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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04027673
Other study ID # IRB19-0602
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 3, 2019
Est. completion date March 30, 2020

Study information

Verified date April 2020
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 432
Est. completion date March 30, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Survey of Parent/Provider Expectations and Knowledge (SPEAK) Provider knowledge of child language development 6 months
Primary Course Content Knowledge 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
Primary Tool to Measure Parenting Self Efficacy (TOPSE) 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 Experience survey 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
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