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...

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Main Authors: H Gerry Taylor, Renee Lajiness-O'Neill, Seth Warschausky, Alissa Huth-Bocks, Judith Brooks, Angela Lukomski, Trivellore Eachambadi Raghunathan, Patricia Berglund, Angela D Staples, Laszlo Erdodi, Stephen Schilling
Format: Article
Language:English
Published: BMJ Publishing Group 2021-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/11/12/e050488.full
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author H Gerry Taylor
Renee Lajiness-O'Neill
Seth Warschausky
Alissa Huth-Bocks
Judith Brooks
Angela Lukomski
Trivellore Eachambadi Raghunathan
Patricia Berglund
Angela D Staples
Laszlo Erdodi
Stephen Schilling
author_facet H Gerry Taylor
Renee Lajiness-O'Neill
Seth Warschausky
Alissa Huth-Bocks
Judith Brooks
Angela Lukomski
Trivellore Eachambadi Raghunathan
Patricia Berglund
Angela D Staples
Laszlo Erdodi
Stephen Schilling
author_sort H Gerry Taylor
collection DOAJ
description 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.
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spelling doaj-art-69658daedbe9426da01212072f9368fa2025-08-20T02:20:12ZengBMJ Publishing GroupBMJ Open2044-60552021-12-01111210.1136/bmjopen-2021-050488PediaTrac 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 monthsH Gerry Taylor0Renee Lajiness-O'Neill1Seth Warschausky2Alissa Huth-Bocks3Judith Brooks4Angela Lukomski5Trivellore Eachambadi Raghunathan6Patricia Berglund7Angela D Staples8Laszlo Erdodi9Stephen Schilling10Department of Pediatrics, Case Western Reserve University and Rainbow Babies & Children`s Hospital, Cleveland, Ohio, USAPsychology, Eastern Michigan University, Ypsilanti, Michigan, USAPhysical Medicine and Rehabilitation, University of Michigan Michigan Medicine, Ann Arbor, Michigan, USAPediatrics, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USADietetics and Human Nutrition, Eastern Michigan University, Ypsilanti, Michigan, USANursing, Eastern Michigan University, Ypsilanti, Michigan, USASurvey Research Center, Institute for Social Research, University of Michigan Institute for Social Research, Ann Arbor, Michigan, USASurvey Research Center, Institute for Social Research, University of Michigan Institute for Social Research, Ann Arbor, Michigan, USAPsychology, Eastern Michigan University, Ypsilanti, Michigan, USAPsychology, University of Windsor, Windsor, Ontario, CanadaSurvey Research Center, Institute for Social Research, University of Michigan Institute for Social Research, Ann Arbor, Michigan, USAIntroduction 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.https://bmjopen.bmj.com/content/11/12/e050488.full
spellingShingle H Gerry Taylor
Renee Lajiness-O'Neill
Seth Warschausky
Alissa Huth-Bocks
Judith Brooks
Angela Lukomski
Trivellore Eachambadi Raghunathan
Patricia Berglund
Angela D Staples
Laszlo Erdodi
Stephen Schilling
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
BMJ Open
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url https://bmjopen.bmj.com/content/11/12/e050488.full
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