Baby's First Years

Study acronym: BFY
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary endpoints removed 32 → 30 primary endpoints
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Record History

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  1. Notable Primary endpoint(s) modified Show 4 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 210 to 211
    • Study description expanded, about 53 words
    • Publications: 25 to 30
  2. Minor Secondary endpoints revised (210)
    • Publications: 22 to 25
    v17
  3. Minor Secondary endpoints: details revised at 4 of 210 entries
    • Publications: 17 to 22
    v16
  4. Notable Primary endpoints: 10 to 32v15 Show 4 more changesShow less
    • Secondary endpoints: 134 to 210
    • Study description expanded, about 39 words
    • Publications: 8 to 17
    • Eligibility criteria expanded, about 2 words
  5. Notable Primary completion date: Jun 30, 2023 to Jul 31, 2027
    • Study completion date: Jul 31, 2024 to Aug 31, 2028
    • Secondary endpoints: 135 to 134
    • Study description expanded, about 63 words
    v14
Show 12 earlier versionsHide 12 earlier versions
  1. Notable Results first posted: Sep 13, 2023
    • Secondary endpoints revised (135)
    • Collaborators: 9 to 10
    v13
  2. Notable Primary endpoints: 12 to 10
    • Secondary endpoints: 134 to 135
    • Study description shortened, about 1 word
    v12
  3. Minor Secondary endpoints: 133 to 134
    • Study description expanded, about 45 words
    v11
  4. Notable Primary endpoints: 14 to 12v10 Show 4 more changesShow less
    • Primary completion date: Jun 1, 2023 to Jun 30, 2023
    • Secondary endpoints: 113 to 133
    • Study description expanded, about 138 words
    • Collaborators revised (9)
  5. Notable Primary completion date: Jun 1, 2022 to Jun 1, 2023v9 Show 4 more changesShow less
    • Primary endpoints: 17 to 14
    • Study completion date: Jul 31, 2022 to Jul 31, 2024
    • Secondary endpoints: 112 to 113
    • Study description expanded, about 42 words
  6. Notable Primary endpoints: 13 to 17
    • Secondary endpoints: 118 to 112
    v8
  7. 2 versions Re-verified since Jul 13, 2020, no change to tracked fieldsv6-v7
  8. Minor Secondary endpoints: 123 to 118
    • Collaborators: 8 to 9
    v5
  9. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    • Collaborators revised (8)
    v4
  10. Re-verified, no change to tracked fieldsv3
  11. Notable Primary endpoints: 9 to 13v2 Show 5 more changesShow less
    • Primary completion date: May 1, 2022 to Jun 1, 2022
    • Interventions: Cash Gift Payments (Behavioral) to Monthly cash gift payments of $20 (Behavioral), Monthly cash gift payments of $333 (Behavioral)
    • Secondary endpoints: 34 to 123
    • Study description shortened, about 155 words
    • Study site revised
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03593356
Lead Sponsor University of California, Irvine
Collaborators: Columbia University, University of Wisconsin, Madison, New York University, University of Maryland, University of Nebraska, University of Minnesota, University of New Orleans, University of Michigan, Duke University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)
Child Development, Brain Development, Household and Family Processes
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov