Study Results
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View full resultsBasic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
1000 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-05-09
Study Completion Date
2028-08-31
Brief Summary
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Recent advances in developmental neuroscience suggest that experiences early in life can have profound and enduring influences on the developing brain. Family economic resources shape the nature of many of these experiences, yet the extent to which they affect children's development is unknown. The project's team of neuroscientists, economists and developmental psychologists is seeking to fill important gaps in scientific knowledge about the role of economic resources in early development by evaluating the first U.S. randomized controlled trial to determine whether unconditional cash gift payments have a causal effect on the cognitive, socio-emotional and brain development of infants and toddlers in low-income U.S. families.
Specifically, 1,000 mothers of infants with incomes below the federal poverty line from four diverse U.S. communities were recruited from post-partum wards and are receiving monthly cash gift payments by debit card for the first 76 months of the child's life. Parents in the experimental group and receiving $333 per month ($3,996 per year), whereas parents in the active comparator group are receiving a nominal monthly payment of $20. In order to understand the impacts of the added income on children's cognitive and behavioral development, the investigators are assessing treatment group differences at ages 4 (this lab assessment was postponed from age 3 to age 4 due to Covid-19), 6, and 8 in lab-administered measures of cognitive, language, and self-regulation development and maternal reports of socio-emotional development. A number of other maternal-reported child outcome measures were gathered at ages 1, 2 and 3. Brain circuitry may be sensitive to the effects of early experience even before early behavioral differences can be detected. In order to understand the impacts of added income on children's brain functioning at age 4, 6, and 8, the investigators will assess, during a lab visit, experimental/active comparator group differences in measures of brain activity (electroencephalography \[EEG\]). The targeted age for each data collection wave is around the child's birthday, i.e. at 12 months, 24 months, 36 months, 48 months, 72 months, and 96 months.
To understand how family economic behavior, parenting, and parent stress and well-being change in response to income enhancement, the investigators will assess experimental/active comparator differences in family expenditures, food insecurity, housing and neighborhood quality, family routines and time use, parent stress, mental health and cognition, parenting practices, and child care and preschool arrangements. School readiness and outcomes are being assessed at ages 6 and 8. This study will thus provide the first definitive understanding of the extent to which income plays a causal role in determining early child cognitive, socio-emotional and brain development among low-income families.
Specifically, 1,000 mothers of infants with incomes below the federal poverty line from four diverse U.S. communities were recruited from post-partum wards and are receiving monthly cash gift payments by debit card for the first 76 months of the child's life. Parents in the experimental group and receiving $333 per month ($3,996 per year), whereas parents in the active comparator group are receiving a nominal monthly payment of $20. In order to understand the impacts of the added income on children's cognitive and behavioral development, the investigators are assessing treatment group differences at ages 4 (this lab assessment was postponed from age 3 to age 4 due to Covid-19), 6, and 8 in lab-administered measures of cognitive, language, and self-regulation development and maternal reports of socio-emotional development. A number of other maternal-reported child outcome measures were gathered at ages 1, 2 and 3. Brain circuitry may be sensitive to the effects of early experience even before early behavioral differences can be detected. In order to understand the impacts of added income on children's brain functioning at age 4, 6, and 8, the investigators will assess, during a lab visit, experimental/active comparator group differences in measures of brain activity (electroencephalography \[EEG\]). The targeted age for each data collection wave is around the child's birthday, i.e. at 12 months, 24 months, 36 months, 48 months, 72 months, and 96 months.
To understand how family economic behavior, parenting, and parent stress and well-being change in response to income enhancement, the investigators will assess experimental/active comparator differences in family expenditures, food insecurity, housing and neighborhood quality, family routines and time use, parent stress, mental health and cognition, parenting practices, and child care and preschool arrangements. School readiness and outcomes are being assessed at ages 6 and 8. This study will thus provide the first definitive understanding of the extent to which income plays a causal role in determining early child cognitive, socio-emotional and brain development among low-income families.
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Detailed Description
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In the Baby's First Years (BFY) study, one thousand infants born to mothers with incomes falling below the federal poverty threshold in four metropolitan areas in the United States were assigned at random within each of the metropolitan areas to one of two cash gift conditions. The sites are: New York City, the greater New Orleans metropolitan area, the greater Omaha metropolitan area, and the Twin Cities. IRB and recruiting issues led to a distribution of the 1,000 mothers across sites of 121 in one site (the Twin Cities), 295 in two of the other sites (New Orleans and Omaha) and 289 in New York. (The investigators have also randomly sampled 80 of the participating families in the Twin Cities and New Orleans to participate in an in-depth qualitative study, but do not elaborate on those plans in this document.) Mothers were recruited in postpartum wards of the 12 participating hospitals shortly after giving birth and, after consenting, were administered a 30-minute baseline interview. They then were asked to agree to receive the cash gifts. The "high-cash gift" treatment group mothers (40% of all mothers) are receiving unconditioned cash payments of $333 per month ($4,000 per year) via debit card for 76 months. Mothers in the "low-cash gift" comparator group (60% of all mothers) are receiving a nominal payment - $20 per month, delivered in the same way and also for 76 months. The 40/60 randomization assignment is stratified by site, but not by hospitals, within each of the four sites. The investigators have worked with state and local officials to ensure that, to the extent feasible, the cash gifts payments are not considered countable income for the purposes of determining benefit levels from social assistance programs.
BFY was originally formulated to study the effects of monthly unconditional cash transfers on child development for the first three years of life, with the cash gifts set to be distributed for 40 months (3 years, 4 months). In response to the COVID-19 pandemic and the need to postpone in-person research activities, the cash transfers were extended for an additional year, through 52 months (4 years, 4 months), enabling us to postpone in-person direct child assessments to age 4. The investigators successfully arranged funding to extend the cash gifts for a total of 76 months - the approximate boundary between early and middle childhood - and informed the study participants in August 2022 about the additional 2-year extension of cash transfer.
The targeted age for each data collection wave is around the child's birthday, i.e. at 12 months, 24 months, 36 months, 48 months, 72 months, and 96 months. Interviews conducted at child ages 1, 2 and 3 provided information about family functioning as well as several maternal reports of developmentally-appropriate measures of children's cognitive and behavioral development. At ages 4, 6 and 8 measures of cognitive, language, and self-regulation development were or will be administered in university labs, while socio-emotional development is assessed via maternal report. EEG-based measures of brain activity were assessed in the home at age 1 and in labs at ages 4, 6 and 8. At age 6 and 8 the investigators will collect school behavior and engagement data.
Conditional on participants' consent and our success in securing agreements with state and county agencies, the investigators are also collecting state and local administrative data regarding parental employment, utilization of public benefits such as Medicaid and Supplemental Nutrition Assistance Programs (SNAP), and any involvement in child protective services.
The family process measures that the investigators will gather are based on two theories of change surrounding the income supplements: that increased investment and reduced stress will facilitate children's healthy development. The investigators are obtaining measures of both of these pathways annually. Investment pathway: Additional resources enable parents to buy goods and services for their families and children that support cognitive development. These include higher quality housing, nutrition and non-parental child care; more cognitively stimulating home environments and learning opportunities outside of the home; and, by reducing or restructuring work hours, more parental time spent with children. Stress pathway: A second pathway is that additional economic resources may reduce parents' own stress and improve their mental health. This may allow parents to devote more positive attention to their children, thus providing a more predictable family life, less conflicted relationships, and warmer and more responsive interactions.
The compensation difference between families in the high and low cash gift groups will boost family incomes by $3,760 per year, an amount shown in the economics and developmental psychology literatures to be associated with socially significant and policy relevant improvements in children's school achievement. After accounting for likely attrition, a total sample size of 800 at age 4, 6 and 8 years, divided 40/60 between high and low payment groups, provides sufficient statistical power to detect meaningful (roughly .20 SD) differences in cognitive, emotional and brain functioning, and key dimensions of family context.
Measures and preregistered hypotheses about child- and family-based measures at all data collection waves are shown in the two tables in the Statistical Analysis Plan in "Other Documents" below; child-focused preregistered hypotheses are presented in Appendix Table 9 and maternal and family focused preregistered hypotheses are presented in Appendix Table 10. The investigators will update this registry with Age 8 measures and preregistered hypotheses before data collection begins in July 2026. The lab-based assessments at child ages 6 and 8 are part of Phase 2 of the project. The Phase 1 analysis plan covers ages 1-4.
BFY was originally formulated to study the effects of monthly unconditional cash transfers on child development for the first three years of life, with the cash gifts set to be distributed for 40 months (3 years, 4 months). In response to the COVID-19 pandemic and the need to postpone in-person research activities, the cash transfers were extended for an additional year, through 52 months (4 years, 4 months), enabling us to postpone in-person direct child assessments to age 4. The investigators successfully arranged funding to extend the cash gifts for a total of 76 months - the approximate boundary between early and middle childhood - and informed the study participants in August 2022 about the additional 2-year extension of cash transfer.
