Comparing a Workplace Resilience and a Physical Activity Intervention on Early Childhood Educators Well-being

NCT ID: NCT06919952

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 640 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-11
• Study Completion Date: 2029-02-28

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Resilience

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.

Group Type: EXPERIMENTAL

Resilience

Intervention Type: BEHAVIORAL

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 Activity

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.

Group Type: ACTIVE_COMPARATOR

Physical Activity

Intervention Type: BEHAVIORAL

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.

Interventions

Resilience

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.

Intervention Type: BEHAVIORAL

Physical Activity

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Derek Hales, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Deborah Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC Center for Health Promotion and Disease Prevention

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Regan V Burney, PhD

Role: CONTACT

reganb@email.unc.edu

336-71-7459

Deborah J Jones, PhD

Role: CONTACT

djjones@email.unc.edu

919-724-2157

Facility Contacts

Regan V Burney, PhD

Role: primary

reganb@email.unc.edu

336-971-7459

Other Identifiers

R01AT012620

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25-0016

Identifier Type: -

Identifier Source: org_study_id