Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Brain Development
  • Child Development
  • Household and Family Processes
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Parallel assignmentMasking: Single (Participant)Masking Description: 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 interviewers will be blind to the extent possible.Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

One thousand infants born to mothers with incomes falling below the federal poverty threshold in four metropolitan areas in the United States are being assigned at random within metropolitan area to experimental or active comparator groups. The sites are: New York City, the greater New Orleans metro...

One thousand infants born to mothers with incomes falling below the federal poverty threshold in four metropolitan areas in the United States are being assigned at random within metropolitan area to experimental or active comparator groups. 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 will likely lead to a distribution of the 1,000 mothers across sites of 115 in one site (the Twin Cities) and 295 in each of the three other sites. Experimental group mothers (40% of all mothers) will receive unconditioned cash payments of $333 per month ($4,000 per year) for 40 months. The active comparator group (60% of all mothers) receives a nominal payment - $20 per month, delivered in the same way and also for 40 months. Mothers are being recruited in maternity wards of the 12 participating hospitals shortly after giving birth and, after consenting, are administered a 30-minute baseline interview. The three follow-up waves of data collection conducted at child ages 1, 2 and 3 will provide information about family functioning as well as developmentally appropriate measures of children's cognitive and behavioral development. the investigators will collect information about the mother and child in the home when the child is 12 and 24 months of age. At age 3, mothers and children will be assessed and interviewed in research laboratories at each site. The investigators will additionally collect 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 investigators also have plans to randomly sample 80 of the 1,000 families to participate in an in-depth qualitative study, but do not elaborate on those plans in this document. The compensation difference between families in the experimental and active comparator groups will boost family incomes by $3,760 per year, an amount shown in economics and developmental psychology 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 3 years, divided 40%/60% between experimental and active comparator groups, provides sufficient statistical power to detect meaningful differences in cognitive, emotional and brain functioning, and key dimensions of family context (see below). Cognitive and emotional development measures will be gathered at 12, 24, and 36 months of age. At the age-three lab visit the investigators will administer validated, reliable and developmentally sensitive measures of language, memory, executive functioning and socioemotional skills. The investigators will also collect direct measures of young children's brain development at ages 1 and 3. 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 will obtain data measuring 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.

Tracking Information

NCT #
NCT03593356
Collaborators
  • Columbia University
  • University of Wisconsin, Madison
  • New York University
  • University of Maryland, College Park
  • University of Nebraska
  • University of Minnesota
  • University of New Orleans
  • University of Michigan
  • Duke University
Investigators
Study Director: Greg Duncan, PhD University of California, Irvine