Clinical Trial

Integrating Systems and Basic Income: Improving Outcomes for Families of Young Children

Recruiting
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-11-21; most recent amendment 2026-02-10.
Trial Details
NCT Number NCT07261254
Lead Sponsor Stanford University
Collaborators: Health Plan of San Mateo, The Fidelity Charitable Trust, Silicon Valley Community Foundation, San Mateo County Health, First 5 San Mateo County, The Jackie Speier Foundation, Valhalla Foundation
Conditions Income, Infant, Newborn, Mothers, Poverty, United States, Healthcare Disparities, Child Care, Child Health +6 more
Enrollment 2,400 participants
Start Date 2025-04-07
Primary Completion 2030-03 (estimated)
Study Completion 2030-03 (estimated)
Updated on ClinicalTrials.gov 2026-02-12