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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 40 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 40 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. The three follow-up waves of data collection conducted at child ages 1, 2 and 3 will provide information about family functioning as well as developmentally appropriate measures of children’s cognitive and behavioral development. An additional feature of our ages 1-3 data collection plans is that we will randomly assign a designated interview date within a one-month interval centered on the child’s birthday. This provides variation in the timing of outcome data with respect to participants’ receipt of the cash gift that will enable us to learn more about the incremental value of a stable predictable monthly infusion of cash. We will collect information about the mother and child in the home when the child is 12 and 24 months of age. At age 3, mothers and children will be assessed and interviewed in research laboratories at each site. Conditional on participants’ consent and our success in securing agreements with state and county agencies, we will also 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. We also have plans to randomly sample 80 of the participating families in two of the sites (the Twin Cities and New Orleans) 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 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. (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, and 36 months of age. At the age-three 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 3. 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. 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 40 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 40 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. The three follow-up waves of data collection conducted at child ages 1, 2 and 3 will provide information about family functioning as well as developmentally appropriate measures of children’s cognitive and behavioral development. An additional feature of our ages 1-3 data collection plans is that we will randomly assign a designated interview date within a one-month interval centered on the child’s birthday. This provides variation in the timing of outcome data with respect to participants’ receipt of the cash gift that will enable us to learn more about the incremental value of a stable predictable monthly infusion of cash. We will collect information about the mother and child in the home when the child is 12 and 24 months of age. At age 3, mothers and children will be assessed and interviewed in research laboratories at each site. Conditional on participants’ consent and our success in securing agreements with state and county agencies, we will also 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. We also have plans to randomly sample 80 of the participating families in two of the sites (the Twin Cities and New Orleans) 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 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. (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, and 36 months of age. At the age-three 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 3. 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
Last Published July 15, 2019 03:03 PM July 13, 2020 12:58 PM
Primary Outcomes (End Points) 1. Child Language Development at age 36 months 2. Child Executive Function and Self-Regulation at age 36 months 3. Child Socioemotional Processing at age 36 months 4. Child IQ at age 36 months 5. Child Brain Function at age 36 months 6. Child Sleep at age 36 months 7. Child Body Mass Index at age 36 months 8. Child Sleep at 36 months 9. Child Health at 36 months 10. Child's School Achievement starting at age 6 years 11. Household Economic Hardship at ages 12, 24, 36 months 12. Maternal Physiological Stress at age 24 months 13. Parent-Child Interaction Quality at age 24 months 1. Child Language Development at age 36 months 2. Child Executive Function and Self-Regulation at age 36 months 3. Child Socio-emotional Processing at age 36 months 4. Child IQ at age 36 months 5. Child Brain Function at age 36 months 6. Child Sleep at age 36 months 7. Child Body Mass Index at age 36 months 8. Child Health at 36 months 9. Child's School Achievement starting at age 6 years 10. Maternal Physiological Stress at age 36 months 11. Parent-Child Interaction Quality at age 24 months
