- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03433872
Professional Development Tools to Improve the Quality of Infant and Toddler Care (Q-CCIIT PD)
Mathematica Policy Research, funded by OPRE, ACF, DHHS, will conduct a field test of We Grow Together: The Q-CCIIT Professional Development System. These professional development (PD) tools and the interactive website featuring the materials were developed to promote high-quality caregiver-child interactions in non-parental care settings serving infants and toddlers. This field test aims to: (1) examine changes in caregiver practice that the investigators expect to be associated with use of the We Grow Together system, and (2) examine implementation of We Grow Together. As a secondary goal, the investigators will further evaluate the psychometrics of the Q-CCIIT observational measure of interaction quality.
Collecting data from field test participants will occur from fall 2018 through spring 2019. First, the investigators plan to collect a background survey with caregivers and PD providers in fall 2018. Second, in fall 2018 and spring 2019 the investigators plan two rounds of classroom observations using the Q-CCIIT measure and classroom rosters. Third, the investigators plan to collect data on the use and implementation of We Grow Together through the interactive website from fall 2018 through spring 2019. Finally, the investigators plan to conduct a feedback survey with caregivers and PD providers in spring 2019.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The We Grow Together intervention is designed to help caregivers understand how caregiver interactions with children support the children's development to strengthen high quality caregiver interactions with infants and toddlers. The starting point for the We Grow Together process is assessment of a caregiver's interactions with infants and toddlers in early childhood care and education (ECE) settings, using the Quality of Caregiver-Child Interactions with Infants and Toddlers (Q-CCIIT) observational measure. Data from the Q CCIIT observations highlight areas for growth in the caregiver's practices and inform a PD goal-setting process, with the support of a PD Provider.
The investigators have developed an array of We Grow Together materials targeting principles and practices assessed by the Q-CCIIT measure, organized into modules, and delivered on an interactive website. Over the course of a program year, each caregiver in the study will work with a PD provider who is trained in guiding caregivers through the use of We Grow Together materials.
As part of the We Grow Together intervention, all PD providers will receive training in using We Grow Together to support caregivers' understanding and practices. PD providers' training will focus on understanding the caregiving principles, relationship skills, adult learning principles, and coaching strategies that facilitate use of We Grow Together and promote growth of caregivers' knowledge and skills. PD providers will also have access to a set of PD provider materials to support implementation of We Grow Together. These materials support the ongoing relationship-based PD between the PD Provider and caregiver.
The purpose of information collected under the current request is to examine the implementation and the outcomes associated with use of We Grow Together. The goals of the field test will be to: (1) implement We Grow Together for five months in a variety of settings, (2) collect information on the implementation of We Grow Together, and (3) collect information on care practices the investigators hypothesize are associated with use of We Grow Together. The investigators propose the following data collection activities, to be carried out in fall 2018 through spring 2019:
- An ECE setting eligibility screening will determine if a setting is eligible and if family child care (FCC) and center directors and individual personnel are willing to participate in the field test.
- A background survey, completed by all caregivers and PD providers
- Observations of caregiver interactions by the investigators using the Q-CCIIT measure, to assess the quality of care provided by participating caregivers.
- A classroom information roster, completed by caregivers at the time of the observation, about the composition and activities within care settings.
- Web-user pop-up questions for caregivers and PD providers, collected monthly at website login.
- A feedback survey, completed by caregivers and PD providers.
- A PD provider training survey.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Louisa Tarullo, Ed.D.
- Phone Number: (617) 588-6720
- Email: LTarullo@Mathematica-mpr.com
Study Contact Backup
- Name: Shannon Monahan, Ph.D.
- Phone Number: (609) 275-2207
- Email: SMonahan@mathematica-mpr.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
To be eligible for the study caregivers and PD providers in center-based and FCC ECE settings must meet the following criteria:
- Operate within one of the selected geographical areas.
- Caregivers must have a current PD provider with whom the caregiver works one-on-one with at least once a month.
- Serve children between the ages of birth to 36 months.
- Written knowledge of English.
- Caregivers and PD providers must agree to participate in the We Grow Together professional development system for approximately 5 months.
Exclusion Criteria:
- Does not meet the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Caregivers
"Caregiver" refers to teachers and child care providers in infant and toddler classrooms in center-based or FCC settings.
All caregivers in the study will be assigned to the intervention.
The PD providers supporting these caregivers will be trained in the We Grow Together: The Q-CCIIT Professional Development System.
|
We Grow Together is designed to strengthen high quality caregiver interactions with infants and toddlers.
The starting point for the We Grow Together study is assessment of a caregiver's interactions with infants and toddlers in the caregiver's ECE setting, using the Q-CCIIT observational measure.
Data from the Q CCIIT observations highlight areas for growth in the caregiver's practices and will inform a PD goal-setting process, with the help of a PD Provider.
An array of We Grow Together materials targeting practices assessed by the Q-CCIIT measure and informed by professional development and behavior change research are organized into modules, and delivered on an interactive website.
Over the course of a program year, each caregiver in the study will work with a PD provider who is trained in guiding caregivers through the use of We Grow Together materials.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Caregiver Child Interaction with Infant and Toddlers (Q-CCIIT)
Time Frame: 2-3 hours
|
Observational measure
|
2-3 hours
|
Beliefs about Infant-Toddler Development
Time Frame: Up to 3 months
|
Study developed survey of knowledge and beliefs about child development
|
Up to 3 months
|
Beliefs about Infant-Toddler Caregiving
Time Frame: Up to 3 months
|
Study developed survey of beliefs about quality care for infants and toddlers
|
Up to 3 months
|
Self-reported beliefs about PD
Time Frame: Up to 3 months
|
Study developed survey of professional development
|
Up to 3 months
|
Use of website PD tools
Time Frame: Up to 5 months
|
Website analytics (metadata)
|
Up to 5 months
|
Satisfaction with We Grow Together professional development system
Time Frame: Up to 3 months
|
Study developed survey of professional development
|
Up to 3 months
|
Use of PD strategies
Time Frame: Up to 3 months
|
Study developed survey of professional development
|
Up to 3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- 50192
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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