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Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design
Gross, Rachel; Thaweethai, Tanayott; Rosenzweig, Erika B; Chan, James; Chibnik, Lori B; Cicek, Mine S; Elliott, Amy J; Flaherman, Valerie J; Foulkes, Andrea S; Witvliet, Margot Gage; Gallagher, Richard; Gennaro, Maria Laura; Jernigan, Terry L; Karlson, Elizabeth W; Katz, Stuart D; Kinser, Patricia A; Kleinman, Lawrence C; Lamendola-Essel, Michelle F; Milner, Joshua D; Mohandas, Sindhu; Mudumbi, Praveen C; Newburger, Jane W; Rhee, Kyung E; Salisbury, Amy L; Snowden, Jessica N; Stein, Cheryl R; Stockwell, Melissa S; Tantisira, Kelan G; Thomason, Moriah E; Truong, Dongngan T; Warburton, David; Wood, John C; Ahmed, Shifa; Akerlundh, Almary; Alshawabkeh, Akram N; Anderson, Brett R; Aschner, Judy L; Atz, Andrew M; Aupperle, Robin L; Baker, Fiona C; Balaraman, Venkataraman; Banerjee, Dithi; Barch, Deanna M; Baskin-Sommers, Arielle; Bhuiyan, Sultana; Bind, Marie-Abele C; Bogie, Amanda L; Buchbinder, Natalie C; Bueler, Elliott; Bükülmez, Hülya; Casey, B J; Chang, Linda; Clark, Duncan B; Clifton, Rebecca G; Clouser, Katharine N; Cottrell, Lesley; Cowan, Kelly; D'Sa, Viren; Dapretto, Mirella; Dasgupta, Soham; Dehority, Walter; Dummer, Kirsten B; Elias, Matthew D; Esquenazi-Karonika, Shari; Evans, Danielle N; Faustino, E Vincent S; Fiks, Alexander G; Forsha, Daniel; Foxe, John J; Friedman, Naomi P; Fry, Greta; Gaur, Sunanda; Gee, Dylan G; Gray, Kevin M; Harahsheh, Ashraf S; Heath, Andrew C; Heitzeg, Mary M; Hester, Christina M; Hill, Sophia; Hobart-Porter, Laura; Hong, Travis K F; Horowitz, Carol R; Hsia, Daniel S; Huentelman, Matthew; Hummel, Kathy D; Iacono, William G; Irby, Katherine; Jacobus, Joanna; Jacoby, Vanessa L; Jone, Pei-Ni; Kaelber, David C; Kasmarcak, Tyler J; Kluko, Matthew J; Kosut, Jessica S; Laird, Angela R; Landeo-Gutierrez, Jeremy; Lang, Sean M; Larson, Christine L; Lim, Peter Paul C; Lisdahl, Krista M; McCrindle, Brian W; McCulloh, Russell J; Mendelsohn, Alan L; Metz, Torri D; Morgan, Lerraughn M; Müller-Oehring, Eva M; Nahin, Erica R; Neale, Michael C; Ness-Cochinwala, Manette; Nolan, Sheila M; Oliveira, Carlos R; Oster, Matthew E; Payne, R Mark; Raissy, Hengameh; Randall, Isabelle G; Rao, Suchitra; Reeder, Harrison T; Rosas, Johana M; Russell, Mark W; Sabati, Arash A; Sanil, Yamuna; Sato, Alice I; Schechter, Michael S; Selvarangan, Rangaraj; Shakti, Divya; Sharma, Kavita; Squeglia, Lindsay M; Stevenson, Michelle D; Szmuszkovicz, Jacqueline; Talavera-Barber, Maria M; Teufel, Ronald J; Thacker, Deepika; Udosen, Mmekom M; Warner, Megan R; Watson, Sara E; Werzberger, Alan; Weyer, Jordan C; Wood, Marion J; Yin, H Shonna; Zempsky, William T; Zimmerman, Emily; Dreyer, Benard P
