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Abstract 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 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 will likely lead to a distribution of the 1,000 mothers across sites of roughly 115 in one site (the Twin Cities) and 295 in each of the three other sites. The high cash gift treatment group mothers (40% of all mothers) will receive 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) receive 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. 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. They then are asked to consent to the cash gifts. We originally planned for three follow-up waves of data collection conducted at child ages 1, 2 and 3, but due to the pandemic had to split the age 3 assessments into an age 3 maternal survey and an age 4 lab assessment. Each of the now four waves 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 months of age and via maternal survey at 24 and 36 months. At age 45-48 months, 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 4 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). (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 accounting for likely attrition, our total sample size of 800 at age 3 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). Cognitive and emotional development measures will be gathered at 12, 24, 36, and 45-48 months of age. At the capstone 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 4. Measures and preregistered hypotheses about them as well as family-based measures are shown in the documents attached to this registry. 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. For current information about the study, please see babysfirstyears.com. Publicly available data from the baseline survey and completed waves of data collection can be found here: https://www.icpsr.umich.edu/web/ICPSR/studies/37871. 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 maternity 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. 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.
Trial End Date July 31, 2023 July 31, 2024
Last Published June 30, 2021 06:17 PM July 01, 2022 10:10 AM
Intervention (Public) 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 52 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 45-48 months. Cognitive and emotional development measures will be gathered at 12, 24, 36, and 45-48 months of age. At the age-45-48 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 45-48 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. 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 52 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.
Intervention End Date June 01, 2023 June 30, 2023
Primary Outcomes (End Points) 1. Child Language Development at age 36 months 2. Child Language Development at age 45-48 months 3. Child Executive Function and Self-Regulation at age 45-48 months 4. Child Socio-emotional Processing at age 36 months 5. Child IQ at age 45-48 months 6. Child Brain Function at age 45-48 months 7. Child Body Mass Index at age 45-48 months 8. Child Sleep at age 36 months 9. Child Health at 36 months 10. Child's School Achievement starting at age 6 years 11. Maternal Physiological Stress at age 45-48 months 12. Parent-Child Interaction Quality at age 45-48 months 1. Child Language Development: Vocabulary [Age 48 months] 2. Child Language Development: Maternal Concern for Language Delay [Age 36 months] 3. Child Executive Function & Behavioral Regulation: Executive Function [Age 48 months] 4. Child Socio-Emotional Processing: Behavior/Problems [Age 36 months] 5. Child Socio-Emotional Processing: Behavior/Problems [Age 48 months] 6. Child Socio-Emotional Processing: Maternal Concern for Behavioral and Social-Emotional Problems [Age 36 months] 7. Child Intelligence Quotient [Age 48 months] 8. Child Resting Brain Function: Resting Brain Function [Age 48 months] 9. Child Health, Sleep [Age 36 months] 10. Child Health, Other Indicators [Age 36 months] 11. Diagnosis of Developmental Condition [Age 48 months] 12. School Achievement and Behavior: School Test Scores for Target Child [Starting at child age 6 years]
