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Baby's First Years (BFY)

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status

Active, not recruiting

Conditions

Brain Development
Child Development
Household and Family Processes

Treatments

Behavioral: Monthly cash gift payments of $20
Behavioral: Monthly cash gift payments of $333

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03593356
20163336
2R01HD087384 (U.S. NIH Grant/Contract)
R01HD087384 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,000 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Exclusion criteria

Mothers will not be eligible unless all of the above eight criteria are met.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,000 participants in 2 patient groups

Monthly cash gift payments of $333
Experimental group
Description:
These subjects receive $333 each month for 76 months via debit card.
Treatment:
Behavioral: Monthly cash gift payments of $333
Monthly cash gift payments of $20
Active Comparator group
Description:
These subjects receive $20 each month for 76 months via debit card.
Treatment:
Behavioral: Monthly cash gift payments of $20

Trial documents
5

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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