Multisite Prospective Cohort Research Articles

Establishing a model of peer support for pregnant persons with a substance use disorder as an innovative approach for engaging participants in the healthy brain and child development study.

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The goal is to recruit over 7000 caregiver-child dyads across the United States, with 25 % of the study population comprising children exposed in utero to substances to better understanding the effects of prenatal substance exposure on fetal and child development. However, barriers of mistrust for pregnant persons who are substance involved can create challenges to recruiting and retaining this population. The HBCD Study is utilizing a novel approach in research, the inclusion of support professionals (i.e. study navigators) as research team members to boost recruitment, engagement, and retention in this population and other marginalized and underrepresented groups. This article describes the conceptualization and early implementation of a support model utilizing certified peer support specialists, and the evolution to a broader study navigator model (SNM). Core skills, training, and support necessary for integrating such support professionals onto the research team are outlined. A reflection on challenges and next steps describes how the early implementation of the SNM encourages a paradigm shift in longitudinal research that humanizes and centers the participants.

Epidemiology of norovirus disease in the first 2 years of life: A prospective multisite cohort study in Lima, Peru.

Norovirus is associated with 18% of acute gastroenteritis (AGE) cases worldwide. We aim to document the norovirus-related AGE incidence in peri-urban areas of Lima (Peru), evaluating the potential impact of a norovirus vaccine introduction. A prospective, community-based pediatric cohort study was established at two sites in Lima. Healthy children between 5 and 18 months were contacted weekly for AGE detection during a 6-month period. Stool samples from AGE cases were tested for norovirus by RT-PCR. Incidence and coinfection of norovirus-associated AGE were analyzed. All norovirus-positive samples were genotyped by Sanger DNA sequencing. Among 498 enrolled children, 461 (93%) completed the follow-up period. We detected 799 AGE cases, yielding 676 valid stool samples. Norovirus was detected in 216 samples (32%), with an incidence of 7.7 episodes per 100 child-months (95% CI: 6.7-8.8). Genotypes GII.4 (31%) and GII.6 (22%) were frequent. Campylobacter (43%) and Salmonella spp. (15%) were the most common coinfections with norovirus. Ninety-five percent of study children had received an oral rotavirus vaccine. Norovirus was the second most frequent cause of AGE in this Peruvian cohort with high rotavirus vaccine coverage. An effective norovirus vaccine would have an important public health benefit in this population.

Monitoring drug Efficacy through Multi-Omics Research initiative in Alzheimer’s Disease (MEMORI-AD): A protocol for a multisite exploratory prospective cohort study on the drug response-related clinical, genetic, microbial and metabolomic signatures in Filipino patients with Alzheimer’s disease

IntroductionDementia is one of the leading causes of disability among older people aged 60 years and above, with majority eventually being diagnosed with Alzheimer’s disease (AD). Pharmacological agents approved for...

Salivary cortisol is not associated with dexamethasone response in preterm infants with evolving bronchopulmonary dysplasia.

Short-term treatment efficacy of systemic dexamethasone (DEX) in preterm infants with bronchopulmonary dysplasia (BPD) is highly variable. Our objective was to assess if salivary cortisol may serve as a reliable biomarker of steroid response. Multi-site prospective observational cohort study. Salivary cortisol was measured before and after DEX treatment. Respiratory Severity Score (RSS) quantified clinical response. Fifty-four infants with median (inter-quartile range) gestational age of 25.1 (24.1,26.5) weeks initiated DEX at 30 (23,48) days' postnatal age. Median baseline and post-treatment cortisol levels were 0.3 (0.2,0.6) μg/dl; 8.3 (5.5,16.5) nmol/L and 0.2 (0.1,0.3) μg/dl; 5.5 (2.8,8.3) nmol/L, respectively. RSS values decreased by a median of 3.1(1.6,5.0) Change in RSS did not correlate with baseline cortisol or change in cortisol levels. In this first study to assess salivary cortisol as a biomarker for DEX response in BPD, salivary cortisol did not predict dexamethasone response.

