About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Licensed with no plans to close in the next 2 years
Been in operation for at least 1 year
Has at least 4 employees
Must be at least 18 years old
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Resilience
BehavioralThe 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
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Change in Resilience from 3 months to 9 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.
Change in Resilience from 9 to 15 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.
Change in Well-Being from Baseline to 3 months
Global assessment of well-being will be measured through the General Health Questionnaire. This is a 30-item survey captures a broad spectrum of psychological distress encompassing emotional, cognitive, and social aspects of mental health. Scores range from 0-90, with higher scores indicating greater psychological distress.
Change in Organizational Support and Resources from Baseline to 3 months
Organizational support and resources will be assessed using the NIOSH worker well-being questionnaire (WellBQ). Specifically, eight Likert-type items from the supportive work culture and health culture at work sections of the survey will be averaged to create this outcome. Items are rated on 1 to 4 scale from strongly disagree to strongly agree, with the final outcome being an average score ranging from 1.00 to 4.00.
Sponsors and contacts
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University of North Carolina, Chapel Hill
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator