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

NCT ID: NCT07261254

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-07

Study Completion Date

2030-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Group A: Coordinated Care

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

Group Type EXPERIMENTAL

Community Health Worker

Intervention Type 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 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.

Group Type EXPERIMENTAL

Community Health Worker + Guaranteed Basic Income

Intervention Type 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 C: Standard of care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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)
Minimum Eligible Age

0 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health Plan of San Mateo

UNKNOWN

Sponsor Role collaborator

The Fidelity Charitable Trust

UNKNOWN

Sponsor Role collaborator

Silicon Valley Community Foundation

OTHER

Sponsor Role collaborator

San Mateo County Health

UNKNOWN

Sponsor Role collaborator

First 5 San Mateo County

UNKNOWN

Sponsor Role collaborator

The Jackie Speier Foundation

UNKNOWN

Sponsor Role collaborator

Valhalla Foundation

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Lisa Chamberlain

Professor of Pediatrics, Stanford School of Medicine, Arline and Pete Harman Faculty Scholar, Associate Chair, Policy & Community Engagement, Professor by Courtesy, Stanford Graduate School of Education

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa Chamberlain, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Elise Kuechle

Role: CONTACT

(650) 498-5684

Ryan Padrez, MD

Role: CONTACT

Facility Contacts

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Elise Kuechle

Role: primary

650-497-7541

Ryan Padrez, MD

Role: backup

650-497-7541

References

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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.

Reference Type BACKGROUND
PMID: 29705725 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39073390 (View on PubMed)

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

Reference Type 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/

Reference Type 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

Reference Type 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.

Reference Type BACKGROUND
PMID: 40726482 (View on PubMed)

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

Reference Type 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

Reference Type 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

Reference Type 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

Reference Type 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.

Reference Type BACKGROUND
PMID: 30180831 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39348149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29621932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34475270 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39112497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39035030 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38907028 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39096582 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39333888 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37120800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39037892 (View on PubMed)

Related Links

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http://first5sanmateo.org/baby-bonus/

San Mateo County Baby Bonus Website

Other Identifiers

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78517

Identifier Type: -

Identifier Source: org_study_id

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