Recruiting

Community Health WorkersIntegrating Systems and Basic Income: Improving Outcomes for Families of Young Children

Sponsor:

Stanford University

Code:

NCT07261254

Conditions

Income

Infant, Newborn

Mothers

Poverty

United States

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Community Health Worker

Community Health Worker + Guaranteed Basic Income

Study Details

Brief summary:

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

Income

Infant, Newborn

Mothers

Poverty

United States

Study ID

NCT07261254

Start date

Apr 7, 2025

Status verified date

Feb, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

2400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Group A: Coordinated Care

Participants will receive coordinated Services via a Community Health Worker for 3 years in a hybrid format.

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.

no intervention: Group C: Standard of care

Participants in this group and will receive no treatment or intervention.

Interventions

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.

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.

Primary outcome measure

Change in attendance at well-child visits [ Time Frame: 12, 24 and 36 months ]
Change in attendance at maternal postpartum follow-up visits [ Time Frame: 12 months ]
Change in pediatric Emergency Department visits [ Time Frame: 12 months, 24 months and 36 months ]
Change in referrals to Child Protective Services [ Time Frame: 12 months, 24 months and 36 months ]
Change in utilization of the Women Infants and Children program (WIC) - survey parents [ Time Frame: Baseline, year 1, year 2, year 3 ]
Change in utilization of the Women Infants and Children program (WIC) - administrative data [ Time Frame: Baseline, 12 months, 24 months and 36 months ]
Change in utilization of Supplemental Nutrition Assistance Program (SNAP) services - survey parents [ Time Frame: Baseline, year 1, year 2, year 3 ]
Change in utilization of SNAP services - administrative data [ Time Frame: Baseline, 12 months, 24 months and 36 months ]
Change in food insecurity scale score as measured by U.S. Household Food Security Survey Module [ Time Frame: Baseline, year 1, year 2, year 3 ]
Change in financial well-being scale score [ Time Frame: Baseline, year 1, year 2, year 3 ]
Number of participants who will be able or unable to cover a $400 unexpected expense. [ Time Frame: Baseline, year 1, year 2, year 3 ]
Change in child developmental trajectory [ Time Frame: Approximately 18 to 22 months, and approximately 30 to 34 months. ]

Central Contacts and Locations

Central contacts

Elise Kuechle, MA

(650) 498-5684 ekuechle@stanford.edu

Locations

Lucile Packard Children's Hospital Stanford

Recruiting

Palo Alto, California, United States, 94304

Contacts

Elise Kuechle

650-497-7541 ekuechle@stanford.edu

Ryan Padrez, MD

650-497-7541 rpadrez@stanford.edu

Principal Investigator:

Lisa Chamberlain, MD, MPH

More Information

Sponsor

Stanford University

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

Guaranteed Basic Income
Community Health Workers
Medicaid
Medi-Cal
Community Partners
Coordinated Care
Coordinated Services
randomized trial
surveys
infant, newborn
newborn nursery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-02-12.