Caregiver-reported development in term and preterm infants from birth to nine months of age: Psychometrics of the PediaTracTM social/communication/cognition domain.

Term and preterm neonates were assessed at the newborn (NB) period (term, term equivalent) and at 2, 4, 6, and 9 months in a study of the psychometric properties of the Social/Communication/Cognition (SCG) domain of PediaTrac™ v3.0, a novel caregiver-based developmental monitoring instrument. Item response theory (IRT) was used to model item parameters and estimate theta, an index of the latent trait, social/communication/cognition. Exploratory factor analysis (EFA) was conducted to further clarify the dimensionality of the domain. In a cohort of 571 caregiver-infant dyads (331 term, 240 preterm), mean theta values could be reliably estimated at all time periods, with term infants demonstrating significantly more advanced social/communication/cognition abilities at 9 months of age. Item discrimination and item difficulty of the 15, 15, 35, 47, and 57 items at the NB, 2-, 4-, 6-, and 9-month periods, respectively, could be reliably modeled across the range of ability. Total Information for the SCG domain was high and the reliability ranged from 0.97 to 0.99 (NB = .98, 2 month = .97, 4 month = .98, 6 month = .99 and 9 month = .99). EFA revealed second-order factors at each time period, with two factors at the NB period (affect/emotional expression, social responsiveness) accounting for 43% of variance; three factors at 2, 4, and 6 months (affect/emotional expression, social responsiveness imitation/emerging communication), accounting for 43%, 34%, and 34% of the variance, respectively; and four factors at 9 months (imitation/communication, nonverbal/gestural communication, affect expression, and social responsiveness), accounting for 34% of the variance. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Caregiver-reported newborn term and preterm motor abilities: psychometrics of the PediaTracTM Motor domain.

BACKGROUND: Approximately 5-10% of children exhibit developmental deviations in motor skills or other domains; however, physicians detect less than one-third of these abnormalities. Systematic tracking and early identification of motor deviations are fundamental for timely intervention. METHODS: Term and preterm neonates were prospectively assessed at the newborn (NB) period in a study of the psychometric properties of the Motor (MOT) domain of PediaTracTM v3.0, a novel caregiver-based development tracking instrument. Item response theory graded response modeling was used to model item parameters and estimate theta, an index of the latent trait, motor ability. Exploratory factor analysis (EFA) was conducted to examine the dimensionality and factor structure. RESULTS: In a cohort of 571 caregiver/infant dyads (331 term, 240 preterm), NB MOT domain reliability was high (rho = 0.94). Item discrimination and item difficulty of each of the 15 items could be reliably modeled across the range of motor ability. EFA confirmed that the items constituted a single dimension with second-order factors, accounting for 43.20% of variance. CONCLUSIONS: The latent trait, motor ability, could be reliably estimated at the NB period. IMPACT: The caregiver-reported Motor domain of PediaTrac provides a reliable estimate of the latent trait of motor ability during the newborn period. This is the first known caregiver-reported instrument that can assess motor ability in the newborn period with high reliability in term and preterm infants. Item response theory methods were employed that will allow for future characterization of developmental subgroups and motor trajectories. The PediaTrac Motor domain can support early identification of at-risk infants. Including caregivers in digital reporting and child-centered monitoring of motor functioning may improve access to care.

Cumulative risk, infant sleep, and infant social-emotional development.

The effect of cumulative biological, psychosocial, and demographic risk and infant sleep on infant social-emotional functioning in 12-month-old infants (46% female) was examined in data from racially (30% Black, 60% White, 10% multiracial/other) and socioeconomically (41% below median income) diverse caregivers (N = 468, M = 30.42 years old, SD = 5.65) recruited from two midwestern states in 2019-2020. Due to the major changes in sleep patterns during infancy and the reported association between sleep and social-emotional functioning, this study also examined whether sleep moderates the association between risk and infant social-emotional functioning and potentially promotes healthy social-emotional functioning despite risk. Greater cumulative risk was associated with poorer sleep efficiency and more social-emotional problems, but was not associated with the general acquisition of social-emotional milestones. Results also suggested that poorer sleep efficiency was associated with more social-emotional problems and poorer social-emotional milestone acquisition. No significant interaction effects were found between cumulative risk and infant sleep. Risk and sleep appear to have unique associations with infant social-emotional problems and development; thus both could be targeted in early intervention to promote social-emotional functioning during infancy and early childhood.

