Recruiting

PARENT Model

Sponsor:

Seattle Children's Hospital

Code:

NCT05852392

Conditions

Pediatric

Well Child Care

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

Interventions

Adapted PARENT Model

Study Details

Brief 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 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.

Conditions

Pediatric

Well Child Care

Study ID

NCT05852392

Start date

Jun 30, 2023

Status verified date

Apr, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

Inclusion Criteria:

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:

1. are age ≥9 and ≤15 months on day of data collection,
2. have ≥1 visit at the practice in previous 9 months
3. are insured by Partners for Kids, the Accountable Care Organization (ACO) for NCH-PCN

Exclusion Criteria:

  • N/A

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Adapted PARENT Model

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.

no intervention: Traditional Well-Child Care

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.

Interventions

Adapted PARENT Model

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.

Primary outcome measure

  • Receipt of preventive care services [ Time Frame: Every 9 months, up to 5 years ]
  • Healthcare Utilization [ Time Frame: Every 9 months, up to 5 years ]
  • Parent Experiences of Care [ Time Frame: Every 9 months, up to 5 years ]

Central Contacts and Locations

Central contacts

Teah Hoopes, MPH

206-884-4255teah.hoopes@seattlechildrens.org

Tumaini Coker, MD, MBA

808-369-1237tumaini.coker@hphmg.org

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Alex Kemper, MD, MPH, MS

614-355-3605alex.kemper@nationwidechildrens.org

Principal Investigator:

Alex Kemper, MD, MPH, MS

More Information

Sponsor

Seattle Children's Hospital

Last update posted

May 7, 2026

Last verified

Apr, 2026

Keywords

  • Community Health Workers
  • Well Child Care
  • Black Children
  • Black Families
  • Preventive Care
  • Early Childhood
  • Patient-centered economic outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2026-05-07.