ANZCTR search results

Many Australian families are unable to access evidence-based psychological treatments for their child’s Disruptive Behavioural Disorder (DBD) due to their geographical location and limited availability of appropriate mental health services. For these families, Internet-delivered treatment may be a promising means of overcoming these barriers. The aim of this study is to test the feasibility, acceptability, and efficacy of Internet-delivered Parent Child Interaction Therapy (I-PCIT), as compared to standard, clinic-delivered Parent-Child Interaction Therapy (PCIT), using a non-inferiority, randomized control trial. It is expected that I-PCIT children will show non-inferior reductions in ODD/CD rates, and in oppositionality, aggression, noncompliance, and hyperactivity, relative to standard PCIT children. It is also expected that I-PCIT parents, relative to standard PCIT parents, will show (i) non-inferior increases in the use of effective commands, labeled praise for child compliance, behavioural descriptions, verbal reflections, and household consistency and follow-through, (ii) non-inferior reductions in the use of criticisms and indirect commands, (iii) non-inferior improvements in family functioning, and (iv) non-inferior reductions in parental stress and depressive symptoms. Families are eligible to participate if their 2-7 year old child meets clinical criteria for a DBD, parent(s) are fluent in English, not intellectually disabled or with a history of severe physical or mental impairments, and own a computer. Eligible parent-child dyads randomly allocated to I-PCIT will receive 14 weekly one-hour PCIT therapy sessions delivered over secure online videoconferencing software by a trained PCIT therapist under the supervision of a Master Trainer. Dyads allocated to the standard PCIT condition will similarly receive 14 weekly one-hour PCIT therapy sessions delivered in-clinic at the UNSW Parent-Child Research Clinic. All participating dyads will complete four identical 1.5 hour assessment sessions over videoconference or in-person at pre-treatment, mid treatment, immediately post-treatment, and 3-months post-treatment. These sessions will involve coded observations of parent-child interactions, computer-based questionnaires completed by parent(s), and a clinical interview with a research assistant blind to treatment condition.

1.To demonstrate the feasibility of conducting a RCT using omega-3 supplementation with a community sample of impulsive, repeat-violent offenders. Secondary objectives 1.To collect information about the effectiveness of omega-3 supplementation on 3-month behavioural measures of impulsivity, anger, depression and irritability in impulsive, repeat-violent offenders. 2.To collect information about the effectiveness of omega-3 supplementation in reducing self-reported offending among impulsive, repeat-violent offenders.

Preterm infants are highly susceptible to bacterial late-onset sepsis (LOS) and necrotizing enterocolitis (NEC), both are major causes of systemic inflammation and contribute to brain injury and long-term disability in premature infants. Treating LOS and NEC are essential for survival, but suppressing systemic inflammation can also help reduce mortality, hospital stay and disability due to brain injury. The current treatments for NEC and LOS are limited to antibiotics, supportive care and surgery in some NEC cases, all of which do not aid in reducing systemic inflammation, therefore there is a need to reduce systemic inflammation. Pentoxifylline is a safe, low-cost, non-steroidal drug with potent immune-modulating activity with the potential of suppressing systemic inflammation induced by LOS or NEC. A recent Cochrane Review of 6 randomised controlled trials (RCT) suggests that PTX, given with antibiotics in neonatal sepsis, reduces mortality and length of hospital stay. We will enrol and consent 23 preterm infants (<29 weeks gestational age) and intravenously administer Pentoxifylline, adjunct to standard care, for 48hrs within 6 hours of the onset of symptoms suggestive of sepsis or NEC. After 48 hours treatment will cease if diagnosis is refuted or will continue for 4 days if diagnosis is proven. To measure the pharmacokinetic profile of Pentoxifylline a series of four small blood samples will be taken prior to starting treatment and during treatment. The pharmacokinetic profile will allow us to model the optimal infusion frequency and duration, which will be used as a guideline in larger randomised controlled trials that will assess white matter injury and long-term disability.

