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NCT Number: NCT07261254

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

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.

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Key information

Conditions

Income Behavior Child Care Child Development Child Health Community Health Workers Health Behavior Health Services Utilization Healthcare Disparities Hispanic or Latino Infant, Newborn Medicaid Mothers Patient Acceptance of Health Care Poverty Social Services Utilization Treatment Adherence and Compliance United States

Age range

0 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location status: Recruiting

Location contact

Elise Kuechle

CONTACT

[email protected]

650-497-7541

Lisa Chamberlain, MD, MPH

PRINCIPAL_INVESTIGATOR

Philip Fisher, PhD

SUB_INVESTIGATOR

Ryan Padrez, MD

CONTACT

[email protected]

650-497-7541

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Change in attendance at maternal postpartum follow-up visits

    Time frame: 12 months

    Dates of visits for postpartum checks in HPSM claims data.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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

  10. 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)

  11. 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

  12. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. Change in the breastfeeding duration

    Time frame: Baseline, Year 1, year 2

    Research coordinators will survey participants about the number of months breastfeeding.

  7. 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.

  8. Number of parents applying to preschool

    Time frame: Year 3

    Research coordinators will survey parents if they applied for preschool for their child.

  9. 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.

  10. 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.

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Kuechle, MA

CONTACT

[email protected]

(650) 498-5684

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Dec 3, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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