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IncomeNCT07261254

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

A study testing Community Health Worker and Community Health Worker + Guaranteed Basic Income in people with Income and Infant, Newborn, run by Stanford University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 days and older
Conditions the study is for
Income, Infant, Newborn, Mothers
What is being tested?
Community Health Worker and Community Health Worker + Guaranteed Basic Income
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,400 participants
Where
1 siteUnited States
Study dates
7 Apr 2025to Mar 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 days and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elise Kuechle, MA contact

(650) 498-5684

ekuechle@stanford.edu

United States1 site, 1 recruiting
  • Lucile Packard Children's Hospital Stanford

    Palo Alto, California, 94304

    Elise Kuechle, 650-497-7541, ekuechle@stanford.edu

    Ryan Padrez, MD, 650-497-7541, rpadrez@stanford.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
Community Health Worker, Community Health Worker + Guaranteed Basic Income
Keywords
Guaranteed Basic Income, Community Health Workers, Medicaid, Medi-Cal, Community Partners, Coordinated Care, Coordinated Services, randomized trial, surveys, infant, newborn, newborn nursery
Medical subject headings
Patient Acceptance of Health Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community Health WorkerBehavioural

    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 IncomeBehavioural

    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.

Study groups in NCT07261254
Study groupRoleWhat they receive
Group A: Coordinated CareExperimentalParticipants will receive coordinated Services via a Community Health Worker for 3 years in a hybrid format.
Receives: Behavioral: Community Health Worker
Group B: Coordinated Care + Monthly Income SupportExperimentalParticipants will receive the same coordinated services as in group A in addition to guaranteed basic income for 36 months.
Receives: Behavioral: Community Health Worker + Guaranteed Basic Income
Group C: Standard of careNo interventionParticipants in this group and will receive no treatment or intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12, 24 and 36 months

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

    Dates of visits for postpartum checks in HPSM claims data.

    Measured: 12 months

  3. Change in pediatric Emergency Department visits

    Number of visits to the pediatric Emergency Department as per the HPSM claims data.

    Measured: 12 months, 24 months and 36 months

  4. Change in referrals to Child Protective Services

    Number of referrals to Child Protective Services in San Mateo County Human Services Agency administrative data.

    Measured: 12 months, 24 months and 36 months

  5. 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

    Measured: Baseline, year 1, year 2, year 3

  6. 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

    Measured: Baseline, 12 months, 24 months and 36 months

  7. Change in utilization of Supplemental Nutrition Assistance Program (SNAP) services - survey parents

    Research coordinators will complete a phone survey with parents regarding SNAP usage

    Measured: Baseline, year 1, year 2, year 3

  8. Change in utilization of SNAP services - administrative data

    Administrative data regarding SNAP obtained from San Mateo County Human Services Agency.

    Measured: Baseline, 12 months, 24 months and 36 months

  9. 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

    Measured: Baseline, year 1, year 2, year 3

  10. 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)

    Measured: Baseline, year 1, year 2, year 3

  11. 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

    Measured: Baseline, year 1, year 2, year 3

  12. 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.

    Measured: Approximately 18 to 22 months, and approximately 30 to 34 months.

Secondary outcomes (11)
  1. Change in parent depression scale score as measured by Patient Health Questionnaire (PHQ-9)

    Research coordinators will administer the PHQ-9 survey to parents to evaluate parent depression level.

    Measured: Baseline, year 1, year 2, year 3

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

    Assessed through claims data from HPSM Diagnosis ICD-10 of MH/BH diagnoses and BH utilization by provider type

    Measured: Administrative data at baseline, 12, 24 and 36 months

  3. Change in referrals for mental and behavioral health services for the parent - administrative data Family Health Services (FHS)

    Assessed through FHS Administrative Data: Maternal mental health referrals, BHRS Admin Data: Enrollment in BHRS mental health services.

    Measured: Administrative data at baseline, 12, 24 and 36 months

  4. Change in referrals for mental and behavioral health services for the parent - administrative data from Behavioral health and Recovery Services (BHRS)

    Assessed through BHRS Admin Data: Enrollment in BHRS mental health services.

    Measured: Administrative data at baseline, 12, 24 and 36 months

  5. Change in parent stress level

    Research coordinators will administer the Parental Stress Index (PSI) to parents to evaluate the birthing parent's stress level.

    Measured: Year 1, year 2, year 3

  6. Change in the breastfeeding duration

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

    Measured: Baseline, Year 1, year 2

  7. Number of parents applying to childcare

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

    Measured: Year 1, year 2, year 3

  8. Number of parents applying to preschool

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

    Measured: Year 3

  9. Change in the purchase pattern for the child at home.

    Research coordinators will survey parents about purchasing books, clothes, diapers, and toys for their child.

    Measured: Year 1, year 2, year 3

  10. Change in parental involvement with child

    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.

    Measured: Year 1, year 2, year 3

  11. Change in protective factors scale score as measured by Protective Factors Survey, 2nd Edition (PFS-2).

    Research coordinators will administer the PFS-2 to parents.

    Measured: Baseline, year 1, year 2, year 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2025
  2. Study start7 Apr 2025
  3. Primary completionMar 2030 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
2,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07261254
Sponsor's protocol ID
78517
Status last verified
Feb 2026
First submitted
21 Nov 2025
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39073390
  • Rhodes, E. (2024, December 5). Insights from OpenResearch on the 2021 Expanded Child Tax Credit. Open Research. https://www.openresearchlab.org/findings/ctc

  • 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/

  • 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

  • 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.

    PubMed 40726482
  • 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

  • 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

  • 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

  • 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

  • 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.

    PubMed 30180831
  • 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.

    PubMed 39348149
  • 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.

    PubMed 29621932
  • 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.

    PubMed 29705725
  • 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.

    PubMed 34475270
  • 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.

    PubMed 39112497

Questions about this trial

What is this clinical trial studying?

A study testing Community Health Worker and Community Health Worker + Guaranteed Basic Income in people with Income and Infant, Newborn, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elise Kuechle, MA ((650) 498-5684, ekuechle@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in attendance at well-child visits (time frame: 12, 24 and 36 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07261254, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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