Primary Outcomes (Explanation) Here we list primary outcome measures. Details can be found in Appendix Tables 5 and 6 of the "Analysis Plan and Measures" document . 1. Child Language Development at age 36 months: Maternal Concern for Language Delay measured using two items from the Pediatric Evaluation of Developmental Status (PEDS) (see Appendix Table 5 in the document titled "Analysis Plan and Measures" for items). 2. Child Language Development at age 45-48 months: Language Processing measured using the Quick Interactive Language Screener- Language Processing Subscale (QUILS) (subject to change following pilot testing; we will estimate the statistical significance of the entire family of related measures in the Child Language Development outcome cluster using stepdown resampling methods for multiple testing). 3. Child Executive Function and Self-Regulation at age 45-48 months: Executive Function measured using Minnesota Executive Function Scale and Self-Regulation measured using Preschool Self-Regulation Assessment (we will estimate the statistical significance of the entire family of related measures in the Child Executive Function and Self-Regulation outcome cluster using stepdown resampling methods for multiple testing). 4. Child Socio-emotional Processing at age 36 months: Behavior/Emotional Problems measured using a shortened version of the Child Behavior Checklist and Maternal Concern for Behavioral and Social-Emotional Problems measured using two items from the Pediatric Evaluation of Developmental Status (PEDS; see Appendix Table 5 in the document titled "Analysis Plan and Outcome Measures" for items) (we will estimate the statistical significance of the entire family of related measures in the Child Socio-emotional Processing outcome cluster using stepdown resampling methods for multiple testing). 5. Child IQ at age 45-48 months measured using the Wechsler Nonverbal Scale of Ability. 6. Child Brain Function at age 45-48 months: Resting brain function measuring Gamma, Alpha and Theta power using EEG resting high-frequency power (waves adjusted for multiple testing bias) (we will estimate the statistical significance of the entire family of related measures in the Child Brain Function outcome cluster using stepdown resampling methods for multiple testing). 7. Child Body Mass Index at age 45-48 months measured using CDC scales 8. Child Sleep at age 36 months using the Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance (SD) Short Form. 9. Child Health at 36 months measured using an additive index of six survey items (see Appendix Table 5 in the document titled "Analysis Plan and Outcome Measures" for items). 10. Child's School Achievement starting at age 6 measured using administrative test score data. 11. Maternal Physiological Stress at age 45-48 months measured using maternal hair cortisol. 12. Parent-Child Interaction Quality at age 45-48 months: Using a coding scheme of the NICHD Study of Early Child Care and Youth Development Mother-Child Interaction Task (adapted script) (to be determined following pilot testing; we will estimate the statistical significance of the entire family of related measures in the Parent-Child Interaction Quality outcome cluster using stepdown resampling methods for multiple testing). Here we list primary outcome measures. Details can be found in Appendix Tables 7 and 8 of the "Analysis Plan and Measures" document. 1. Child Language Development: Vocabulary [Age 48 months] measured by Receptive One Word Picture Vocabulary Test (ROWPVT). 2. Child Language Development: Maternal Concern for Language Delay [Age 36 months] measured by the sum of the two questions from the Parents' Evaluation of Developmental Status (PEDS). 3. Child Executive Function & Behavioral Regulation: Executive Function [Age 48 months] measured by Minnesota Executive Function Scale. 4. Child Socio-Emotional Processing: Behavior/Problems [Age 36 months] measured by Child Behavior Checklist (CBCL). 5. Child Socio-Emotional Processing: Behavior/Problems [Age 48 months] measured by Child Behavior Checklist (CBCL). 6. Child Socio-Emotional Processing: Maternal Concern for Behavioral and Social-Emotional Problems [Age 36 months] measured by the sum of two questions included in the Parents' Evaluation of Developmental Status (PEDS). 7. Child Intelligence Quotient [Age 48 months] measured by the Wechsler Nonverbal Scale of Ability. 8. Child Resting Brain Function: Resting Brain Function [Age 48 months] measured by high-density in-lab electroencephalography. 9. Child Health, Sleep [Age 36 months] measured by an adapted Short Form of Patient-Reported Outcomes Measurement Information System (PROMIS™). 10. Child Health, Other Indicators [Age 36 months] measured by an index of survey items. 11. Diagnosis of Developmental Condition [Age 48 months] measured by one dichotomous survey item 12. School Achievement and Behavior: School Test Scores for Target Child [Starting at child age 6 years] measured by administrative data of target child's test scores.
Secondary Outcomes (End Points) 1. Child Language Development at ages 12, 24, 36, 45-48 months 2. Child Socioemotional Processing at ages 12, 24, 45-48 months 3. Child Brain Function at ages 12 and 45-48 months 4. Child Physiological Stress at age 45-48 months 5. Child Sleep at ages 12, 24 months 6. Child Health at ages 12, 24 months 7. Child Epigenetic Age at age 45-48 months 8. Child DNA Methylation at age 45-48 months 9. Child Nutrition at age 24 months 10. Any Maternal Concern for Developmental Delay at age 36 months 11. Child's Siblings' School Achievement starting at age 6 years 12. Child and Sibling School Behavior starting at age 6 years 13. Household Economic Hardship at ages 12, 24, 36 months 14. Social Services Receipt at ages 12, 24, 36 months 15. Mother's Labor Market and Education Participation at ages 12, 24, 36 months 16. Child-Focused Expenditures at ages 12, 24, 36 months 17. Housing and Neighborhood Quality at ages 12, 24, 36 months 18. Family and Maternal Perceived Stress at ages 12, 24, 36 months 19. Maternal Happiness and Optimism at ages 12, 24, 36 months 20. Maternal Physiological Stress at age 12 months 21. Maternal Mental Resources at age 45-48 months 22. Maternal Mental Health at ages 12, 24, 36 months 23. Maternal Substance Abuse at ages 12 and 36 months 24. Chaos in the Home at ages 12 and 24 months 25. Maternal Relationships at ages 12, 24, 36 months 26. Maternal Physical Health at ages 12, 24, 36, 45-48 months 27. Parent-Child Interaction Quality at ages 12 and 45-48 months 28. Maternal Epigenetic Age at age 45-48 months 29. Maternal DNA Methylation at age 45-48 months 30. Frequency of Parent-Child Activity at ages 12, 24, 36 months 31. Maternal Discipline at ages 12, 24, 36 months Secondary outcomes 1. Child Language Development: Language Milestones [Age 12 months] 2. Child Language Development: Vocabulary [Age 24 months] 3. Child Executive Function: Executive Function [Age 48 months] 4. Child Socio-Emotional Processing: Behavior [Age 12 months] 5. Child Socio-Emotional Processing: Problems [Age 12 months] 6. Child Socio-Emotional Processing: Problems [Age 24 months] 7. Child Pre-Literacy: Pre-Literacy [Age 48 months] 8. Child Resting Brain Function [Age 12 months] 9. Child Resting Brain Function [Age 48 months] 10. Child Task-Related Brain Function [Age 48 months] 11. Child Health: BMI [Age 48 months] 12. Child Health, Physiological Stress [Age 48 months] 13. Child Health, Sleep [Age 12 Months] 14. Child Health, Sleep [Age 24 months] 15. Child Health, Other Indicators: Overall health, medical care, diagnosis of condition or disability [Age 12 months] 16. Child Health, Other Indicators: Overall health, medical care, diagnosis of condition or disability [Age 24 months] 17. Child Health, Other Indicators: Overall Health, Diagnosis of Condition or Disability [Age 48 months] 18. Child Epigenetic Age: Methylation pace of aging [Age 48 months] 19. Child DNA Methylation [Age 48 months] 20. Child Nutrition: Consumption of healthy foods [Age 24 months] 21. Child Nutrition: Consumption of unhealthy foods [Age 24 months] 22. Any Maternal Concern for Developmental Delay: Total "predictive concerns" in the Parents' Evaluation of Developmental Status (PEDS) [Age 36 months] 23. Any Maternal Concern for Developmental Delay: Parents' Evaluation of Developmental Status (PEDS) [Age 36 months] 24. School Achievement and Behavior: School Test Scores for Target Child's Siblings [Starting at child age 6 years] 25. School Achievement and Behavior: Student Behavioral Data for Target Child [Starting at child age 6 years] 26. School Achievement and Behavior: Student Behavioral Data for Target Child's Siblings [Starting at child age 6 years] 27. Household Economic Hardship: Household Poverty Rate [Age 12 months] 28. Household Economic Hardship: Index of Economic Stress [Age 12 months] 29. Household Economic Hardship: Index of Food Insecurity [Age 12 months] 30. Household Economic Hardship: Index of Economic Stress [Age 24 months] 31. Household Economic Hardship: Household Poverty Rate [Age 24 months] 32. Household Economic Hardship: Index of Food Insecurity [Age 24 months] 33. Household Economic Hardship: Index of Economic Stress [Age 36 months] 34. Household Economic Hardship: Household Poverty Rate [Age 36 months] 35. Household Economic Hardship: Index of Food Insecurity [Age 36 months] 36. Household