¿Donde están? Hispanic/Latine inclusion, diversity and representation in the HEALthy Brain and Child Development Study (HBCD)

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. Central to its mission of reducing health disparities is the establishment of the Spanish Language and Culture Committee (SLCC) within the HBCD framework, a significant step towards demographic representation and inclusivity in research. By addressing linguistic and sociocultural barriers and embracing the diverse identities of Hispanic/Latine individuals nationwide, the SLCC aims to promote inclusion, equity, and representation of all Hispanic/Latine subgroups, a population that has been historically misrepresented in health research. In this paper we describe the role of the SLCC in advocating for Hispanic/Latine families within the study, ensuring their inclusion from inception. This report also provides an overview of the SLCC organization, workflow, challenges and lessons learned thus far to reduce stigma and improve study outcomes, highlighting recruitment and retention strategies for the Hispanic/Latine population, and expanding outreach to promote inclusion across diverse Hispanic/Latine subgroups in the United States.

Maternal vitamin D status, fetal growth patterns, and adverse pregnancy outcomes in a multisite prospective pregnancy cohort

BackgroundFew studies have examined maternal vitamin D status and fetal growth patterns across gestation. Furthermore, time points in pregnancy at which maternal vitamin D status is most critical for optimal fetal growth and pregnancy outcomes are uncertain. ObjectivesOur objective was to examine whether first and second trimester maternal vitamin D status are associated with fetal growth patterns and pregnancy outcomes. MethodsWe conducted a secondary analysis using data and samples from a multisite prospective cohort study of nulliparous pregnant females in the United States. We measured serum 25-hydroxyvitamin D (25(OH)D) for 351 participants at 6–13 and 16–21 weeks of gestation. Fetal growth was measured by ultrasound at 16–21 and 22–29 weeks of gestation, and neonatal anthropometric measures at birth. We constructed fetal growth curves using length, weight, and head circumference z-scores, and calculated risk of preterm birth (<37 wk) and small for gestational age (SGA). We examined outcomes across 25(OH)D concentrations assessed continuously, using Institute of Medicine (IOM) cutoffs (<50 compared with ≥50 nmol/L), and using exploratory cutoffs (<40, 40–59.9, 60–79.9, ≥80 nmol/L). ResultsVitamin D insufficiency (25(OH)D <50 nmol/L) was prevalent in 20% of participants in the first trimester. Each 10 nmol/L increase in first trimester 25(OH)D was associated with a 0.05 [95% confidence interval (CI): 0.01, 0.10] increase in length-for-age z-score but was not associated with weight or head circumference. There were no differences in risk of preterm birth or SGA using IOM cutoffs; participants with first trimester 25(OH)D <40 compared with ≥80 nmol/L had 4.35 (95% CI: 1.14, 16.55) times risk of preterm birth. Second trimester 25(OH)D was not associated with fetal growth patterns or with pregnancy outcomes. ConclusionsFirst trimester 25(OH)D is positively associated with linear growth. Low first trimester 25(OH)D (<40 nmol/L) is associated with a higher risk of preterm birth. Second trimester 25(OH)D is not associated with fetal growth or pregnancy outcomes assessed.

Navigating ethical and legal challenges in the HEALthy Brain and Child Development Study: Lessons learned from the ethics, law, policy working group

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The HBCD study has faced several ethical and legal challenges due to its goal of enrolling pregnant people (including those with substance use disorder) and their newborns. Challenges not fully anticipated at the outset emerged from the rapidly changing legal landscape around reproductive rights in the United States. By embedding scholars in bioethics and law within research teams and engaging them in conversation with each other and other study personnel, we were able to address many challenges proactively and respond promptly to unanticipated challenges. In this paper, we highlight several important ethical and legal challenges that arose from the first phase of funding through the beginning of participant enrollment. We explain the methods used to address these challenges, the ethical and legal tradeoffs that arose, and the resolution of challenges through the design of the study. Based on this experience, we provide recommendations for research teams, sponsors, and reviewers to address legal risks and promote the ethical conduct of studies with pregnant people and caregivers. We highlight the importance of collaboration with bioethics and legal scholars in studies involving complex and evolving legal risks, as well as the necessity of designing robust approaches to informed consent and maintaining participant trust while navigating ethical challenges in research.

