- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04027673
Thirty Million Words-Early Childhood Educator (TMW-ECE)
TMW-Early Childhood Educator Program
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Treatment
Participants in the treatment group complete interactive modules.
They will be asked to complete one module per week, for a total of eight weeks.
|
The TMW-ECE program will constitute the treatment arm of the study (Cohort A) which will complete the multi-media online professional development course beginning Summer 2019.
|
|
NO_INTERVENTION: Control
Participants in the control group will have no active study requirements for the eight weeks following Survey Session 1.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survey of Parent/Provider Expectations and Knowledge (SPEAK)
Time Frame: 6 months
|
Provider knowledge of child language development
|
6 months
|
|
Course Content Knowledge
Time Frame: 6 months
|
This survey includes questions specific to the course content conveyed in the professional development modules.
True/false, and multiple-choice questions will measure participants' uptake of course material.
|
6 months
|
|
Tool to Measure Parenting Self Efficacy (TOPSE)
Time Frame: 6 months
|
The TOPSE measures parents attitudes and beliefs about their parenting style and behaviors.
In this study, it is administered only to participants who identified as having a child living in the home
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Experience survey
Time Frame: 3 months
|
This survey asks about providers' experiences with the online professional development program format, including ease of use, opinions about the quality of the curriculum, suggestions for how the program can be improved in the future, and how providers have used what they learned in the curriculum in their own classroom.
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB19-0602
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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