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

Stanford University

Status: Enrolling

Conditions: Health Services Utilization; Poverty; Income; Medicaid; Community Health Workers; Child Development; Child Health; United States; Infant, Newborn; Child Care; Hispanic or Latino; Social Services Utilization; Healthcare Disparities; Mothers

Treatments: Behavioral: Community Health Worker + Guaranteed Basic Income; Behavioral: Community Health Worker

Study type: Interventional

Funder types: Other

Identifiers

NCT07261254

78517

Details and patient eligibility

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. 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.

Enrollment: 2,400 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

2,400 participants in 3 patient groups

Group A: Coordinated Care

Experimental group

Description:

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

Treatment:

Behavioral: Community Health Worker

Group B: Coordinated Care + Monthly Income Support

Experimental group

Description:

Participants will receive the same coordinated services as in group A in addition to guaranteed basic income for 36 months.

Treatment:

Behavioral: Community Health Worker + Guaranteed Basic Income

Group C: Standard of care

No Intervention group

Description:

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