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

Primary Purpose

Preterm Birth

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unconditional Cash Transfer (High-Value)
Unconditional Cash Transfer (Low-Value)
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Birth focused on measuring Preterm Birth, Unconditional Cash Transfers, Parental Stress, Breastfeeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Philadelphia
  • Hospital of the University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-Value Cash Transfer

Low-Value Cash Transfer

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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%.

Secondary Outcome Measures

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.

Full Information

First Posted
June 26, 2023
Last Updated
August 29, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05930327
Brief Title
COIN: A Pilot Study of Cash Transfers to Improve Outcomes in Low-Income Preterm Neonates and Their Families
Official Title
COIN: A Pilot Study of Cash Transfers to Improve Outcomes in Low-Income Preterm Neonates and Their Families
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
Preterm Birth, Unconditional Cash Transfers, Parental Stress, Breastfeeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-Value Cash Transfer
Arm Type
Experimental
Arm Description
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.
Arm Title
Low-Value Cash Transfer
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Unconditional Cash Transfer (High-Value)
Intervention Description
Monthly, Unconditional Cash Transfer ($325) for 4-months
Intervention Type
Other
Intervention Name(s)
Unconditional Cash Transfer (Low-Value)
Intervention Description
Monthly, Unconditional Cash Transfer ($25) for 4-months
Primary Outcome Measure Information:
Title
Acceptability of randomizing high-value and low-value unconditional cash transfers (UCT) to low income birthing parents of preterm infants.
Description
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.
Time Frame
1 year
Title
Feasibility of enrolling caregivers of preterm infants in the study procedures and receipt of UCTs.
Description
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%.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Lived experiences of caring for a preterm infant admitted to the neonatal intensive care unit.
Description
Birthing parents' perspectives and measures of birthing parent psychological stress as measured through semi-structured interviews.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Duncan, MD
Phone
267-425-1485
Email
duncana2@chop.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy Nelin, MD
Phone
267-425-1485
Email
nelint@chop.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Duncan, MD
Organizational Affiliation
Children's Hospital of Philadelphia/University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Duncan, MD
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Duncan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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