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Burnout, CaregiverWELLNCT05416216

Wellbeing of the ECE Workforce in Low-resourced Locations

A study testing WELL in people with Burnout, Caregiver and Stress, run by Colorado School of Public Health at 5 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Burnout, Caregiver, Stress, Mental Health Wellness
What is being tested?
WELL
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
5 sitesUnited States
Study dates
1 Nov 2021to 30 Sep 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Early childcare education providers employed in one of five Head Start-funded ECE centers in Colorado who are providing care for children ages 0-5
  • Aged 18 years or older

Who cannot join

  • N/A

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites
  • Adams County Head Start

    Brighton, Colorado, 80601

  • Denver Great Kids Head Start

    Denver, Colorado, 80202

  • Otero Junior College Head Start

    La Junta, Colorado, 81050

  • Jefferson County Head Start

    Lakewood, Colorado, 80002

  • Lakewood Head Start

    Lakewood, Colorado, 80228

Other trials in United States

About this study

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.
Read the detailed 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.

Being tested
WELL
Medical subject headings
Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WELLBehavioural

    The WELL intervention is a multi-level, three-strategy program to promote the wellbeing of the ECE workforce.

Study groups in NCT05416216
Study groupRoleWhat they receive
ControlNo interventionIn the stepped wedge design, ECE centers start the trial at the same point in time and act as controls with no intervention until they are randomized to crossover from control to intervention conditions.
WELL interventionExperimental'WELL intervention' is when implementation of the one-year, three-strategy WELL intervention begins (see description).
Receives: Behavioral: WELL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Early care and Education Worker Wellbeing

    Measured as a latent construct via a 68-item National Institute of Occupational Safety and Health Worker Wellbeing Questionnaire that encompasses 5 domains (work evaluation and experience, work safety and physical climate, work policies and culture, health status, and home community and society). The scale total ranges from 0-68 with higher scores indicating higher well-being

    Measured: Pre-Post Years 1-5

Secondary outcomes (2)
  1. Burnout

    Measured quantitatively via the 22-item Maslach Burnout Inventory Survey. The scale ranges from 0 to 132 with higher scores indicating higher levels of burnout.

    Measured: Pre-Post Years 1-5

  2. Turnover Intent

    Measured quantitatively via 2-items from the Turnover Intent Scale. Scores range from 2 to 10 with higher scores indicating higher turnover intent.

    Measured: Pre-Post Years 1-5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2022
  2. Study start1 Nov 2021
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
Stepped Wedge Cluster Randomized Trial. To evaluate the effectiveness of the WELL intervention the researchers will implement a stepped wedge cluster randomized trial. In this 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.
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05416216
Sponsor's protocol ID
21-4662
Acronym
WELL
Status last verified
Feb 2024
First submitted
6 Jun 2022
Last updated
7 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing WELL in people with Burnout, Caregiver and Stress, run by Colorado School of Public Health at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early care and Education Worker Wellbeing (time frame: Pre-Post Years 1-5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.

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