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Purpose

Early childhood is a critical period, laying the foundation for future growth and deveopment. This foundational period has an outsized effect, impacting health, well-being and achievement across one's lifespan. The U.S. lacks a cohesive early childhood system to support families with young children ages 0-5. The goal of this randomized controlled trial(RCT) is to test if community-based support via community health workers(CHWs) improves social and health services utilization, and child development. Furthermore, the trial will examine if income support enhances the impact of a CHW integrated system. Participants are English and Spanish speaking families with healthy newborns. This RCT was designed based on family priorities, community capacity and needs in a collective impact model. This trial is anchored at a university based children's hospital and involves many partners: families, county health, county leadership, a leading early childhood non-profit organization, the county's Medicaid managed care organization.

Conditions

Eligibility

Eligible Ages
Over 0 Days
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Caregiver Eligibility Criteria - 18 and Older - Family plans to reside in San Mateo County - Does not plan to move from the County in the next year - Speaks English and/or Spanish - Cared for in Postpartum Maternity unit Child Eligibility Criteria - Baby is being cared for in well newborn nursery - Child is enrolled in Medicaid - 36 weeks or older - To be discharged home in the custody of the caregiver

Exclusion Criteria

Caregiver Exclusion Criteria - Will not consent to share data via Epic/Study - Caregiver has significant cognitive impairment - Caregiver under contact isolation Child Exclusion Criteria - Sibling already enrolled in the Baby Bonus Study - Child has significant genetic disorder issues at birth - Child is a multiple (not a singleton)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group A: Coordinated Care 		Participants will receive coordinated Services via a Community Health Worker for 3 years in a hybrid format.
  • Behavioral: Community Health Worker
    A Community Health Worker will assist participants in navigating the medical system and connecting the participants to community services during the first three years of their child's life.
Experimental
Group B: Coordinated Care + Monthly Income Support 		Participants will receive the same coordinated services as in group A in addition to guaranteed basic income for 36 months.
  • Behavioral: Community Health Worker + Guaranteed Basic Income
    A Community Health Worker will assist participants in navigating the medical system and connecting the participants to community services during the first three years of their child's life. Participants will also receive a monthly unconditional cash gift for the first three years of their child's life.
No Intervention
Group C: Standard of care 		Participants in this group and will receive no treatment or intervention.

Recruiting Locations

Lucile Packard Children's Hospital Stanford
Palo Alto 5380748, California 5332921 94304
Contact:
Elise Kuechle
650-497-7541
ekuechle@stanford.edu

More Details

Status
Recruiting
Sponsor
Stanford University

Study Contact

Elise Kuechle
(650) 498-5684
ekuechle@stanford.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.