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2. Perspectives on the Initial Adoption of Multitiered Systems of Support for Behavior

Author

Lloyd, Blair P., Carter, Erik W., Shuster, Brooke C., Axelroth, Tara L., Davis, A. Dia, Hine, Melissa C., Porritt, Marilynn M., Haynes, Rebecca L., Fareed, Sunya A., and Slaughter, James C.

Abstract

Although the number of U.S. schools implementing multitiered systems of support for behavior (MTSS-B) continues to grow, most schools have still not adopted these evidence-based frameworks. We examined the views of educators (N = 561) at the outset of adopting MTSS-B in their schools or districts. Our survey addressed the (a) reasons schools and districts decided to adopt MTSS-B, (b) challenges they anticipated with respect to implementation, and (c) expected outcomes of MTSS-B. We also compared views across three groups of stakeholders: local school team members, building administrators, and district representatives. Although most participants reported multiple motivations for adopting MTSS-B, concerns about student behavior and the need for staff support in this area were among the primary reasons. Anticipated challenges varied by group, with district representatives affirming those challenges most strongly. Responses also suggest these stakeholders have high expectations regarding the impact of MTSS-B in their school or district. We discuss implications for technical assistance providers related to supporting a more widespread adoption of MTSS-B.

Published
2023
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3. A Longitudinal RCT of P-ESDM with and without Parental Mindfulness Based Stress Reduction: Impact on Child Outcomes

Author

Weitlauf, Amy S., Broderick, Neill, Alacia Stainbrook, J., Slaughter, James C., Taylor, Julie Lounds, Herrington, Catherine G., Nicholson, Amy G., Santulli, Madeline, Dorris, Kristin, Garrett, LaTamara Jackson, Hopton, Michelle, Kinsman, Amy, Morton, Mary, Vogel, Ashley, Dykens, Elisabeth M., Pablo Juárez, A., and Warren, Zachary E.

Abstract

This randomized controlled trial (NCT03889821) examined Mindfulness Based Stress Reduction (MBSR) in conjunction with the Parent-implemented Early Start Denver Model (P-ESDM). A previous report described improved metrics of parental distress (Weitlauf et al. in Pediatrics 145(Supplement 1):S81-S92, 2020). This manuscript examines child outcomes. 63 children with ASD (< 36 months) and their parents received 12 P-ESDM sessions. Half of parents also received MBSR. Longitudinal examination of whole sample means revealed modest improvements in autism severity, cognitive, and adaptive skills. There was not a significant time × group interaction for children whose parents received MBSR. Future work should examine more proximal markers of child or dyadic change to enhance understanding of the impact of providing direct treatment for parents as part of early intervention initiatives.

Published
2022
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7. COVID-19 Severity Is Tripled in the Diabetes Community: A Prospective Analysis of the Pandemic’s Impact in Type 1 and Type 2 Diabetes

Author

Gregory, Justin M, Slaughter, James C, Duffus, Sara H, Smith, T Jordan, LeStourgeon, Lauren M, Jaser, Sarah S, McCoy, Allison B, Luther, James M, Giovannetti, Erin R, Boeder, Schafer, Pettus, Jeremy H, and Moore, Daniel J

Subjects
Diabetes, Prevention, Clinical Research, Infectious Diseases, Metabolic and endocrine, Good Health and Well Being, COVID-19, Comorbidity, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Electronic Health Records, Female, Hospitalization, Humans, Hypertension, Male, Middle Aged, Odds Ratio, Prospective Studies, Severity of Illness Index
Abstract

ObjectiveTo quantify and contextualize the risk for coronavirus disease 2019 (COVID-19)-related hospitalization and illness severity in type 1 diabetes.Research design and methodsWe conducted a prospective cohort study to identify case subjects with COVID-19 across a regional health care network of 137 service locations. Using an electronic health record query, chart review, and patient contact, we identified clinical factors influencing illness severity.ResultsWe identified COVID-19 in 6,138, 40, and 273 patients without diabetes and with type 1 and type 2 diabetes, respectively. Compared with not having diabetes, people with type 1 diabetes had adjusted odds ratios of 3.90 (95% CI 1.75-8.69) for hospitalization and 3.35 (95% CI 1.53-7.33) for greater illness severity, which was similar to risk in type 2 diabetes. Among patients with type 1 diabetes, glycosylated hemoglobin (HbA1c), hypertension, race, recent diabetic ketoacidosis, health insurance status, and less diabetes technology use were significantly associated with illness severity.ConclusionsDiabetes status, both type 1 and type 2, independently increases the adverse impacts of COVID-19. Potentially modifiable factors (e.g., HbA1c) had significant but modest impact compared with comparatively static factors (e.g., race and insurance) in type 1 diabetes, indicating an urgent and continued need to mitigate severe acute respiratory syndrome coronavirus 2 infection risk in this community.

Published
2021

8. A Longitudinal RCT of P-ESDM With and Without Parental Mindfulness Based Stress Reduction: Impact on Child Outcomes

Author

Weitlauf, Amy S., Broderick, Neill, Alacia Stainbrook, J., Slaughter, James C., Taylor, Julie Lounds, Herrington, Catherine G., and Nicholson, Amy G.

Subjects
Stress management -- Evaluation, Parenting -- Methods -- Evaluation, Autistic children -- Family -- Care and treatment, Mindfulness meditation -- Evaluation, Health
Abstract

This randomized controlled trial (NCT03889821) examined Mindfulness Based Stress Reduction (MBSR) in conjunction with the Parent-implemented Early Start Denver Model (P-ESDM). A previous report described improved metrics of parental distress (Weitlauf et al. in Pediatrics 145(Supplement 1):S81-S92, 2020). This manuscript examines child outcomes. 63 children with ASD (< 36 months) and their parents received 12 P-ESDM sessions. Half of parents also received MBSR. Longitudinal examination of whole sample means revealed modest improvements in autism severity, cognitive, and adaptive skills. There was not a significant time x group interaction for children whose parents received MBSR. Future work should examine more proximal markers of child or dyadic change to enhance understanding of the impact of providing direct treatment for parents as part of early intervention initiatives., Author(s): Amy S. Weitlauf [sup.1] , Neill Broderick [sup.1] , J. Alacia Stainbrook [sup.1] , James C. Slaughter [sup.2] , Julie Lounds Taylor [sup.1] , Catherine G. Herrington [sup.1] , [...]

Published
2022
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13. Rate of Change in Cardiac Magnetic Resonance Imaging Measures Is Associated With Death in Duchenne Muscular Dystrophy

Author

Starnes, Joseph R., primary, Xu, Meng, additional, George‐Durrett, Kristen, additional, Crum, Kimberly, additional, Raucci, Frank J., additional, Spurney, Christopher F., additional, Hor, Kan N., additional, Cripe, Linda H., additional, Husain, Nazia, additional, Buddhe, Sujatha, additional, Gambetta, Katheryn, additional, Tamaroff, Jaclyn, additional, Slaughter, James C., additional, Markham, Larry W., additional, and Soslow, Jonathan H., additional

Published
2024
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17. A combination of two human neutralizing antibodies prevents SARS-CoV-2 infection in cynomolgus macaques

Author

Cobb, Ronald R., Nkolola, Joseph, Gilchuk, Pavlo, Chandrashekar, Abishek, Yu, Jingyou, House, Robert V., Earnhart, Christopher G., Dorsey, Nicole M., Hopkins, Svetlana A., Snow, Doris M., Chen, Rita E., VanBlargan, Laura A., Hechenblaickner, Manuel, Hoppe, Brian, Collins, Laura, Tomic, Milan T., Nonet, Genevieve H., Hackett, Kyal, Slaughter, James C., Lewis, Mark G., Andersen, Hanne, Cook, Anthony, Diamond, Michael S., Carnahan, Robert H., Barouch, Dan H., and Crowe, James E., Jr.

Published
2022
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18. Hydroxyurea for primary stroke prevention in children with sickle cell anaemia in Nigeria (SPRING): a double-blind, multicentre, randomised, phase 3 trial

Author

Abdullahi, Shehu U, Jibir, Binta W, Bello-Manga, Halima, Gambo, Safiya, Inuwa, Hauwa, Tijjani, Aliyu G, Idris, Nura, Galadanci, Aisha, Hikima, Mustapha S, Galadanci, Najibah, Borodo, Awwal, Tabari, Abdulkadir M, Haliru, Lawal, Suleiman, Aisha, Ibrahim, Jamila, Greene, Brittany C, Ghafuri, Djamila L, Rodeghier, Mark, Slaughter, James C, Kirkham, Fenella J, Neville, Kathleen, Kassim, Adetola, Trevathan, Edwin, Jordan, Lori C, Aliyu, Muktar H, and DeBaun, Michael R

Published
2022
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19. Provider-ordered viral testing and antibiotic administration practices among children with acute respiratory infections across healthcare settings in Nashville, Tennessee

Author

Rankin, Danielle A., primary, Katz, Sophie E., additional, Amarin, Justin Z., additional, Hayek, Haya, additional, Stewart, Laura S., additional, Slaughter, James C., additional, Deppen, Stephen, additional, Yanis, Ahmad, additional, Romero, Yesenia Herazo, additional, Chappell, James D., additional, Khankari, Nikhil K., additional, and Halasa, Natasha B., additional

Published
2024
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39. IκB Kinase Activity Drives Fetal Lung Macrophage Maturation along a Non-M1/M2 Paradigm