Multilevel Resilience and Appointment Attendance Among African American/Black Adults with HIV: A Prospective Multisite Cohort Study.

Attending clinic appointments supports HIV viral suppression, yet racial disparities are documented. We assessed whether multilevel resilience resources were associated with appointment attendance among African American/Black (AA/B) adults living with HIV in the United States. We ascertained data from 291 AA/B clinical cohort participants from 2018 to 2021. We assessed resilience using the Multilevel Resilience Resource Measure. Binary outcomes were a nonrepeated indicator of attending ≥87.5% of scheduled HIV appointments over 12 months (i.e., visit adherence) and a repeated measure of attending appointments during two sequential 6-month follow-up windows (i.e., clinic attendance). Modified Poisson models estimated adjusted risk ratios (aRRs). The aRR for clinic attendance among participants with greater versus lesser multilevel resilience resource endorsement was 0.95 (95% confidence interval: 0.88, 1.0). The aRR for visit adherence among participants with greater versus lesser multilevel resilience resource endorsement was 1.2 (0.95, 1.4). This analysis is one of the first to assess appointment attendance as a function of resilience. Findings should be confirmed in larger cohorts.

Prenatal detection of placenta accreta spectrum using a sonographic checklist.

The European Working Group for Abnormally Invasive Placenta proposed a checklist of ultrasound features for the antenatal detection of placenta accreta spectrum (PAS). This study aims to assess the performance of the checklist in identifying histopathologically confirmed PAS cases in a cohort with a high pre-test probability of PAS, and identify if particular features are associated with PAS. This is a prospective multi-site cohort study conducted between 2018 and 2023. Consecutive patients who underwent ultrasound assessment for suspicion of PAS were included, and the sonographic checklist was completed at the time of ultrasound. Cases were defined as PAS where they had intraoperative findings as described by the International Federation of Gynecology and Obstetrics (FIGO) grading, and histopathological findings for hysterectomy and myometrial resection cases. All non-PAS cases in this study had placenta previa and at least one prior cesarean delivery. Seventy-eight participants met inclusion criteria, of whom 63 (80.7%) were diagnosed with PAS. Cesarean hysterectomy was performed in 49 cases (62.8%). Overall, third-trimester ultrasound performed at a median gestational age of 32 weeks (IQR 30-34 weeks) had a sensitivity of 0.84 (95% CI 0.73 to 0.92) and specificity of 0.73 (95% CI 0.45 to 0.92) for detecting PAS, with a positive and negative likelihood ratio of 3.15 (95% CI 1.35 to 7.35) and 0.22 (95% CI 0.11 to 0.41), respectively. Features most associated with PAS were abnormal placental lacunae (Odds Ratio [OR] 5.40 [95% CI 1.61 to 18.03] and myometrial thinning OR 6.87 [95% CI 1.93 to 24.4]). While many of the ultrasound features seen in PAS were also present in cases of placenta previa with prior Cesarean section, the median (IQR) number of features present in PAS cases was significantly higher than in the non-PAS placenta previa group (six features [3-8] vs. two features [0-3] p = 0.001). No case of non-PAS placenta previa had more than five features present. The use of a standardized sonographic checklist had a high sensitivity and good specificity for the detection of PAS in this prospective cohort of well-classified PAS cases.

