Baby's First Years

Last registered on July 03, 2024

Pre-Trial

Trial Information

General Information

Title
Baby's First Years
RCT ID
AEARCTR-0003262
Initial registration date
June 21, 2019

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
July 02, 2019, 5:30 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
July 03, 2024, 2:11 PM EDT

Last updated is the most recent time when changes to the trial's registration were published.

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Primary Investigator

Affiliation
University of California, Irvine

Other Primary Investigator(s)

PI Affiliation
University of Wisconsin
PI Affiliation
Teacher's College, Columbia University
PI Affiliation
Duke University
PI Affiliation
University of Maryland
PI Affiliation
New York University

Additional Trial Information

Status
On going
Start date
2018-05-09
End date
2028-08-31
Secondary IDs
CTR NCT03593356
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
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. (The investigators 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 agree to receive 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 card for 76 months. Mothers in the “low-cash gift” comparator group (60% of all mothers) are receiving a nominal payment – $20 per month, delivered in the same way and also for 76 months. The 40/60 randomization assignment is stratified by site, but not by hospitals, within each of the four sites. The investigators have worked with state and local officials to ensure that, to the extent feasible, the cash gifts are not considered countable income for the purposes of determining benefit levels from social assistance programs.
BFY was originally formulated to study the effects of monthly unconditional cash gifts 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 gifts 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. The investigators successfully arranged funding to extend the cash gifts for a total of 76 months and informed the study participants in August 2022 about the additional 2-year extension of cash transfer.
The targeted age for each data collection wave is around the child’s birthday, i.e. at 12 months, 24 months, 36 months, 48 months, 72 months, and 96 months. Interviews conducted at child ages 1, 2 and 3 provided information about family functioning as well as several maternal reports of developmentally-appropriate measures of children’s cognitive and behavioral development. At ages 4, 6 and 8 measures of cognitive, language, and self-regulation development were or will be administered at university sites, while socio-emotional development is assessed via maternal report. EEG-based measures of brain activity were assessed in the home at age 1 and at university sites at ages 4, 6 and 8. At age 6 and 8 the investigators will collect school behavior and engagement data.
Conditional on participants’ consent and our success in securing agreements with state and county agencies, the investigators are also collecting state and local administrative data regarding maternal employment, utilization of public benefits such as TANF and Supplemental Nutrition Assistance Programs (SNAP), and any involvement in child protective services.
The family process measures that the investigators 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. The investigators are obtaining some measures to capture each 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 improve parenting, a more predictable family life, less conflicted relationships, and warmer and more responsive interactions.
The cash gift difference between families in the high and low cash gift groups equals $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, a total sample size of 800 at age 4, 6 and 8 years, divided 40/60 between high and low cash gift groups, provides sufficient statistical power to detect meaningful (roughly .20 SD) differences in cognitive, emotional and brain functioning, and key dimensions of family context.
Measures and preregistered hypotheses about child- and family-based measures are shown in the two tables in the statistical analysis plan. Child-focused preregistered hypotheses are presented in Appendix Table 9 and maternal and family focused preregistered hypotheses are presented in Appendix Table 10 in the Statistical Analysis Plan. The investigators will update this registry with Age 8 measures and preregistered hypotheses before data collection begins in July 2026. The assessments at child ages 6 and 8 are part of Phase 2 of the project. The Phase 1 analysis plan can be found in the previous version of this document.

For current information about the study, please see babysfirstyears.com. Publicly available data from the baseline survey and Age 1, 2, and 3 can be found here: https://www.icpsr.umich.edu/web/ICPSR/studies/37871.
External Link(s)

Registration Citation

Citation
Duncan, Greg et al. 2024. "Baby's First Years." AEA RCT Registry. July 03. https://doi.org/10.1257/rct.3262-12.0
Former Citation
Duncan, Greg et al. 2024. "Baby's First Years." AEA RCT Registry. July 03. https://www.socialscienceregistry.org/trials/3262/history/227273
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Experimental Details

Interventions

Intervention(s)
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 gifts each month ($4,000 each year) for each of the first 76 months of the children’s lives, with the first cash gifts 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 cash gifts ($20 per month) offered to 60% of participants. Based on our and others’ prior work, the $3,760 annual difference will be large enough to produce and detect meaningful differences in children’s cognitive development.

Moreover, to understand how poverty reduction improves brain functioning, we have six follow-up waves of data collection conducted at child ages 1, 2, 3, 4, 6, and 8 years. The targeted age for each data collection wave is around the child’s birthday, i.e. at 12 months, 24 months, 36 months, 48 months, 72 months, and 96 months. Cognitive and social-emotional development measures will be gathered at all ages. At the age-4, age-6, and age-8 university-based visit we will administer validated, reliable and developmentally sensitive measures of language, memory, health, executive functioning and socioemotional skills. We will collect direct measures of young children’s brain development at ages 1, 4, 6, and 8 years, and school readiness and school achievement measures at ages 6 and 8.

The family process measures that we will gather are based on two theories of change surrounding the income supplements: that increased investment and reduced stress will facilitate children’s healthy development. We will obtain data measuring both of these pathways annually. Investment pathway: Additional resources enable parents to buy goods and services for their families and children that support cognitive development. These include higher quality housing, nutrition and non-parental child care; more cognitively stimulating home environments and learning opportunities outside of the home; and, by reducing or restructuring work hours, more parental time spent with children. Stress pathway: A second pathway is that additional economic resources may reduce parents’ own stress and improve their mental health. This may allow parents to devote more positive attention to their children, thus providing a more predictable family life, less conflicted relationships, and warmer and more responsive interactions.

We have worked with state and local officials to ensure to the extent feasible that our cash gifts are not considered countable income for the purposes of determining benefit levels from social assistance programs.
Intervention Start Date
2018-05-09
Intervention End Date
2025-09-18

Primary Outcomes

Primary Outcomes (end points)
1. Child Language Development: Vocabulary [Age 48 months]
2. Child Language Development: Vocabulary [Age 6]
3. Child Language Development: Vocabulary [Age 8]]
4. Child Language Development: Maternal Concern for Language Delay [Age 36 months]
5. Child Executive Function & Behavioral Regulation: Executive Function [Age 48 months]
6. Child Executive Function & Behavioral Regulation: Executive Function [Age 6]
7. Child Executive Function & Behavioral Regulation: Executive Function [Age 8]
8. Child Executive Function & Behavioral Regulation: Inhibitory Control and Attention [Age 6]
9. Child Executive Function & Behavioral Regulation: Inhibitory Control and Attention [Age 8]
10. Child Executive Function & Behavioral Regulation: Working Memory [Age 6]
11. Child Executive Function & Behavioral Regulation: Working Memory [Age 8]
12. Child Socio-Emotional Processing: Behavior/Problems [Age 36 months]
13. Child Socio-Emotional Processing: Maternal Concern for Behavioral and Social-Emotional Problems [Age 36 months]
14. Child Socio-Emotional Processing: Behavior/Problems [Age 48 months]
15. Child Socio-Emotional Processing: Behavior/Problems [Age 6]
16. Child Socio-Emotional Processing: Behavior/Problems [Age 8]
17. Child Resting Brain Function [Age 48 months]
18. Child Resting Brain Function [Age 6]
19. Child Resting Brain Function [Age 8]
20. Child Health, Sleep [Age 36 months]
21. Child Health, Other Indicators [Age 36 months]
22. Child Academic Achievement: Reading [Age 6]
23. Child Academic Achievement: Reading [Age 8]
24. Child Academic Achievement: Reading Comprehension [Age 8]
25. Child Academic Achievement: Math [Age 6]
26. Child Academic Achievement: Math [Age 8]
27. Child Fluid Reasoning [Age 6]
28. Child Perceptual Reasoning [Age 8]
29. Child Physiological Stress: Nail Cortisol [Age 6]
30. Child Physiological Stress: Nail Cortisol [Age 8]
31. Maternal Attentional Resources [Age 6]
32. Maternal Attentional Resources [Age 8]

Primary Outcomes (explanation)
Hypotheses, measure descriptions, and references can be found in Appendix Tables 9 and 10 of the "Analysis Plan Phase 2" document.

Secondary Outcomes

Secondary Outcomes (end points)
Secondary outcomes for ages 6 and 8 are listed in Tables 9 and 10 in "Analysis Plan Phase 2"
Age 1-4 only are listed here due to space restrictions:
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
23. Maternal Concern for Developmental Delay: Parents' Evaluation of Developmental Status [Age 36 months]
24. School Achievement and Behavior: School Test Scores for Target Child's Siblings [Starting at age 6 years]
25. School Achievement and Behavior: Student Behavioral Data for Target Child [Starting at age 6 years]
26. School Achievement and Behavior: Student Behavioral Data for Target Child's Siblings [Starting at 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: measure had to be dropped.
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]
Secondary Outcomes (explanation)
Hypotheses, measure descriptions, and references can be found in Appendix Tables 9 and 10 of the "Analysis Plan Phase 2" document.

Experimental Design

Experimental Design
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.

Experimental Design Details
Not available
Randomization Method
Computer-randomized and computer-accessed lists of experimental and control status for participants in each for the four sites. Interviewers are notified of experimental/control data during their enrollment interviews. All of the four metropolitan sites will have a 40/60 distribution of experimental and control cases.
Randomization Unit
Individual
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
4 metropolitan areas
Sample size: planned number of observations
1,000 mother/infant pairs, recruited in hospitals shortly after birth. Inclusion conditions (all must be met) include: 1. mother 18 years or older 2. household income below the federal poverty threshold in the calendar year prior to the interview, counting the newborn 3. infant admitted to the newborn nursery and not requiring admittance to the intensive care unit 4. residence in the state of recruitment 5. mother reports not "highly likely" to move to a different state or country in the next 12 months 6. infant to be discharged in the custody of the mother 7. Mother English or Spanish speaking (necessary for administration of instruments used to measure some of the child outcomes) 8. Singleton birth
Sample size (or number of clusters) by treatment arms
400 in experimental group; 600 in control group. In New York City, we recruited 289 mother-infant dyads. We recruited 295 mother-infant dyads in the Omaha metropolitan area and the New Orleans metropolitan area. Lastly, we recruited 121 mother-infant dyads in the Twin Cities, MN.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
.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.
Supporting Documents and Materials

Documents

Document Name
Research Strategy Phase 1 (Age 0-4)
Document Type
proposal
Document Description
Funded by NICHD on the basis of the research proposed in the Research Strategy document. Note that due to the pandemic, the laboratory-based in-person age-3 assessments were postponed to age 4, and an additional wave of interviews was added at age 3.
File
Research Strategy Phase 1 (Age 0-4)

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SHA1: a6d5ff6f70edaf9bdb2b15a1dea91fabdc6a70ba

Uploaded At: December 22, 2022

Document Name
Research Strategy Phase 2 (Age 5-8)
Document Type
proposal
Document Description
The Phase 2 research strategy includes the planned assessments for ages 6 and 8 of this study.
File
Research Strategy Phase 2 (Age 5-8)

MD5: 5b108b9b687d13c2c805d5d48f0d841f

SHA1: af61dd59aee85ff0b0f58134fe5d20fb2f0d9f7c

Uploaded At: January 29, 2024

IRB

Institutional Review Boards (IRBs)

IRB Name
Teachers College, Columbia University
IRB Approval Date
2023-09-08
IRB Approval Number
18-210
IRB Name
University of California, Irvine (original study approval)
IRB Approval Date
2017-06-19
IRB Approval Number
2016-3336; reliance agreement #3196 starting 2023-05-15
Analysis Plan

Analysis Plan Documents

Analysis Plan and Measures- Updated for (and prior to) age 24 months data collection

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Analysis Plan and Measures- Update for (and prior to) age 12 months data collection

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Uploaded At: July 12, 2020

Analysis Plan and Measures - Updated for (and prior to) age 48 months data collection

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Uploaded At: August 16, 2022

Analysis Plan and Measures - Updated for (and prior to) age 36 months data collection

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Uploaded At: June 30, 2021

Analysis Plan and Measures - Updated during age 48 months data collection to reflect protocol changes

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Uploaded At: December 22, 2022

Analysis Plan Phase 2 with Hypotheses and Measures - Updated for (and prior to) age 72 months data collection

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