Baby's First Years

Last registered on June 30, 2021

Pre-Trial

Trial Information

General Information

Title
Baby's First Years
RCT ID
AEARCTR-0003262
Initial registration date
June 21, 2019
Last updated
June 30, 2021, 6:17 PM EDT

Locations

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Primary Investigator

Affiliation
University of California, Irvine

Other Primary Investigator(s)

PI Affiliation
University of Maryland
PI Affiliation
New York University
PI Affiliation
University of Wisconsin, Madison
PI Affiliation
Teachers College Columbia University
PI Affiliation
Duke University

Additional Trial Information

Status
On going
Start date
2018-05-09
End date
2023-07-31
Secondary IDs
CTR NCT03593356
Abstract
One thousand infants born to mothers with incomes falling below the federal poverty threshold in four metropolitan areas in the United States are being assigned at random within metropolitan area to one of two cash gift conditions. The sites are: New York City, the greater New Orleans metropolitan area, the greater Omaha metropolitan area, and the Twin Cities. IRB and recruiting issues will likely lead to a distribution of the 1,000 mothers across sites of roughly 115 in one site (the Twin Cities) and 295 in each of the three other sites. The high cash gift treatment group mothers (40% of all mothers) will receive unconditioned cash payments of $333 per month ($4,000 per year) via debit care for 52 months. Mothers in the low cash gift comparator group (60% of all mothers) receive a nominal payment – $20 per month, delivered in the same way and also for 52 months. The 40/60 randomization assignment is stratified by site but not by hospitals within each of the four sites.

Mothers are being recruited in maternity wards of the 12 participating hospitals shortly after giving birth and, after consenting, are administered a 30-minute baseline interview. They then are asked to consent to the cash gifts. We originally planned for three follow-up waves of data collection conducted at child ages 1, 2 and 3, but due to the pandemic had to split the age 3 assessments into an age 3 maternal survey and an age 4 lab assessment. Each of the now four waves will provide information about family functioning as well as developmentally appropriate measures of children's cognitive and behavioral development. The investigators will collect information about the mother and child in the home when the child is 12 months of age and via maternal survey at 24 and 36 months. At age 45-48 months, mothers and children will be assessed and interviewed in research laboratories at each site. The investigators will additionally collect state and local administrative data regarding parental employment, utilization of public benefits such as Medicaid and Supplemental Nutrition Assistance Programs (SNAP), and any involvement in child protective services. The investigators also have plans to randomly sample 80 of the 1,000 families to participate in an in-depth qualitative study, but do not elaborate on those plans in this document.

The compensation difference between families in the experimental and active comparator groups will boost family incomes by $3,760 per year, an amount shown in economics and developmental psychology to be associated with socially significant and policy relevant improvements in children's school achievement. After accounting for likely attrition, our total sample size of 800 at age 4 years, divided 40%/60% between experimental and active comparator groups, provides sufficient statistical power to detect meaningful differences in cognitive, emotional and brain functioning, and key dimensions of family context (see below). (We have worked with state and local officials to ensure to the extent feasible that our cash gifts are not considered countable income for the purposes of determining benefit levels from social assistance programs.) After accounting for likely attrition, our total sample size of 800 at age 3 years, divided 40/60 between high and low payment groups, provides sufficient statistical power to detect meaningful differences in cognitive, emotional and brain functioning, and key dimensions of family context (see below).

Cognitive and emotional development measures will be gathered at 12, 24, 36, and 45-48 months of age. At the capstone lab visit the investigators will administer validated, reliable and developmentally sensitive measures of language, memory, executive functioning and socioemotional skills. The investigators will also collect direct measures of young children's brain development at ages 1 and 4. Measures and preregistered hypotheses about them as well as family-based measures are shown in the documents attached to this registry.

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

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

Registration Citation

Citation
Duncan, Greg et al. 2021. "Baby's First Years." AEA RCT Registry. June 30. https://doi.org/10.1257/rct.3262-8.299999999999999
Former Citation
Duncan, Greg et al. 2021. "Baby's First Years." AEA RCT Registry. June 30. https://www.socialscienceregistry.org/trials/3262/history/95070
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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 payments each month ($4,000 each year) for each of the first 52 months of the children’s lives, with the first payments occurring shortly after the baby’s birth and this experimental condition offered to 40% of the participants, or (2) an active comparator group that receives much smaller payments ($20 per month) offered to 60% of participants. Based on our and others’ prior work, the $3,760 annual difference will be large enough to produce and detect meaningful differences in children’s cognitive development.

Moreover, to understand how poverty reduction improves brain functioning, we have four follow-up waves of data collection conducted at child ages 12, 24, 36, and 45-48 months. Cognitive and emotional development measures will be gathered at 12, 24, 36, and 45-48 months of age. At the age-45-48 month lab visit we will administer validated, reliable and developmentally sensitive measures of language, memory, executive functioning and socioemotional skills. We will also collect direct measures of young children’s brain development at ages 1 and 45-48 months.

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

We have worked with state and local officials to ensure to the extent feasible that our cash gifts are not considered countable income for the purposes of determining benefit levels from social assistance programs.
Intervention Start Date
2018-05-09
Intervention End Date
2023-06-01

Primary Outcomes

Primary Outcomes (end points)
1. Child Language Development at age 36 months
2. Child Language Development at age 45-48 months
3. Child Executive Function and Self-Regulation at age 45-48 months
4. Child Socio-emotional Processing at age 36 months
5. Child IQ at age 45-48 months
6. Child Brain Function at age 45-48 months
7. Child Body Mass Index at age 45-48 months
8. Child Sleep at age 36 months
9. Child Health at 36 months
10. Child's School Achievement starting at age 6 years
11. Maternal Physiological Stress at age 45-48 months
12. Parent-Child Interaction Quality at age 45-48 months
Primary Outcomes (explanation)
Here we list primary outcome measures. Details can be found in Appendix Tables 5 and 6 of the "Analysis Plan and Measures" document .

1. Child Language Development at age 36 months: Maternal Concern for Language Delay measured using two items from the Pediatric Evaluation of Developmental Status (PEDS) (see Appendix Table 5 in the document titled "Analysis Plan and Measures" for items).
2. Child Language Development at age 45-48 months: Language Processing measured using the Quick Interactive Language Screener- Language Processing Subscale (QUILS) (subject to change following pilot testing; we will estimate the statistical significance of the entire family of related measures in the Child Language Development outcome cluster using stepdown resampling methods for multiple testing).
3. Child Executive Function and Self-Regulation at age 45-48 months: Executive Function measured using Minnesota Executive Function Scale and Self-Regulation measured using Preschool Self-Regulation Assessment (we will estimate the statistical significance of the entire family of related measures in the Child Executive Function and Self-Regulation outcome cluster using stepdown resampling methods for multiple testing).
4. Child Socio-emotional Processing at age 36 months: Behavior/Emotional Problems measured using a shortened version of the Child Behavior Checklist and Maternal Concern for Behavioral and Social-Emotional Problems measured using two items from the Pediatric Evaluation of Developmental Status (PEDS; see Appendix Table 5 in the document titled "Analysis Plan and Outcome Measures" for items) (we will estimate the statistical significance of the entire family of related measures in the Child Socio-emotional Processing outcome cluster using stepdown resampling methods for multiple testing).
5. Child IQ at age 45-48 months measured using the Wechsler Nonverbal Scale of Ability.
6. Child Brain Function at age 45-48 months: Resting brain function measuring Gamma, Alpha and Theta power using EEG resting high-frequency power (waves adjusted for multiple testing bias) (we will estimate the statistical significance of the entire family of related measures in the Child Brain Function outcome cluster using stepdown resampling methods for multiple testing).
7. Child Body Mass Index at age 45-48 months measured using CDC scales
8. Child Sleep at age 36 months using the Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance (SD) Short Form.
9. Child Health at 36 months measured using an additive index of six survey items (see Appendix Table 5 in the document titled "Analysis Plan and Outcome Measures" for items).
10. Child's School Achievement starting at age 6 measured using administrative test score data.
11. Maternal Physiological Stress at age 45-48 months measured using maternal hair cortisol.
12. Parent-Child Interaction Quality at age 45-48 months: Using a coding scheme of the NICHD Study of Early Child Care and Youth Development Mother-Child Interaction Task (adapted script) (to be determined following pilot testing; we will estimate the statistical significance of the entire family of related measures in the Parent-Child Interaction Quality outcome cluster using stepdown resampling methods for multiple testing).




