Child DevelopmentNCT06329778
Home-Based Child Care Toolkit for Nurturing School-Age Children Study
An observational study of Child Development, run by Mathematica Policy Research, Inc. at 1 site in United States.
Trial summary
The goal of this observational study is to build psychometric evidence for the Home-Based Child Care Toolkit for Nurturing School-Age Children (HBCC-NSAC Toolkit) provider questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Child Development
- How many people
- 419 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2024to 26 Jul 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study team will collect information from up to 150 home-based providers who at the time of collection regularly care for at least one school-age child (age 5 and in kindergarten, or ages 6 through 12) as well as from up to 150 family members with at least one school-age child in HBCC. The study team will use a non-probability, purposive approach to select a convenience sample of home-based providers to participate in at least 10 states in different regions of the United States (states vary on HBCC licensing rules). Of the 150 providers, the team will recruit 50 of these providers to participate in observations in a subset (at least 2) of the study states. The study team will recruit family respondents by asking participating providers to distribute the family survey to all eligible families in their care.
Who may be able to join
None listed.
Who cannot join
- Child care providers who do not care for at least one school-age child in a home setting for at least 10 hours per week and 8 weeks per year.
- Parents or guardians of children (families) who do not have school-age children who receive child care in a home for at least 10 hours per week and 8 weeks per year.
- Any providers or family members who are below 18 years old.
- Any providers or family members who cannot read and answer questions in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mathematica Policy Research
Washington D.C., District of Columbia, 20002
About this study
The goal of this observational study is to build psychometric evidence for the Home-Based Child Care Toolkit for Nurturing School-Age Children (HBCC-NSAC Toolkit) provider questionnaire. The main objectives of the study are to: 1) assess the reliability of the HBCC-NSAC Toolkit provider questionnaire, 2) assess the evidence for its validity compared to other existing measures of HBCC quality, and 3) examine invariance across subgroups (that is, look for the absence of any differential item functioning [DIF]). HBCC provider participants will complete a questionnaire in the HBCC-NSAC Toolkit. A subset of providers will also participate in an observation of their child care setting. Parents or guardians of children receiving care from HBCC providers will complete a survey.
Read the detailed description
Home-based child care (HBCC), child care and early education (CCEE) offered in a provider's or child's home by someone other than a parent, is the most common form of nonparental child care in the United States and is essential for many families. However, HBCC settings often use quality measures designed for center-based settings. The Home-Based Child Care Supply and Quality (HBCCSQ) project developed the Home-Based Child Care Toolkit for Nurturing School-Age Children (HBCC-NSAC Toolkit) to address the gaps in existing measures used in HBCC settings. The HBCC-NSAC Toolkit is intended to help HBCC providers who regularly care for at least one school-age child identify and reflect on their caregiving strengths and areas of growth. It consists of a self-administered provider questionnaire (composed of multiple newly developed measures) and a family communication questionnaire (composed of one communication tool). The provider questionnaire focuses on practices that may be more likely to take place in or be implemented differently in HBCC settings, such as racial and ethnic socialization, interactions among children of different ages, and interactions among children of similar ages. The current study builds upon the pilot study (completed under NCT05730075), which provided findings used to further refine the HBCC-NSAC Toolkit instruments and improve procedures for the subsequent validation study.
This validation study will recruit 150 purposively selected providers from diverse backgrounds to complete the English version of the HBCC-NSAC Toolkit provider questionnaire. The study team will ask providers to recruit one or more families to complete a family survey, for a total of up to 166 families. The study team will complete in-person observations in a subset of 50 providers' homes.
Results from the study will assist the field in understanding the extent to which the HBCC-NSAC Toolkit provider questionnaire can support home-based providers as well as how the HBCC-NSAC Toolkit addresses gaps in existing measurement.
- Conditions
- Child Development
- Keywords
- childcare, quality measures, early education, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HBCC providers (no observation) | This group will include 100 purposively selected providers from diverse backgrounds who will each complete the provider questionnaire and will also be asked to recruit one or more families to complete the family survey. | |
| HBCC providers (observation) | This group will include 50 purposively selected providers from diverse backgrounds who will each complete the provider questionnaire, be asked to recruit one or more families to complete the family survey, and agree to have their child care setting observed by a field staff member. | |
| Families | This group will include up to 166 purposively selected families who will each receive the family survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Home-Based Child Care Toolkit for Nurturing School-Age Children provider questionnaire
We will assess reliability and validity of the English version of the HBCC-NSAC Toolkit provider questionnaire by administering the provider questionnaire by web/paper/phone to HBCC providers.
It was developed by the study team to collect information about how providers support children in their care across five domains: 1) Support for social development, 2) Support for emotional development, 3) Positive and proactive behavior management, 4) Support for learning, 5) Support for health and physical development.
Scales, # of items, range scores Emotional development (33 items): 33-231 Social development (41 items): 41-287 Behavior management (22 items): 22-154 Learning (26 items): 26-182 Health and physical development (27 items): 27-189
Higher scores indicate provider does practices more often.
Measured: 6 months
Emlen Scales
For validation purposes in this study, we will administer items from sub-scales in the Emlen Scales (Emlen 2000; composite subscale, parent's perception of caregiver's cultural sensitivity subscale and happy, safe, secure subscale). These items will be embedded in the family survey administered to family respondents. The study team selected the Emlen subscales from measures used in the field that the team hypothesized are associated with constructs represented in the domains and dimensions in the provider questionnaire. We will compare families' responses to the Emlen scale against provider's responses in the provider questionnaire in order to help validate the provider questionnaire.
Scales, number of items, and range of scores:
Parent scale measuring quality of child care (composite scale, 15 items): 15-75 Risks to health, safety, and well-being (10 items): 10-50 Rich activities and environment (5 items): 5-25 Higher scores indicate higher parent satisfac
Measured: 6 months
Multicultural Teaching Competency Scale
For validation purposes, we will administer items from the Multicultural Teaching Competency Scale (MTCS; Spanierman, 2011). These items will be embedded in the provider questionnaire administered to providers. We will compare responses to the MTCS against provider's responses to certain items in the provider questionnaire in order to help validate specific dimensions in the provider questionnaire.
Multicultural Teaching Competency scales, number of items, and range of scores Multicultural Teaching Skill (10 items): 10-60 Multicultural Teaching Knowledge (6 items): 6-36 Total score (16 items): 16-96 Higher scores indicate greater levels of multicultural teaching competency.
Measured: 6 months
Family Child Care Program Quality Assessment (FCC PQA)
For validation purposes, we will conduct observations of providers' child care settings using the Family Child Care Program Quality Assessment (FCC PQA). The FCC PQA is designed to assess quality in FCC homes that is appropriate across various FCC size settings and age groups, including school age. The FCC PQA assesses the setting's learning environment, adult-child interactions, daily routine, and safety considerations. We will conduct the observations in-person and each observation will take approximately 3 to 4 hours to complete.
Family Child Care Program Quality Assessment scales, number of items, and range of scores Daily Schedule Sum Score (8 items): 8-40 Learning Environment Sum Score (9 items): 9-45 Provider-Child Interaction Sum Score (12 items): 12-60 Safe and Healthy Environment Sum Score (7 items): 7-35 Total Sum Score (36 items): 36-180
Higher scores indicate higher setting quality.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start15 Mar 2024
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Ashley Kopack Klein, Study director, Mathematica Policy Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329778
- Sponsor's protocol ID
- 50884b
- Status last verified
- Aug 2024
- First submitted
- 11 Mar 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Child Care Toolkit for Nurturing School-Age Children Study
- ClinicalTrials.gov ID
- NCT06329778
- Acronym / sponsor ID
- 50884b
- Conditions
- Child Development
- Keywords
- childcare, quality measures, early education, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 26 Mar 2024 (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 goal of this observational study is to build psychometric evidence for the Home-Based Child Care Toolkit for Nurturing School-Age Children (HBCC-NSAC Toolkit) provider questionnaire. The main objectives of the study are to: 1) assess the reliability of the HBCC-NSAC Toolkit provider questionnaire, 2) assess the evidence for its validity compared to other existing measures of HBCC quality, and 3) examine invariance across subgroups (that is, look for the absence of any differential item functioning [DIF]). HBCC provider participants will complete a questionnaire in the HBCC-NSAC Toolkit. A subset of providers will also participate in an observation of their child care setting. Parents or guardians of children receiving care from HBCC providers will complete a survey.
Detailed description
Home-based child care (HBCC), child care and early education (CCEE) offered in a provider's or child's home by someone other than a parent, is the most common form of nonparental child care in the United States and is essential for many families. However, HBCC settings often use quality measures designed for center-based settings. The Home-Based Child Care Supply and Quality (HBCCSQ) project developed the Home-Based Child Care Toolkit for Nurturing School-Age Children (HBCC-NSAC Toolkit) to address the gaps in existing measures used in HBCC settings. The HBCC-NSAC Toolkit is intended to help HBCC providers who regularly care for at least one school-age child identify and reflect on their caregiving strengths and areas of growth. It consists of a self-administered provider questionnaire (composed of multiple newly developed measures) and a family communication questionnaire (composed of one communication tool). The provider questionnaire focuses on practices that may be more likely to take place in or be implemented differently in HBCC settings, such as racial and ethnic socialization, interactions among children of different ages, and interactions among children of similar ages. The current study builds upon the pilot study (completed under NCT05730075), which provided findings used to further refine the HBCC-NSAC Toolkit instruments and improve procedures for the subsequent validation study.
This validation study will recruit 150 purposively selected providers from diverse backgrounds to complete the English version of the HBCC-NSAC Toolkit provider questionnaire. The study team will ask providers to recruit one or more families to complete a family survey, for a total of up to 166 families. The study team will complete in-person observations in a subset of 50 providers' homes.
Results from the study will assist the field in understanding the extent to which the HBCC-NSAC Toolkit provider questionnaire can support home-based providers as well as how the HBCC-NSAC Toolkit addresses gaps in existing measurement.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HBCC providers (no observation) | – | –This group will include 100 purposively selected providers from diverse backgrounds who will each complete the provider questionnaire and will also be asked to recruit one or more families to complete the family survey. |
| HBCC providers (observation) | – | –This group will include 50 purposively selected providers from diverse backgrounds who will each complete the provider questionnaire, be asked to recruit one or more families to complete the family survey, and agree to have their child care setting observed by a field staff member. |
| Families | – | –This group will include up to 166 purposively selected families who will each receive the family survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study team will collect information from up to 150 home-based providers who at the time of collection regularly care for at least one school-age child (age 5 and in kindergarten, or ages 6 through 12) as well as from up to 150 family members with at least one school-age child in HBCC. The study team will use a non-probability, purposive approach to select a convenience sample of home-based providers to participate in at least 10 states in different regions of the United States (states vary on HBCC licensing rules). Of the 150 providers, the team will recruit 50 of these providers to participate in observations in a subset (at least 2) of the study states. The study team will recruit family respondents by asking participating providers to distribute the family survey to all eligible families in their care.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Child care providers who do not care for at least one school-age child in a home setting for at least 10 hours per week and 8 weeks per year.
- Parents or guardians of children (families) who do not have school-age children who receive child care in a home for at least 10 hours per week and 8 weeks per year.
- Any providers or family members who are below 18 years old.
- Any providers or family members who cannot read and answer questions in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Home-Based Child Care Toolkit for Nurturing School-Age Children provider questionnaire
Time frame: 6 months
We will assess reliability and validity of the English version of the HBCC-NSAC Toolkit provider questionnaire by administering the provider questionnaire by web/paper/phone to HBCC providers. It was developed by the study team to collect information about how providers support children in their care across five domains: 1) Support for social development, 2) Support for emotional development, 3) Positive and proactive behavior management, 4) Support for learning, 5) Support for health and physical development. Scales, # of items, range scores Emotional development (33 items): 33-231 Social development (41 items): 41-287 Behavior management (22 items): 22-154 Learning (26 items): 26-182 Health and physical development (27 items): 27-189 Higher scores indicate provider does practices more often.
Emlen Scales
Time frame: 6 months
For validation purposes in this study, we will administer items from sub-scales in the Emlen Scales (Emlen 2000; composite subscale, parent's perception of caregiver's cultural sensitivity subscale and happy, safe, secure subscale). These items will be embedded in the family survey administered to family respondents. The study team selected the Emlen subscales from measures used in the field that the team hypothesized are associated with constructs represented in the domains and dimensions in the provider questionnaire. We will compare families' responses to the Emlen scale against provider's responses in the provider questionnaire in order to help validate the provider questionnaire. Scales, number of items, and range of scores: Parent scale measuring quality of child care (composite scale, 15 items): 15-75 Risks to health, safety, and well-being (10 items): 10-50 Rich activities and environment (5 items): 5-25 Higher scores indicate higher parent satisfac
Multicultural Teaching Competency Scale
Time frame: 6 months
For validation purposes, we will administer items from the Multicultural Teaching Competency Scale (MTCS; Spanierman, 2011). These items will be embedded in the provider questionnaire administered to providers. We will compare responses to the MTCS against provider's responses to certain items in the provider questionnaire in order to help validate specific dimensions in the provider questionnaire. Multicultural Teaching Competency scales, number of items, and range of scores Multicultural Teaching Skill (10 items): 10-60 Multicultural Teaching Knowledge (6 items): 6-36 Total score (16 items): 16-96 Higher scores indicate greater levels of multicultural teaching competency.
Family Child Care Program Quality Assessment (FCC PQA)
Time frame: 6 months
For validation purposes, we will conduct observations of providers' child care settings using the Family Child Care Program Quality Assessment (FCC PQA). The FCC PQA is designed to assess quality in FCC homes that is appropriate across various FCC size settings and age groups, including school age. The FCC PQA assesses the setting's learning environment, adult-child interactions, daily routine, and safety considerations. We will conduct the observations in-person and each observation will take approximately 3 to 4 hours to complete. Family Child Care Program Quality Assessment scales, number of items, and range of scores Daily Schedule Sum Score (8 items): 8-40 Learning Environment Sum Score (9 items): 9-45 Provider-Child Interaction Sum Score (12 items): 12-60 Safe and Healthy Environment Sum Score (7 items): 7-35 Total Sum Score (36 items): 36-180 Higher scores indicate higher setting quality.
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 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Ashley Kopack Klein study director
Mathematica Policy Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development, run by Mathematica Policy Research, Inc. 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 4 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 Aug 2024. 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?
The Home-Based Child Care Toolkit for Nurturing School-Age Children provider questionnaire (time frame: 6 months). The study lists 4 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 9 Aug 2024.