Baby's First Years — BFY  

Child Development Clinical Trial

Official title: Household Income and Child Development in the First Three Years of Life (Phase 1) Household Income and Child Development in the First Years of Life (Phase 2)

Status Active, not recruiting

Clinical Trial Summary

Recent advances in developmental neuroscience suggest that experiences early in life 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. Our team of neuroscientists, economists and developmental psychologists proposes to fill important gaps in scientific knowledge about the role of economic resources in early development by evaluating the first 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 will receive monthly cash gift payments by debit card for the first 76 months of the child's life. Parents in the experimental group will receive $333 per month ($4,000 per year), whereas parents in the active comparator group will receive 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 will assess experimental/active comparator group differences at age 4 (this lab assessment was postponed from age 3 to age 4 due to Covid-19), age 6, and age 8, and, for a subset of measures - ages 1, 2 and 3 via maternal survey - on measures of cognitive, language, self-regulation and socio-emotional development. 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]). 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. We add school readiness and school outcomes 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.

Clinical Trial 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. (We 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 consent to 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.

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. In planning future data collection waves and fundraising for another cash transfer extension for the study families, we were able to inform the study participants in August 2022 about an additional 2-year extension of cash transfers lasting to 76 months (6 years, 4 months). Interviews conducted at child ages 1, 2 and 3 are providing information about family functioning as well as several maternal reports of developmentally-appropriate measures of children's cognitive and behavioral development. The current analysis plan includes lab-based assessments at child ages 6 and 8 (Phase 2). The Phase 1 analysis plan can be found in the previous version.

Conditional on participants' consent and our success in securing agreements with state and county agencies, we 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. (We have worked with state and local officials to ensure to the extent feasible that our cash gifts are not considered countable income for the purposes of determining benefit levels from social assistance programs.) 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, our 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 differences in cognitive, emotional and brain functioning, and key dimensions of family context (see below).

At the age 4 lab visit we will administer validated, reliable and developmentally sensitive measures of language, executive functioning and socioemotional skills. We will also collect direct EEG- and ERP-based measures of young children's brain development at age 4. Measures and preregistered hypotheses about them as well as family-based measures are shown in the two tables at the end of this document. Child-focused preregistered hypotheses are presented in Appendix Table 7 and maternal and family focused preregistered hypotheses are presented in Appendix Table 8 in the Statistical Analysis Plan for Phase 1 (see previous version). We will update this registry with Age 6 measures and preregistered hypotheses before data collection begins in July 2024, and with Age 8 measures before July 2026 (Statistical Analysis Plan for Phase 2).

The family process measures that we 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. We 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. ;

Related Conditions & MeSH terms

• Brain Development
• Child Development
• Household and Family Processes

• NCT number: NCT03593356
• Study type: Interventional
• Source: University of California, Irvine
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 9, 2018
• Completion date: August 31, 2028