The targeted age for each data collection wave is around the child's birthday, i.e. at 12 months, 24 months, 36 months, 48 months, 72 months, and 96 months. Interviews conducted at child ages 1, 2 and 3 provided information about family functioning as well as several maternal reports of developmentally-appropriate measures of children's cognitive and behavioral development. At ages 4, 6 and 8 measures of cognitive, language, and self-regulation development were or will be administered in university labs, while socio-emotional development is assessed via maternal report. EEG-based measures of brain activity were assessed in the home at age 1 and in labs at ages 4, 6 and 8. At age 6 and 8 the investigators will collect school behavior and engagement data.
Conditional on participants' consent and our success in securing agreements with state and county agencies, the investigators are also collecting state and local administrative data regarding parental employment, utilization of public benefits such as Medicaid and Supplemental Nutrition Assistance Programs (SNAP), and any involvement in child protective services.
The family process measures that the investigators will gather are based on two theories of change surrounding the income supplements: that increased investment and reduced stress will facilitate children's healthy development. The investigators are obtaining measures of both of these pathways annually. Investment pathway: Additional resources enable parents to buy goods and services for their families and children that support cognitive development. These include higher quality housing, nutrition and non-parental child care; more cognitively stimulating home environments and learning opportunities outside of the home; and, by reducing or restructuring work hours, more parental time spent with children. Stress pathway: A second pathway is that additional economic resources may reduce parents' own stress and improve their mental health. This may allow parents to devote more positive attention to their children, thus providing a more predictable family life, less conflicted relationships, and warmer and more responsive interactions.
The compensation difference between families in the high and low cash gift groups will boost family incomes by $3,760 per year, an amount shown in the economics and developmental psychology literatures to be associated with socially significant and policy relevant improvements in children's school achievement. After accounting for likely attrition, a total sample size of 800 at age 4, 6 and 8 years, divided 40/60 between high and low payment groups, provides sufficient statistical power to detect meaningful (roughly .20 SD) differences in cognitive, emotional and brain functioning, and key dimensions of family context.
Measures and preregistered hypotheses about child- and family-based measures at all data collection waves are shown in the two tables in the Statistical Analysis Plan in "Other Documents" below; child-focused preregistered hypotheses are presented in Appendix Table 9 and maternal and family focused preregistered hypotheses are presented in Appendix Table 10. The investigators will update this registry with Age 8 measures and preregistered hypotheses before data collection begins in July 2026. The lab-based assessments at child ages 6 and 8 are part of Phase 2 of the project. The Phase 1 analysis plan covers ages 1-4.
Conditions
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Child Development
Brain Development
Household and Family Processes
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Parallel assignment
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
SINGLE
Participants
Researchers know about amount of cash payment subjects receive at the point of enrollment because they assist subjects with credit card activation and instructions. For follow-up assessments at age 1, 2, 3, 4, 6, 8 interviewers will be blind to the extent possible.
Study Groups
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Monthly cash gift payments of $333
These subjects receive $333 each month for 76 months via debit card.
Group Type
EXPERIMENTAL
Monthly cash gift payments of $333
Intervention Type
BEHAVIORAL
These subjects receive $333 each month for 76 months via debit card.
Monthly cash gift payments of $20
These subjects receive $20 each month for 76 months via debit card.
Group Type
ACTIVE_COMPARATOR
Monthly cash gift payments of $20
Intervention Type
BEHAVIORAL
These subjects receive $20 each month for 76 months via debit card.
Interventions
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Monthly cash gift payments of $333
These subjects receive $333 each month for 76 months via debit card.