Primary Outcomes (Explanation) Here we list primary outcome measures. Details can be found in Appendix Tables 1 and 2 of the document "Analysis Plan and Measures". 1. Child Language Development at age 36 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) 2. Child Executive Function and Self-Regulation at age 36 months: Executive Function measured using one of the following (to be determined following pilot testing): Minnesota Executive Function Scale, EF Touch Executive Functioning, or Wechsler preschool and primary scale of intelligence—fourth edition- Working Memory Scale (WPPSI-IV) 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) 3. Child Socioemotional Processing at age 36 months: Social-Emotional Problems measured using the Brief Infant-Toddler Social and Emotional Assessment (BITSEA) and Behavior/Emotional Problems measured using the Child Behavior Checklist (we will estimate the statistical significance of the entire family of related measures in the Child Socioemotional Processing outcome cluster using stepdown resampling methods for multiple testing) 4. Child IQ at age 36 months measured using the Wechsler preschool and primary scale of intelligence—fourth edition (WPPSI-IV) 5. Child Brain Function at age 36 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) 6. Child Sleep at age 36 months using the Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance (SD) Short Form 7. Child Body Mass Index at age 36 months measured using CDC scales 8. Child Sleep at 36 months measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form (see Appendix Table 1 in the document titled "Analysis Plan and Outcome Measures" for items) 9. Child Health at 36 months measured using an additive index of six survey items (see Appendix Table 1 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. Household Economic Hardship at ages 12, 24, 36 months measured using the household poverty rate using the Census Bureau's poverty thresholds by size of family (we will estimate the statistical significance of the entire family of related measures in the Household Economic Hardship outcome cluster using stepdown resampling methods for multiple testing) 12. Maternal Physiological Stress at age 24 months measured using maternal hair cortisol 13. Parent-Child Interaction Quality at age 24 months measured: 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) (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 3 and 4 of the "Analysis Plan and Measures" document . 1. Child Language Development at age 36 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) 2. Child Executive Function and Self-Regulation at age 36 months: Executive Function measured using one of the following (to be determined following pilot testing): Minnesota Executive Function Scale, EF Touch Executive Functioning, or Wechsler preschool and primary scale of intelligence—fourth edition- Working Memory Scale (WPPSI-IV) 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) 3. Child Socio-emotional Processing at age 36 months: Social-Emotional Problems measured using the Brief Infant-Toddler Social and Emotional Assessment (BITSEA) and Behavior/Emotional Problems measured using the Child Behavior Checklist (we will estimate the statistical significance of the entire family of related measures in the Child Socioemotional Processing outcome cluster using stepdown resampling methods for multiple testing) 4. Child IQ at age 36 months measured using the Wechsler preschool and primary scale of intelligence—fourth edition (WPPSI-IV) 5. Child Brain Function at age 36 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) 6. Child Sleep at age 36 months using the Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance (SD) Short Form 7. Child Body Mass Index at age 36 months measured using CDC scales 8. Child Health at 36 months measured using an additive index of six survey items (see Appendix Table 3 in the document titled "Analysis Plan and Outcome Measures" for items) 9. Child's School Achievement starting at age 6 measured using administrative test score data 10. Maternal Physiological Stress at age 36 months measured using maternal hair cortisol 11. Parent-Child Interaction Quality at age 24 months measured: 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) (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)
Secondary Outcomes (End Points) 1. Child Language Development at ages 12, 24, 36 months 2. Child Socioemotional Processing at ages 12, 24 months 3. Child Brain Function at age 12, 36 months 4. Child Physiological Stress at age 24 months 5. Child Sleep at ages 12, 24 months 6. Child Health at ages 12, 24 months 7. Child's Siblings' School Achievement starting at age 6 years 8. Child and Sibling School Behavior starting at age 6 years 9. Household Economic Stress at age 12, 24, 36 months 10. Social Services Receipt at ages 12, 24, 36 months 11. Mother's Labor Market and Education Participation at ages 12, 24, 36 months 12. Child-Focused Expenditures at age 12, 24, 36 months 13. Housing and Neighborhood Quality at ages 12, 24, 36 months 