Measurement of emerging neurocognitive and language skills in the HEALthy Brain and Child Development (HBCD) study

The HEALthy Brain and Child Development (HBCD) study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The study plans enrolling over 7000 families across 27 sites. This manuscript presents the measures from the Neurocognition and Language Workgroup. Constructs were selected for their importance in normative development, evidence for altered trajectories associated with environmental influences, and predictive validity for child outcomes. Evaluation of measures considered psychometric properties, brevity, and developmental and cultural appropriateness. Both performance measures and caregiver report were used wherever possible. A balance of norm-referenced global measures of development (e.g., Bayley Scales of Infant Development-4) and more specific laboratory measures (e.g., deferred imitation) are included in the HBCD study battery. Domains of assessment include sensory processing, visual-spatial reasoning, expressive and receptive language, executive function, memory, numeracy, adaptive behavior, and neuromotor. Strategies for staff training and quality control procedures, as well as anticipated measures to be added as the cohort ages, are reviewed. The HBCD study presents a unique opportunity to examine early brain and neurodevelopment in young children through a lens that accounts for prenatal exposures, health and socio-economic disparities.

Quantifying brain development in the HEALthy Brain and Child Development (HBCD) Study: The magnetic resonance imaging and spectroscopy protocol

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The acquisition of multimodal magnetic resonance-based brain development data is central to the study’s core protocol. However, application of Magnetic Resonance Imaging (MRI) methods in this population is complicated by technical challenges and difficulties of imaging in early life. Overcoming these challenges requires an innovative and harmonized approach, combining age-appropriate acquisition protocols together with specialized pediatric neuroimaging strategies. The HBCD MRI Working Group aimed to establish a core acquisition protocol for all 27 HBCD Study recruitment sites to measure brain structure, function, microstructure, and metabolites. Acquisition parameters of individual modalities have been matched across MRI scanner platforms for harmonized acquisitions and state-of-the-art technologies are employed to enable faster and motion-robust imaging. Here, we provide an overview of the HBCD MRI protocol, including decisions of individual modalities and preliminary data. The result will be an unparalleled resource for examining early neurodevelopment which enables the larger scientific community to assess normative trajectories from birth through childhood and to examine the genetic, biological, and environmental factors that help shape the developing brain.

The development and structure of the HEALthy Brain and Child Development (HBCD) Study EEG protocol

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. Electroencephalography (EEG) is one of two brain imaging modalities central to the HBCD Study. EEG records electrical signals from the scalp that reflect electrical brain activity. In addition, the EEG signal can be synchronized to the presentation of discrete stimuli (auditory or visual) to measure specific cognitive processes with excellent temporal precision (e.g., event-related potentials; ERPs). EEG is particularly helpful for the HBCD Study as it can be used with awake, alert infants, and can be acquired continuously across development. The current paper reviews the HBCD Study’s EEG/ERP protocol: (a) the selection and development of the tasks (Video Resting State, Visual Evoked Potential, Auditory Oddball, Face Processing); (b) the implementation of common cross-site acquisition parameters and hardware, site setup, training, and initial piloting; (c) the development of the preprocessing pipelines and creation of derivatives; and (d) the incorporation of equity and inclusion considerations. The paper also provides an overview of the functioning of the EEG Workgroup and the input from members across all steps of protocol development and piloting.

Biospecimens in the HEALthy Brain and Child Development (HBCD) Study: Rationale and protocol

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The longitudinal collection of biological samples from over 7000 birthing parents and their children within the HBCD study enables research on pre- and postnatal exposures (e.g., substance use, toxicants, nutrition), and biological processes (e.g., genetics, epigenetic signatures, proteins, metabolites) on neurobehavioral developmental outcomes. The following biosamples are collected from the birthing parent: 1) blood (i.e., whole blood, serum, plasma, buffy coat, and dried blood spots) during pregnancy, 2) nail clippings during pregnancy and one month postpartum, 3) urine during pregnancy, and 4) saliva during pregnancy and at in-person postnatal assessments. The following samples are collected from the child at in-person study assessments: 1) saliva, 2) stool, and 3) urine. Additionally, placenta tissue, cord blood, and cord tissue are collected by a subset of HBCD sites. Here, we describe the rationale for the collection of these biospecimens, their current and potential future uses, the collection protocol, and collection success rates during piloting. This information will assist research teams in the planning of future studies utilizing this collection of biological samples.

