Comparing a Workplace Resilience and a Physical Activity Intervention on Early Childhood Educators Well-being
OnWARD
A Cluster-randomized Control Trial of a Workplace Resilience Intervention for Child Care Providers' Mental Health & Well-being
2 other identifiers
interventional
640
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2025
CompletedFirst Posted
Study publicly available on registry
April 9, 2025
CompletedStudy Start
First participant enrolled
August 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
February 20, 2026
February 1, 2026
2.5 years
April 2, 2025
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and 3 months
Secondary Outcomes (6)
Change in Resilience from 3 months to 9 months
3 months and 9 months
Change in Resilience from 9 to 15 months
9 months and 15 months
Change in Well-Being from Baseline to 3 months
Baseline and 3 months
Change in Organizational Support and Resources from Baseline to 3 months
Baseline and 3 months
Absenteeism from Baseline to 3 months
Baseline to 3 months
- +1 more secondary outcomes
Study Arms (2)
Resilience
EXPERIMENTALCenters 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 COMPARATORCenters 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UNC Center for Health Promotion and Disease Prevention
Chapel Hill, North Carolina, 27599-7426, United States
Related Publications (1)
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.
PMID: 41824507DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Derek Hales, PhD
University of North Carolina, Chapel Hill
- PRINCIPAL INVESTIGATOR
Deborah Jones, PhD
University of North Carolina, Chapel Hill
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2025
First Posted
April 9, 2025
Study Start
August 11, 2025
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2029
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Beginning at 9 months and continuing for 36 months following publication.
- Access Criteria
- Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC-CH.
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).