Language DevelopmentNCT04027673
Thirty Million Words-Early Childhood Educator (TMW-ECE)
A study testing TMW ECE Curriculum in people with Language Development, run by University of Chicago at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Language Development
- What is being tested?
- TMW ECE Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2019to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Language Development
- Being tested
- TMW ECE Curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMW ECE CurriculumBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants in the treatment group complete interactive modules. They will be asked to complete one module per week, for a total of eight weeks. Receives: Behavioral: TMW ECE Curriculum |
| Control | No intervention | Participants in the control group will have no active study requirements for the eight weeks following Survey Session 1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey of Parent/Provider Expectations and Knowledge (SPEAK)
Provider knowledge of child language development
Measured: 6 months
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.
Measured: 6 months
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
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start3 Jun 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Language DevelopmentStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana Suskind, MD, Principal investigator, University of ChicagoKristin Leffel, AB, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027673
- Sponsor's protocol ID
- IRB19-0602
- Status last verified
- Apr 2020
- First submitted
- 11 Jul 2019
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Descriptive IPD will not be shared
Publications
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.
PubMed 18489424
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TMW-Early Childhood Educator Program
- ClinicalTrials.gov ID
- NCT04027673
- Acronym / sponsor ID
- IRB19-0602
- Conditions
- Language Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: TMW ECE CurriculumParticipants in the treatment group complete interactive modules. They will be asked to complete one module per week, for a total of eight weeks. |
| Control | No intervention | –Participants in the control group will have no active study requirements for the eight weeks following Survey Session 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMW ECE CurriculumThe 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. | Behavioural | Treatment |
Primary outcome
Survey of Parent/Provider Expectations and Knowledge (SPEAK)
Time frame: 6 months
Provider knowledge of child language development
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.
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
1 secondary outcome
Experience survey
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Background: PubMed 18489424Mashburn 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.
- Click here for more information about the Thirty Million WordsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Descriptive IPD will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana Suskind, MD principal investigator
University of Chicago
Kristin Leffel, AB study chair
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMW ECE Curriculum in people with Language Development, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survey of Parent/Provider Expectations and Knowledge (SPEAK) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04027673, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.