3 research outputs found
Maternal Experiences of Parenting Children with Autism Spectrum Disorder: A Qualitative Analysis
Despite the increased prevalence rates of autism spectrum disorders (ASD) over the last two decades (Centers for Disease Control and Prevention, 2015), little is known about the parenting of children with ASD, including parenting behaviors, parent-child interactions, and how the specific characteristics of children with ASD affect parenting practices. The goals of this qualitative study were: (1) To explore parenting practices and behaviors among mothers of children with ASD; and (2) To illuminate the unique experiences of mothers raising children with ASD. Three research questions guided the inquiry: 1) What are the parenting practices and behaviors that mothers use with their preschool age children with ASD?; 2) What are the beliefs and experiences of mothers relative to raising preschool aged children with ASD?; and 3) What facilitates or hinders mothers' parenting of their preschool aged children with ASD? In this qualitative inquiry, six mothers and their preschool-age children with ASD were recruited from the Autism Center in a metropolitan children's hospital. Each mother participated in three 1-1 ½ hour long semi-structured audio-recorded interviews that entailed a series of open-ended questions about the unique experiences associated with raising a child with ASD. Two home observations and one public observation of mother-child interactions lasting 1-2 hours in length were conducted per family. Eleven themes emerged during the coding process: 1) positivity within the mother-child relationship, 2) schedules and routines, 3) strategies encouraging child cooperation, 4) crisis management, 5) perspectives on child's maladaptive behavior, 6) perspectives on child's abilities, 7) perceptions and experiences around public interfacing, 8) stress associated with caring for a child with ASD, 9) maternal resources, 10) interpersonal supports, and 11) ecological factors. These results shed light on factors that contribute to the everyday realities and experiences of parents who have children with ASD, thereby allowing for a more accurate understanding of their parenting approaches and behaviors. Findings from this study can be considered in the context of developing interventions focused on parenting children with ASD
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Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial
We aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19.
In this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978.
Between Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50–72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74–1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67–1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74–1·58]; BRII-196 plus BRII-198 1·00 [0·68–1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91–1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88–1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90.
Neither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19.
US National Institutes of Health and Operation Warp Spee