Intervention Type
BEHAVIORAL
Monthly cash gift payments of $20
These subjects receive $20 each month for 76 months via debit card.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
1. mother 18 years or older;
2. household income below the federal poverty threshold in the calendar year prior to the interview, counting the newborn;
3. infant admitted to the newborn nursery and not requiring admittance to the intensive care unit;
4. residence in the state of recruitment;
5. mother not "highly likely" to move to a different state or country in the next 12 months;
6. infant to be discharged in the custody of the mother;
7. English or Spanish speaking (necessary for administration of instruments used to measure some of the child outcomes);
8. singleton birth
2. household income below the federal poverty threshold in the calendar year prior to the interview, counting the newborn;
3. infant admitted to the newborn nursery and not requiring admittance to the intensive care unit;
4. residence in the state of recruitment;
5. mother not "highly likely" to move to a different state or country in the next 12 months;
6. infant to be discharged in the custody of the mother;
7. English or Spanish speaking (necessary for administration of instruments used to measure some of the child outcomes);
8. singleton birth
Exclusion Criteria
Mothers will not be eligible unless all of the above eight criteria are met.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Columbia University
OTHER
Sponsor Role
collaborator
University of Wisconsin, Madison
OTHER
Sponsor Role
collaborator
New York University
OTHER
Sponsor Role
collaborator
University of Maryland
OTHER
Sponsor Role
collaborator
University of Nebraska
OTHER
Sponsor Role
collaborator
University of Minnesota
OTHER
Sponsor Role
collaborator
University of New Orleans
OTHER
Sponsor Role
collaborator
University of Michigan
OTHER
Sponsor Role
collaborator
Duke University
OTHER
Sponsor Role
collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Sponsor Role
collaborator
University of California, Irvine
OTHER
Sponsor Role
lead
Responsible Party
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Greg Duncan
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Greg Duncan, PhD
Role: STUDY_DIRECTOR
University of California, Irvine
Locations
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12 hospitals in the following four metropolitan areas: New York, Omaha, New Orleans, and Twin Cities
New York, New York, United States
Site Status
Countries
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United States
References
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Troller-Renfree SV, Morales S, Leach SC, Bowers ME, Debnath R, Fifer WP, Fox NA, Noble KG. Feasibility of assessing brain activity using mobile, in-home collection of electroencephalography: methods and analysis. Dev Psychobiol. 2021 Sep;63(6):e22128. doi: 10.1002/dev.22128. Epub 2021 Jun 4.
Reference Type
RESULT
Troller-Renfree SV, Sperber JF, Hart ER, Costanzo MA, Gennetian LA, Meyer JS, Fox NA, Noble KG. Associations between maternal stress and infant resting brain activity among families residing in poverty in the U.S. Biol Psychol. 2023 Nov;184:108683. doi: 10.1016/j.biopsycho.2023.108683. Epub 2023 Sep 15.
Reference Type
RESULT
Costanzo MA, Magnuson KA, Gennetian LA, Halpern-Meekin S, Noble KG, Yoshikawa H. Contraception use and satisfaction among mothers with low income: Evidence from the Baby's First Years study. Contraception. 2024 Jan;129:110297. doi: 10.1016/j.contraception.2023.110297. Epub 2023 Oct 6.
Reference Type
RESULT
Sperber JF, Gennetian LA, Hart ER, Kunin-Batson A, Magnuson K, Duncan GJ, Yoshikawa H, Fox NA, Halpern-Meekin S, Noble KG. Unconditional Cash Transfers and Maternal Assessments of Children's Health, Nutrition, and Sleep: A Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2335237. doi: 10.1001/jamanetworkopen.2023.35237.
Reference Type
RESULT
Premo EM, Magnuson KA, Lorenzo NE, Fox NA, Noble KG. Mental health and sleep quality of low-income mothers of one-year-olds during the COVID-19 pandemic. Infant Ment Health J. 2023 Jul;44(4):572-586. doi: 10.1002/imhj.22074.
Reference Type
RESULT
Troller-Renfree SV, Hart ER, Sperber JF, Fox NA, Noble KG. Associations among stress and language and socioemotional development in a low-income sample. Dev Psychopathol. 2022 May;34(2):597-605. doi: 10.1017/S0954579421001759. Epub 2022 Mar 8.
Reference Type
RESULT
Collins JM, Halpern-Meekin S, Harvey M, Hoiting J. "I Don't Like All Those Fees" Pragmatism About Financial Services Among Low-Income Parents. J Fam Econ Issues. 2022 Nov 5:1-14. doi: 10.1007/s10834-022-09873-w. Online ahead of print.
Reference Type
RESULT
Yoo PY, Duncan GJ, Magnuson K, Fox NA, Yoshikawa H, Halpern-Meekin S, Noble KG. Unconditional cash transfers and maternal substance use: findings from a randomized control trial of low-income mothers with infants in the U.S. BMC Public Health. 2022 May 5;22(1):897. doi: 10.1186/s12889-022-12989-1.
Reference Type
RESULT
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.
Reference Type
RESULT
Troller-Renfree SV, Costanzo MA, Duncan GJ, Magnuson K, Gennetian LA, Yoshikawa H, Halpern-Meekin S, Fox NA, Noble KG. The impact of a poverty reduction intervention on infant brain activity. Proc Natl Acad Sci U S A. 2022 Feb 1;119(5):e2115649119. doi: 10.1073/pnas.2115649119.
Reference Type
RESULT
Adams EJ, Scott ME, Amarante M, Ramirez CA, Rowley SJ, Noble KG, Troller-Renfree SV. Fostering inclusion in EEG measures of pediatric brain activity. NPJ Sci Learn. 2024 Apr 2;9(1):27. doi: 10.1038/s41539-024-00240-y.
