strategies used are meant to help establish, improve or maintain healthy physical activity habits.
| Study group | Role | What they receive |
|---|---|---|
| Resilience | Experimental | Centers randomized to Resilience will receive the Stress Management And Resilience Training program. Participating staff will be led through the program by a behavioral health counselor for 3 months. This counselor will orient participants to the Resilience program and the 4 modules. The counselor will also provide 4 coaching calls with directors (at the start of each module). Additionally, the counselor will provide a webinar every 3 weeks (at the end of each module) to all participants. Participants will have access to video lessons and resources. They will receive weekly reminders and encouragement through text messages. Receives: Behavioral: Resilience |
| Physical Activity | Active comparator | Centers randomized to the control arm will receive a physical activity program. Participating staff will be led through the program by a behavioral health counselor for 3 months. This counselor will orient participants to the physical activity program and the 4 modules. The counselor will also provide 4 coaching calls with directors (at the start of each module). Additionally, the counselor will provide a webinar every 3 weeks (at the end of each module) to all participants. Participants will have access to video lessons and resources. They will receive weekly reminders and encouragement through text messages. Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Resilience from Baseline to 3 months
Resilience of ECE staff will be assessed using the Connor-Davidson Resilience Scale (CD-RISC). ECE staff will fill out through an online survey. The CD-RISC is a 25-item scale. Scores range from 0-100 with higher scores reflecting greater resilience.
Measured: Baseline and 3 months
Secondary outcomes (6)
Change in Resilience from 3 months to 9 months
Resilience of ECE staff will be assessed using the Connor-Davidson Resilience Scale (CD-RISC). ECE staff will fill out through an online survey. The CD-RISC is a 25-item scale. Scores range from 0-100 with higher scores reflecting greater resilience.
Measured: 3 months and 9 months
Change in Resilience from 9 to 15 months
Resilience of ECE staff will be assessed using the Connor-Davidson Resilience Scale (CD-RISC). ECE staff will fill out through an online survey. The CD-RISC is a 25-item scale. Scores range from 0-100 with higher scores reflecting greater resilience.
Measured: 9 months and 15 months
Change in Well-Being from Baseline to 3 months
Global assessment of well-being will be measured through the General Health Questionnaire. This is a 30-item survey captures a broad spectrum of psychological distress encompassing emotional, cognitive, and social aspects of mental health. Scores range from 0-90, with higher scores indicating greater psychological distress.
Measured: Baseline and 3 months
Change in Organizational Support and Resources from Baseline to 3 months
Organizational support and resources will be assessed using the NIOSH worker well-being questionnaire (WellBQ). Specifically, eight Likert-type items from the supportive work culture and health culture at work sections of the survey will be averaged to create this outcome. Items are rated on 1 to 4 scale from strongly disagree to strongly agree, with the final outcome being an average score ranging from 1.00 to 4.00.
Measured: Baseline and 3 months
Absenteeism from Baseline to 3 months
Staff absenteeism will be assessed by asking staff how often they "missed a full day of work" and "missed 1/2 day of work" in the past 4 weeks. Directors will also be asked "On average, how many days per month do staff miss a full day of work when scheduled to be at your center?". Items will be combined to estimate "Days per month staff missed work" at a center.
Measured: Baseline to 3 months
Staff Turnover rate from Baseline to 3 months
Staff turnover will be assessed by asking directors: "How many total staff work at center?" "How many staff have left, quit, or been fired in the past 3 months?", and "how many of those staff have you replaced in the past three months or are currently trying to replace?". Questions will be asked at baseline and 3 month follow-up. Turnover rate for a center will be expressed as: ((# staff left job-(#staff not need replacing)/(# total staff)) * 100 = % turnover.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start11 Aug 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ResilienceStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Derek Hales, PhD, Principal investigator, University of North Carolina, Chapel HillDeborah Jones, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919952
- Sponsor's protocol ID
- 25-0016
- Other IDs
- R01AT012620
- Acronym
- OnWARD
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina-Chapel Hill (UNC-CH).
Publications
Hales D, Burney R, Willis E, Clarke E, Peterson S, Branch S, Fowlin B, Chesak S, Linnan LA, Sood A, Suazo NC, Jones DJ. Protocol for a cluster-randomized control trial of a remote workplace resilience intervention for early care and education providers: The OnWARD trial. PLoS One. 2026 Mar 13;21(3):e0340915. doi: 10.1371/journal.pone.0340915. eCollection 2026.
PubMed 41824507
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster-randomized Control Trial of a Workplace Resilience Intervention for Child Care Providers' Mental Health & Well-being
- ClinicalTrials.gov ID
- NCT06919952
- Acronym / sponsor ID
- OnWARD / 25-0016
- Conditions
- Resilience
- Keywords
- child care provider well-being, child care centers, early childhood education, physical activity, resilience, behavior change
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this 15-month cluster clinical trial is to compare a resilience and stress management program to a physical activity program for early childhood education (ECE) staff on change in well-being. It will also look to see if changes in well-being continue over time.
The study sample will include 80 child care centers. Including 80 ECE center directors and approximately 560 ECE center staff.
Some ECE centers will receive only the remotely delivered Resilience program. This program works with ECE staff and helps them recognize and strengthen their resilience assets and resources. Other ECE centers will receive only the remotely delivered Physical Activity program that will focus on staff physical activity habits and strength training.
There will be 3 months of active program participation and 12 months of a maintenance period where participants will only have access to program materials.