PediaTrac V.3.0 protocol: a prospective, longitudinal study of the development and validation of a web-based tool to measure and track infant and toddler development from birth through 18 months.

INTRODUCTION: The need for an efficient, low-cost, comprehensive measure to track infant/toddler development and treatment outcomes is critical, given the importance of early detection and monitoring. This manuscript describes the protocol for the development and testing of a novel measure, PediaTrac, that collects longitudinal, prospective, multidomain data from parents/caregivers to characterise infant/toddler developmental trajectories in term and preterm infants. PediaTrac, a web-based measure, has the potential to become the standard method for monitoring development and detecting risk in infancy and toddlerhood. METHODS AND ANALYSES: Using a multisite, prospective design, primarcaregivers will complete PediaTrac V.3.0, a survey tool that queries core domains of early development, including feeding/eating/elimination, sleep, sensorimotor, social/sensory information processing, social/communication/cognition and early relational health. Information also will be obtained about demographic, medical and environmental factors and embedded response bias indices are being developed as part of the measure. Using an approach that systematically measures infant/toddler developmental domains during a schedule that corresponds to well-child visits (newborn, 2, 4, 6, 9, 12, 15, 18 months), we will assess 360 caregiver/term infant dyads and 240 caregiver/preterm infant dyads (gestational age <37 weeks). Parameter estimates of our items and latent traits (eg, sensorimotor) will be estimated by theta using item response theory-graded response modelling. Participants also will complete legacy (ie, established) measures of development and caregiver health and functioning, used to provide evidence for construct (discriminant) validity. Predictive validity will be evaluated by examining relationships between the PediaTrac domains and the legacy measures in the total sample and in a subsample of 100 participants who will undergo a neurodevelopmental assessment at 24 months of age. ETHICS AND DISSEMINATION: This investigation has single Institutional Review Board (IRB) multisite approval from the University of Michigan (IRB HUM00151584). The results will be presented at prominent conferences and published in peer-reviewed scientific journals.

Development and validation of PediaTrac™: A web-based tool to track developing infants.

OBJECTIVE: PediaTrac™, a 363-item web-based tool to track infant development, administered in modules of ∼40-items per sampling period, newborn (NB), 2--, 4--, 6--, 9-- and 12--months was validated. Caregivers answered demographic, medical, and environmental questions, and questions covering the sensorimotor, feeding/eating, sleep, speech/language, cognition, social-emotional, and attachment domains. METHODS: Expert Panel Reviews and Cognitive Interviews (CI) were conducted to validate the item bank. Classical Test Theory (CTT) and Item Response Theory (IRT) methods were employed to examine the dimensionality and psychometric properties of PediaTrac with pooled longitudinal and cross-sectional cohorts (N = 132). RESULTS: Intraclass correlation coefficients (ICC) for the Expert Panel Review revealed moderate agreement at 6 -months and good reliability at other sampling periods. ICC estimates for CI revealed moderate reliability regarding clarity of the items at NB and 4 months, good reliability at 2--, 9-- and 12--months and excellent reliability at 6 -months. CTT revealed good coefficient alpha estimates (α ≥ 0.77 for five of the six ages) for the Social-Emotional/Communication, Attachment (α ≥ 0.89 for all ages), and Sensorimotor (α ≥ 0.75 at 6-months) domains, revealing the need for better targeting of sensorimotor items. IRT modeling revealed good reliability (r = 0.85-0.95) for three distinct domains (Feeding/Eating, Social-Emotional/Communication and Attachment) and four subdomains (Feeding Breast/Formula, Feeding Solid Food, Social-Emotional Information Processing, Communication/Cognition). Convergent and discriminant construct validity were demonstrated between our IRT-modeled domains and constructs derived from existing developmental, behavioral and caregiver measures. Our Attachment domain was significantly correlated with existing measures at the NB and 2-month periods, while the Social-Emotional/Communication domain was highly correlated with similar constructs at the 6-, 9- and 12-month periods. CONCLUSION: PediaTrac has potential for producing novel and effective estimates of infant development via the Sensorimotor, Feeding/Eating, Social-Emotional/Communication and Attachment domains.