Economic Hardship: Household Poverty Rate [Age 48 months] 37. Household Economic Hardship: Index of Economic Stress [Age 48 months] 38. Household Economic Hardship: Index of Food Insecurity [Age 48 months] 39. Social Services Receipt; Number of Benefits Received by Mother [Age 12 months] 40. Social Services Receipt; Number of Benefits Received by Mother [Age 24 months] 41. Social Services Receipt; Number of Benefits Received by Mother [Age 36 months] 42. Mother's Labor Market and Education Participation: Time to Labor Market Re-entry from Birth [Age 12 months] 43. Mother's Labor Market and Education Participation: Time to Full-Time Labor Market Reentry from Birth [Age 12 months] 44. Mother's Labor Market and Education Participation: Mother's Education and Training Attainment [Age 12 months] 45. Mother's Labor Market and Education Participation: Mother's Education and Training Attainment [Age 24 months] 46. Mother's Labor Market and Education Participation: Mother's Education and Training Attainment [Age 36 months] 47. Mother's Labor Market and Education Participation: Mother's Labor Market Participation [Age 48 months] 48. Child-Focused Expenditures: Index of Expenditures since birth [Age 12 months] 49. Child-Focused Expenditures: Index of Expenditures in past 30 days [Age 12 months] 50. Child-Focused Expenditures: Index of Expenditures in past 30 days [Age 24 months] 51. Child-Focused Expenditures: Index of Expenditures in past 30 days [Age 36 months] 52. Child-Focused Expenditures: Index of Expenditures in past 30 days [Age 48 months] 53. Child-Focused Expenditures: Cost of Paid Child Care [Age 12 months] 54. Child-Focused Expenditures: Cost of Paid Child Care [Age 24 months] 55. Child-Focused Expenditures: Cost of Paid Child Care [Age 36 months] 56. Child-Focused Expenditures: Cost of Paid Child Care [Age 48 months] 57. Child-Focused Expenditures: Use of Center-Based Care [Age 12 months] 58. Child-Focused Expenditures: Use of Center-Based Care [Age 24 months] 59. Child-Focused Expenditures: Use of Center-Based Care [Age 36 months] 60. Child-Focused Expenditures: Use of Center-Based Care [Age 48 months] 61. Housing and Neighborhoods: Index of Perceptions of Neighborhood Safety [Age 12 months] 62. Housing and Neighborhoods: Index of Perceptions of Neighborhood Safety [Age 24 months] 63. Housing and Neighborhoods: Index of Perceptions of Neighborhood Safety [Age 36 months] 64. Housing and Neighborhoods: Index of Housing Quality [Age 12 months] 65. Housing and Neighborhoods: Index of Housing Quality [Age 24 months] 66. Housing and Neighborhoods: Excessive Residential Mobility [Age 12 months] 67. Housing and Neighborhoods: Excessive Residential Mobility [Age 24 months] 68. Housing and Neighborhoods: Excessive Residential Mobility [Age 36 months] 69. Housing and Neighborhoods: Homelessness [Age 12 months] 70. Housing and Neighborhoods: Homelessness [Age 24 months] 71. Housing and Neighborhoods: Homelessness [Age 36 months] 72. Housing and Neighborhoods: Homelessness [Age 48 months] 73. Housing and Neighborhoods: Neighborhood Poverty [Age 12 months] 74. Housing and Neighborhoods: Neighborhood Poverty [Age 24 months] 75. Housing and Neighborhoods: Neighborhood Poverty [Age 36 months] 76. Housing and Neighborhoods: Neighborhood Poverty [Age 48 months] 77. Family and Maternal Perceived Stress: Perceived Stress [Age 12 months] 78. Family and Maternal Perceived Stress: Perceived Stress [Age 24 months] 79. Family and Maternal Perceived Stress: Parenting Stress [Age 24 months] 80. Family and Maternal Perceived Stress: Perceived Stress [Age 36 months] 81. Family and Maternal Perceived Stress: Parenting Stress [Age 12 months] 82. Family and Maternal Perceived Stress: Parenting Stress [Age 48 months] 83. Maternal Happiness and Optimism: Global Happiness [Age 12 months] 84. Maternal Happiness and Optimism: Global Happiness [Age 24 months] 85. Maternal Happiness and Optimism: Global Happiness [Age 36 months] 86. Maternal Happiness and Optimism: Maternal Agency [Age 12 months] 87. Maternal Happiness and Optimism: Maternal Agency [Age 24 months] 88. Maternal Happiness and Optimism: Maternal Agency [Age 36 months] 89. Maternal Physiological Stress: Maternal Hair Cortisol [Age 12 months] 90. Maternal Physiological Stress: Maternal Hair Cortisol [Age 48 months] 91. Maternal Mental Resources: Maternal Cognitive Resources [Age 48 months] 