Clinical trial NCT04027673: Thirty Million Words-Early Childhood Educator (TMW-ECE)
Official title: TMW-Early Childhood Educator Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Language Development
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the proposed study is to determine the efficacy of an eight-module interactive, online multi-media professional development course on our target population: individuals over the age of 18, who have no more than a bachelor's degree, and are employed as early childhood educators of children between the ages of 0 and 3. Outcomes of interest include changing caregiver knowledge and beliefs about child development, and encouraging the use of strategies provided to strengthen early learning environments. The investigators will also measure how participants interact with the online course in order to determine which features help and hinder the online professional development process.

The investigators hypothesize that the TMW-ECE intervention will be effective in improving educator beliefs and knowledge of their role in children's foundational brain development, and increasing the frequency of behaviors that are known to support children's language and cognitive development among our target population.

Detailed description: The intervention modules are experimental. The modules will be completed by subjects online using their own computer and internet connection.

TMW will send email reminders to participants whose participation has lapsed for more than 3 weeks (no activity in the learning management system (LMS) during that time).

Phase 1: Pre-Intervention Participant completes a demographics survey on RedCap to determine eligibility based on the exclusion criteria listed below. If they are eligible and desire to participate, they will complete the informed consent process online prior to beginning the intervention.

Participants will be randomized into either the treatment or control group after providing their consent. All participants will be notified via email with detailed instructions on how to complete the study measures online and, if treatment group, how to view the modules.

Survey Session 1: Participant completes the following surveys online: Survey of Parent/Provider Expectations and Knowledge (SPEAK), Course Content Survey, and Theories of Intelligence (TOI).

Phase 2: Intervention Participants in the treatment group complete interactive modules. They will be asked to complete one module per week, for a total of eight weeks.

Participants in the control group will have no active study requirements for the eight weeks following Survey Session 1.

Phase 3: Post-Intervention Upon completion of Module 8, participants in the treatment group will be invited by email to complete Survey Session 2, which includes the following surveys: SPEAK,Theories of Intelligence (TOI) survey, Course Content Knowledge, and the qualitative Course Experience survey.

Participants in the control group will be invited to complete Survey Session 2 exactly eight weeks after they complete Survey Session 1, which corresponds to how long the investigators anticipate treatment group participants needing to complete the 8 modules. This Survey Session will include the same surveys as the treatment group: SPEAK, Theories of Intelligence (TOI) survey, Course Content Knowledge, and a qualitative Course Experience survey on their most recent professional development.

All participants in both experimental groups will be invited by email to complete Survey Session 3 exactly 12 weeks after the completion of Survey Session 2. Surveys include: SPEAK, Course Content Knowledge, and Theories of Intelligence (TOI) survey.

At the conclusion of the study, participants in the treatment group may be asked to participate in a phone interview about their experience with the program, their opinions on the curriculum, and how they interact with the children in their care. This interview will be conducted with a trained member of the research team. The investigators hope to interview all treatment group participants but are limited in human capacity to complete the phone interviews for our expected recruitment goals. The investigators will ask as many treatment group members to participate in the phone interview but will start with the most engaged participants and those who enrolled first.

Eligibility criteria: Exclusion Criteria:

* Educators who report having a higher level of education (above a bachelor's degree, including any graduate school coursework).
* Educators who do not work with children ages 0-3 as their primary age group.
* Educators who are under the age of 18.
* Educators who do not have access to a computer or tablet with access to the internet.
* Anyone not employed by a childcare program (either home or center-based).
* Anyone whose role within a childcare setting is not that of an educator (primary teacher or assistant teacher)

Primary outcomes:
measure: Survey of Parent/Provider Expectations and Knowledge (SPEAK)
timeFrame: 6 months
measure: Course Content Knowledge
timeFrame: 6 months
measure: Tool to Measure Parenting Self Efficacy (TOPSE)
timeFrame: 6 months
Secondary outcomes:
measure: Experience survey
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Dana Suskind, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Kristin Leffel, AB
role: STUDY_CHAIR
References:
citation: Mashburn AJ, Pianta RC, Hamre BK, Downer JT, Barbarin OA, Bryant D, Burchinal M, Early DM, Howes C. Measures of classroom quality in prekindergarten and children's development of academic, language, and social skills. Child Dev. 2008 May-Jun;79(3):732-49. doi: 10.1111/j.1467-8624.2008.01154.x.