NCT06919952

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
640

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Aug 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Aug 2025Feb 2029

First Submitted

Initial submission to the registry

April 2, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

August 11, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

April 2, 2025

Last Update Submit

February 18, 2026

Conditions

Keywords

child care provider well-beingchild care centersearly childhood educationphysical activityresiliencebehavior change

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

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.

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.

Behavioral: Physical Activity

Interventions

ResilienceBEHAVIORAL

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.

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.

Physical Activity

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

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.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Derek Hales, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR
  • Deborah Jones, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Regan V Burney, PhD

CONTACT

Deborah J Jones, PhD

CONTACT

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

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).

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.

Locations