Detailed description
This study is two-group clustered randomized trial comparing two remotely delivered programs to early childhood education (ECE) center staff, a Resilience program and a Physical Activity program, on ECE center staff change in well-being. The investigators will randomized (by center 1:1 ratio) 80 ECE centers, including 640 ECE staff from these centers, to one of arms (Resilience or Physical Activity) for a 15 month trial (3 months active intervention and 12 months maintenance period). The specific aims are to 1) increase resilience assets and resources for ECE staff, 2) increase overall well-being and organizational assets and resources, and 3) maintain increases in resilience assets and resources, well-being, and organizational assets and resources for ECE staff over time.
Once randomized, all program tasks and activities will be remotely delivered, and guidance will be provided by a behavioral health counselor. Participants will complete their assigned program over four modules spanning 3 months (3 weeks per module). Activities will include an orientation, modules consisting of video lessons and resources, 3 webinars for all participants, text messages (3-5 per week), and 4 coaching calls for ECE center directors only.
Measures will be collected at four timepoints: baseline (0 months), post-intervention (3 months), and long-term maintenance (9 and 15 months). Secondary outcomes will include changes in overall mental health, negative and positive mental health indicators, social support, and organizational assets and resources. Additionally, potential moderators' (e.g., sociodemographic, social determinants of health) influence on treatment effects will be explored. The Reach Effectiveness-Adoption Implementation Maintenance (RE-AIM) Framework will be used to determine reach and representativeness, and potential for organizational level adoption, implementation, and maintenance of the SMART program.
Primary analyses will involve testing change in the total score from the Connor- Davidson Resilience Scale (CD-RISC) between Resilience and Physical Activity arms at 3 months. Using maximum likelihood methods, multi-level linear mixed models (PROC MIXED) that include random effect for cluster to account for covariance between participants within the same center as well as fixed effects for time (0, 3, 9, 15 months), trial arm (resilience or physical activity), time*arm interaction will be used. Similar analyses will be completed for secondary outcomes. Baseline variables including center and worker demographics and social determinants of health will be included as covariates to assess their potential moderating effect.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resilience | Experimental | Behavioral: ResilienceCenters randomized to Resilience will receive the Stress Management And Resilience Training program. Participating staff will be led through the program by a behavioral health counselor for 3 months. This counselor will orient participants to the Resilience program and the 4 modules. The counselor will also provide 4 coaching calls with directors (at the start of each module). Additionally, the counselor will provide a webinar every 3 weeks (at the end of each module) to all participants. Participants will have access to video lessons and resources. They will receive weekly reminders and encouragement through text messages. |
| Physical Activity | Active comparator | Behavioral: Physical ActivityCenters randomized to the control arm will receive a physical activity program. Participating staff will be led through the program by a behavioral health counselor for 3 months. This counselor will orient participants to the physical activity program and the 4 modules. The counselor will also provide 4 coaching calls with directors (at the start of each module). Additionally, the counselor will provide a webinar every 3 weeks (at the end of each module) to all participants. Participants will have access to video lessons and resources. They will receive weekly reminders and encouragement through text messages. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Child Care Centers
- Licensed with no plans to close in the next 2 years
- Been in operation for at least 1 year
- Has at least 4 employees
- ECE Staff
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 |
|---|---|---|
| ResilienceThe Resilience program focuses on drawing on resilience assets and resources, both internal and external. Participants will have access to materials (e.g., lessons, videos, webinars, coaching calls) supporting the adoption of strategies for improving well-being. Behavior change strategies used are meant to increase intervention adherence and improve well-being and resilience. | Behavioural | Resilience |
| Physical ActivityThe Physical Activity program focuses on supporting physical activity health habits. Participants will have access to materials (e.g., lessons, videos, webinars, coaching calls) supporting the adoption of strategies of evidence-based strategies for physical activity goals. Behavior change strategies used are meant to help establish, improve or maintain healthy physical activity habits. | Behavioural | Physical Activity |
Primary outcome
Change in Resilience from Baseline to 3 months
Time frame: Baseline and 3 months
Resilience of ECE staff will be assessed using the Connor-Davidson Resilience Scale (CD-RISC). ECE staff will fill out through an online survey. The CD-RISC is a 25-item scale. Scores range from 0-100 with higher scores reflecting greater resilience.
6 secondary outcomes
Change in Resilience from 3 months to 9 months
Time frame: 3 months and 9 months
Change in Resilience from 9 to 15 months
Time frame: 9 months and 15 months
Change in Well-Being from Baseline to 3 months
Time frame: Baseline and 3 months
Change in Organizational Support and Resources from Baseline to 3 months
Time frame: Baseline and 3 months
Absenteeism from Baseline to 3 months
Time frame: Baseline to 3 months
Staff Turnover rate from Baseline to 3 months
Time frame: Baseline to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Derived from this study: PubMed 41824507Hales D, Burney R, Willis E, Clarke E, Peterson S, Branch S, Fowlin B, Chesak S, Linnan LA, Sood A, Suazo NC, Jones DJ. Protocol for a cluster-randomized control trial of a remote workplace resilience intervention for early care and education providers: The OnWARD trial. PLoS One. 2026 Mar 13;21(3):e0340915. doi: 10.1371/journal.pone.0340915. eCollection 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina-Chapel Hill (UNC-CH).
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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.
Derek Hales, PhD principal investigator
University of North Carolina, Chapel Hill
Deborah Jones, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience and Physical Activity in people with Resilience, run by University of North Carolina, Chapel Hill 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 9 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Regan V Burney, PhD (336-71-7459, reganb@email.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Resilience from Baseline to 3 months (time frame: Baseline and 3 months). 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 NCT06919952, which also lists 1 linked publication.
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 Sep 2026.