92. Maternal Mental Health: Index of Maternal Depression [Age 12 months] 93. Maternal Mental Health: Index of Maternal Depression [Age 24 months] 94. Maternal Mental Health: Index of Maternal Depression [Age 36 months] 95. Maternal Mental Health: Index of Maternal Depression [Age 48 months] 96. Maternal Mental Health: Index of Maternal Anxiety [Age 12 months] 97. Maternal Mental Health: Index of Maternal Anxiety [Age 24 months] 98. Maternal Mental Health: Index of Maternal Anxiety [Age 36 months] 99. Maternal Mental Health: Index of Maternal Anxiety [Age 36 months] 100. Maternal Mental Health: Index of Maternal Anxiety [Age 48 months] 101. Maternal Substance Abuse: Alcohol and Cigarette Use [Age 12 months] 102. Maternal Substance Abuse: Alcohol and Cigarette Use [Age 36 months] 103. Maternal Substance Abuse: Opioid Use [Age 12 months] 104. Maternal Substance Abuse: Opioid Use [Age 36 months] 105. Chaos in the Home: Index of Chaos in the Home [Age 12 months] 106. Chaos in the Home: Index of Chaos in the Home [Age 24 months] 107. Maternal Relationships: Physical Abuse [Age 12 months] 108. Maternal Relationships: Physical Abuse [Age 24 months] 109. Maternal Relationships: Frequency of Arguing [Age 12 months] 110. Maternal Relationships: Frequency of Arguing [Age 24 months] 111. Maternal Relationships: Relationship Quality [Age 12 months] 112. Maternal Relationships: Relationship Quality [Age 24 months] 113. Maternal Relationships: Relationship Quality [Age 36 months] 114. Maternal Relationships: Relationship Quality [Age 48 months] 115. Maternal Physical Health: Global Health [Age 12 months] 116. Maternal Physical Health: Global Health [Age 24 months] 117. Maternal Physical Health: Sleep [Age 12 months] 118. Maternal Physical Health: Sleep [Age 36 months] 119. Maternal Physical Health: Body Mass Index [Age 48 months] 120. Parent-Child Interaction Quality: Adult Word Count [Age 12 months] 121. Parent-Child Interaction Quality: Conversational Turns [Age 12 months] 122. Parent-Child Interaction Quality: Index of Mother's Positive Parenting Behaviors [Age 12 months] 123. Parent-Child Interaction Quality: Index of Mother's Positive Parenting Behaviors [Age 48 months] 124. Maternal Epigenetic Age [Age 48 months] 125. Maternal DNA Methylation [Age 48 months] 126. Frequency of Parent-Child Activity: Self-Report of Parent-Child Activities [Age 12 months] 127. Frequency of Parent-Child Activity: Self-Report of Parent-Child Activities [Age 24 months] 128. Frequency of Parent-Child Activity: Self-Report of Parent-Child Activities [Age 36 months] 129. Frequency of Parent-Child Activity: Time on mother-focal child activities [Age 48 months] 130. Frequency of Parent-Child Activity: Child meal and sleep routine index [Age 48 months] 131. Maternal Discipline: Spanking Discipline Strategy [Age 12 months] 132. Maternal Discipline: Spanking Discipline Strategy [Age 24 months] 133. Maternal Discipline: Spanking Discipline
Secondary Outcomes (Explanation) Here we list secondary outcomes. Details can be found in Appendix Tables 5 and 6 of "Analysis Plan and Measures". 1. Child Language Development at ages 12, 24, 36, 45-48 months: Language Milestones measured using Ages and Stages Questionnaire (ASQ)- Communication Subscale (age 12 months); Vocabulary measured using the short-form of MacArthur Communicative Development Inventories (at age 24 months) and measured using the Receptive and Expressive One Word Picture Vocabulary Tests (at ages 45-48 months); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing). 2. Child Socioemotional Processing at ages 12, 24, 45-48 months: Social-Emotional Problems measured using the Brief Infant-Toddler Social and Emotional Assessment (BITSEA) (at ages 12, 24 months); Social-Emotional Behavior measured using the NICHD SECCYD Mother-Child Interaction Task (positive/negative mood, activity level, sustained attention, positive engagement) (at ages 12) and codes agency, negativity, persistence, affection (45-48 months); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing). 3. Child Brain Function at ages 12 and 45-48 months: Resting brain function measuring Gamma, Alpha and Theta power using EEG resting high-frequency power (waves adjusted for multiple testing bias) (age 12 months); Auditory Discrimination Brain Function measured using mismatch negativity event-related potentials (at age 45-48 months); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing). 