14. Family and Maternal Perceived Stress at ages 12, 24, 36 months 15. Maternal Happiness and Optimism at ages 12, 24, 36 months 16. Maternal Physiological Stress at age 12 months 17. Maternal Mental Resources at age 24 months 18. Maternal Mental Health at ages 12, 24, 36 months 19. Maternal Physical Health at ages 12, 24, 36 months 20. Maternal Substance Abuse at ages 12, 24, 36 months 21. Chaos in the Home at ages 12, 24, 36 months 22. Maternal Relationship Quality at ages 12, 24, 36 months 23. Parent-Child Interaction Quality at ages 12, 24 months 24. Maternal Epigenetic Age at age 24 months 25. Maternal DNA Methylation at age 24 months 26. Frequency of Parent-Child Activity at ages 12, 24 months 27. Maternal Discipline at ages 12, 24, 36 months 1. Child Language Development at ages 12, 24, 36 months 2. Child Socioemotional Processing at ages 12, 24 months 3. Child Brain Function at ages 12 and 36 months 4. Child Physiological Stress at age 36 months 5. Child Sleep at ages 12, 24 months 6. Child Health at ages 12, 24 months 7. Child Epigenetic Age at age 24 months 8. Child DNA Methylation at age 24 months 9. Child's Siblings' School Achievement starting at age 6 years 10. Child and Sibling School Behavior starting at age 6 years 11. Child Nutrition at age 24 months 12. Household Economic Hardship at ages 12, 24, 36 months 13. Social Services Receipt at ages 12, 24, 36 months 14. Mother's Labor Market and Education Participation at ages 12, 24, 36 months 15. Child-Focused Expenditures at ages 12, 24, 36 months 16. Housing and Neighborhood Quality at ages 12, 24, 36 months 17. Family and Maternal Perceived Stress at ages 12, 24, 36 months 18. Maternal Happiness and Optimism at ages 12, 24, 36 months 19. Maternal Physiological Stress at age 12 months 20. Maternal Mental Resources at age 24 months 21. Maternal Mental Health at ages 12, 24, 36 months 22. Maternal Physical 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, 24, 36 months 25. Maternal Relationships at ages 12, 24, 36 months 26. Parent-Child Interaction Quality at ages 12, 24 months 27. Maternal Epigenetic Age at age 24 months 28. Maternal DNA Methylation at age 24 months 29. Frequency of Parent-Child Activity at ages 12 and 24 months 30. Maternal Discipline at ages 12 and 24 months
Secondary Outcomes (Explanation) Here we list secondary outcome measures. Details can be found in Appendix Tables 1 and 2 of the document "Analysis Plan and Measures". 1. Child Language Development at ages 12, 24, 36 months: Language Milestones measured using Ages and Stages Questionnaire (ASQ)- Communication Subscale; Child Vocalizations measured using LENA Technology software (at age 24 months); Communicative Development measured using the MacArthur Communicative Development Inventories (at age 24 months); Verbal Comprehension measured using the Wechsler Preschool and Primary Scale of Intelligence-fourth edition (WPPSI-IV)- Vocabulary Subscale (at age 36 months) (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) 2. Child Socioemotional Processing at ages 12, 24 months: Social-Emotional Problems measured using the Brief Infant-Toddler Social and Emotional Assessment (BITSEA)- Problem Scale; Social-Emotional Behavior measured using the NICHD SECCYD Mother-Child Interaction Task (positive/negative mood, activity level, sustained attention, positive engagement); Behavior/Emotional Problems measured using the Child Behavior Checklist (at age 24 months) (we will estimate the statistical significance of the entire family of related measures in the Child Socioemotional Processing outcome cluster using stepdown resampling methods for multiple testing) 3. Child Brain Function at ages 12, 36 months: Resting brain function measuring Gamma, Alpha and Theta power using EEG resting high-frequency power (waves adjusted for multiple testing bias) at 12 months; Language-related brain function measuring Alpha, Gamma and Theta power using EEG (waves adjusted for multiple testing bias) at 36 months (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) 4. Child Physiological Stress at age 24 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 measured using an index of six items (see Appendix Table 1 in the document titled "Analysis Plan and Outcome Measures" for items) 7. Child's Siblings' School Achievement starting at age 6 years using administrative test score data 8. Child and Sibling School Behavior starting at age 6 years using administrative data 9. Household Economic Stress at ages 12, 24, 36 months: 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 2 in the document titled "Analysis Plan and Outcome Measures" for items); Household Poverty measured using Census Bureau's thresholds (we will estimate the statistical significance of the entire family of related measures in the Household Economic Stress outcome cluster using stepdown resampling methods for multiple testing) 10. Social Services Receipt at ages 12, 24, 36 months measured by the number of benefits received by mother (see Appendix Table 2 in the document titled "Analysis Plan and Outcome Measures" for items) 11. Mother's Labor Market and Education Participation at ages 12, 24, 36 months: Time to labor market reentry from birth; Time to full-time labor market reentry from birth, Dichotomous indicator of mother's education and training activity participation (see Appendix Table 2 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 Mother's Labor Market and Education Participation outcome cluster using stepdown resampling methods for multiple testing) 12. Child-Focused Expenditures at age 12, 24, 36 months: Index of child-focused expenditures since birth (at age 12 months); Total dollar amount of child-focused expenditures in the past 30 days; Cost of paid child care in dollars; Use of center-based care (see Appendix Table 2 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-Focused Expenditures outcome cluster using stepdown resampling methods for multiple testing) 13. 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; Additive index of items indicating experiences with homelessness; Indicator of three or more residential moves; Neighborhood Poverty Rate using census data (see Appendix Table 2 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 Housing and Neighborhood Quality outcome cluster using stepdown resampling methods for multiple testing) 14. Family and Maternal Perceived Stress at ages 12, 24, 36 months: Perceived Stress Scale (PSS) and Aggravation in Parenting Scale (we will estimate the statistical significance of the entire family of related measures in the Family and Maternal Perceived Stress outcome cluster using stepdown resampling methods for multiple testing) 15. Maternal Happiness and Optimism at ages 12, 24, 36 months: Global happiness item and HOPE Scale (we will estimate the statistical significance of the entire family of related measures in the Family and Maternal Happiness and Optimism outcome cluster using stepdown resampling methods for multiple testing) 16. Maternal Physiological Stress at age 12 months measured using maternal hair cortisol 17. Maternal Mental Resources at age 24 months measured using the Flanker Inhibitory Control and Attention Test 18. Maternal Mental Health at ages 12, 24, 36 months: PHQ-8 and Beck Anxiety Inventory (we will estimate the statistical significance of the entire family of related measures in the Maternal Mental Health outcome cluster using stepdown resampling methods for multiple testing) 19. Maternal Physical Health at ages 12, 24, 36 months: Global health measured using a survey item; Sleep measured using an additive index of survey items; Mother's Body Mass Index measured by dividing weight by stature (at age 36 months) see Appendix Table 2 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 Maternal Substance Abuse outcome cluster using stepdown resampling methods for multiple testing) 20. Maternal Substance Abuse at ages 12, 24, 36 months: Index of frequency of alcohol and cigarette use; frequency of opioid use (see Appendix Table 2 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 Maternal Substance Abuse outcome cluster using stepdown resampling methods for multiple testing) 21. Chaos in the Home at ages 12, 24, 36 months: Home Environment Chaos Scale 22. Maternal Relationship Quality at ages 12, 24, 36 months: Index of frequency of arguing; Presence of physical abuse, Index of relationship quality (see Appendix Table 2 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 Maternal Relationship Quality outcome cluster using stepdown resampling methods for multiple testing) 23. Parent-Child Interaction Quality at ages 12, 24 months: Adult word count measured using LENA Technology software; Conversational turns measured using LENA Technology software; 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) at 12 months (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) 24. Maternal Epigenetic Age at age 24 months measured using the Horvath Method 25. Maternal DNA Methylation at age 24 months 26. Frequency of Parent-Child Activity at age 12, 24 months measured by self-report of frequency of activities (see Appendix Table 2 in the document titled "Analysis Plan and Outcome Measures" for items) 27. Maternal Discipline at ages 12, 24, 36 months: indicator of use of spanking as a discipline strategy (see Appendix Table 2 in the document titled "Analysis Plan and Outcome Measures" for items) Here we list secondary outcome measures. Details can be found in Appendix Tables 3 and 4 of the document "Analysis Plan and Measures". 1. Child Language Development at ages 12, 24, 36 months: Language Milestones measured using Ages and Stages Questionnaire (ASQ)- Communication Subscale (at ages 12 and 36 months); Child Vocalizations measured using LENA Technology software (at age 24 months); Communicative Development measured using the short-form versions of the MacArthur Communicative Development Inventories (at age 24 months); Verbal Comprehension measured using the Wechsler Preschool and Primary Scale of Intelligence-fourth edition (WPPSI-IV)- Vocabulary Subscale (at age 36 months); (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) 2. Child Socioemotional Processing at ages 12 and 24 months: Social-Emotional Problems measured using the Brief Infant-Toddler Social and Emotional Assessment (BITSEA); Social-Emotional Behavior measured using the NICHD SECCYD Mother-Child Interaction Task (positive/negative mood, activity level, sustained attention, positive engagement); (we will estimate the statistical significance of the entire family of related measures in the Child Socioemotional Processing outcome cluster using stepdown resampling methods for multiple testing) 3. Child Brain Function at ages 12 and 36 months: Resting brain function measuring Gamma, Alpha and Theta power using EEG resting high-frequency power (waves adjusted for multiple testing bias) (at age 12 months); Language-related brain function measuring Alpha, Gamma and Theta power using EEG (waves adjusted for multiple testing bias) (at age 36 months); (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) 4. Child Physiological Stress at age 36 months measured using child's Hair cortisol 5. Child Sleep at ages 12 and 24 months measured using the Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance (SD) Short Form 6. Child Health at ages 12 and 24 months measured using an index of survey items (see Appendix Table 3 in the document titled "Analysis Plan and Outcome Measures" for items) 7. Child Epigenetic Age at age 24 months: Measured using the method following Fiorito et al. (2017) (see the Bibliography of Child Focused Pre-registered Hypotheses in in the document titled "Analysis Plan and Outcome Measures" for the full citation) 8. Child DNA Methylation at age 24 months: Measured using the method following Hughes et al. (2018) and Cao-Lei et al. (2014) (see the Bibliography of Child Focused Pre-registered Hypotheses in in the document titled "Analysis Plan and Outcome Measures" for the full citation) 9. Child's Siblings' School Achievement starting at age 6 years using administrative test score data 10. Child and Sibling School Behavior starting at age 6 years using administrative data 11. 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 4 in the document titled "Analysis Plan and Outcome Measures" for items) 12. Household Economic Hardship at ages 12, 24, 36 months: Index of food insufficiency 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 4 in the document titled "Analysis Plan and Outcome Measures" for items); Household Poverty measured using Census Bureau's thresholds; (we will estimate the statistical significance of the entire family of related measures in the Household Economic Stress outcome cluster using stepdown resampling methods for multiple testing) 13. Social Services Receipt at ages 12, 24, 36 months measured by the number of benefits received by mother (see Appendix Table 4 in the document titled "Analysis Plan and Outcome Measures" for items) 14. Mother's Labor Market and Education Participation at ages 12, 24, 36 months: Time to labor market reentry from birth (at age 12 months); Time to full-time labor market reentry from birth (at age 12 months); Dichotomous indicator of mother's education and training activity participation (see Appendix Table 4 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 Mother's Labor Market and Education Participation outcome cluster using stepdown resampling methods for multiple testing) 15. Child-Focused Expenditures at age 12, 24, 36 months: Index of child-focused expenditures since birth (at 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 4 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-Focused Expenditures outcome cluster using stepdown resampling methods for multiple testing) 16. 