COIN: A Pilot Study of Cash Transfers to Improve Outcomes in Low-Income Preterm Neonates and Their Families

The investigators are conducting a pilot randomized controlled trial of unconditional cash transfers among Medicaid-eligible birthing parents of preterm infants in a single neonatal intensive care unit (NICU) in Pennsylvania.

The investigators will measure the feasibility and acceptability of the intervention, birthing parents' lived experiences of having a preterm infant and the impacts of cash transfers, and conduct a preliminary assessment of efficacy on birthing parent psychological stress and ability to invest in their infant's care.

Study Overview

• Status: Completed
• Conditions: Preterm Birth
• Intervention / Treatment: Other: Unconditional Cash Transfer (High-Value); Other: Unconditional Cash Transfer (Low-Value)

Detailed Description

Poverty is an important social determinant of health and contributes to child heath disparities. Among preterm infants, low-income is associated with worse long-term health outcomes. Given the connection between poverty and poor health outcomes, an urgent need exists to move beyond describing health disparities for low-income infants and towards interventions that interrupt these pathways in early childhood to improve outcomes.

A growing body of literature suggests that monthly unconditional cash transfers (UCTs) - no strings attached monthly cash payments - to low-income families may be an effective intervention to reduce poverty and financial stress, improve psychological health, and improve child health outcomes. However, current studies on UCTs focus primarily on term infants or heterogenous samples of children, with only a single pilot delivering direct financial assistance to low-income preterm infants. Thus, despite well-documented disparities in outcomes for low-income preterm infants, the impact of UCTs among low-income preterm infants and their families remains unknown.

Toward that end, the investigators are conducting a pilot randomized controlled trial of unconditional cash transfers among Medicaid-eligible birthing parents of preterm infants in a single NICU in Pennsylvania. The investigators have three specific aims:

Aim 1: To determine the feasibility and acceptability of randomizing high-value ($325/month) and low-value ($25/month) UCTs to low-income birthing parents of preterm infants beginning in the first month of life.

Aim 2: To examine birthing parents' lived experiences managing the financial impact of having a preterm infant and the perceived impact.

Exploratory Aim 3: To conduct a preliminary assessment of the efficacy of monthly UCTs on birthing parent psychological stress and ability to invest in their infant's care, recognizing the pilot is not designed to be powered for statistical significance.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Duncan, MD; Phone Number: 267-425-1485; Email: duncana2@chop.edu
• Study Contact Backup: Name: Timothy Nelin, MD; Phone Number: 267-425-1485; Email: nelint@chop.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
      • Contact: Andrea Duncan, MD
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
      • Contact: Andrea Duncan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Medicaid-insured or uninsured by meets income requirements for Medicaid-eligibility, Over 18 years old, Speaks English or Spanish fluently, Lives in Philadelphia county, Has an infant born >=22 and <36 weeks gestational age

Exclusion Criteria:

• Reports being "highly likely" to move to a different state in the next 12 months, Reports planning to place the infant up for adoption at the time of enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-Value Cash Transfer; Participants in the treatment group will receive four $325 payments. The first payment will be disbursed at the time of enrollment (between birth and 4 weeks of age), and second payment on the infant's one-month birthday, third payment on the infant's two-month birthday, and the fourth payment on the infant's three-month birthdays.	Other: Unconditional Cash Transfer (High-Value); Monthly, Unconditional Cash Transfer ($325) for 4-months
Active Comparator: Low-Value Cash Transfer; Participants in the control group will receive four $25 payments. The first payment will be disbursed at the time of enrollment (between birth and 4 weeks of age), and second payment on the infant's one-month birthday, third payment on the infant's two-month birthday, and the fourth payment on the infant's three-month birthdays.	Other: Unconditional Cash Transfer (Low-Value); Monthly, Unconditional Cash Transfer ($25) for 4-months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of randomizing high-value and low-value unconditional cash transfers (UCT) to low income birthing parents of preterm infants.	The investigators define acceptability as greater than or equal to 90% of respondents reporting "agree" to "strongly agree" to each of the 4 measures of acceptability on the follow-up surveys at 2-months.	1 year
Feasibility of enrolling caregivers of preterm infants in the study procedures and receipt of UCTs.	The investigators will measure the percentage of eligible subjects enrolled in study procedures, percentage of participants eligible for cash transfers who consented to receive the cash transfers, percentage of participants receiving monthly payments delivered within 1-2 days of the the child's monthly birthday. The investigators define feasibility as greater than 60% of those eligible enrolling in the study procedures, greater than or equal to 90% of those eligible for cash transfers to consent to cash transfers, and greater than or equal to 95% of monthly payments delivered within 1-2 days on either side of the child's monthly birthday. The investigators will additionally measure the attrition rate of survey and follow-up interview completion, aiming for an attrition rate less than or equal to 20%.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lived experiences of caring for a preterm infant admitted to the neonatal intensive care unit.	Birthing parents' perspectives and measures of birthing parent psychological stress as measured through semi-structured interviews.	1 year

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: University of Pennsylvania
• Investigators: Principal Investigator: Andrea Duncan, MD, Children's Hospital of Philadelphia/University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2023
• Primary Completion (Actual): November 14, 2023
• Study Completion (Actual): November 14, 2023

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Breastfeeding; Preterm Birth; Parental Stress; Unconditional Cash Transfers
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: 23-021011; 852454 (Other Identifier: University of Pennsylvania)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No