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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07261254
Status
Recruiting
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Conditions

  • Child Care
  • Child Development
  • Child Health
  • Community Health Workers
  • Health Services Utilization
  • Healthcare Disparities
  • Hispanic or Latino
  • Income
  • Infant, Newborn
  • Medicaid
  • Mothers
  • Poverty
  • Social Services Utilization
  • United States

Eligibility Criteria

Sex
ALL
Age
0 Days - N/A
Healthy Volunteers
Not accepted

Interventions

  • Community Health Worker — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Apr 7, 2025
Status verified
Feb 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
2,400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

Change in attendance at well-child visits [ Time Frame: 12, 24 and 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lucile Packard Children's Hospital StanfordPalo AltoCalifornia94304
Elise Kuechle
[email protected]
650-497-7541
Ryan Padrez, MD
[email protected]
650-497-7541
Lisa Chamberlain, MD, MPH (PRINCIPAL_INVESTIGATOR)
Philip Fisher, PhD (SUB_INVESTIGATOR)

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By research site
Lucile Packard Children's Hospital Stanford· Palo Alto, CA

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