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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0+
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

2,400 Participants
are divided into 3 treatment groups
Group A: Group A: Coordinated CareExperimental treatment 1 intervention
Group B: Group B: Coordinated Care + Monthly Income SupportExperimental treatment 1 intervention
Group C: Group C: Standard of careNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
12 months
3

Change in pediatric Emergency Department visits

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

Time frame
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.

Time frame
12 months, 24 months and 36 months

Secondary outcomes

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.

Time frame
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

Time frame
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.

Time frame
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.

Time frame
Administrative data at baseline, 12, 24 and 36 months

Other outcomes

Sponsors and contacts

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Stanford University

Lead sponsor

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