Professional Development Tools to Improve the Quality of Infant and Toddler Care (Q-CCIIT PD)

February 14, 2018 updated by: Mathematica Policy Research, Inc.

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

Status

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

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 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

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 (Anticipated)

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.
475

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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:

  1. Operate within one of the selected geographical areas.
  2. Caregivers must have a current PD provider with whom the caregiver works one-on-one with at least once a month.
  3. Serve children between the ages of birth to 36 months.
  4. Written knowledge of English.
  5. 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

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
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.
Other: 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

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
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

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.
Mathematica Policy Research, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oklahoma
Department of Health and Human Services
Zero to Three

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 (Anticipated)

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.
May 1, 2018

Primary Completion (Anticipated)

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.
December 30, 2020

Study Completion (Anticipated)

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.
December 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).
January 23, 2018

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.
February 8, 2018

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.
February 15, 2018

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.
February 19, 2018

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.
February 14, 2018

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.
February 1, 2018

More Information

Terms related to this study

Keywords

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.
  • 50192

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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