NCT05416216

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Nov 2021Sep 2026

Study Start

First participant enrolled

November 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

4.9 years

First QC Date

June 6, 2022

Last Update Submit

February 5, 2024

Conditions

Outcome Measures

Primary Outcomes (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

    Pre-Post Years 1-5

Secondary Outcomes (2)

  • Burnout

    Pre-Post Years 1-5

  • Turnover Intent

    Pre-Post Years 1-5

Study Arms (2)

Control

NO INTERVENTION

In 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 intervention

EXPERIMENTAL

'WELL intervention' is when implementation of the one-year, three-strategy WELL intervention begins (see description).

Behavioral: WELL

Interventions

WELLBEHAVIORAL

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

WELL intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Adams County Head Start

Brighton, Colorado, 80601, United States

Location

Denver Great Kids Head Start

Denver, Colorado, 80202, United States

Location

Otero Junior College Head Start

La Junta, Colorado, 81050, United States

Location

Jefferson County Head Start

Lakewood, Colorado, 80002, United States

Location

Lakewood Head Start

Lakewood, Colorado, 80228, United States

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 6, 2022

First Posted

June 13, 2022

Study Start

November 1, 2021

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations