PediatricNCT05852392
Comparing a Team-Based Approach to Standard Well-Child Visits To Improve Preventive Care Services
A study testing Adapted PARENT Model in people with Pediatric and Well Child Care, run by Seattle Children's Hospital at 3 sites in United States.
Trial summary
Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based approach to care that utilizes a community health worker in a health educator role ("Parent's Coach") to provide many of the Well-Child Care (WCC) services that children and families should receive, addresses specific needs faced by… Read more about this study
- Who is it for?
- Ages 9 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Pediatric, Well Child Care
- What is being tested?
- Adapted PARENT Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jun 2023to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants are not individually recruited or enrolled; rather we collect de-identified Electronic Health Record (EHR) and administrative data on all children in the practices who:
- are age ≥9 and ≤15 months on day of data collection,
- have ≥1 visit at the practice in previous 9 months
- are insured by Partners for Kids, the Accountable Care Organization (ACO) for NCH-PCN
Who cannot join
- N/A
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Alex Kemper, MD, MPH, MS, 614-355-3605, alex.kemper@nationwidechildrens.org
Alex Kemper, MD, MPH, MS
- Active, not recruiting
Hawaii Pacific Health
Honolulu, Hawaii, 96826
- Active, not recruiting
Seattle Children's Research Institute
Seattle, Washington, 98104
About this study
Official title: Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) Trial: Comparing Two Models of Well-Child Care for Black Families
Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based approach to care that utilizes a community health worker in a health educator role ("Parent's Coach") to provide many of the Well-Child Care (WCC) services that children and families should receive, addresses specific needs faced by families in low-income communities, and decreases reliance on the clinician as the primary provider of WCC services. The model was developed in partnership with clinics and parents in low-income communities and previously tested among largely Latino, Medicaid-insured populations. The aims of this study are to (1) Adapt the PARENT intervention to meet the needs of a diverse, largely Black population of underserved families, (2) Determine the effect of adapted PARENT on receipt of nationally recommended preventive care services, emergency department utilization, and parent experiences of care, (3) Determine whether the effectiveness of adapted PARENT differs by family-level factors, (4) Explore parents' experiences in receiving adapted PARENT, (5) Examine the economic impact of adapted PARENT from the parent stakeholder perspective, (6) Examine the economic impact of adapted PARENT from the pediatric provider and clinic stakeholder perspective, and (7) Examine the economic impact of adapted PARENT on healthcare utilization, from the perspectives of parents and families.
This study will evaluate the effectiveness of the adapted PARENT model as compared to traditional guideline-based WCC and assess the patient-centered economic outcomes of the adapted PARENT model.
Read the detailed description
Clinical Practice Redesign can lead to innovative systems that improve preventive care for racial and ethnic minority children in low-income communities. Although several strategies to redesign the structure of Well-Child Care (WCC) have been proposed and studied, there are few evidence-based comprehensive models that are financially sustainable alternatives to current WCC. The Parent Focused Redesign for Encounters, Infants to Toddlers (PARENT) is a comprehensive early childhood WCC delivery model designed to improve the delivery of WCC for infants and toddlers in low-income communities. PARENT includes a community health worker as part of a team-based approach to WCC. The "Parent's Coach" partners with the clinician to independently provide comprehensive and family-centered care that includes anticipatory guidance, social needs screening, developmental screening, and connection to needed community resources. The Parent's Coach reduces the reliance on a clinician as the sole primary provider of routine WCC services. The intervention changes the structure of WCC by adding the Parent's Coach to the team (personnel), and changing the process, or provision of care, which impacts the receipt of preventive care, and thus health outcomes.
In previous trials of PARENT, among a predominately Latino population of Medicaid-insured children, we have reported intervention effects of better parent experiences of care, greater receipt of preventive care services, and more effective utilization of care. Although these trials were not powered for sub-analyses by race, exploratory analyses indicate that while Black and Latino families had similar intervention effects for receipt of services, Black families did not have the positive intervention effects on parent experiences of care or the reduction of emergency department (ED) visits that Latino families did. Thus, adaptation, implementation, and testing of PARENT in a trial with a large sample of Black families is needed to optimize outcomes for Black families. PARENT will be adapted, implemented, and tested in clinics that serve a large proportion of low-income Black families, providing findings to aid our understanding of how the intervention can be adapted to meet the needs of low-income Black families.
The adapted intervention, if found to be more effective than usual care in providing family-centered, comprehensive preventive care services to families, has the potential to be implemented and disseminated to other clinical settings that serve a large proportion of children in low-income areas. However, our stakeholders for early childhood WCC will require additional information on family-centered economic outcomes to make decisions regarding the implementation and dissemination of this new model for early childhood preventive care. To address this need, we will examine patient-centered economic outcomes during the stepped wedge trial of the adapted intervention that will provide additional information to help WCC stakeholders make decisions about the delivery of care for early childhood WCC services.
The study team will collaborate with investigators at Nationwide Children's Hospital Primary Care Network (NCH-PCN) to conduct this study. NCH-PCN is one of the largest Children's Hospital owned primary care networks in the country. Its 12 practices serve a patient population that is over 96% publicly insured, 50% Black, and 16% Latino. Collaboration on this study represents a unique opportunity to meet a clinical need at NCH-PCN and address key research questions of PARENT adaptation, implementation, and impact for Black families.
The study will conducted using a stepped wedge randomized trial design in order to evaluate the intervention's effectiveness as well as its patient-centered economic outcomes.
- Conditions
- Pediatric, Well Child Care
- Being tested
- Adapted PARENT Model
- Keywords
- Community Health Workers, Well Child Care, Black Children, Black Families, Preventive Care, Early Childhood, Patient-centered economic outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted PARENT ModelOther
PARENT is a team-based approach to care that utilizes a clinic-based community health worker as part of the WCC team to provide comprehensive and family-centered preventive care services.
| Study group | Role | What they receive |
|---|---|---|
| Adapted PARENT Model | Experimental | PARENT is a team-based approach to care that utilizes a community health worker (called a "coach") as part of the WCC team to provide comprehensive and family-centered preventive care services, address concerns related to family social needs, and decrease reliance on the clinician as the sole provider of preventive care services. The coach independently meets with the family at every early childhood well-child care visit to provide anticipatory guidance, social needs screening, developmental screening, and connection to needed community resources. All NCH-PCN practices will start in the control group, and then sequentially (by random assignment) move to become intervention. Practices will implement the adapted PARENT model for all well-visits, newborn through 15 months of age, and have a 9-month implementation exposure period to ensure that children ≤15 months of age at the practice have received the intervention; thereafter the practices maintain the intervention. Receives: Other: Adapted PARENT Model |
| Traditional Well-Child Care | No intervention | Our comparator is traditional well-child care, which follows national preventive care guidelines including structured and standardized developmental and social needs screening, and is in widespread use. These are well-child care visits led by the primary care clinician without a community health worker. All NCH-PCN practices will start in the control group, and then sequentially (by random assignment) move to become intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of preventive care services
Child and parent receipt of three key preventive care services: anticipatory guidance, social needs screening, and structured developmental screening
Measured: Every 9 months, up to 5 years
Healthcare Utilization
Emergency department visits
Measured: Every 9 months, up to 5 years
Parent Experiences of Care
Family-Centeredness Measure
Measured: Every 9 months, up to 5 years
Secondary outcomes (3)
Receipt of additional preventive care services
Receipt of a) social needs referral (e.g., to a food bank), b) successful connection with social needs source (e.g., parent reports accessing food bank), c) developmental or behavioral referral (e.g., Early Intervention Center), and d) successful connection with developmental needs source (e.g., visit at Early Intervention completed).
Measured: Every 9 months, up to 5 years
Other Healthcare Utilization
WCC and acute care visits, and hospitalizations
Measured: Every 9 months, up to 5 years
"At-risk" for developmental delay
Identified as "at-risk" following developmental screening
Measured: Every 9 months, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start30 Jun 2023
- Primary completion30 Sep 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- We will use a stepped wedge design, in which each of 12 clinical practice site starts in the control group, and then sequentially (by random assignment) moves to become intervention. Under "enrollment" below, we list the number of clinics to be randomized, as individual participants are not randomized or enrolled.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital, Patient-Centered Outcomes Research Institute, Hawaii Pacific Health
- Responsible party
- Principal investigator, Tumaini Coker, Hawaii Pacific Health
- Investigators
- Tumaini Coker, MD, MBA, Principal investigator, Hawaii Pacific HealthAlice Ellyson, PhD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852392
- Sponsor's protocol ID
- STUDY00004147
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2023
- Last updated
- 7 May 2026
- 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 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) Trial: Comparing Two Models of Well-Child Care for Black Families
- ClinicalTrials.gov ID
- NCT05852392
- Acronym / sponsor ID
- STUDY00004147
- Conditions
- Pediatric, Well Child Care
- Keywords
- Community Health Workers, Well Child Care, Black Children, Black Families, Preventive Care, Early Childhood, Patient-centered economic outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital, Patient-Centered Outcomes Research Institute, Hawaii Pacific Health
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 10 May 2023 (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.
Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based approach to care that utilizes a community health worker in a health educator role ("Parent's Coach") to provide many of the Well-Child Care (WCC) services that children and families should receive, addresses specific needs faced by families in low-income communities, and decreases reliance on the clinician as the primary provider of WCC services. The model was developed in partnership with clinics and parents in low-income communities and previously tested among largely Latino, Medicaid-insured populations. The aims of this study are to (1) Adapt the PARENT intervention to meet the needs of a diverse, largely Black population of underserved families, (2) Determine the effect of adapted PARENT on receipt of nationally recommended preventive care services, emergency department utilization, and parent experiences of care, (3) Determine whether the effectiveness of adapted PARENT differs by family-level factors, (4) Explore parents' experiences in receiving adapted PARENT, (5) Examine the economic impact of adapted PARENT from the parent stakeholder perspective, (6) Examine the economic impact of adapted PARENT from the pediatric provider and clinic stakeholder perspective, and (7) Examine the economic impact of adapted PARENT on healthcare utilization, from the perspectives of parents and families.
This study will evaluate the effectiveness of the adapted PARENT model as compared to traditional guideline-based WCC and assess the patient-centered economic outcomes of the adapted PARENT model.
Detailed description
Clinical Practice Redesign can lead to innovative systems that improve preventive care for racial and ethnic minority children in low-income communities. Although several strategies to redesign the structure of Well-Child Care (WCC) have been proposed and studied, there are few evidence-based comprehensive models that are financially sustainable alternatives to current WCC. The Parent Focused Redesign for Encounters, Infants to Toddlers (PARENT) is a comprehensive early childhood WCC delivery model designed to improve the delivery of WCC for infants and toddlers in low-income communities. PARENT includes a community health worker as part of a team-based approach to WCC. The "Parent's Coach" partners with the clinician to independently provide comprehensive and family-centered care that includes anticipatory guidance, social needs screening, developmental screening, and connection to needed community resources. The Parent's Coach reduces the reliance on a clinician as the sole primary provider of routine WCC services. The intervention changes the structure of WCC by adding the Parent's Coach to the team (personnel), and changing the process, or provision of care, which impacts the receipt of preventive care, and thus health outcomes.
In previous trials of PARENT, among a predominately Latino population of Medicaid-insured children, we have reported intervention effects of better parent experiences of care, greater receipt of preventive care services, and more effective utilization of care. Although these trials were not powered for sub-analyses by race, exploratory analyses indicate that while Black and Latino families had similar intervention effects for receipt of services, Black families did not have the positive intervention effects on parent experiences of care or the reduction of emergency department (ED) visits that Latino families did. Thus, adaptation, implementation, and testing of PARENT in a trial with a large sample of Black families is needed to optimize outcomes for Black families. PARENT will be adapted, implemented, and tested in clinics that serve a large proportion of low-income Black families, providing findings to aid our understanding of how the intervention can be adapted to meet the needs of low-income Black families.
The adapted intervention, if found to be more effective than usual care in providing family-centered, comprehensive preventive care services to families, has the potential to be implemented and disseminated to other clinical settings that serve a large proportion of children in low-income areas. However, our stakeholders for early childhood WCC will require additional information on family-centered economic outcomes to make decisions regarding the implementation and dissemination of this new model for early childhood preventive care. To address this need, we will examine patient-centered economic outcomes during the stepped wedge trial of the adapted intervention that will provide additional information to help WCC stakeholders make decisions about the delivery of care for early childhood WCC services.
The study team will collaborate with investigators at Nationwide Children's Hospital Primary Care Network (NCH-PCN) to conduct this study. NCH-PCN is one of the largest Children's Hospital owned primary care networks in the country. Its 12 practices serve a patient population that is over 96% publicly insured, 50% Black, and 16% Latino. Collaboration on this study represents a unique opportunity to meet a clinical need at NCH-PCN and address key research questions of PARENT adaptation, implementation, and impact for Black families.
The study will conducted using a stepped wedge randomized trial design in order to evaluate the intervention's effectiveness as well as its patient-centered economic outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will use a stepped wedge design, in which each of 12 clinical practice site starts in the control group, and then sequentially (by random assignment) moves to become intervention. Under "enrollment" below, we list the number of clinics to be randomized, as individual participants are not randomized or enrolled.
| Arm | Type | Receives |
|---|---|---|
| Adapted PARENT Model | Experimental | Other: Adapted PARENT ModelPARENT is a team-based approach to care that utilizes a community health worker (called a "coach") as part of the WCC team to provide comprehensive and family-centered preventive care services, address concerns related to family social needs, and decrease reliance on the clinician as the sole provider of preventive care services. The coach independently meets with the family at every early childhood well-child care visit to provide anticipatory guidance, social needs screening, developmental screening, and connection to needed community resources. All NCH-PCN practices will start in the control group, and then sequentially (by random assignment) move to become intervention. Practices will implement the adapted PARENT model for all well-visits, newborn through 15 months of age, and have a 9-month implementation exposure period to ensure that children ≤15 months of age at the practice have received the intervention; thereafter the practices maintain the intervention. |
| Traditional Well-Child Care | No intervention | –Our comparator is traditional well-child care, which follows national preventive care guidelines including structured and standardized developmental and social needs screening, and is in widespread use. These are well-child care visits led by the primary care clinician without a community health worker. All NCH-PCN practices will start in the control group, and then sequentially (by random assignment) move to become intervention. |
Who may qualify
- Ages
- 9 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participants are not individually recruited or enrolled; rather we collect de-identified Electronic Health Record (EHR) and administrative data on all children in the practices who:
- are age ≥9 and ≤15 months on day of data collection,
- have ≥1 visit at the practice in previous 9 months
- are insured by Partners for Kids, the Accountable Care Organization (ACO) for NCH-PCN
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Adapted PARENT ModelPARENT is a team-based approach to care that utilizes a clinic-based community health worker as part of the WCC team to provide comprehensive and family-centered preventive care services. | Other | Adapted PARENT Model |
Primary outcome
Receipt of preventive care services
Time frame: Every 9 months, up to 5 years
Child and parent receipt of three key preventive care services: anticipatory guidance, social needs screening, and structured developmental screening
Healthcare Utilization
Time frame: Every 9 months, up to 5 years
Emergency department visits
Parent Experiences of Care
Time frame: Every 9 months, up to 5 years
Family-Centeredness Measure
3 secondary outcomes
Receipt of additional preventive care services
Time frame: Every 9 months, up to 5 years
Other Healthcare Utilization
Time frame: Every 9 months, up to 5 years
"At-risk" for developmental delay
Time frame: Every 9 months, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Patient-Centered Outcomes Research Institute (PCORI):Comparing a Team-Based Approach to Standard Well-Child Visits To Improve Preventive Care ServicesLink provided by the sponsor.
- 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.
Tumaini Coker, MD, MBA principal investigator
Hawaii Pacific Health
Alice Ellyson, PhD principal investigator
Seattle Children's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted PARENT Model in people with Pediatric and Well Child Care, run by Seattle Children's Hospital at 3 sites 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 4 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: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teah Hoopes, MPH (206-884-4255, teah.hoopes@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of preventive care services (time frame: Every 9 months, up to 5 years). 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?
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 7 May 2026.