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

NCT07261254 | Recruiting

• 1 other identifier: 78517
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief 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

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; Income; Infant, Newborn

Keywords

Guaranteed Basic Income; Community Health Workers; Medicaid; Medi-Cal; Community Partners; Coordinated Care; Coordinated Services; randomized trial; surveys; infant, newborn; newborn nursery

Outcome Measures

Primary Outcomes (12)

• Change in attendance at well-child visits

  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

  Dates of visits for postpartum checks in HPSM claims data.

  12 months

• Change in pediatric Emergency Department visits

  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

  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

  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

  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

  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

  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

  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

  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.

  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

  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 Outcomes (11)

• Change in parent depression scale score as measured by Patient Health Questionnaire (PHQ-9)

  Baseline, year 1, year 2, year 3

• Change in diagnoses for mental and behavioral health services for the parent - claims data

  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)

  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)

  Administrative data at baseline, 12, 24 and 36 months

• Change in parent stress level

  Year 1, year 2, year 3

Study Arms (3)

Group A: Coordinated Care

EXPERIMENTAL

Participants will receive coordinated Services via a Community Health Worker for 3 years in a hybrid format.

Behavioral: Community Health Worker

Group B: Coordinated Care + Monthly Income Support

EXPERIMENTAL

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

Group C: Standard of care

NO INTERVENTION

Participants in this group and will receive no treatment or intervention.

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.

Group A: Coordinated Care

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.

Group B: Coordinated Care + Monthly Income Support

Eligibility Criteria

• Age: 0 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregiver Eligibility Criteria
• 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
• weeks or older
• To be discharged home in the custody of the caregiver

You may not qualify if:

• Will not consent to share data via Epic/Study
• Caregiver has significant cognitive impairment
• Caregiver under contact isolation
• Sibling already enrolled in the Baby Bonus Study
• Child has significant genetic disorder issues at birth
• Child is a multiple (not a singleton)

Sponsors & Collaborators

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

Study Sites (1)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

RECRUITING

Related Publications (21)

• Egan-Dailey S, Gennetian LA, Magnuson K, Duncan GJ, Yoshikawa H, Fox NA, Noble KG. Child-directed speech in a large sample of U.S. mothers with low income. Child Dev. 2024 Nov-Dec;95(6):2045-2061. doi: 10.1111/cdev.14139. Epub 2024 Jul 29.

  PMID: 39073390 BACKGROUND

• Rhodes, E. (2024, December 5). Insights from OpenResearch on the 2021 Expanded Child Tax Credit. Open Research. https://www.openresearchlab.org/findings/ctc

  BACKGROUND

• Reyes-Velarde, A. (2024, January 30). They're getting $1,000 a month for 3 years. How guaranteed income is changing lives in L.A. County. CalMatters. http://calmatters.org/california-divide/2024/01/guaranteed-income-program/

  BACKGROUND

• De Andrade, L. H. A., Ylikännö, M., & Kangas, O. (2021). Increased Trust in the Finnish UBI Experiment - Is the Secret Universalism or Less Bureaucracy? Basic Income Studies, 17(1), 95-115. https://doi.org/10.1515/bis-2021-0004

  BACKGROUND

• Sauval M, Duncan GJ, Gennetian LA, Magnuson KA, Fox NA, Noble KG, Yoshikawa H. Unconditional Cash Transfers and Maternal Employment: Evidence from the Baby's First Years Study. J Public Econ. 2024 Aug;236:105159. doi: 10.1016/j.jpubeco.2024.105159. Epub 2024 Jul 5.

  PMID: 40726482 BACKGROUND

• Rojas, N. M., Yoshikawa, H., Gennetian, L., Lemus Rangel, M., Melvin, S., Noble, K., Duncan, G., & Magunson, K. (2020). Exploring the experiences and dynamics of an unconditional cash transfer for low-income mothers: A mixed-methods study. Journal of Children and Poverty, 26(1), 64-84. https://doi.org/10.1080/10796126.2019.1704161

  BACKGROUND

• Murray, M., Bridges, K., Solano, M., Greiner, K., & Woodward, J. (2023). Food RX + CHW: Investigating the Role of Community Health Workers to Close the Food Insecurity Gap. Annals of Family Medicine, 21(Suppl 1), 4231. https://doi.org/10.1370/afm.21.s1.4231

  BACKGROUND

• Miller, S., Rhodes, E., Bartik, A., Broockman, D., Krause, P., & Vivalt, E. (2024). Does Income Affect Health? Evidence from a Randomized Controlled Trial of a Guaranteed Income (No. w32711; p. w32711). National Bureau of Economic Research. https://doi.org/10.3386/w32711

  BACKGROUND

• Magnuson, K., Duncan, G., Yoshikawa, H., Yoo, P., Han, S., Gennetian, L. A., Fox, N., Halpern-Meekin, S., & Noble, K. (2024). Can Cash Transfers Improve Maternal Well-being and Family Processes among Families with Young Children? An Experimental Analysis. SSRN. https://doi.org/10.2139/ssrn.4955765

  BACKGROUND

• Savage JS, Kling SMR, Cook A, Hess L, Lutcher S, Marini M, Mowery J, Hayward S, Hassink S, Hosterman JF, Paul IM, Seiler C, Bailey-Davis L. A patient-centered, coordinated care approach delivered by community and pediatric primary care providers to promote responsive parenting: pragmatic randomized clinical trial rationale and protocol. BMC Pediatr. 2018 Sep 4;18(1):293. doi: 10.1186/s12887-018-1263-z.