IMPORTANCE/UNASSIGNED:The prevalence, pathophysiology, and long-term outcomes of COVID-19 (post-acute sequelae of SARS-CoV-2 [PASC] or "Long COVID") in children and young adults remain unknown. Studies must address the urgent need to define PASC, its mechanisms, and potential treatment targets in children and young adults. OBSERVATIONS/UNASSIGNED:cohort incorporates three tiers of data collection: 1) remote baseline assessments (Tier 1, n=6000); 2) longitudinal follow-up for up to 4 years (Tier 2, n=6000); and 3) a subset of participants, primarily the most severely affected by PASC, who will undergo deep phenotyping to explore PASC pathophysiology (Tier 3, n=600). Youth enrolled in the ABCD study participate in Tier 1. The pediatric protocol was developed as a collaborative partnership of investigators, patients, researchers, clinicians, community partners, and federal partners, intentionally promoting inclusivity and diversity. The protocol is adaptive to facilitate responses to emerging science. CONCLUSIONS AND RELEVANCE/UNASSIGNED:RECOVER-Pediatrics seeks to characterize the clinical course, underlying mechanisms, and long-term effects of PASC from birth through 25 years old. RECOVER-Pediatrics is designed to elucidate the epidemiology, four-year clinical course, and sociodemographic correlates of pediatric PASC. The data and biosamples will allow examination of mechanistic hypotheses and biomarkers, thus providing insights into potential therapeutic interventions. CLINICAL TRIALSGOV IDENTIFIER/UNASSIGNED:Clinical Trial Registration: http://www.clinicaltrials.gov . Unique identifier: NCT05172011.
PMID: 37214806
CID: 5770522
Tiered universal and targeted early childhood interventions: Enhancing attendance across families with varying needs
Canfield, Caitlin F.; Miller, Elizabeth B.; Zhang, Yudong; Shaw, Daniel; Morris, Pamela; Galan, Chardee; Mendelsohn, Alan L.
This study examined whether a two-tiered parenting program, which provides universal primary prevention along with targeted secondary prevention only for families with increased needs, would have mutually beneficial impacts on attendance across two program components. A secondary analysis of the Smart Beginnings (SB) randomized controlled trial was conducted. SB takes place from birth to age 3 and combines universal delivery of the Video Interaction Project (VIP) with targeted delivery of the Family Check-Up (FCU) for families identified as having increased risks following yearly screening. The current study analyzed whether attendance in VIP in the first six months was associated with FCU attendance for eligible families at six months, and whether FCU attendance at six and 18 months was associated with subsequent VIP attendance. Analyses included logistic and mixed-effects Poisson regression, as well as group-based trajectory analysis. VIP attendance predicted later FCU attendance (AOR = 5.43, p <.01), and FCU attendance predicted later VIP attendance (IRR = 1.35, p <.01) and a high-stable VIP attendance trajectory (AOR=14.98, p <.01). Findings provide strong support for the ability of tiered models to engage parents, to promote effective and efficient service delivery to reduce disparities in school readiness, and their potential to overcome common barriers to attendance and scaling by addressing the heterogeneity of risk among low-income families.
SCOPUS:85146482262
ISSN: 0885-2006
CID: 5409012
Promoting Cognitive Stimulation in Parents across Infancy and Toddlerhood: A Randomized Clinical Trial
Miller, Elizabeth B; Roby, Erin; Zhang, Yudong; Coskun, Lerzan; Rosas, Johana M; Scott, Marc A; Gutierrez, Juliana; Shaw, Daniel S; Mendelsohn, Alan L; Morris-Perez, Pamela A
OBJECTIVE:To test the impact of the fully integrated Smart Beginnings model on parental support of cognitive stimulation from 6-24 months across infancy and toddlerhood. STUDY DESIGN/METHODS:Single-blind, two-site randomized clinical trial of the SB intervention. Enrollment took place at birth in postpartum units of hospitals in New York City and Pittsburgh, PA with a consecutive sample of 403 mother-infant dyads. SB combines Video Interaction Project (VIP) - 14-session universal primary prevention program delivered in the pediatric clinic at the time of well-child visits birth-36 months - with potential for Family Check-Up (FCU) - 3-4-session targeted secondary prevention home-visiting program. The principal outcome was parental support of cognitive stimulation assessed via parent survey and video-recorded observations of parent-child interactions. Ordinary least squares and mixed effects regressions were conducted. RESULTS:Families were mostly Black/African-American (50%) or Latinx (42%); all were Medicaid eligible (100%). SB significantly promoted cognitive stimulation during infancy and toddlerhood for most survey outcomes across time, including StimQ common total (Effect Size [ES]=.25, p=.01) and READ Quantity (ES=.19, p=.04) and Quality (ES=.30, p=.001). For the observations, the impact of SB varied by time, with significant impacts at 6 (ES=.37-.40, p<.001) and 24 (ES=.27-.30, p<.001) months, but not 18 months. CONCLUSIONS:SB positively promotes cognitive stimulation from infancy through toddlerhood using the integrated model. This study adds to the body of research showing preventive interventions in pediatric primary care and home visiting can support early relational health including parental support of cognitive stimulation.
PMID: 36481243
ISSN: 1097-6833
CID: 5383142
Validation of the StimQ2: A parent-report measure of cognitive stimulation in the home
Cates, Carolyn Brockmeyer; Roby, Erin; Canfield, Caitlin F; Johnson, Matthew; Raak, Caroline; Weisleder, Adriana; Dreyer, Benard P; Mendelsohn, Alan L
Considerable evidence demonstrates the importance of the cognitive home environment in supporting children's language, cognition, and school readiness more broadly. This is particularly important for children from low-income backgrounds, as cognitive stimulation is a key area of resilience that mediates the impact of poverty on child development. Researchers and clinicians have therefore highlighted the need to quantify cognitive stimulation; however existing methodological approaches frequently utilize home visits and/or labor-intensive observations and coding. Here, we examined the reliability and validity of the StimQ2, a parent-report measure of the cognitive home environment that can be delivered efficiently and at low cost. StimQ2 improves upon earlier versions of the instrument by removing outdated items, assessing additional domains of cognitive stimulation and providing new scoring systems. Findings suggest that the StimQ2 is a reliable and valid measure of the cognitive home environment for children from infancy through the preschool period.
PMCID:10365315
PMID: 37486914
ISSN: 1932-6203
CID: 5591962
Validation of Parenting Your Baby and Parenting Your Toddler and Associations with Engagement in Parenting Intervention
Guyon-Harris, Katherine L.; Rosas, Johana; Dolcini-Catania, Luciano; Mendelsohn, Alan; Morris, Pamela; Gill, Anne; Shaw, Daniel S.
ISI:000983747100001
ISSN: 1062-1024
CID: 5496092
Pre-pandemic support for shared reading buffers adverse parenting impacts: an RCT in Brazil
Piccolo, Luciane R; Oliveira, João B A; Hirata, Guilherme; Canfield, Caitlin F; Roby, Erin; Mendelsohn, Alan L
BACKGROUND:To examine whether (1) a parent-child reading program (Universidade do Bebê [UBB]), conducted in Brazil pre-pandemic can support parenting and parent-child reading 6 months into the pandemic, (2) cognitive stimulation at pandemic onset mediates effects of UBB on these outcomes, and (3) UBB pre-pandemic buffers associations between COVID-19-related distress and parenting/parent-child reading 6 months into the pandemic. METHODS:400 women, either pregnant or with children 0-24 months, were randomized to UBB (n = 200) or control groups. UBB consisted of monthly parent workshops focusing on parent-child reading and a book-lending library. Assessments pre-pandemic (June-2019) and at pandemic onset (April-2020) included cognitive stimulation. Assessments 6 months into the pandemic (October-2020) included COVID-19 exposure/impact/distress, as well as parenting and parent-child reading. RESULTS:133 families (n = 69 UBB) contributed data 6 months into the