As a low risk, readily available treatment, PRP injections are becoming an increasingly popular therapeutic adjunct offered by musculoskeletal clinicians. However, there is a clear need to scientifically assess the merits of this treatment option for athletes with ankle syndesmosis injury in order to establish recommendations for evidence-based practice. We published a pilot study entitled- "Effectiveness of a single platelet-rich plasma injection to promote recovery in rugby players with ankle syndesmosis injury". Available at http://bmjopensem.bmj.com/content/1/1/e000033.full.pdf+html We found a reduction in return to play by 20.7 days for the intervention (PRP) group, when compared to an historical control treated with the same rehabilitation protocol. The study supports the viability of an RCT to fully evaluate this treatment. We have calculated that a minumum of 30 participants would be required to detect a significant difference between groups in return to play, but would define a clinically significant difference as a minimum of one week. We will conduct a prospective randomised controlled trial comparing single US-guided PRP injection to an active placebo prolotherapy. Assessors, investigators and participants will be blinded to their allocation and only the treating radiologist who will only interact with particpants to perform injections, will know allocations. Prospective participants from Rugby union clubs within the Sydney Rugby Union Championship will be invited to enrol. On clinical assessment, only those with a low probability for ASI will not be referred for MRI. After MRI, those meeting enrolment criteria and consenting to participate will be randomly allocated to PRP or active placebo groups, and given usual injury management in accordance with our previously published milestone based rehabilitation protocol (Samra et al 2015). A single injection by co-author JL will be provided within 14 days of injury. A central randomisation register will provide the allocation to JL only. The injection protocol will be identical between groups, except for lack of injection of the PRP in the active placebo group. 1-2mL of 2% lignocaine will be infiltrated to the skin and superficial tissues. Blood will be drawn and centrifuged at 3000RPM for 8 minutes. The PRP will be manually aspirated. 0.5-1mL of PRP will be injected with a 25 guage needle into the defect of the AITFL seen on ultrasound in the intervention group. The active placebo group will undergo the same process with the omission of injection of the PRP. Instead, a peppering technique of 5 passes into the AITFL will be performed. Participants will be given oral analgesia and post-injection care information and followup. No other injections of the ankle will be permitted during the rehabilitation of these athletes or within 1 week of return to play. Return to play will be recorded in days from injury onset to first competitive match (of any duration) played since injury

ABSTRACT Background: People with low literacy and low health literacy have poorer health outcomes. Literacy and health literacy are distinct but overlapping constructs that impact wellbeing. Interventions that target both could improve health outcomes. Methods & Design This is a cluster randomised controlled trial with a qualitative component. Participants are 300 adults enrolled in basic language, literacy and numeracy programs at adult education centres across New South Wales, Australia. Each adult education institute (regional administrative centre) contributes (at least) two classes matched for student demographics, which may be at the same or different campuses. Classes (clusters) are randomly allocated to receive either the health literacy intervention (an 18-week program with health knowledge and skills embedded in language, literacy, and numeracy training (LLN)), or the standard Language Literacy and Numeracy (LLN) program (usual LLN classes, specifically excluding health content). The primary outcome is functional health literacy skills – knowing how to use a thermometer, and read and interpret food and medicine labels. The secondary outcomes are self-reported confidence, health literacy; shared decision making skills, patient activation, health knowledge and self-reported health behaviour. Data is collected at baseline, and immediately and 6 months post intervention. A sample of participating teachers, students, and community health workers will be interviewed in-depth about their experiences with the program. Ethics and dissemination The study has ethical approval from the University of Sydney and 10 NSW Institutes of TAFE. Results will be published in peer reviewed journals, and reported to partner organisations.

Background: Continuous enteral feeding mode that is aimed at achieving daily caloric target is the standard practice in ICU. However, there is no strong evidence in favour of continuous enteral feeding over intermittent feeding. Continuous feeding infusions are interrupted for nearly 25% of the time and are often delivered at a reduced rate for reasons such as perceived gut intolerance or dysmotility and the need to withhold feeds for concurrent medical, surgical and diagnostic procedures. Consequently, patients in ICU are often underfed. Intermittent enteral feeding is more physiological. It mimics the natural ingestion-fasting cycle and preserves the natural cyclical secretion of gut hormones such as gastrin and motilin. These hormones are closely related to the cycle of meal ingestion and the period of fasting between two meals. It is plausible that continuous feeding interferes with ingestion-fasting cycle and interrupts the natural rhythm of hormonal secretion that is primarily responsible for gastrointestinal motility. Further, intermittent feeding mode is less affected by frequent interruptions, and therefore may also be more effective in achieving daily caloric target. Additionally, there is evidence for more efficient gastric emptying in the right lateral position (J Nucl Med. 1996). Delivering intermittent feeds while in right lateral position seems feasible, as regular posture turns are part of standard nursing care. However, such posture-aided intermittent feeding has not yet been investigated. Aim: To determine whether intermittent enteral feeding during the right lateral tilt position results in less gastrointestinal intolerance compared to standard care among mechanically ventilated patients. Methods: 120 eligible patients who are likely to require mechanical ventilation in ICU for at least 24 hours will be randomly allocated to either standard care arm or intermittent feeding arm. The feeding formulae and target feed volume and continuous infusion rate will be determined prior to randomization. Patients in the intermittent feeding arm will be fed at least three times a day with one third of daily target feed volume infused over one hour each time. Informed consent will be sought from the person responsible or the legal surrogate. Patients will be followed until ICU discharge or maximum 14 days whichever is earlier. Primary end-point: Incidence rate of gastrointestinal intolerance (vomiting, diarrhea or constipation). Secondary end-points: Days free of gastrointestinal intolerance (vomiting, diarrhea or constipation) until day 14, episodes of vomiting and diarrhea per patient, time to vomiting or diarrhea, mean diet volume ratio (diet received/ diet prescribed) expressed as percentage, ventilator-free days until day 14, and all-cause hospital mortality.