Secondary Outcomes

Secondary Outcomes (end points)
1. Child Language Development at ages 12, 24, 36, 45-48 months
2. Child Socioemotional Processing at ages 12, 24, 45-48 months
3. Child Brain Function at ages 12 and 45-48 months
4. Child Physiological Stress at age 45-48 months
5. Child Sleep at ages 12, 24 months
6. Child Health at ages 12, 24 months
7. Child Epigenetic Age at age 45-48 months
8. Child DNA Methylation at age 45-48 months
9. Child Nutrition at age 24 months
10. Any Maternal Concern for Developmental Delay at age 36 months
11. Child's Siblings' School Achievement starting at age 6 years
12. Child and Sibling School Behavior starting at age 6 years
13. Household Economic Hardship at ages 12, 24, 36 months
14. Social Services Receipt at ages 12, 24, 36 months
15. Mother's Labor Market and Education Participation at ages 12, 24, 36 months
16. Child-Focused Expenditures at ages 12, 24, 36 months
17. Housing and Neighborhood Quality at ages 12, 24, 36 months
18. Family and Maternal Perceived Stress at ages 12, 24, 36 months
19. Maternal Happiness and Optimism at ages 12, 24, 36 months
20. Maternal Physiological Stress at age 12 months
21. Maternal Mental Resources at age 45-48 months
22. Maternal Mental Health at ages 12, 24, 36 months
23. Maternal Substance Abuse at ages 12 and 36 months
24. Chaos in the Home at ages 12 and 24 months
25. Maternal Relationships at ages 12, 24, 36 months
26. Maternal Physical Health at ages 12, 24, 36, 45-48 months
27. Parent-Child Interaction Quality at ages 12 and 45-48 months
28. Maternal Epigenetic Age at age 45-48 months
29. Maternal DNA Methylation at age 45-48 months
30. Frequency of Parent-Child Activity at ages 12, 24, 36 months
31. Maternal Discipline at ages 12, 24, 36 months
Secondary Outcomes (explanation)
Here we list secondary outcomes. Details can be found in Appendix Tables 5 and 6 of "Analysis Plan and Measures".
1. Child Language Development at ages 12, 24, 36, 45-48 months: Language Milestones measured using Ages and Stages Questionnaire (ASQ)- Communication Subscale (age 12 months); Vocabulary measured using the short-form of MacArthur Communicative Development Inventories (at age 24 months) and measured using the Receptive and Expressive One Word Picture Vocabulary Tests (at ages 45-48 months); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing).
2. Child Socioemotional Processing at ages 12, 24, 45-48 months: Social-Emotional Problems measured using the Brief Infant-Toddler Social and Emotional Assessment (BITSEA) (at ages 12, 24 months); Social-Emotional Behavior measured using the NICHD SECCYD Mother-Child Interaction Task (positive/negative mood, activity level, sustained attention, positive engagement) (at ages 12) and codes agency, negativity, persistence, affection (45-48 months); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing).
3. Child Brain Function at ages 12 and 45-48 months: Resting brain function measuring Gamma, Alpha and Theta power using EEG resting high-frequency power (waves adjusted for multiple testing bias) (age 12 months); Auditory Discrimination Brain Function measured using mismatch negativity event-related potentials (at age 45-48 months); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing).
4. Child Physiological Stress at age 45-48 months measured using child's hair cortisol.
5. Child Sleep at ages 12, 24 months measured using the Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance (SD) Short Form.
6. Child Health at ages 12, 24 months at ages 12, 24 months measured using an index of survey items (see Appendix Table 5 in "Analysis Plan and Outcome Measures" for items).
7. Child Epigenetic Age at age 45-48 months: Measured using the method following Fiorito et al. (2017) (see Bibliography in "Analysis Plan and Outcome Measures" for the full citation).
8. Child DNA Methylation at age 45-48 months: Measured using the method following Hughes et al. (2018) and Cao-Lei et al. (2014) (see Bibliography in "Analysis Plan and Outcome Measures" for the full citation).
9. Child Nutrition at age 24 months: Consumption of healthy foods measured using an additive index of survey items; Consumption of unhealthy foods measured using an additive index of survey items; (see Appendix Table 5 in "Analysis Plan and Outcome Measures" for items).
10. Any Maternal Concern for Developmental Delay at age 36 months: Parental Evaluation of Developmental Status measured using the Parental Evaluation of Developmental Status (PEDS) and the total “predictive concerns” named in the Parental Evaluation of Developmental Status (PEDS); (see Appendix Table 5 in "Analysis Plan and Outcome Measures" for items); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing).
11. Child's Siblings' School Achievement starting at age 6 years using administrative test score data.
12. Child and Sibling School Behavior starting at age 6 years.
13. Household Economic Hardship at ages 12, 24, 36 months: Index of food insecurity measured using the U.S. Household Food Security Survey Module: Six-Item Short Form; Index of economic stress using an additive index of survey items, with higher score indicating higher stress (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items); Household Poverty measured using Census Bureau's thresholds; (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing).
14. Social Services Receipt at ages 12, 24, 36 months measured by the number of benefits received by mother (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items).
15. Mother's Labor Market and Education Participation at ages 12, 24, 36 months: Time to labor market reentry from birth (age 12 months); Time to full-time labor market reentry from birth (age 12 months); Dichotomous indicator of mother's education and training activity participation (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing)
16. Child-Focused Expenditures at age 12, 24, 36 months: Index of child-focused expenditures since birth (age 12 months); Total dollar amount of child-focused expenditures in the past 30 days; Cost of paid child care in dollars; Dichotomous indicator of use of center-based care (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing).
17. Housing and Neighborhood Quality at ages 12, 24, 36 months: Additive index of perceptions of neighborhood safety with higher score indicating feeling more safe; Additive index of housing quality (ages 12, 24 months); Additive index of items indicating experiences with homelessness; Excessive residential mobility measured using an indicator of three or more residential moves; Neighborhood Poverty Rate using census data (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing).
18. Family and Maternal Perceived Stress at ages 12, 24, 36 months: Perceived Stress Scale (PSS); Parenting Stress measured using the Aggravation in Parenting Scale (ages 12, 24 months); (we will estimate the statistical significance of the family of related measures in the Family and Maternal Perceived Stress domain using stepdown resampling methods for multiple testing).
19. Maternal Happiness and Optimism at ages 12, 24, 36 months: Global happiness measured using a survey item (see Appendix Table 5 in "Analysis Plan and Outcome Measures" for item); Maternal Agency measured using the HOPE Scale; (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing).
20. Maternal Physiological Stress age 12 months measured using maternal hair cortisol.
21. Maternal Mental Resources at age 45-48 months measured using Flanker Inhibitory Control and Attention Test.
22. Maternal Mental Health at ages 12, 24, 36 months: Depression measured using PHQ-8; Anxiety measured using Beck Anxiety Inventory (at ages 12, 36 months) and using GAD-7 (at age 24, 36 months); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing).
23. Maternal Substance Abuse at ages 12, 36 months: Index of frequency of alcohol and cigarette use; frequency of opioid use (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items) (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing).
24. Chaos in the Home at ages 12, 24 months: Measured using the Home Environment Chaos Scale.
25. Maternal Relationships at ages 12, 24, 36 months: Frequency of arguing (at age 12, 24 months); Physical abuse measured using a dichotomous indicator, Relationship quality measured using survey items (at age 12, 24 months); dichotomous indicator of high or low quality relationship, where 0 is defined as not in a relationship or a score above 26 on the Index of relationship quality and 1 is defined as in a relationship and a score of 26 or below on the Index of Relationship quality (at ages 24, 36 months); (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items); (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing).
26. Maternal Physical Health at ages 12, 24, 36, 45-48 months: Global health measured using survey item (at ages 12, 24 months); Sleep measured using an additive index of survey items (at ages 12, 36 months); Mother's Body Mass Index measured dividing weight by stature (at age 45-48 months) (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items) (we will estimate the statistical significance of the family of related measures using stepdown resampling methods for multiple testing).
27. Parent-Child Interaction Quality at ages 12 and 45-48 months: Adult word count measured using LENA Technology (age 12 months); Conversational turns measured using LENA Technology (age 12 months); Index of mother's positive parenting behaviors measured using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO™) to code NICHD SECCYD Mother-Child Interaction Task (adapted script) (age 12 months); (we will estimate the statistical significance of the family of related measures in the domain).
28. Maternal Epigenetic Age at age 45-48 months: Epigenetic age measured following Fiorito et al. (2017) (see Bibliography in "Analysis Plan and Outcome Measures" for the full citation).
29. Maternal DNA Methylation at age 45-48 months: DNA methylation analyzed using genomic-wide differences.
30. Frequency of Parent-Child Activity at ages 12, 24, 36 months: Self-report of parent-child activities measured using additive index of survey items; (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for items).
31. Maternal Discipline at ages 12, 24, 36 months: Spanking discipline measured using survey item; (see Appendix Table 6 in "Analysis Plan and Outcome Measures" for item).