pandemic. Participation in UBB pre-pandemic was associated with parent-child reading but not parenting 6 months into the pandemic. Indirect effects of UBB through cognitive stimulation at pandemic onset were observed for both outcomes. Increased COVID-19-related distress was significantly associated with reduced parenting/parent-child reading 6 months into the pandemic in the control group only. CONCLUSION/CONCLUSIONS:Promotion of cognitive stimulation pre-pandemic may have reduced risk for effects of the pandemic on parenting/parent-child reading. CLINICAL TRIAL REGISTRATION/BACKGROUND:The trial has been registered with the Brazilian Clinical Trials Registry RBR-29RZDH on 05/28/2018. IMPACT/CONCLUSIONS:This is the first study showing sustained impacts of a reading aloud intervention beginning in pregnancy and early infancy implemented pre-pandemic. Findings suggest that participation in a reading-aloud intervention buffered associations between COVID-19 distress and parenting/parent-child reading 6 months into the pandemic. Novel empirical evidence suggests that promotion of cognitive stimulation prior to the pandemic may buffer its impacts on parenting and parent-child book reading following onset in low- and middle-income countries. Findings provide important new support for implementation of parent-child reading aloud programs and likely have implications for early childhood development beyond the COVID-19 pandemic for disasters generally.
PMCID:9753875
PMID: 36522551
ISSN: 1530-0447
CID: 5382432
Supporting Reading Aloud Beginning Prenatally and in Early Infancy: A Randomized Trial in Brazil
Piccolo, Luciane R; Batista Araujo Oliveira, João; Hirata, Guilherme; Duarte Neto, Walfrido; Mendelsohn, Alan L
OBJECTIVE:A previous study of a reading aloud intervention in Brazil, called Universidade do Bebê (UBB), demonstrated impacts on parenting and child outcomes for families with toddlers and preschoolers, even for parents with low literacy, and cognitive stimulation mediated effects on child outcomes. In a new study, we sought to determine whether similar results would be found when UBB was provided beginning in pregnancy through early toddlerhood, including (1) impacts on parenting and child development, (2) variation in impact on parenting and child outcomes by parent literacy level, and (3) indirect impacts on child outcomes through cognitive stimulation. METHOD/METHODS:Women with low income who were either pregnant or with children aged 0 to 24 months were randomized to UBB or control groups. UBB consisted of monthly workshops focused on reading aloud complemented by a book-lending library. Participants were evaluated at baseline and approximately 11 months later (M = 11.0, SD = 0.4; range 9.9-12.2 months) on parenting (cognitive stimulation, beliefs about early reading, screen time, and discipline) and child development. RESULTS:Four hundred families (n = 200 UBB) were randomized; 286 (71.5%; n = 150 UBB) received 11-month follow-up. UBB families showed increased cognitive stimulation (Cohen's d = 0.92) and awareness about the importance of early reading (d = 0.90) than controls, with no differences by parent literacy level. UBB was associated with reduced screen time and increased vocabulary, but only for families with low parent literacy. UBB effects on child outcomes were mediated by cognitive stimulation. CONCLUSION/CONCLUSIONS:The findings support implementation of reading aloud programs beginning in pregnancy and early childhood.
PMID: 36103251
ISSN: 1536-7312
CID: 5336252
Effects of maternal trauma and associated psychopathology on atypical maternal behavior and infant social withdrawal six months postpartum
Burtchen, Nina; Alvarez-Segura, Mar; Urben, Sébastien; Giovanelli, Chiara; Mendelsohn, Alan L; Guedeney, Antoine; Schechter, Daniel S
UNLABELLED:Maternal psychopathology given a history of maltreatment and domestic violence exposure increases the risk for child psychopathology. Infant social withdrawal is one warning sign of adverse developmental outcomes including child anxiety and depression. It remains unclear how maternal trauma-related psychopathology might affect infant social withdrawal six-months postpartum. METHODS:One-hundred ninety-five women and their six-month-old infants were studied in an at-risk community sample. Maternal trauma history, posttraumatic stress (PTSD) and major depressive (MDD) disorders were assessed. Maternal and infant behaviors were coded from videotaped interactions. RESULTS:Maternal trauma was correlated with atypical maternal behavior (AMB) and infant social withdrawal (p ≤ .001). PTSD and MDD, and comorbid PTSD/MDD predicted increased AMB (p ≤ .001) but only maternal MDD was predictive of infant social withdrawal (p ≤ .001). Effects of maternal MDD on infant withdrawal were mediated by AMB. CONCLUSIONS:At six-months postpartum, maternal MDD was associated with infant withdrawal. AMB is an important target for early intervention.
