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Recruiting NCT06919952

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

No phase Interventional Resilience

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Resilience, Physical Activity.
Who it may be relevant to
Registry conditions: Resilience. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Cluster-randomized Control Trial of a Workplace Resilience Intervention for Child Care Providers' Mental Health & Well-being

Overview

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.

Interventions

  • Behavioral 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.
  • 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.

Primary outcome measures

  • Change in Resilience from Baseline to 3 months [Time frame: Baseline and 3 months]
Secondary outcome measures (6)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • UNC Center for Health Promotion and Disease Prevention — Chapel Hill

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. PMID 41824507

Identifiers

NCT: NCT06919952 · 25-0016 · R01AT012620

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