| Field | Before | After |
|---|---|---|
| Field Abstract | Before 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 care for 52 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 52 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 Aug 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 age 4. 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 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. 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. For current information about the study, please see babysfirstyears.com. Publicly available data from the baseline survey and Age 1 can be found here: https://www.icpsr.umich.edu/web/ICPSR/studies/37871. | After 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 care 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 Aug 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 age 4, 6, and 8. 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 administer validated, reliable and developmentally sensitive measures of language, executive functioning and socioemotional skills. We 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. 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. 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. For current information about the study, please see babysfirstyears.com. Publicly available data from the baseline survey and Age 1, 2, and 3 can be found here: https://www.icpsr.umich.edu/web/ICPSR/studies/37871. |
| Field Trial End Date | Before July 31, 2024 | After July 31, 2028 |
| Field Last Published | Before December 22, 2022 01:03 PM | After January 29, 2024 02:32 PM |
| Field Intervention (Public) | Before We are randomly assigning 1,000 US low-income mothers and their newborns in four ethnically and geographically diverse metropolitan areas to either (1) an experimental group that receives $333 in cash payments each month ($4,000 each year) for each of the first 76 months of the children’s lives, with the first payments occurring shortly after the baby’s birth and this experimental condition offered to 40% of the participants, or (2) an active comparator group that receives much smaller payments ($20 per month) offered to 60% of participants. Based on our and others’ prior work, the $3,760 annual difference will be large enough to produce and detect meaningful differences in children’s cognitive development. Moreover, to understand how poverty reduction improves brain functioning, we have four follow-up waves of data collection conducted at child ages 12, 24, 36, and 48 months. Cognitive and emotional development measures will be gathered at 12, 24, 36, and 48 months of age. At the age-48 month lab visit we will administer validated, reliable and developmentally sensitive measures of language, memory, executive functioning and socioemotional skills. We will also collect direct measures of young children’s brain development at ages 1 and 48 months. 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 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. 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. | After We are randomly assigning 1,000 US low-income mothers and their newborns in four ethnically and geographically diverse metropolitan areas to either (1) an experimental group that receives $333 in cash payments each month ($4,000 each year) for each of the first 76 months of the children’s lives, with the first payments occurring shortly after the baby’s birth and this experimental condition offered to 40% of the participants, or (2) an active comparator group that receives much smaller payments ($20 per month) offered to 60% of participants. Based on our and others’ prior work, the $3,760 annual difference will be large enough to produce and detect meaningful differences in children’s cognitive development. Moreover, to understand how poverty reduction improves brain functioning, we have six follow-up waves of data collection conducted at child ages 1, 2, 3, 4, 6, and 8 years. Cognitive and social-emotional development measures will be gathered at all ages. At the age-4, age-6, and age-8 laboratory-based visit we will administer validated, reliable and developmentally sensitive measures of language, memory, health, executive functioning and socioemotional skills. We will collect direct measures of young children’s brain development at ages 1, 4, 6, and 8 years, and school readiness and school achievement measures at ages 6 and 8. 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 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. 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. |
| Field Intervention End Date | Before June 30, 2023 | After June 30, 2027 |
| Field | Before | After |
|---|---|---|
| Field Document | Before |
After
2023_Phase 2 Statistical Analysis Plan.pdf
MD5:
9be1774675f7e4f01ae09ac1b6d07b7a
SHA1:
4344ddb7105766c132d4f254271444ba77de90f4
|
| Field Title | Before | After Anallysis Plan Phase 2 (measures to be added prior to Age 6/8 data collection waves) |
| Field | Before | After |
|---|---|---|
| Field Document Name | Before Research Strategy | After Research Strategy Phase 1 (Age 0-4) |
| Field Description | Before Funded by NICHD on the basis of the research proposed in the Research Strategy document. Some of the proposed measures in the application have been replaced by measures listed in other sections of the registry (see Appendix Tables 1 and 2 for the measures used in data collection at age 12 months in the document titled "Analysis Plan and Measures- Update for (and prior to) age 12 months data collection"; see Appendix Tables 3 and 4 in the document titled "Analysis Plan and Measures- Update for (and prior to) age 24 months data collection" for the measures for data collection at age 24 months; see Appendix Tables 5 and 6 in the document titled "Analysis Plan and Measures- Update for (and prior to) age 36 months data collection" for the measures for data collection at age 36 months) and Appendix Tables 7 and 8 in the document titled "Analysis Plan and Measures- Update for (and prior to) age 48 months data collection" for the measure for data collection at 48 months. Additionally, a few other details have changed since this proposal was funded in 2017. | After Funded by NICHD on the basis of the research proposed in the Research Strategy document. Note that due to the pandemic, the laboratory-based in-person age-3 assessments were postponed to age 4, and an additional wave of interviews was added at age 3. |
| Field | Before | After |
|---|---|---|
| Field Document Name | Before | After Research Strategy Phase 2 (Age 5-8) |
| Field File | Before |
After
Phase 2_Research Strategy 6-23-2022.pdf
MD5:
5b108b9b687d13c2c805d5d48f0d841f
SHA1:
af61dd59aee85ff0b0f58134fe5d20fb2f0d9f7c
|
| Field Description | Before | After The Phase 2 research strategy includes the planned assessments for ages 6 and 8 of this study. |
| Field Public | Before | After Yes |
| Field | Before | After |
|---|---|---|
| Field IRB Name | Before University of California, Irvine | After University of California, Irvine (original study approval) |
| Field IRB Approval Date | Before April 27, 2022 | After June 19, 2017 |
| Field IRB Approval Number | Before 2016-3336 | After 2016-3336; reliance agreement #3196 starting 2023-05-15 |
| Field | Before | After |
|---|---|---|
| Field IRB Approval Date | Before October 12, 2022 | After September 08, 2023 |