Remote data collection of infant activity and sleep patterns via wearable sensors in the HEALthy Brain and Child Development Study (HBCD)

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. Wearable and remote sensing technologies have advanced data collection outside of laboratory settings to enable exploring, in more detail, the associations of early experiences with brain development and social and health outcomes. In the HBCD Study, the Novel Technology/Wearable Sensors Working Group (WG-NTW) identified two primary data types to be collected: infant activity (by measuring leg movements) and sleep (by measuring heart rate and leg movements). These wearable technologies allow for remote collection in the natural environment. This paper illustrates the collection of such data via wearable technologies and describes the decision-making framework, which led to the currently deployed study design, data collection protocol, and derivatives, which will be made publicly available. Moreover, considerations regarding actual and potential challenges to adoption and use, data management, privacy, and participant burden were examined. Lastly, the present limitations in the field of wearable sensor data collection and analysis will be discussed in terms of extant validation studies, the difficulties in comparing performance across different devices, and the impact of evolving hardware/software/firmware.

An introduction to the HEALthy Brain and Child Development Study (HBCD) study

The fundamental organization of the human brain is established before birth, with rapid growth continuing over the first postnatal years. Children exposed before or after birth to various biological (e.g., substance exposure) or psychosocial hazards (e.g., maltreatment) are at elevated likelihood of deviating from a typical developmental trajectory, which in turn can be associated with psychological, behavioral, and physical health sequelae. In the HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, brain, physical, biological, cognitive, behavioral, social, and emotional development is being examined starting in pregnancy and planned through age 10 (data are sampled at varying degrees of granularity depending on age, with more dense sampling earlier in life). HBCD aims to determine the short- and long-term impacts of a variety of both harmful and protective factors, including prenatal substance use, on developmental trajectories through early childhood. Organized as a nationwide consortium across 27 sites, the HBCD Study will collect multimodal data that will be made publicly available on a yearly basis, through a data use application and approval process. Here we provide an overview of the HBCD Study design, sampling, protocol development, and data management. Data collected through HBCD will be fundamental to informing future prenatal and early childhood interventions and policies to promote wellbeing and resilience in all children.

Assessing prenatal and early childhood social and environmental determinants of health in the HEALthy Brain and Child Development Study (HBCD)

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The charge of the HBCD Social and Environmental Determinants (SED) working group is to develop and implement a battery of assessments to broadly characterize the social and physical environment during the prenatal period and early life to characterize risk and resilience exposures that can impact child growth and development. The SED battery consists largely of measures that will be repeated across the course of the HBCD Study with appropriate modifications for the age of the child and include participant demographics, indicators of socioeconomic status, stress and economic hardship, bias and discrimination (e.g., racism), acculturation, neighborhood safety, child and maternal exposures to adversity, environmental toxicants, social support, and other protective factors. Special considerations were paid to reducing participant burden, promoting diversity, equity, and inclusion, and adopting trauma-informed practices for the collection of sensitive information such as domestic violence exposure and adverse childhood experiences. Overall, the SED battery will provide essential data to advance understanding of child development and approaches to advance health equity across infant and child development.

Communications, engagement, and dissemination strategies for the HEALthy Brain and Child Development (HBCD) Study

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. Study success depends on the engagement and inclusion of diverse populations of pregnant participants and their children across the United States, including those at high and low risk for prenatal substance use. The Communications, Engagement, and Dissemination (CED) Committee is responsible for the development and implementation of a strategy to promote awareness about the study, encourage participation, and engage HBCD families, community partners, and collaborators. Initial work involved developing versatile recruitment and awareness materials with a consistent and inclusive message that reduces stigma and negative bias towards marginalized populations, including people with substance use and other mental health conditions. These efforts were shaped by an integrated product development workflow and early engagement with HBCD partners to address challenges. Ongoing work includes the expansion of HBCD outreach through newsletters and social media platforms with an emphasis on protecting participant privacy. Future activities will focus on disseminating scientific information through generation of infographics and webinars that will inform participants, families, and the public of discoveries generated from HBCD Study data.

