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IntroductionOne in seven (14%) children aged 4–17 years old meet criteria for a mental illness over a 12-month period. The majority of these children have difficulty accessing clinical assessment and treatment despite evidence demonstrating the importance of early intervention. Schools are increasingly recognised as universal platforms where children with mental health concerns could be identified and supported. However, educators have limited training or access to clinical support in this area.Methods and analysisThis study is a pilot cluster randomised controlled trial of a co-designed health and education model aiming to improve educator identification and support of children with emotional and behavioural difficulties. Twelve Victorian government primary schools representing a range of socio-educational communities will be recruited from metropolitan and rural regions, with half of the schools being randomly allocated to the intervention. Caregivers and educators of children in grades 1–3 will be invited to participate. The intervention is likely to involved regular case-based discussions and paediatric support.Ethics and disseminationInformed consent will be obtained from each participating school, educator and caregiver. Participants are informed of their voluntary participation and ability to withdrawal at any time. Participant confidentiality will be maintained and data will be secured on a password protected, restricted access database on the Murdoch Children’s Research Institute server. Results will be disseminated via peer-reviewed journals and conference presentations. Schools and caregivers will be provided with a report of the study outcomes and implications at the completion of the study.Trial registration numberACTRN12621000652875.

BackgroundObstructive sleep apnoea (OSA) is highly prevalent in people with spinal cord injury (SCI). Polysomnography (PSG) is the gold-standard diagnostic test for OSA, however PSG is expensive and frequently inaccessible, especially in SCI. A two-stage model, incorporating a questionnaire followed by oximetry, has been found to accurately detect moderate to severe OSA (MS-OSA) in a non-disabled primary care population. This study investigated the accuracy of the two-stage model in chronic tetraplegia using both the original model and a modified version for tetraplegia.MethodsAn existing data set of 78 people with tetraplegia was used to modify the original two-stage model. Multivariable analysis identified significant risk factors for inclusion in a new tetraplegia-specific questionnaire. Receiver operating characteristic (ROC) curve analyses of the questionnaires and oximetry established thresholds for diagnosing MS-OSA. The accuracy of both models in diagnosing MS-OSA was prospectively evaluated in 100 participants with chronic tetraplegia across four international SCI units.ResultsInjury completeness, sleepiness, self-reported snoring and apnoeas were included in the modified questionnaire, which was highly predictive of MS-OSA (ROC area under the curve 0.87 (95% CI 0.79 to 0.95)). The 3% oxygen desaturation index was also highly predictive (0.93 (0.87–0.98)). The two-stage model with modified questionnaire had a sensitivity and specificity of 83% (66–93) and 88% (75–94) in the development group, and 77% (65–87) and 81% (68–90) in the validation group. Similar results were demonstrated with the original model.ConclusionImplementation of this simple alternative to full PSG could substantially increase the detection of OSA in patients with tetraplegia and improve access to treatments.Trial registration numberResults, ACTRN12615000896572 (The Australian and New Zealand Clinical Trials Registry) and pre-results, NCT02176928 (clinicaltrials.gov).

IntroductionInfants born very preterm (VPT, <32 weeks’ gestation) are at increased risk for neurodevelopmental impairments including motor, cognitive and behavioural delay. Parents of infants born VPT also have poorer mental health outcomes compared with parents of infants born at term.We have developed an intervention programme called TEDI-Prem (Telehealth for Early Developmental Intervention in babies born very preterm) based on previous research. TEDI-Prem aims to improve neurodevelopmental outcomes and parental well-being in children born VPT. Here we present the protocol outlining a multicentre, pragmatic, parallel-group, randomised controlled trial to determine the efficacy of TEDI-Prem plus usual care, compared with usual care alone.Methods and analysisWe will recruit 466 VPT infants from the neonatal units of five hospitals in Victoria, Australia. Participants will be randomised, stratified by site of recruitment and multiple births, to TEDI-Prem plus usual care or usual care alone. The TEDI-Prem intervention programme involves 13 sessions across three phases. Phase 1 commences in the neonatal unit with four face-to-face sessions with parent/s and a physiotherapist/occupational therapist. Once discharged from the hospital, sessions across phases 2 and 3 (six and three sessions, respectively) continue via telehealth until infants are 12 months’ corrected age (CA).The primary outcome is the Bayley Scales of Infant and Toddler Development-fourth edition (Bayley-4) Motor Composite Score at 12 months’ CA. Secondary outcomes address other neurodevelopmental domains (Bayley-4 cognitive and language composite score; Infant Toddler Social Emotional Assessment), parental mental health (Depression Anxiety and Stress Scale 21), parent–child interaction (Emotional Availability Scale) and programme cost-effectiveness which encompasses parent quality of life (Short-Form Six-Dimension Quality of Life) and child quality of life (EuroQol Toddler and Infant Populations measure) at 12 and 24 months’ CA.Mean differences between groups will be examined using linear regression for continuous outcomes and logistic regression for binary outcomes. All models will be fitted via generalised estimating equations to account for multiple births and adjusted for the hospital sites.Ethics and disseminationThis trial has Royal Children’s Hospital Human Research and Ethics Committee approval (HREC/67604/RCHM-2020) with specific site approval for all participating sites. Findings will be disseminated through peer-reviewed publications, conference presentations, digital and print media and to participants.Trial egistration numberThis trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12621000364875).

