Clinical trial NCT06919952: Comparing a Workplace Resilience and a Physical Activity Intervention on Early Childhood Educators Well-being
Official title: A Cluster-randomized Control Trial of a Workplace Resilience Intervention for Child Care Providers' Mental Health & Well-being
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Resilience
Keywords: child care provider well-being
child care centers
early childhood education
physical activity
resilience
behavior change
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2025-04-09
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

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

Primary outcomes:
measure: Change in Resilience from Baseline to 3 months
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in Resilience from 3 months to 9 months
timeFrame: 3 months and 9 months
measure: Change in Resilience from 9 to 15 months
timeFrame: 9 months and 15 months
measure: Change in Well-Being from Baseline to 3 months
timeFrame: Baseline and 3 months
measure: Change in Organizational Support and Resources from Baseline to 3 months
timeFrame: Baseline and 3 months
measure: Absenteeism from Baseline to 3 months
timeFrame: Baseline to 3 months
measure: Staff Turnover rate from Baseline to 3 months
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Center for Health Promotion and Disease Prevention
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Derek Hales, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Deborah Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: