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Baby's First Years
Last registered on July 15, 2019

Pre-Trial

Trial Information
General Information
Title
Baby's First Years
RCT ID
AEARCTR-0003262
Initial registration date
June 21, 2019
Last updated
July 15, 2019 3:03 PM EDT
Location(s)

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Primary Investigator
Affiliation
University of California, Irvine
Other Primary Investigator(s)
PI Affiliation
Duke University
PI Affiliation
Teachers College Columbia University
PI Affiliation
University of Wisconsin, Madison
PI Affiliation
New York University
PI Affiliation
University of Maryland
Additional Trial Information
Status
On going
Start date
2018-05-09
End date
2022-07-01
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 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.
External Link(s)
Registration Citation
Citation
Duncan, Greg et al. 2019. "Baby's First Years." AEA RCT Registry. July 15. https://doi.org/10.1257/rct.3262-7.0
Former Citation
Duncan, Greg et al. 2019. "Baby's First Years." AEA RCT Registry. July 15. https://www.socialscienceregistry.org/trials/3262/history/50092
Sponsors & Partners

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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 40 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 three follow-up waves of data collection conducted at child ages 12, 24 and 36 months. 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.

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
2022-06-01
Primary Outcomes
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
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)
Secondary Outcomes
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
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)
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 40 months via debit card. The comparison group or low cash gift group (compromising 60% of all participants) receives a monthly $20 cash gift for 40 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 $12,520 over the course of the 40 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 3, 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
Document Type
proposal
Document 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.
File
Research Strategy

MD5: 65737071e51b62299ea4f63117cb3944

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Uploaded At: June 19, 2019

IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Teachers College, Columbia University
IRB Approval Date
2018-02-13
IRB Approval Number
18-210
IRB Name
University of California, Irvine
IRB Approval Date
2017-06-19
IRB Approval Number
2016-3336
Analysis Plan
Analysis Plan Documents
Analysis Plan and Measures

MD5: a69b3045107458475d54f62f1be9cdef

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Uploaded At: June 19, 2019