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; 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 4 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 Housing and Neighborhood Quality outcome cluster using stepdown resampling methods for multiple testing) 17. Family and Maternal Perceived Stress at ages 12, 24, 36 months: Perceived Stress Scale (PSS); Parenting Stress measured using the Aggravation in Parenting Scale; (we will estimate the statistical significance of the entire family of related measures in the Family and Maternal Perceived Stress outcome cluster using stepdown resampling methods for multiple testing) 18. Maternal Happiness and Optimism at ages 12, 24, 36 months: Global happiness measured using a survey item (see Appendix Table 4 in the document titled "Analysis Plan and Outcome Measures" for item); Maternal Agency measured using the HOPE Scale; (we will estimate the statistical significance of the entire family of related measures in the Family and Maternal Happiness and Optimism outcome cluster using stepdown resampling methods for multiple testing) 19. Maternal Physiological Stress at age 12 months measured using maternal hair cortisol 20. Maternal Mental Resources at age 24 months measured using the Flanker Inhibitory Control and Attention Test 21. Maternal Mental Health at ages 12, 24, 36 months: Depression measured using the PHQ-8; Anxiety measured using the Beck Anxiety Inventory (at ages 12 and 36 months); Anxiety measured using the GAD-7 (at age 24 months); (we will estimate the statistical significance of the entire family of related measures in the Maternal Mental Health outcome cluster using stepdown resampling methods for multiple testing) 22. Maternal Physical Health at ages 12, 24, 36 months: Global health measured using a survey item; Sleep measured using an additive index of survey items (at ages 12 and 36 months); Mother's Body Mass Index measured by dividing weight by stature (at age 36 months) (see Appendix Table 4 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 Maternal Substance Abuse outcome cluster using stepdown resampling methods for multiple testing) 23. Maternal Substance Abuse at ages 12 and 36 months: Index of frequency of alcohol and cigarette use; frequency of opioid use (see Appendix Table 4 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 Maternal Substance Abuse outcome cluster using stepdown resampling methods for multiple testing) 24. Chaos in the Home at ages 12, 24, 36 months: Measured using the Home Environment Chaos Scale 25. Maternal Relationship Quality at ages 12, 24, 36 months: Index of frequency of arguing; Presence of physical abuse measured using a dichotomous indicator, Index of relationship quality measured using survey items (at age 12 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 and 36 months); (see Appendix Table 4 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 Maternal Relationship Quality outcome cluster using stepdown resampling methods for multiple testing) 26. Parent-Child Interaction Quality at ages 12 and 24 months: Adult word count measured using LENA Technology software; Conversational turns measured using LENA Technology software; 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) (at age 12 months); (we will estimate the statistical significance of the entire family of related measures in the Parent-Child Interaction
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Analysis Plans

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Document
Statistical+Analysis+Plan+July+2020+gjd.pdf
MD5: 4e6080c63d0686f580eb357537947fec
SHA1: 3ebe1304966774879c896ed2f6673604354aff3f
Title Analysis Plan and Measures- Updated for (and prior to) age 24 months data collection
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Document
Analysis+Plans+and+Measures_61919.pdf
MD5: a69b3045107458475d54f62f1be9cdef
SHA1: 4324aea58a74fecae526a21dc19f8a28289ebd97
Title Analysis Plan and Measures- Update for (and prior to) age 12 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 in the document titled for "Analysis Plan and Measures" for details). 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 and Appendix Tables 3 and 4 for the measures for data collection at age 24 and 36 months) in the document titled for "Analysis Plan and Measures" for details). Additionally, a few other details have changed since this proposal was funded in 2017.
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Sponsors

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Sponsor Name Anonymous- available upon request
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Sponsor Name Brady Education Fund
Sponsor Website (URL) http://bradyeducationfoundation.org/
Public Yes
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Sponsor Name Valhalla Foundation
Sponsor Website (URL) https://fconline.foundationcenter.org/fdo-grantmaker-profile?key=OTSB001
Public Yes
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Fields Removed

Analysis Plans

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Document
Analysis+Plans+and+Measures_61919.pdf
MD5: a69b3045107458475d54f62f1be9cdef
SHA1: 4324aea58a74fecae526a21dc19f8a28289ebd97
Title Analysis Plan and Measures
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