Considering Actionability at the Participant's Research Setting Level for Anticipatable Incidental Findings from Clinical Research.

Determining what constitutes an anticipatable incidental finding (IF) from clinical research and defining whether, and when, this IF should be returned to the participant have been topics of discussion in the field of human subject protections for the last 10 years. It has been debated that implementing a comprehensive IF-approach that addresses both the responsibility of researchers to return IFs and the expectation of participants to receive them can be logistically challenging. IFs have been debated at different levels, such as the ethical reasoning for considering their disclosure or the need for planning for them during the development of the research study. Some authors have discussed the methods for re-contacting participants for disclosing IFs, as well as the relevance of considering the clinical importance of the IFs. Similarly, other authors have debated about when IFs should be disclosed to participants. However, no author has addressed how the "actionability" of the IFs should be considered, evaluated, or characterized at the participant's research setting level. This paper defines the concept of "Actionability at the Participant's Research Setting Level" (APRSL) for anticipatable IFs from clinical research, discusses some related ethical concepts to justify the APRSL concept, proposes a strategy to incorporate APRSL into the planning and management of IFs, and suggests a strategy for integrating APRSL at each local research setting.

Paleolithic nutrition improves plasma lipid concentrations of hypercholesterolemic adults to a greater extent than traditional heart-healthy dietary recommendations.

Recent research suggests that traditional grain-based heart-healthy diet recommendations, which replace dietary saturated fat with carbohydrate and reduce total fat intake, may result in unfavorable plasma lipid ratios, with reduced high-density lipoprotein (HDL) and an elevation of low-density lipoprotein (LDL) and triacylglycerols (TG). The current study tested the hypothesis that a grain-free Paleolithic diet would induce weight loss and improve plasma total cholesterol, HDL, LDL, and TG concentrations in nondiabetic adults with hyperlipidemia to a greater extent than a grain-based heart-healthy diet, based on the recommendations of the American Heart Association. Twenty volunteers (10 male and 10 female) aged 40 to 62 years were selected based on diagnosis of hypercholesterolemia. Volunteers were not taking any cholesterol-lowering medications and adhered to a traditional heart-healthy diet for 4 months, followed by a Paleolithic diet for 4 months. Regression analysis was used to determine whether change in body weight contributed to observed changes in plasma lipid concentrations. Differences in dietary intakes and plasma lipid measures were assessed using repeated-measures analysis of variance. Four months of Paleolithic nutrition significantly lowered (P < .001) mean total cholesterol, LDL, and TG and increased (P < .001) HDL, independent of changes in body weight, relative to both baseline and the traditional heart-healthy diet. Paleolithic nutrition offers promising potential for nutritional management of hyperlipidemia in adults whose lipid profiles have not improved after following more traditional heart-healthy dietary recommendations.

Parent food purchases as a measure of exposure and preschool-aged children's willingness to identify and taste fruit and vegetables.

This study explored whether parents who purchase more fruit/vegetables have preschool-aged children who are able to identify fruit/vegetables and in turn are more likely to consume them. Sixty-two parent-child pairs were recruited during a 4-month period. The data collection included a child interview, a parent/guardian interview, a fruit/vegetable taste test for children, and a month-long food-receipt collection by the parent/guardian. As the percentage of fruit/vegetables purchased by parent increased, the child was more likely to accept all of the fruit/vegetables offered to him/her. A weak correlation was found between the child's ability to name fruit/vegetables and their willingness to try the fruit/vegetables offered. A trend was established between the child's ability to name the 10 fruits/vegetables and parent fruit/vegetable purchases. Parents who purchased the most fruit/vegetables, causing increased exposure, had children who were more willing to taste the fruit/vegetables offered to them.