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

NCT07261254 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2400

Last updated 2026-02-12

No results posted yet for this study

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
  • Healthcare Disparities
  • Child Care
  • Child Health
  • Community Health Workers
  • Hispanic or Latino
  • Medicaid
  • Child Development
  • Social Services Utilization
  • Health Services Utilization

Interventions

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.

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.

Sponsors & Collaborators

  • Health Plan of San Mateo

    collaborator UNKNOWN
  • The Fidelity Charitable Trust

    collaborator UNKNOWN
  • Silicon Valley Community Foundation

    collaborator OTHER
  • San Mateo County Health

    collaborator UNKNOWN
  • First 5 San Mateo County

    collaborator UNKNOWN
  • The Jackie Speier Foundation

    collaborator UNKNOWN
  • Valhalla Foundation

    collaborator OTHER
  • Stanford University

    lead OTHER

Principal Investigators

  • Ryan Padrez, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-07
Primary Completion
2030-03-31
Completion
2030-03-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07261254 on ClinicalTrials.gov