NCT07261254 · Stanford University
Integrating Systems and Basic Income: Improving Outcomes for Families of Young Children
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
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.
Change in attendance at maternal postpartum follow-up visits
Time frame: 12 months
Dates of visits for postpartum checks in HPSM claims data.
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.
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.
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
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
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
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.
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
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)
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Palo Alto, California
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
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 12, 2026 · Source of record for eligibility and locations