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

February 10, 2026 updated by: Ryan Christopher Padrez, Stanford University

Advancing Health Equity Via Basic Income + Early Childhood Systems Integration: An RCT of the Baby Bonus Program

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Lucile Packard Children's Hospital Stanford
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lisa Chamberlain, MD, MPH
        • Sub-Investigator:
          • Philip Fisher, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in attendance at well-child visits
Time Frame: 12, 24 and 36 months
Dates of visits for primary care in Health Plan of San Mateo (HPSM, the county-based Medicaid Managed Care organization) claims data.
12, 24 and 36 months
Change in attendance at maternal postpartum follow-up visits
Time Frame: 12 months
Dates of visits for postpartum checks in HPSM claims data.
12 months
Change in pediatric Emergency Department visits
Time Frame: 12 months, 24 months and 36 months
Number of visits to the pediatric Emergency Department as per the HPSM claims data.
12 months, 24 months and 36 months
Change in referrals to Child Protective Services
Time Frame: 12 months, 24 months and 36 months
Number of referrals to Child Protective Services in San Mateo County Human Services Agency administrative data.
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
Research coordinators will complete a phone survey with parents regarding WIC usage
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
Administrative data from San Mateo County Family Health Services Agency regarding WIC usage
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
Research coordinators will complete a phone survey with parents regarding SNAP usage
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
Administrative data regarding SNAP obtained from San Mateo County Human Services Agency.
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
Research coordinators will complete a phone survey with parents regarding the U.S. Household Food Security Survey Module: Six-Item Short Form
Baseline, year 1, year 2, year 3
Change in financial well-being scale score
Time Frame: Baseline, year 1, year 2, year 3
Research coordinators will complete a phone survey with parents regarding consumer Financial Protection Bureau's (CFPB) Financial Well-Being Scale (10 of 12 items)
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
Research coordinators will complete a phone survey with parents regarding CFPB Financial Well-Being Scale
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.
Study team will invite participants to clinical lab where a trained assessor will complete the Bayley-III Development Assessment for each child.
Approximately 18 to 22 months, and approximately 30 to 34 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in parent depression scale score as measured by Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline, year 1, year 2, year 3
Research coordinators will administer the PHQ-9 survey to parents to evaluate parent depression level.
Baseline, year 1, year 2, year 3
Change in diagnoses for mental and behavioral health services for the parent - claims data
Time Frame: Administrative data at baseline, 12, 24 and 36 months
Assessed through claims data from HPSM Diagnosis ICD-10 of MH/BH diagnoses and BH utilization by provider type
Administrative data at baseline, 12, 24 and 36 months
Change in referrals for mental and behavioral health services for the parent - administrative data Family Health Services (FHS)
Time Frame: Administrative data at baseline, 12, 24 and 36 months
Assessed through FHS Administrative Data: Maternal mental health referrals, BHRS Admin Data: Enrollment in BHRS mental health services.
Administrative data at baseline, 12, 24 and 36 months
Change in referrals for mental and behavioral health services for the parent - administrative data from Behavioral health and Recovery Services (BHRS)
Time Frame: Administrative data at baseline, 12, 24 and 36 months
Assessed through BHRS Admin Data: Enrollment in BHRS mental health services.
Administrative data at baseline, 12, 24 and 36 months
Change in parent stress level
Time Frame: Year 1, year 2, year 3
Research coordinators will administer the Parental Stress Index (PSI) to parents to evaluate the birthing parent's stress level.
Year 1, year 2, year 3
Change in the breastfeeding duration
Time Frame: Baseline, Year 1, year 2
Research coordinators will survey participants about the number of months breastfeeding.
Baseline, Year 1, year 2
Number of parents applying to childcare
Time Frame: Year 1, year 2, year 3
Research coordinators will survey parents if they applied for childcare for their child.
Year 1, year 2, year 3
Number of parents applying to preschool
Time Frame: Year 3
Research coordinators will survey parents if they applied for preschool for their child.
Year 3
Change in the purchase pattern for the child at home.
Time Frame: Year 1, year 2, year 3
Research coordinators will survey parents about purchasing books, clothes, diapers, and toys for their child.
Year 1, year 2, year 3
Change in parental involvement with child
Time Frame: Year 1, year 2, year 3
Research coordinators will survey parents asking if they increased or decreased parental engagement activities with their child such as singing, sharing stories, encouraging behavior and preventing challenging behavior, building up child's interest, reading, and engaging in verbal skills.
Year 1, year 2, year 3
Change in protective factors scale score as measured by Protective Factors Survey, 2nd Edition (PFS-2).
Time Frame: Baseline, year 1, year 2, year 3
Research coordinators will administer the PFS-2 to parents.
Baseline, year 1, year 2, year 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Silicon Valley Community Foundation
Valhalla Foundation
Health Plan of San Mateo
The Fidelity Charitable Trust
San Mateo County Health
First 5 San Mateo County
The Jackie Speier Foundation

Investigators

  • Principal Investigator: Ryan Padrez, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2025

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

November 21, 2025

First Posted (Actual)

December 3, 2025

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 78517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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