Background Understanding how and why de-implementation of low-value practices is sustained remains unclear. The Paediatric Research in Emergency Departments International CollaboraTive (PREDICT) Bronchiolitis Knowledge Translation (KT) Study was a cluster randomised controlled trial conducted in 26 Australian and New Zealand hospitals (May-November 2017). Results showed targeted, theory-informed interventions (clinical leads, stakeholder meetings, train-the-trainer workshop, targeted educational package, audit/feedback) were effective at reducing use of five low-value practices for bronchiolitis (salbutamol, glucocorticoids, antibiotics, adrenaline and chest x-ray) by 14.1% in acute care settings. The primary aim of this study is to determine the sustainability (continued receipt of benefits) of these outcomes at intervention hospitals two-years after the removal of study supports. Secondary aims are to determine sustainability at one-year after removal of study support at intervention hospitals; improvements one-and-two years at control hospitals; and explore factors that influence sustainability at intervention hospitals and contribute to improvements at control hospitals. Methods A mixed-methods study design. The quantitative component is a retrospective medical record audit of bronchiolitis management within 24 hours of emergency department (ED) presentations at 26 Australian ( n  = 20) and New Zealand ( n  = 6) hospitals, which participated in the PREDICT Bronchiolitis KT Study. Data for a total of 1800 infants from intervention and control sites (up to 150 per site) will be collected to determine if improvements (i.e., no use of all five low-value practices) were sustained two- years (2019) post-trial (primary outcome; composite score); and a further 1800 infants from intervention and control sites will be collected to determine sustained improvements one- year (2018) post-trial (secondary outcome). An a priori definition of sustainability will be used. The qualitative component will consist of semi-structured interviews with three to five key emergency department and paediatric inpatient medical and nursing staff per site (total n  = 78-130). Factors that may have contributed to sustaining outcomes and/or interventions will be explored and mapped to an established sustainability framework. Discussion This study will improve our understanding of the sustainability of evidence-based bronchiolitis management in infants. Results will also advance implementation science research by informing future de-implementation strategies to reduce low-value practices and sustain practice change in paediatric acute care. Trial registration Australian and New Zealand Clinical Trials Registry No: ACTRN12621001287820.

Background Up to 60% of children with Attention-Deficit/Hyperactivity Disorder (ADHD) meet diagnostic criteria for at least one anxiety disorder, including Social, Generalized and/or Separation Disorder. Anxiety in children with ADHD has been shown to be associated with poorer child and family functioning. Small pilot studies suggest that treating anxiety in children with ADHD using cognitive-behavioral therapy (CBT) has promising benefits. In a fully powered randomized controlled trial (RCT), we aim to investigate the efficacy of an existing CBT intervention adapted for children with ADHD and comorbid anxiety compared with usual care. Methods This RCT is recruiting children aged 8–12 years ( N  = 228) from pediatrician practices in Victoria, Australia. Eligibility criteria include meeting full diagnostic criteria for ADHD and at least one anxiety disorder (Generalized, Separation or Social). Eligible children are randomized to receive a 10 session CBT intervention (Cool Kids) versus usual clinical care from their pediatrician. The intervention focuses on building child and parent skills and strategies to manage anxiety and associated impairments including cognitive restructuring and graded exposure. Minor adaptations have been made to the delivery of the intervention to meet the needs of children with ADHD including increased use of visual materials and breaks between activities. The primary outcome is change in the proportion of children meeting diagnostic criteria for an anxiety disorder at 5 months randomization. This will be assessed via diagnostic interview with the child’s parent (Anxiety Disorders Interview Schedule for Children V) conducted by a researcher blinded to intervention condition. Secondary outcomes include a range of child (e.g., anxiety symptoms, ADHD severity, behavior, quality of life, sleep, cognitive functioning, school attendance) and parent (e.g., mental health, parenting behaviors, work attendance) domains of functioning assessed at 5 and 12 months post-randomization. Outcomes will be analyzed using logistic and mixed effects regression. Discussion The results from this study will provide evidence on whether treating comorbid anxiety in children with ADHD using a CBT approach leads to improvements in anxiety and/or broader functional outcomes. Trial registration This trial was prospectively registered: Current Controlled Trials ISRCTN59518816 ( https://doi.org/10.1186/ISRCTN59518816 ). The trial was first registered 29/9/15 and last updated 15/1/19.

