Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05416216 |
| Other study ID # |
21-4662 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2021 |
| Est. completion date |
September 30, 2026 |
Study information
| Verified date |
February 2024 |
| Source |
Colorado School of Public Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The WELL program is a multi-strategy early childhood education (ECE) center-based
intervention focused on ensuring that formal ECE providers prioritize their own self-care and
well-being and have access to resources and supports that improve their skills to have stable
and responsive relationships with young children in their care.
The overarching goals of this proposed project include:
- To utilize Head Start-University partnerships to investigate constructs within the
National Institute of Occupational Safety and Health (NIOSH) Worker Wellbeing framework
(e.g., Workplace Physical Environment and Safety Climate, Workplace Policies and
Culture) among Head Start staff (n=360 Head Start staff) that are most associated with
overall well-being.
- To adapt and refine the WELL program to target specific constructs that are most
significantly related to overall well-being among the ECE workforce identified in Aim 1
and then to test the effectiveness of WELL (n=36 Head Start centers; n=360 Head Start
staff).
- To collect data to inform the implementation and dissemination of the WELL project
research findings and products and initiate translation activities to achieve
large-scale adoption.
Description:
To evaluate the effectiveness of the WELL intervention on our primary outcome (well-being)
and secondary outcomes (turnover, burnout, quality of caregiver-child relationship, and child
social-emotional development), the researchers will implement a stepped wedge cluster
randomized trial with 3 cohorts including approximately 12 ECE centers/cohort (Head Start
classrooms with birth - 5-year-olds) (10 Head Start staff/center). In the stepped wedge
design, ECE centers (steps 1-3) start the trial at the same point in time and act as controls
until they are randomized to crossover from control to intervention conditions. This design
has been used for pragmatic public health trials conducted as part of routine practice where
phased implementation is preferable for feasibility and when the interventions are expected
to provide more good than harm. In the context of community-based participatory research, it
allows all participating communities to receive the intervention. It also maximizes
statistical power compared with a parallel cluster randomized design because the intervention
effect is estimated not only between cluster comparisons but also within cluster comparisons.
There are five phases for the study. 1) 'Control' is when the ECE centers receive standard
health promotion/professional development opportunities. The team will document 'usual care'
during the control periods. 2) 'WELL intervention' is when implementation of the
three-strategy WELL intervention begins. 3) 'Plan for sustainability' is the year allocated
to plan for how the project infrastructures and activities will be sustained once research
support/funding is completed. Follow-up technical assistance will be offered in this year,
but it will be much less intensive than during the intervention implementation year. 4)
'Sustaining WELL' is the first phase of withdrawal of research intervention support, drawing
on plans for supplemental funding identified, while maintaining support for research data
collection. 5) 'Observing sustainability at a distance' is the last phase and involves
withdrawal of all funding supports for ECEs and operating expenses while observing the
implementation and sustainability of WELL intervention.
WELL INTERVENTION
The 3-strategy intervention includes:
Strategy 1. Organization-Level: WELL PSE Change Process. Implementing policy, system and
environment (PSE) changes in ECE settings can play a key role in promoting ECE provider
well-being because these are more likely to be sustained over time.51 The WELL PSE Change
Process is a strategic planning process that is an adaptation of Intervention Mapping and is
aligned with community-based participatory research principles.27 The PSE Change Process
involves convening an ECE center-specific interdisciplinary team comprised of an average of
five members including ECE teachers, directors, education supervisors, and human resources
staff. A WELL Program Interventionist will lead the team through one-hour meetings on a
monthly basis (5-7 meetings) and utilize three change-making strategies to implement PSE
changes in the ECE setting: 1) conduct a strengths and needs assessment of their center using
a menu of evidence-based PSE changes related to a specific outcome (e.g. worker well-being),
2) prioritize potential PSE changes based on importance and feasibility, and 3) develop
action plans with specific action steps for implementation and sustainability of their
highest priority PSE changes. The menu of best practices will include PSE changes associated
with the domains of the Worker Well-being Framework that were identified as being most
significantly related to overall well-being in Aim 1. Examples of PSE change options and
alignment with specific worker well-being domains include relaxation breaks built into the
daily schedule (Health Status), updated organizational policy highlighting commitment to
health and safety (Workplace Policies and Culture), and leadership trainings for supervisors
(Work Evaluation and Experience) (n=4 PSE changes/center).
Strategy 2. Interpersonal-Level: WELL Social Support Activities. Social support is
consistently linked to good mental health, in part because supportive actions buffer stress.
The WELL intervention will include several group-based health-promotion activities that
increase social support and networking opportunities among Head Start teachers and between
Head Start teachers and management. These workplace well-being group activities will be
implemented twice/year and will directly link to the PSE changes selected by Head Start
settings. They will aim to increase leadership support and communication, teamwork and
respect in the workplace, which have been shown to be related to ECE workforce well-being.
Examples of social networking activities include: group-based walking and mindfulness
challenges to foster workplace health climate. Additionally, a center-specific Wellness
Champion (WC) will be identified to support coordination of these activities and encourage
staff buy-in and engagement and give out incentives for participation (e.g., yoga mats, water
bottles). A person-centered social network analysis will be conducted with ECE caregivers in
each center to understand the internal social network of a center and to inform the social
connection activities.
Strategy 3. Individual-Level Supports: Self-Care Plan, mWELL and Lunch and Learn Sessions:
Before the implementation of the WELL PSE Change Process, the ECE staff will participate in a
facilitated group training (at pre-service) that will introduce the concept of self-care and
will walk each ECE provider through the creation of their individualized self-care plan with
SMART goals. The self-care plan will cover the following areas: relationship to self;
relationship to others; relationship to environment; relationship to caregiver role; and
relationship to technology. Following the completion of their self-care plan, the ECE
providers will be invited to enroll in the mobile WELL (mWELL) program, a free text messaging
program that will promote self-care and mindfulness practices. Mobile health (mHealth)-based
interventions delivered through text messaging are becoming more widely used to promote
well-being. The mWELL program will be based on the Theory of Planned Behavior (TPB), a theory
that focuses on behavioral intent based on an individual's perceived ability to exert
self-control. There will be 4 text message cycles for a single program year. Each message
cycle will contain 30 core text messages that address the following themes (in this order):
self-care, mindfulness practices, well-being related to the caregiving role, and activities
for promoting high-quality relationships with children. Each theme will contain approximately
7-8 text messages and 2-3 study text messages. Theme texts will be aligned with the mWELL
logic model and based on the theoretical constructs of knowledge, attitudes, subjective
norms, perceived behavioral control, intention, and behavior. Participants will receive an
average of two text messages every week. The messages will be simple and include goal setting
for self-care changes, mindfulness activities, tips specific to caregiver well-being
promotion, and links to Head Start staff-specific resources.
The last WELL program strategy to promote individual-level behavior change related to
self-care and well-being promotion will be the Lunch and Learn (L&L) sessions (n=4/center)
and monthly newsletters for all Head Start staff that focus on each of the PSE changes and
associated worker well-being domains identified by the wellness teams, including, and not
limited to: workplace design, discrimination, work stress, mental health, and organizational
support for work/life balance. The sessions will be based on what is learned in Aim 1 and
will consist of 30-minute workshops comprised of both didactic and experiential activities
led by the WELL Program Interventionist and will support full implementation and
dissemination of the well-being-related changes throughout the ECE setting.
