The Brain and Early Experience Study: Protocol for a Prospective Observational Study.

Background: Children raised in conditions of poverty (or near poverty) are at risk for nonoptimal mental health, educational, and occupational outcomes, many of which may be precipitated by individual differences in executive function (EF) skills that first emerge in early childhood.

Objective: The Brain and Early Experience study considers prenatal and postnatal experiences that may mediate the association between poverty and EF skills, including neural substrates. This paper described the study rationale and aims; research design issues, including sample size determination, the recruitment strategy, and participant characteristics; and a summary of developmental assessment points, procedures, and measures used to test the study hypotheses.

Methods: This is a prospective longitudinal study examining multiple pathways by which poverty influences normative variations in EF skills in early childhood. It is funded by the National Institute of Child Health and Human Development and approved by the institutional review board.

Results: Recruitment is complete with a sample of 203 participants, and data collection is expected to continue from September 2018 to February 2024. Of those recruited as low socioeconomic status (SES), 71% (55/78) reported income-to-needs (ITN) ratios of <2.0, and 35% (27/78) reported ITN ratios of <1.0. Among participants recruited into the not-low SES stratum, only 8.8% (11/125) reported ITN ratios of <2.0, and no participant reported ITN ratios of <1.0. The average ITN ratio for participants recruited into the low-income stratum was significantly lower than the average for the high-income recruitment cell (P<.001). Comparable recruitment outcomes were observed for both Black and non-Black families. Overall, the sample has adequate diversity for testing proposed hypotheses, with 13.3% (27/203) of participants reporting ITN ratios of <1 and >32.5% (66/203) reporting ratios of <2.0.

Conclusions: Preliminary results indicate that the recruitment strategy for maximizing variation in family SES was successful, including variation within race. The findings of this study will help elucidate the complex interplay between prenatal and postnatal risk factors affecting critical neurocognitive developmental outcomes in early childhood.

International Registered Report Identifier (irrid): DERR1-10.2196/34854.