  PMID: 30180831 BACKGROUND

• Yama CL, Rook JM. The Child Tax Credit-Tax Policy as Health Policy. JAMA Pediatr. 2024 Nov 1;178(11):1097-1098. doi: 10.1001/jamapediatrics.2024.3927.

  PMID: 39348149 BACKGROUND

• Sircar NR, Friedman EA. Financial security and public health: How basic income & cash transfers can promote health. Glob Public Health. 2018 Dec;13(12):1878-1888. doi: 10.1080/17441692.2018.1460383. Epub 2018 Apr 6.

  PMID: 29621932 BACKGROUND

• Siddiqi A, Rajaram A, Miller SP. Do cash transfer programmes yield better health in the first year of life? A systematic review linking low-income/middle-income and high-income contexts. Arch Dis Child. 2018 Oct;103(10):920-926. doi: 10.1136/archdischild-2017-314301. Epub 2018 Apr 28.

  PMID: 29705725 BACKGROUND

• Noble KG, Magnuson K, Gennetian LA, Duncan GJ, Yoshikawa H, Fox NA, Halpern-Meekin S. Baby's First Years: Design of a Randomized Controlled Trial of Poverty Reduction in the United States. Pediatrics. 2021 Oct;148(4):e2020049702. doi: 10.1542/peds.2020-049702. Epub 2021 Sep 2.

  PMID: 34475270 BACKGROUND

• Hart ER, Sperber JF, Troller-Renfree SV, Ortells-Faci P, Halpern-Meekin S, Sandre A, Noble KG. Mothers with low incomes view both individual and structural interventions as potentially helpful for supporting early child development. Sci Rep. 2024 Aug 7;14(1):18374. doi: 10.1038/s41598-024-68762-4.

  PMID: 39112497 BACKGROUND

• Halpern-Meekin S, Gennetian LA, Hoiting J, Stilwell L, Meyer L. Monthly unconditional income supplements starting at birth: Experiences among mothers of young children with low incomes in the U.S. J Policy Anal Manage. 2024 Summer;43(3):871-898. doi: 10.1002/pam.22571. Epub 2024 Mar 2.

  PMID: 39035030 BACKGROUND

• Gennetian LA, Duncan GJ, Fox NA, Halpern-Meekin S, Magnuson K, Noble KG, Yoshikawa H. Effects of a monthly unconditional cash transfer starting at birth on family investments among US families with low income. Nat Hum Behav. 2024 Aug;8(8):1514-1529. doi: 10.1038/s41562-024-01915-7. Epub 2024 Jun 21.

  PMID: 38907028 BACKGROUND

• Das A, Osypuk TL, Yoo PY, Magnuson K, Gennetian LA, Noble KG, Bruckner TA. Poverty reduction and childhood opportunity moves: A randomized trial of cash transfers to low-income U.S. families with infants. Health Place. 2024 Sep;89:103320. doi: 10.1016/j.healthplace.2024.103320. Epub 2024 Aug 2.

  PMID: 39096582 BACKGROUND

• Coker TR, Gregory EF, McCord M, Cholera R, Bakken H, Chapman S, Anwar E, Lee J, Henry S, Chamberlain LJ. Integrating community health workers in early childhood well-child care: a statement from the Pediatric Academic Societies Maternal Child Health: First 1,000 days Special Interest Group. BMC Prim Care. 2024 Sep 27;25(1):345. doi: 10.1186/s12875-024-02582-3.

  PMID: 39333888 BACKGROUND

• Coker TR, Liljenquist K, Lowry SJ, Fiscella K, Weaver MR, Ortiz J, LaFontaine R, Silva J, Salaguinto T, Johnson G, Friesema L, Porras-Javier L, Guerra LJS, Szilagyi PG. Community Health Workers in Early Childhood Well-Child Care for Medicaid-Insured Children: A Randomized Clinical Trial. JAMA. 2023 May 23;329(20):1757-1767. doi: 10.1001/jama.2023.7197.

  PMID: 37120800 BACKGROUND

• Agarwal SD, Cook BL, Liebman JB. Effect of Cash Benefits on Health Care Utilization and Health: A Randomized Study. JAMA. 2024 Nov 5;332(17):1455-1463. doi: 10.1001/jama.2024.13004.

  PMID: 39037892 BACKGROUND

Related Links

• San Mateo County Baby Bonus Website

MeSH Terms

Conditions

Patient Acceptance of Health Care

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Ryan Padrez, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise Kuechle, MA

CONTACT

(650) 498-5684; ekuechle@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Pediatrics - General

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: April 7, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)