Early Childhood Professional DevelopmentQ-CCIIT PDNCT03433872
Professional Development Tools to Improve the Quality of Infant and Toddler Care
A study testing We Grow Together: The Q-CCIIT Professional Development System in people with Early Childhood Professional Development, run by Mathematica Policy Research, Inc..
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Professional Development
- What is being tested?
- We Grow Together: The Q-CCIIT Professional Development System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 475 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 30 Dec 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Does not meet the inclusion criteria
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Early Childhood Professional Development
- Being tested
- We Grow Together: The Q-CCIIT Professional Development System
- Keywords
- Infant-toddler care, Early child development, Professional development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
We Grow Together: The Q-CCIIT Professional Development SystemOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | Other | "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. Receives: Other: We Grow Together: The Q-CCIIT Professional Development System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Caregiver Child Interaction with Infant and Toddlers (Q-CCIIT)
Observational measure
Measured: 2-3 hours
Beliefs about Infant-Toddler Development
Study developed survey of knowledge and beliefs about child development
Measured: Up to 3 months
Beliefs about Infant-Toddler Caregiving
Study developed survey of beliefs about quality care for infants and toddlers
Measured: Up to 3 months
Self-reported beliefs about PD
Study developed survey of professional development
Measured: Up to 3 months
Use of website PD tools
Website analytics (metadata)
Measured: Up to 5 months
Satisfaction with We Grow Together professional development system
Study developed survey of professional development
Measured: Up to 3 months
Use of PD strategies
Study developed survey of professional development
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start1 May 2018 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood Professional DevelopmentStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The goal of the field test is to evaluate use of the We Grow Together system by typical early childhood professionals working in a variety of care settings serving infants and toddlers. The field test will take place in 8 to 12 geographic areas across the country. This study will include only centers and FCC settings that already have local PD providers-the investigators will exclude ECE settings without established PD providers. The field test will include a purposive sample of 175 center-based classrooms (approximately half will be affiliated with Early Head Start \[EHS\], and half will be community-based child care programs). The field test sample will also include 125 FCCs, including those operating under EHS and in community-based settings.
- Masking
- None (open label)
- Enrolment
- 475 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, University of Oklahoma, Zero to Three
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433872
- Sponsor's protocol ID
- 50192
- Acronym
- Q-CCIIT PD
- Status last verified
- Feb 2018
- First submitted
- 23 Jan 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Professional Development Tools to Improve the Quality of Infant and Toddler Care
- ClinicalTrials.gov ID
- NCT03433872
- Acronym / sponsor ID
- Q-CCIIT PD / 50192
- Conditions
- Early Childhood Professional Development
- Keywords
- Infant-toddler care, Early child development, Professional development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 475 participants (estimated)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- Department of Health and Human Services, University of Oklahoma, Zero to Three
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 15 Feb 2018 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The goal of the field test is to evaluate use of the We Grow Together system by typical early childhood professionals working in a variety of care settings serving infants and toddlers. The field test will take place in 8 to 12 geographic areas across the country. This study will include only centers and FCC settings that already have local PD providers-the investigators will exclude ECE settings without established PD providers. The field test will include a purposive sample of 175 center-based classrooms (approximately half will be affiliated with Early Head Start [EHS], and half will be community-based child care programs). The field test sample will also include 125 FCCs, including those operating under EHS and in community-based settings.
| Arm | Type | Receives |
|---|---|---|
| Caregivers | Other | Other: We Grow Together: The Q-CCIIT Professional Development System"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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Does not meet the inclusion criteria
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 |
|---|---|---|
| We Grow Together: The Q-CCIIT Professional Development SystemWe 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. | Other | Caregivers |
Primary outcome
Quality of Caregiver Child Interaction with Infant and Toddlers (Q-CCIIT)
Time frame: 2-3 hours
Observational measure
Beliefs about Infant-Toddler Development
Time frame: Up to 3 months
Study developed survey of knowledge and beliefs about child development
Beliefs about Infant-Toddler Caregiving
Time frame: Up to 3 months
Study developed survey of beliefs about quality care for infants and toddlers
Self-reported beliefs about PD
Time frame: Up to 3 months
Study developed survey of professional development
Use of website PD tools
Time frame: Up to 5 months
Website analytics (metadata)
Satisfaction with We Grow Together professional development system
Time frame: Up to 3 months
Study developed survey of professional development
Use of PD strategies
Time frame: Up to 3 months
Study developed survey of professional development
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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Autism Spectrum Disorder (ASD)
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.
Questions about this trial
What is this clinical trial studying?
A study testing We Grow Together: The Q-CCIIT Professional Development System in people with Early Childhood Professional Development, run by Mathematica Policy Research, Inc..
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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louisa Tarullo, Ed.D. ((617) 588-6720, LTarullo@Mathematica-mpr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Caregiver Child Interaction with Infant and Toddlers (Q-CCIIT) (time frame: 2-3 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2018.