PMID: 36371796
ISSN: 1469-2988
CID: 5384692
Collateral benefits from a school-readiness intervention on breastfeeding: A cross-domain impact evaluation
Miller, Elizabeth B; Whipps, Mackenzie D M; Bogen, Debra L; Morris, Pamela A; Mendelsohn, Alan L; Shaw, Daniel S; Gross, Rachel S
This study evaluated the collateral, or unanticipated, impacts of Smart Beginnings (SB), a two-site, tiered intervention designed to promote responsive parenting and school readiness, on breastfeeding intensity in a low-income sample. Impact analyses for the SB intervention were conducted using an intent-to-treat design leveraging a two-arm random assignment structure. Mothers assigned to the SB intervention group were more than three times more likely to give breastmilk as the only milk source at infant age 6 months than mothers assigned to the control group at one site, an effect not evident at the other study site. As development and growth are the two most salient domains of child health, understanding how interventions impact subsequent parenting practices across both domains is critical to address long-term economic and racial/ethnic disparities. Implications of the findings are discussed for improving the efficacy of interventions based on paediatric primary care.
PMID: 36218286
ISSN: 1740-8709
CID: 5348182
Housing Insecurity, Housing Conditions, and Breastfeeding Behaviors for Medicaid-Eligible Families in Urban Settings
Reno, Rebecca; Whipps, Mackenzie; Wallenborn, Jordyn T; Demirci, Jill; Bogen, Debra L; Gross, Rachel S; Mendelsohn, Alan L; Morris, Pamela A; Shaw, Daniel S
BACKGROUND/UNASSIGNED:Research exploring associations between exposure to social determinants of health and breastfeeding is needed to identify breastfeeding barriers. Housing insecurity and household conditions (chaos and crowding) may affect breastfeeding by increasing maternal stress and discomfort and decreasing time available to breastfeed. RESEARCH AIM/UNASSIGNED:We aimed to examine the relationships between housing insecurity, breastfeeding exclusivity intention during the early postnatal period, and breastfeeding exclusivity at 6 months postpartum among a sample "at risk" for suboptimal breastfeeding rates. METHODS/UNASSIGNED:= 361) at near-birth and child aged 6 months, in New York City and Pittsburgh. Structural equation modeling was used to examine direct and indirect effects of housing insecurity on breastfeeding exclusivity at child aged 6 months. RESULTS/UNASSIGNED:The path model showed that experiencing more markers of housing insecurity (i.e., foreclosure/eviction threat, history of homelessness, late rent) was predictive of significantly lower breastfeeding exclusivity at 6 months. This was partially mediated through less exclusive breastfeeding intention during the early postnatal period. Greater household crowding was associated with 6-month breastfeeding exclusivity when mediated by intention. Household crowding had differential effects by study site and participant race/ethnicity. CONCLUSION/UNASSIGNED:Refinement of housing insecurity as a multi-dimensional construct can lead to the development of standardized data collection instruments, inform future methodological decisions in research addressing social determinants of health, and can inform the development of responsive individual- and structural-level interventions.The data used in this study were collected as part of the SMART Beginnings Randomized Controlled Trial (NCT02459327 registered at ClinicalTrials.gov).
PMID: 35775199
ISSN: 1552-5732
CID: 5281452