Reference Type
RESULT
Collins JM, Halpern-Meekin S, Harvey M, Hoiting J. "If I don't have credit, I don't have anything": Perspectives on the credit scoring system among mothers with low incomes. J Consum Aff. 2023 Winter;57(4):1605-1622. doi: 10.1111/joca.12561. Epub 2023 Sep 30.
Reference Type
RESULT
Barnes C, Halpern-Meekin S, Hoiting J. "I Used to Get WIC... But Then I Stopped": How WIC Participants Perceive the Value and Burdens of Maintaining Benefits. RSF. 2023 Sep;9(5):32-55. doi: 10.7758/rsf.2023.9.5.02.
Reference Type
RESULT
Gennetian LA, Duncan G, Fox NA, Halpern-Meekin S, Magnuson K, Noble KG, Yoshikawa H. Unconditional Cash and Family Investments in Infants: Evidence from a Large-Scale Cash Transfer Experiment in the U.S. Res Sq [Preprint]. 2023 Feb 7:rs.3.rs-2507540. doi: 10.21203/rs.3.rs-2507540/v1.
Reference Type
RESULT
Gennetian LA, Duncan GJ, Fox NA, Halpern-Meekin S, Magnuson K, Noble KG, Yoshikawa H. Effects of a monthly unconditional cash transfer starting at birth on family investments among US families with low income. Nat Hum Behav. 2024 Aug;8(8):1514-1529. doi: 10.1038/s41562-024-01915-7. Epub 2024 Jun 21.
Reference Type
RESULT
Halpern-Meekin S, Gennetian LA, Hoiting J, Stilwell L, Meyer L. Monthly unconditional income supplements starting at birth: Experiences among mothers of young children with low incomes in the U.S. J Policy Anal Manage. 2024 Summer;43(3):871-898. doi: 10.1002/pam.22571. Epub 2024 Mar 2.
Reference Type
RESULT
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.
Reference Type
RESULT
Das A, Osypuk TL, Yoo PY, Magnuson K, Gennetian LA, Noble KG, Bruckner TA. Poverty reduction and childhood opportunity moves: A randomized trial of cash transfers to low-income U.S. families with infants. Health Place. 2024 Sep;89:103320. doi: 10.1016/j.healthplace.2024.103320. Epub 2024 Aug 2.
Reference Type
RESULT
Hart ER, Gennetian LA, Sperber JF, Penalva R, Magnuson K, Duncan GJ, Halpern-Meekin S, Yoshikawa H, Fox NA, Noble KG. The effect of unconditional cash transfers on maternal assessments of children's early language and socioemotional development: Experimental evidence from U.S. families residing in poverty. Dev Psychol. 2024 Dec;60(12):2290-2305. doi: 10.1037/dev0001824. Epub 2024 Aug 22.
Reference Type
RESULT
Stilwell L, Morales-Gracia M, Magnuson K, Gennetian LA, Sauval M, Fox NA, Halpern-Meekin S, Yoshikawa H, Noble KG. Unconditional Cash and Breastfeeding, Child Care, and Maternal Employment among Families with Young Children Residing in Poverty. Soc Serv Rev. 2024 Jun;98(2):260-292. doi: 10.1086/729364. Epub 2024 May 22.
Reference Type
RESULT
Duncan GJ, Magnuson K, Kunin-Batson AS, Yoshikawa H, Fox NA, Halpern-Meekin S, Ainsworth NJ, Black SR, Nelson JM, Nelson TD, Georgieff MK, Karhson D, Gennetian LA, Noble KG. Cash Transfers and Their Effect on Maternal and Young Children's Health: A Randomized Clinical Trial. JAMA Pediatr. 2025 Aug 1;179(8):867-875. doi: 10.1001/jamapediatrics.2025.1612.
Reference Type
DERIVED
Sperber JF, Gennetian LA, Hart ER, Kunin-Batson A, Magnuson K, Duncan GJ, Yoshikawa H, Fox NA, Halpern-Meekin S, Noble KG. The Effect of a U.S. Poverty Reduction Intervention on Maternal Assessments of Young Children's Health, Nutrition, and Sleep: A Randomized Control Trial. medRxiv [Preprint]. 2023 May 26:2023.05.25.23290530. doi: 10.1101/2023.05.25.23290530.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol: Phase 1 Study Protocol
Document Type: Study Protocol: Phase 2 Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form: Age 4 Consent
Document Type: Informed Consent Form: Age 6 Consent
Related Links
Access external resources that provide additional context or updates about the study.
http://www.4mybabycard.com
This website is for Study Participants for general study information and contact information.
http://www.babysfirstyears.com
Study Research Website
Other Identifiers
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