Thirty Million Words-Early Childhood Educator (TMW-ECE)

April 8, 2020 updated by: University of Chicago

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
432

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: TMW ECE Curriculum
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 3, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB19-0602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Descriptive IPD will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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