Author

Stouch, Ashley N, Zaynagetdinov, Rinat, Barham, Whitney J, Stinnett, Amanda M, Slaughter, James C, Yull, Fiona E, Hoffman, Hal M, Blackwell, Timothy S, and Prince, Lawrence S

Subjects
Lung, Pediatric, Perinatal Period - Conditions Originating in Perinatal Period, Preterm, Low Birth Weight and Health of the Newborn, Infant Mortality, 1.1 Normal biological development and functioning, 2.1 Biological and endogenous factors, Aetiology, Underpinning research, Respiratory, Reproductive health and childbirth, Animals, Animals, Newborn, Biomarkers, Cell Differentiation, Enzyme Activation, Female, Gene Expression Regulation, Developmental, Gene Expression Regulation, Enzymologic, Humans, I-kappa B Kinase, Immunophenotyping, Inflammation, Lung Diseases, Macrophage Activation, Macrophages, Alveolar, Macrophages, Peritoneal, Male, Mice, Mice, Inbred C57BL, Mice, Transgenic, Immunology
Abstract

In preterm infants, exposure to inflammation increases the risk of bronchopulmonary dysplasia, a chronic, developmental lung disease. Although macrophages are the key cells that initiate lung inflammation, less is known about lung macrophage phenotype and maturation. We hypothesized that fetal lung macrophages mature into distinct subpopulations during mouse development, and that activation could influence macrophage maturation. Expression of the fetal macrophage markers CD68, CD86, CD206, Ym1, fibrinogen-like protein 2, and indolamine-2, 3-dioxygenase was developmentally regulated, with each marker having different temporal patterns. Flow cytometry analysis showed macrophages within the fetal lung were less diverse than the distinctly separate subpopulations in newborn and adult lungs. Similar to adult alveolar macrophages, fetal lung macrophages responded to the TLR4 agonist LPS and the alternative activation cytokines IL-4 and IL-13. Using a macrophage-specific constitutively active IκB Kinase transgenic model (IKFM), we demonstrated that macrophage activation increased proinflammatory gene expression and reduced the response of fetal lung macrophages to IL-4 and IL-13. Activation also increased fetal lung macrophage proliferation. Fetal IKFM lungs contained increased percentages of more mature, CD11b(low)F4/80(high) cells that also expressed higher levels of the alternative activation markers CD204 and CD206. Development of fetal lung macrophages into mature alveolar macrophages may therefore include features of both proinflammatory and alternative activation paradigms.

Published
2014

48. Perspectives from the Society for Pediatric Research. Neonatal encephalopathy clinical trials: developing the future

Author

Benninger, Kristen L., Inder, Terrie E., Goodman, Amy M., Cotten, C. Michael, Nordli, Douglas R., Shah, Tushar A., Slaughter, James C., and Maitre, Nathalie L.

Abstract

Abstract: The next phase of clinical trials in neonatal encephalopathy (NE) focuses on hypothermia adjuvant therapies targeting alternative recovery mechanisms during the process of hypoxic brain injury. Identifying infants eligible for neuroprotective therapies begins with the clinical detection of brain injury and classification of severity. Combining a variety of biomarkers (serum, clinical exam, EEG, movement patterns) with innovative clinical trial design and analyses will help target infants with the most appropriate and timely treatments. The timing of magnetic resonance imaging (MRI) and MR spectroscopy after NE both assists in identifying the acute perinatal nature of the injury (days 3–7) and evaluates the full extent and evolution of the injury (days 10–21). Early, intermediate outcome of neuroprotective interventions may be best defined by the 21-day neuroimaging, with recognition that the full neurodevelopmental trajectory is not yet defined. An initial evaluation of each new therapy at this time point may allow higher-throughput selection of promising therapies for more extensive investigation. Functional recovery can be assessed using a trajectory of neurodevelopmental evaluations targeted to a prespecified and mechanistically derived hypothesis of drug action. As precision medicine revolutionizes healthcare, it should also include the redesign of NE clinical trials to allow safe, efficient, and targeted therapeutics. Impact:

As precision medicine revolutionizes healthcare, it should also include the redesign of NE clinical trials to allow faster development of safe, effective, and targeted therapeutics.

This article provides a multidisciplinary perspective on the future of clinical trials in NE; novel trial design; study management and oversight; biostatistical methods; and a combination of serum, imaging, and neurodevelopmental biomarkers can advance the field and improve outcomes for infants affected by NE.

Innovative clinical trial designs, new intermediate trial end points, and a trajectory of neurodevelopmental evaluations targeted to a prespecified and mechanistically derived hypothesis of drug action can help address common challenges in NE clinical trials and allow for faster selection and validation of promising therapies for more extensive investigation.

Published
2024
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