| 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 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. | 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 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. |
| Field Last Published | Before August 16, 2022 08:03 PM | After December 22, 2022 01:03 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 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. | 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 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. |
| Field Primary Outcomes (End Points) | Before 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] | After 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 Resting Brain Function: Resting Brain Function [Age 48 months] 8. Child Health, Sleep [Age 36 months] 9. Child Health, Other Indicators [Age 36 months] 10. School Achievement and Behavior: School Test Scores for Target Child [Starting at child age 6 years] |
| Field Primary Outcomes (Explanation) | Before 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. | After 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 Resting Brain Function: Resting Brain Function [Age 48 months] measured by high-density in-lab electroencephalography. Because of limitations in power expected with multiple testing adjustments, we are preregistering a single composite of mid-to-high-frequency whole-brain power summing across alpha, beta, and gamma bands, from 7 to 45 Hz. 8. Child Health, Sleep [Age 36 months] measured by an adapted Short Form of Patient-Reported Outcomes Measurement Information System (PROMIS™). 9. Child Health, Other Indicators [Age 36 months] measured by an index of survey items. 10. 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. |
| Field Experimental Design (Public) | Before There are two arms of interventions. The experimental group or high cash gift group (compromising 40% of all participants) receives a monthly $333 cash gift for 52 months via debit card. The comparison group or low cash gift group (compromising 60% of all participants) receives a monthly $20 cash gift for 52 months via debit card. Interviewers are aware of experimental status at enrollment in order to activate the debit card after the participant consents to the study. | After There are two arms of interventions. The experimental group or high cash gift group (compromising 40% of all participants) receives a monthly $333 cash gift for 76 months via debit card. The comparison group or low cash gift group (compromising 60% of all participants) receives a monthly $20 cash gift for 76 months via debit card. Interviewers are aware of experimental status at enrollment in order to activate the debit card after the participant consents to the study. |
| Field Power calculation: Minimum Detectable Effect Size for Main Outcomes | Before .218 sd. The compensation difference between families in the experimental and control groups amounts to $313 per month and $16,276 over the course of the 52 months. This amount is in the range of income increases associated with child impacts of around .20 sd in studies of welfare experiments and the EITC. After accounting for likely 20% attrition, and in the absence of adjustments for sample clustering within hospitals or increased precision owing to the inclusion of baseline covariates in our impact estimates, the sample size of 800 at age 45-48 months, evenly divided between experimental and control groups, provides 80% statistical power to detect a .218 sd impact at p <.05 in a two-tailed test on cognitive functioning and family processes. Given the directional nature of all of our impact hypotheses, it could be argued that a one-tailed test is more appropriate, in which case our 80% power minimum detectable effect (MDE) size drops to .194 sd. The use of baseline covariates in estimation models will improve this power, while the use of bootstrap standard errors will decrease it, yielding offsetting effects of unknown but likely modest magnitudes. | After .218 sd. The compensation difference between families in the experimental and control groups amounts to $313 per month and $16,276 over the course of the 76 months. This amount is in the range of income increases associated with child impacts of around .20 sd in studies of welfare experiments and the EITC. After accounting for likely 20% attrition, and in the absence of adjustments for sample clustering within hospitals or increased precision owing to the inclusion of baseline covariates in our impact estimates, the sample size of 800 at age 48 months, evenly divided between experimental and control groups, provides 80% statistical power to detect a .218 sd impact at p <.05 in a two-tailed test on cognitive functioning and family processes. Given the directional nature of all of our impact hypotheses, it could be argued that a one-tailed test is more appropriate, in which case our 80% power minimum detectable effect (MDE) size drops to .194 sd. The use of baseline covariates in estimation models will improve this power, while the use of bootstrap standard errors will decrease it, yielding offsetting effects of unknown but likely modest magnitudes. |
| Field Secondary Outcomes (End Points) | Before 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 24/36 months] 46. Mother's earnings in previous calendar year [Age 48 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 | After Secondary outcomes 1. Child Language Development: Language Milestones [Age 12 months] 2. Child Language Development: Vocabulary [Age 24 months] 3. Child Intelligence Quotient [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] Note: this measure had to be dropped (see Table 7) 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. Maternal Concern for Developmental Delay: Total "predictive concerns" in the Parents' Evaluation of Developmental Status (PEDS) [Age 36 months] 23. 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 24/36 months] 46. Mother's earnings in previous calendar year [Age 48 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] Note: this measure had to be dropped (see Table 8) 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 Physical Health: Global Health [Age 12 months] 115. Maternal Physical Health: Global Health [Age 24 months] 116. Maternal Physical Health: Sleep [Age 12 months] 117. Maternal Physical Health: Sleep [Age 36 months] 118. Maternal Physical Health: Body Mass Index [Age 48 months] 119. Parent-Child Interaction Quality: Adult Word Count [Age 12 months] 120. Parent-Child Interaction Quality: Conversational Turns [Age 12 months] 121. Parent-Child Interaction Quality: Index of Mother's Positive Parenting Behaviors [Age 12 months] 122. Parent-Child Interaction Quality: Index of Mother's Positive Parenting Behaviors [Age 48 months] 123. Maternal Epigenetic Age [Age 48 months] 124. Maternal DNA Methylation [Age 48 months] 125. Frequency of Parent-Child Activity: Self-Report of Parent-Child Activities [Age 12 months] 126. Frequency of Parent-Child Activity: Self-Report of Parent-Child Activities [Age 24 months] 127. Frequency of Parent-Child Activity: Self-Report of Parent-Child Activities [Age 36 months] 128. Frequency of Parent-Child Activity: Time on mother-focal child activities [Age 48 months] 129. Frequency of Parent-Child Activity: Child meal and sleep routine index [Age 48 months] 130. Maternal Discipline: Spanking Discipline Strategy [Age 12 months] 131. Maternal Discipline: Spanking Discipline Strategy [Age 24 months] 132. Maternal Discipline: Spanking Discipline Strategy [Age 36 months] |
| Field | Before | After |
|---|---|---|
| Field Document | Before |
After
CTR_Statistical Analysis Plan_PDF:A 2a.pdf
MD5:
7615c86fafccc504bffd5764b56b576e
SHA1:
71231c32a4d18cc6cbf645832e11cd62bb320b69
|
| Field Title | Before | After Analysis Plan and Measures - Updated during age 48 months data collection to reflect protocol changes |
| Field | Before | After |
|---|---|---|
| Field Document Name | Before | After Research Strategy |
| Field File | Before |
After
Research Strategy_62719.pdf
MD5:
7c7a2357babc1f44551ab026400636e1
SHA1:
a6d5ff6f70edaf9bdb2b15a1dea91fabdc6a70ba
|
| Field Description | Before | After 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. |
| Field Public | Before | After Yes |
| Field | Before | After |
|---|---|---|
| Field IRB Approval Date | Before November 19, 2021 | After October 12, 2022 |
| Field | Value |
|---|---|
| Field Document Name | Value Research Strategy |
| Field File | Value |
| Field Description | Value 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. |
| Field Public | Value Yes |