Background Bronchiolitis is the most common reason for hospitalisation in infants. All international bronchiolitis guidelines recommend supportive care, yet considerable variation in practice continues with infants receiving non-evidence based therapies. We developed six targeted, theory-informed interventions; clinical leads, stakeholder meeting, train-the-trainer, education delivery, other educational materials, and audit and feedback. A cluster randomised controlled trial (cRCT) found the interventions to be effective in reducing use of five non-evidence based therapies in infants with bronchiolitis. This process evaluation paper aims to determine whether the interventions were implemented as planned (fidelity), explore end-users’ perceptions of the interventions and evaluate cRCT outcome data with intervention fidelity data. Methods A pre-specified mixed-methods process evaluation was conducted alongside the cRCT, guided by frameworks for process evaluation of cRCTs and complex interventions. Quantitative data on the fidelity, dose and reach of interventions were collected from the 13 intervention hospitals during the study and analysed using descriptive statistics. Qualitative data identifying perception and acceptability of interventions were collected from 42 intervention hospital clinical leads on study completion and analysed using thematic analysis. Results The cRCT found targeted, theory-informed interventions improved bronchiolitis management by 14.1%. The process evaluation data found variability in how the intervention was delivered at the cluster and individual level. Total fidelity scores ranged from 55 to 98% across intervention hospitals (mean = 78%; SD = 13%). Fidelity scores were highest for use of clinical leads (mean = 98%; SD = 7%), and lowest for use of other educational materials (mean = 65%; SD = 19%) and audit and feedback (mean = 65%; SD = 20%). Clinical leads reflected positively about the interventions, with time constraints being the greatest barrier to their use. Conclusion Our targeted, theory-informed interventions were delivered with moderate fidelity, and were well received by clinical leads. Despite clinical leads experiencing challenges of time constraints, the level of fidelity had a positive effect on successfully de-implementing non-evidence-based care in infants with bronchiolitis. These findings will inform widespread rollout of our bronchiolitis interventions, and guide future practice change in acute care settings. Trial registration Australian and New Zealand Clinical Trials Registry: ACTRN12616001567415 .

Study designObservational study.ObjectivesTo quantify diurnal blood pressure (BP) patterns and nocturnal hypertension and to measure diurnal urine production in people with chronic spinal cord injury (SCI), compared with controls without SCI.SettingChronic SCI population in the community in Victoria, Australia.MethodsParticipants were recruited by advertisement, and sustained SCI at least a year prior or were healthy able-bodied volunteers. Participants underwent ambulatory BP monitoring (ABPM), measurement of urine production, and completed questionnaires regarding orthostatic symptoms. Comparisons were made between participants with tetraplegia or paraplegia and able-bodied controls. Participants with night:day systolic BP < 90% were classified as dippers, 90–100% as nondippers, and >100% as reverse dippers.ResultsGroups with tetraplegia (n = 51) and paraplegia (n = 33) were older (42.1 ± 15 and 41.1 ± 15 vs. 32.4 ± 13 years, mean ± s.d.) and had a higher prevalence of males (88 and 85% vs. 60%) than controls (n = 52). The average BP was 110.8 ± 1.5/64.4 ± 1.2 mmHg, 119.4 ± 2.1/69.8 ± 1.5 mmHg, and 118.1 ± 1.4/69.8 ± 1.0 mmHg in tetraplegia, paraplegia, and controls, respectively. Of participants with tetraplegia, paraplegia and controls, reverse dipping was observed in 45, 13, and 2% (p < 0.001), while nocturnal hypertension was observed in 13, 23, and 18%, respectively (p = 0.48). A reduction in nocturnal urine flow rate compared with the day was observed in paraplegia and controls, but not tetraplegia.ConclusionsSimilar to the effects of acute SCI, chronic SCI, specifically tetraplegia, also causes isolated nocturnal hypertension, reverse dipping, orthostatic intolerance, and nocturnal polyuria. Cardiovascular risk management and assessment of orthostatic symptoms should include ABPM.