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 52 months via debit card. The comparison group or low cash gift group (compromising 60% of all participants) receives a monthly $20 cash gift for 52 months via debit card. Interviewers are aware of experimental status at enrollment in order to activate the debit card after the participant consents to the study.

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)
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 52 months. This amount is in the range of income increases associated with child impacts of around .20 sd in studies of welfare experiments and the EITC. After accounting for likely 20% attrition, and in the absence of adjustments for sample clustering within hospitals or increased precision owing to the inclusion of baseline covariates in our impact estimates, the sample size of 800 at age 45-48 months, evenly divided between experimental and control groups, provides 80% statistical power to detect a .218 sd impact at p <.05 in a two-tailed test on cognitive functioning and family processes. Given the directional nature of all of our impact hypotheses, it could be argued that a one-tailed test is more appropriate, in which case our 80% power minimum detectable effect (MDE) size drops to .194 sd. The use of baseline covariates in estimation models will improve this power, while the use of bootstrap standard errors will decrease it, yielding offsetting effects of unknown but likely modest magnitudes.
Supporting Documents and Materials

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IRB

Institutional Review Boards (IRBs)

IRB Name
University of California, Irvine
IRB Approval Date
2017-06-19
IRB Approval Number
2016-3336
IRB Name
Teachers College, Columbia University
IRB Approval Date
2018-02-13
IRB Approval Number
18-210
Analysis Plan

Analysis Plan Documents

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

MD5: a69b3045107458475d54f62f1be9cdef

SHA1: 4324aea58a74fecae526a21dc19f8a28289ebd97

Uploaded At: July 12, 2020

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

MD5: 4e6080c63d0686f580eb357537947fec

SHA1: 3ebe1304966774879c896ed2f6673604354aff3f

Uploaded At: July 07, 2020

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

MD5: 49bc510407261f5b0f3eac922cf109e7

SHA1: 7a3c72af8802de1b9e293f6e0f5c1f27e9f39fc9

Uploaded At: June 30, 2021