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Last Published July 02, 2019 05:30 PM July 06, 2019 01:52 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 Health at 36 months 9. Child's School Achievement starting at age 6 years 10. Household Economic Hardship at ages 12, 24, 36 months 11. Maternal Physiological Stress at age 24 months 12. 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 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
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 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) 9. Child's School Achievement starting at age 6 measured using administrative test score data 10. 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) 11. Maternal Physiological Stress at age 24 months measured using maternal hair cortisol 12. 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 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)
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 Substance Abuse at ages 12, 24, 36 months 20. Chaos in the Home at ages 12, 24, 36 months 21. Maternal Relationship Quality at ages 12, 24, 36 months 22. Parent-Child Interaction Quality at ages 12, 24 months 23. Maternal Epigenetic Age at age 24 months 24. Maternal DNA Methylation at age 24 months 25. Frequency of Parent-Child Activity at ages 12, 24 months 26. 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 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
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; 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 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) 20. Chaos in the Home at ages 12, 24, 36 months: Home Environment Chaos Scale 21. 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) 22. Parent-Child Interaction Quality at ages 12, 24 months: Adult word count measured using LENA Technology software; Conversational turns measured using LENA Technology software (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) 23. Maternal Epigenetic Age at age 24 months measured using the Horvath Method 24. Maternal DNA Methylation at age 24 months 25. 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) 26. 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 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)
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