4. Child Physiological Stress at age 45-48 months measured using child's hair cortisol. 5. Child Sleep at ages 12, 24 months measured using the Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance (SD) Short Form. 6. Child Health at ages 12, 24 months at ages 12, 24 months measured using an index of survey items (see Appendix Table 5 in "Analysis Plan and Outcome Measures" for items). 7. Child Epigenetic Age at age 45-48 months: Measured using the method following Fiorito et al. (2017) (see Bibliography in "Analysis Plan and Outcome Measures" for the full citation). 8. Child DNA Methylation at age 45-48 months: Measured using the method following Hughes et al. (2018) and Cao-Lei et al. (2014) (see Bibliography in "Analysis Plan and Outcome Measures" for the full citation). 9. Child Nutrition at age 24 months: Consumption of healthy foods measured using an additive index of survey items; Consumption of unhealthy foods measured using an additive index of survey items; (see Appendix Table 5 in "Analysis Plan and Outcome Measures" for items). 10. Any Maternal Concern for Developmental Delay at age 36 months: Parental Evaluation of Developmental Status measured using the Parental Evaluation of Developmental Status (PEDS) and the total “predictive concerns” named in the Parental Evaluation of Developmental Status (PEDS); (see Appendix Table 5 in "Analysis Plan and Outcome Measures" for items); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing). 11. Child's Siblings' School Achievement starting at age 6 years using administrative test score data. 12. Child and Sibling School Behavior starting at age 6 years. 13. Household Economic Hardship at ages 12, 24, 36 months: Index of food insecurity measured using the U.S. Household Food Security Survey Module: Six-Item Short Form; Index of economic stress using an additive index of survey items, with higher score indicating higher stress (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items); Household Poverty measured using Census Bureau's thresholds; (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing). 14. Social Services Receipt at ages 12, 24, 36 months measured by the number of benefits received by mother (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items). 15. Mother's Labor Market and Education Participation at ages 12, 24, 36 months: Time to labor market reentry from birth (age 12 months); Time to full-time labor market reentry from birth (age 12 months); Dichotomous indicator of mother's education and training activity participation (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing) 16. Child-Focused Expenditures at age 12, 24, 36 months: Index of child-focused expenditures since birth (age 12 months); Total dollar amount of child-focused expenditures in the past 30 days; Cost of paid child care in dollars; Dichotomous indicator of use of center-based care (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing). 17. Housing and Neighborhood Quality at ages 12, 24, 36 months: Additive index of perceptions of neighborhood safety with higher score indicating feeling more safe; Additive index of housing quality (ages 12, 24 months); Additive index of items indicating experiences with homelessness; Excessive residential mobility measured using an indicator of three or more residential moves; Neighborhood Poverty Rate using census data (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing). 18. Family and Maternal Perceived Stress at ages 12, 24, 36 months: Perceived Stress Scale (PSS); Parenting Stress measured using the Aggravation in Parenting Scale (ages 12, 24 months); (we will estimate the statistical significance of the family of related measures in the Family and Maternal Perceived Stress domain using stepdown resampling methods for multiple testing). 19. Maternal Happiness and Optimism at ages 12, 24, 36 months: Global happiness measured using a survey item (see Appendix Table 5 in "Analysis Plan and Outcome Measures" for item); Maternal Agency measured using the HOPE Scale; (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing). 20. Maternal Physiological Stress age 12 months measured using maternal hair cortisol. 