For patients that survive ICU there are considerable long-term burdens from being so unwell and the treatments administered in ICU. Because of the long-term health issues it has been proposed that patients who survive ICU should be able to access specialised services via so-called ‘follow-up clinics’. However, the health budget is relatively fixed and so an increase in provision of one health service means that another health service must be reduced. Follow-up clinics are expensive and currently there is no evidence that these follow-up clinics benefit patients. Accordingly, it is imperative that we establish whether these follow-up clinics are helpful or represent a waste of valuable resources. We will study a very specific group of patients, those with diabetes who have survived ICU. We are studying this group of patients as patients with diabetes make up a significant proportion of patients in ICU. It is also likely, but not yet known, that patients with pre-existing diabetes who survive ICU may be particularly vulnerable to poor health outcomes after ICU. The intervention we will study is a follow-up clinic run by physicians with expertise in ICU (intensivist) and diabetes (endocrinologist). Our study will provide preliminary information as to whether this type of ICU follow-up clinic is of benefit. If the preliminary data are promising we will undertake a much larger study so that we can precisely measure the effects of these clinics.

Little is known about how patients function in the community following discharge from rehabilitation. Despite the assumption that patients will continue to improve on their own, limited data suggests that they do not. We will assess the function of older adults living in the community within 12 months of being discharged from inpatient rehabilitation. Analysis will identify factors associated with ageing well in the community and factors that predict functional decline. This will provide important data to aid rehabilitation clinicians to tailor their care to optimise function and prevent functional decline.

The uptake and timeliness of the primary immunisation series in infancy is critical to preventing infectious diseases morbidity and mortality. There is a high burden of vaccine preventable diseases in Aboriginal and Torres Strait Islander children irrespective of geographic location, however limited attention has been paid to those living in urban and regional settings. The need to improve the timeliness of the primary series has been known for at least 10 years but there has been little change over that time. Recent data from a cohort of Aboriginal and Torres Strait Islander children in Caboolture, Queensland suggests approximately 44% of children have not completed the primary series by 7 months of age. Identifying simple, culturally appropriate and cost effective interventions to improve timeliness is therefore a priority. This trial aims to To evaluate the effectiveness of targeted, culturally appropriate short messaging service (SMS) and/or home visiting in improving the uptake and timeliness of the primary immunisation series in urban/regional Aboriginal and Torres Strait Islander children

This study has been designed to elucidate when is the optimal time to introduce weight management to newly diagnosed patients with OSA who are about to commence on standard care which is overnight CPAP. We have designed this trial to have a step wedge element so that each person will be exposed to the intervention over a 12 month period. To address aim 1) Primary outcome (weight) as measured during each month during the control and intervention periods of the stepped wedge design will be compared between periods. The main effect of the intervention will be examined using a multilevel, mixed effects, linear mixed model analysis approach. Fixed effects will be included in this model for “time” and “intervention”, while a random effect will be included for the effect of “participant”. To address aim 2) We will examine the association between lifestyle intervention commencement month and weight at 12 month follow-up (adjusted for baseline weight). This analysis will treat "lifestyle intervention commencement month" as a continuous variable and examine both a linear and quadratic relationship with the outcome. This design has certain advantages over standard randomized controlled trials which include enabling every participant to be exposed to the intervention and that the impact of time is assessed. This design consists of an initial period, where no one is exposed to the intervention. Eventually, at regular intervals (the “steps”) one cluster (one group) will be randomised to cross from the control to the intervention under evaluation.