Baby's First Years

NCT03593356 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-02-14

Study results available
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Summary

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.

Conditions

  • Child Development
  • Brain Development
  • Household and Family Processes

Interventions

BEHAVIORAL

Monthly cash gift payments of $333

These subjects receive $333 each month for 76 months via debit card.

BEHAVIORAL

Monthly cash gift payments of $20

These subjects receive $20 each month for 76 months via debit card.

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER
  • University of Wisconsin, Madison

    collaborator OTHER
  • New York University

    collaborator OTHER
  • University of Maryland

    collaborator OTHER
  • University of Nebraska

    collaborator OTHER
  • University of Minnesota

    collaborator OTHER
  • University of New Orleans

    collaborator OTHER
  • University of Michigan

    collaborator OTHER
  • Duke University

    collaborator OTHER
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Greg Duncan, PhD · University of California, Irvine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2027-07-31
Completion
2028-08-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03593356 on ClinicalTrials.gov