21. Maternal Mental Resources at age 45-48 months measured using Flanker Inhibitory Control and Attention Test. 22. Maternal Mental Health at ages 12, 24, 36 months: Depression measured using PHQ-8; Anxiety measured using Beck Anxiety Inventory (at ages 12, 36 months) and using GAD-7 (at age 24, 36 months); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing). 23. Maternal Substance Abuse at ages 12, 36 months: Index of frequency of alcohol and cigarette use; frequency of opioid use (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items) (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing). 24. Chaos in the Home at ages 12, 24 months: Measured using the Home Environment Chaos Scale. 25. Maternal Relationships at ages 12, 24, 36 months: Frequency of arguing (at age 12, 24 months); Physical abuse measured using a dichotomous indicator, Relationship quality measured using survey items (at age 12, 24 months); dichotomous indicator of high or low quality relationship, where 0 is defined as not in a relationship or a score above 26 on the Index of relationship quality and 1 is defined as in a relationship and a score of 26 or below on the Index of Relationship quality (at ages 24, 36 months); (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing). 26. Maternal Physical Health at ages 12, 24, 36, 45-48 months: Global health measured using survey item (at ages 12, 24 months); Sleep measured using an additive index of survey items (at ages 12, 36 months); Mother's Body Mass Index measured dividing weight by stature (at age 45-48 months) (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items) (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing). 27. Parent-Child Interaction Quality at ages 12 and 45-48 months: Adult word count measured using LENA Technology (age 12 months); Conversational turns measured using LENA Technology (age 12 months); Index of mother's positive parenting behaviors measured using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO™) to code NICHD SECCYD Mother-Child Interaction Task (adapted script) (age 12 months); (we will estimate the statistical significance of the family of related measures in the domain). 28. Maternal Epigenetic Age at age 45-48 months: Epigenetic age measured following Fiorito et al. (2017) (see Bibliography in "Analysis Plan and Outcome Measures" for the full citation). 29. Maternal DNA Methylation at age 45-48 months: DNA methylation analyzed using genomic-wide differences. 30. Frequency of Parent-Child Activity at ages 12, 24, 36 months: Self-report of parent-child activities measured using additive index of survey items; (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items). 31. Maternal Discipline at ages 12, 24, 36 months: Spanking discipline measured using survey item; (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for item). For explanations of all secondary outcomes, please see Appendix Tables 7 and 8 of "Analysis Plan and Measures".
Building on Existing Work No
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Analysis Plans

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Document
AEA SREE Statistical Analysis Plan 7122.pdf
MD5: 6e24f06330f4ac01ecda218503b783c0
SHA1: 92f08d07512ceb98b4d1d408f7d9bc99303df2b1
Title Analysis Plan and Measures - Updated for (and prior to) age 48 months data collection
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Documents

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Description 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). Additionally, a few other details have changed since this proposal was funded in 2017. 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.
Public No Yes
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Irbs

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IRB Approval Date June 19, 2017 April 27, 2022
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Field Before After
IRB Approval Date February 13, 2018 November 19, 2021
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Sponsors

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Sponsor Name The City of New York New York City Mayor’s Office for Economic Opportunity
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Sponsor Name Klingenstein Philanthropies Andrew and Julie Klingenstein Family Fund
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Fields Removed

Sponsors

Field Value
Sponsor Name Anonymous- available upon request
Public Yes
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