Prevalence and incidence of pressure injuries among nursing home residents with darker skin tones: A prospective cohort study.

To measure the prevalence and incidence of nursing home-acquired pressure injuries in older adults residing in Sri Lankan nursing homes. Pressure injury prevalence and incidence are indicators of safety and quality of care. A significant portion of the global population has a skin color dominated by the presence of melanin. Yet, the number of nursing home residents with darker skin tones who develop pressure injuries in nursing homes is relatively unknown. Prospective multisite cohort study conducted in nine nursing homes in Sri Lanka. The sample comprised 210 residents aged ≥60 years old. Semi structured observations and chart audits were used to gather data from July to October 2023. Head-to-toe visual skin assessment to check for nursing home- acquired pressure injuries, Braden pressure injury risk scale and Fitzpatrick skin tone assessments were conducted on all recruited residents at baseline. All recruited residents were followed-up weekly for 12 weeks until detection of a new pressure injury, death, discharge, or transfer. Pressure injury point prevalence at baseline was 8.1% (17/210). Cumulative incidence was 17.1% (36/210). Incidence density was 15.8 per 1000 resident weeks. Most nursing home-acquired pressure injuries were located on the ankle at baseline (29.4%; 5/17) and in the follow-up period (27.8%; 10/36). Stage I pressure injuries were most common: 58.8% (10/17) and 44.4% (16/36) at baseline and during follow-up respectively. About one in six nursing home residents developed a new pressure injury over the 12-week follow-up period. Despite staff and resource constraints, there remains a need to focus on the prevention of pressure injuries in Sri Lankan nursing homes. Studies on the burden of pressure injuries among darker skin tone nursing home residents are lacking and the current evidence available are predominantly from Western countries. The findings of this study highlight the need of targeted preventive measures for nursing home residents with darker skin tones.

Advancing high quality longitudinal data collection: Implications for the HEALthy Brain and Child Development (HBCD) Study design and recruitment

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The HBCD Study aims to reflect the sociodemographic diversity of pregnant individuals in the U.S. The study will also oversample individuals who use substances during pregnancy and enroll similar individuals who do not use to allow for generalizable inferences of the impact of prenatal substance use on trajectories of child development. Without probability sampling or a randomization-based design, the study requires innovation during enrollment, close monitoring of group differences, and rigorous evaluation of external and internal validity across the enrollment period. In this article, we discuss the HBCD Study recruitment and enrollment data collection processes and potential analytic strategies to account for sources of heterogeneity and potential bias. First, we introduce the adaptive design and enrollment monitoring indices to assess and enhance external and internal validity. Second, we describe the visit schedule for in-person and remote data collection where dyads are randomly assigned to visit windows based on a jittered design to optimize longitudinal trajectory estimation. Lastly, we provide an overview of analytic procedures planned for estimating trajectories.

Capturing the complexity of child behavior and caregiver-child interactions in the HEALthy Brain and Child Development (HBCD) Study using a rigorous and equitable approach

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. This article outlines methodological considerations and the decision-making process for measurement selection for child behavior, parenting/caregiver-child interactions, and the family/home environment for HBCD. The decision-making process is detailed, including formation of a national workgroup (WG-BEH) that focused on developmentally appropriate measures that take a rigorous and equitable approach and aligned with HBCD objectives. Multi-level-observational and caregiver-report measures were deemed necessary for capturing the desired constructs across multiple contexts while balancing the nuance of observational data with pragmatic considerations. WG-BEH prioritized developmentally sensitive, validated assessments with psychometrics supporting use in diverse populations and focused on mechanistic linkages and prediction of desired constructs. Other considerations included participant burden and retention, staff training needs, and cultural sensitivity. Innovation was permitted when it was grounded in evidence and filled key gaps. Finally, this article describes the rationale for the selected constructs (e.g., temperament, social-emotional development, parenting behaviors, family organization) and corresponding measures chosen for HBCD visits from early infancy through 17 months of age.