Many individuals with obstructive sleep apnea (OSA) experience working- and autobiographical-memory impairments, and high rates of depressive symptoms. This study aimed to examine (i) behavioral responses and (ii) neural activation patterns elicited by autobiographical and working memory tasks in moderate-severe untreated obstructive sleep apnea (OSA) patients and healthy controls, and (iii) whether variability in autobiographical and working memory activation are associated with task performance, OSA severity and depressive symptoms. Seventeen untreated OSA participants were comparable to 16 age-matched healthy controls with regards to both activation and behavioural performance. OSA was associated with worse mood symptoms and poorer personal semantic memory. Higher levels of nocturnal hypoxia were associated with increased activation in the occipital cortex and right cerebellum in OSA participants, however, no significant relationships between activation and task performance or depressive symptomatology were observed. The neurocognitive substrates supporting autobiographical recall of recent events and working memory in younger, recently-diagnosed, individuals with OSA appear to be indistinguishable from healthy age-matched individuals. These finding point to the importance of early diagnosis and treatment of OSA in order to preserve cognitive function.

Ambulatory polysomnography (PSG) does not commonly include an objective measure of light to determine the time of lights off (Loff), and thus cannot be used to calculate important indices such as sleep onset latency and sleep efficiency. This study examined the technical specifications and appropriateness of a prototype light sensor (LS) for use in ambulatory Compumedics Somte PSG.Two studies were conducted. The first examined the light measurement characteristics of the LS when used with a portable PSG device, specifically recording trace range, linearity, sensitivity, and stability. This involved the LS being exposed to varying incandescent and fluorescent light levels in a light controlled room. Secondly, the LS was trialled in 24 home and 12 hospital ambulatory PSGs to investigate whether light levels in home and hospital settings were within the recording range of the LS, and to quantify the typical light intensity reduction at the time of Loff. A preliminary exploration of clinical utility was also conducted. Linearity between LS voltage and lux was demonstrated, and the LS trace was stable over 14 hours of recording. The observed maximum voltage output of the LS/PSG device was 250 mV, corresponding to a maximum recording range of 350 lux and 523 lux for incandescent and fluorescent light respectively. At the time of Loff, light levels were within the recording range of the LS, and on average dropped by 72 lux (9-245) in the home and 76 lux (4-348) in the hospital setting. Results suggest that clinical utility was greatest in hospital settings where patients are less mobile. The LS was a simple and effective objective marker of light level in portable PSG, which can be used to identify Loff in ambulatory PSG. This allows measurement of additional sleep indices and support with clinical decisions.

ObjectiveTo assess the acceptability, feasibility and outcomes of a codesigned health education model aiming to improve outcomes for children with emotional and behavioural difficulties (EBD).Methods12 Australian primary schools from metropolitan and rural settings participated. Half of the schools from each setting were randomised to the intervention and half to the control group. Intervention group educators in grades 1, 2 and 3 codesigned a school-based intervention and took part in fortnightly communities of practice with a paediatrician over 6 months. Educator and caregiver surveys were collected at baseline and after the 6 month intervention period. Surveys measured child EBD (Strengths and Difficulties Questionnaire), a single-item question and health service recommendations and use. All educators were asked about their confidence in identifying and supporting children with EBD and the study designed acceptability questions.ResultsCaregiver participation was 138 (22% of those eligible) for control schools and 348 (37% of those eligible) for intervention schools. Educator participation was 17 (81% of those eligible) for control schools and 36 (78% of those eligible) for intervention schools. Intervention educators reported a high level of acceptability and feasibility. Compared with educators in the control group, those in the intervention group reported greater confidence in identifying and supporting children with EBD at 6 months. There were no differences in educator or caregiver reports of child EBD or health service recommendation and use between groups. 85% of educators reported they would participate again and 92% said they would recommend the intervention to other educators.ConclusionsA health education intervention is feasible and acceptable to educators and improves educator confidence in identifying and supporting children with EBD. Future research should assess its effectiveness in an adequately powered controlled trial.Trial registration numberAustralian New Zealand Clinical Trials Registry approval number 381239.