ANZCTR search results

The study aims to investigate the links between the parent-adolescent relationship and adolescent mental health and functioning, and how these variables may be mediated by participation in a brief parenting intervention. One hundred and fourteen (114) parent-adolescent dyads will be recruited. Adolescents will be aged 11 to 17 years and will meet diagnostic criteria for i) an Anxiety Disorder, ii) Conduct Disorder or iii) no psychiatric disorder (No Disorder). The goal is to recruit equal numbers of parent-adolescent dyads within each diagnostic category. The main objectives are: 1) to evaluate the influence of differential aspects of the parent-adolescent relationship, particularly connectedness and hostility, on adolescent mental health; and 2) to assess the effectiveness of the parenting group for promoting supportive parenting, improved parent-adolescent relationships (i.e., increased connectedness and reduced hostility), and improved adolescent functioning. Parent-adolescent dyads will take part in two face-to-face multi-method assessment sessions, approximately six to eight weeks apart. Following the first assessment session (pre-intervention, Time 1), parents will participate a brief, stand-alone 2-hour parenting intervention, the Triple P-Positive Parenting Program discussion group: ‘Coping with Teenagers’ Emotions’. The intervention aims to enhance parenting skills and knowledge and introduce strategies to help parents encourage their teenager to better manage their own emotions. The second assessment session (post-intervention, Time 2) will be held approximately two to four weeks following parent attendance at the parenting group. Parent-adolescent dyads will be followed up via online questionnaires six months after completing the second assessment session (6-month follow-up, Time 3).

Aims: The aim of the proposed study is to determine feasibility and efficacy of a strategy where BP targets during management of shock in ICU are individualized for each patient based on his/her basal-BP. Primary objective: To demonstrate that compared to the standard care of patients with shock in ICU, a strategy of targeting patients’ basal-BP would minimize the degree of untreated relative hypotension (BP-deficit) during vasopressor therapy by at least 75%. Secondary objectives: To determine whether in this study design, the interventional phase, as compared to conventional care, can (a) enrol at least one patient per week (b) complete follow up for all patients with >90% of data collection (c) reduce the incidence of significant AKI (at least two AKI-stage increase) during the first 14 study days, (d) reduce the peak increase in serum creatinine during the first 7 days among patients not on renal replacement therapy (RRT), (e) reduce percentage of time-points spent with >20% BP-deficit by at least 75%, and (f) be implemented without any appreciable increase in new-onset arrhythmias or serious adverse events. Methods: This is a prospective before-and-after pilot study at multidisciplinary academic ICUs. The study will be conducted over eight consecutive months- first four months of conventional care, followed by the last four months of individualized BP targets. All consecutive eligible patients screened during the two periods will be enrolled in the study. Besides demographics, severity score and clinical outcomes, the study will collect four hourly data on the difference between basal-BP and achieved-BP during the first five days of vasopressor therapy.

The aim of this pilot study in premature infants who are on nasal continuous positive airway pressure (nCPAP) is to determine if surfactant given by aerosol is safe, tolerable, and able to reduce the need for mechanical ventilation and use of instilled surfactant administered using an endotracheal tube.

Placebo-controlled, First-In-Human study assessing the safety and tolerability of PRN2246 in healthy volunteers. Participants in Part A of the study will receive a single dose of PRN2246. Participants in Part B of the study will receive one dose of PRN2246 per day for up to 10 days

Once a woman with gestational diabetes mellitus (GDM) gives birth and her GDM resolves, Little attention is paid to her future risk of developing type 2 diabetes mellitus (T2DM). Women with GDM have up to a 7 times greater risk of developing T2DM than women without GDM. Despite this increased risk, ongoing care or support programs tailored to the unique characteristics on this group are not currently available nor easily accessible. This study proposes to address this gap. We will evaluate the impact of a tailored, self-administered Internet program, with or without individualised video coaching to empower women with a history of GDM to improve their nutrition and physical activity behaviours and reduce their T2DM risk.

Soluble fibre is a source of plasma short chain fatty acids (SCFA), which are known to have antiinflammatory properties. This study will investigate the plasma short chain fatty acid (SCFA) yield over 10 hours following consumption of four different soluble fibre supplements in healthy adult males and females. This will provide a proxy for rating the antiinflammatory potential of each type of soluble fibre. This information will be used in the design of future clinical intervention trials.

The efficacy of the Grit wellbeing program, which targets psychological, emotional, and social wellbeing, will be examined in substance using populations, through a cohort analytic study, comparing Grit in combination with the a six week recovery program (at Mirikai residential rehabilitation centre) compared to the six week recovery program alone (at Logan House residential rehabilitation centre). There will be a minimum of 90 participants (45 at each site) aged 18-35. It is anticipated that those who participate in the Grit Wellbeing Program will have greater reductions in substance use and mental ill-health, show greater increases in wellbeing, resilience and social engagement than those who participate in standard treatment alone.

It is well established that physical activity is associated with many physical and psychological health benefits. Participating in regular physical activity during childhood is also vital for optimal growth and development and kids who are active show greater resilience and increased social-emotional wellbeing. However, more than 80% of adolescent girls do not meet government physical activity recommendations and there is a striking difference in activity levels between boys and girls at all ages. Current strategies to engage girls in physical activity and sports programs have had minimal impact and innovative approaches that address the underlying socio-cultural barriers that girls face are needed. Targeting fathers to take an active role in increasing their daughters’ physical activity levels may be one such innovation. The DADEE Program is an intervention which engages fathers in positive lifestyle role modelling and effective parenting strategies to improve the physical activity behaviours, physical confidence, sport skills and social-emotional wellbeing of their daughters. Importantly, DADEE also targets girls to improve the fitness and physical activity levels, and parenting skills of their fathers. The DADEE program has been previously been evaluated in an efficacy RCT (ACTRN12615000022561) and an effectiveness RCT (ACTRN12616001270404). The primary aim of this study is to research the long-term effectiveness of the DADEE program in a larger scale community roll-out. In total, 12 programs will be evaluated over three years using a non-randomized, prospective design with 12-month follow-up for each program.

BACKGROUND: The hybrid artificial pancreas or hybrid closed loop insulin pump (HCL) has been shown to be effective in improving glycaemia in individuals with type 1 diabetes (T1DM). Recently the Medtronic e-PID HCL algorithm with insulin feedback (670G 3.0 HCL system) has been modified (670G 3.1 HCL system) to enhance its effectiveness manage blood glucose levels. The impact of the modifications implemented in 670G 3.1 have yet to be demonstrated. AIMS: The study aims to compare the relative effectiveness of the two HCL systems in managing blood glucose levels METHODS: The study is a two-stage randomized crossover study in a supervised live in setting. Pump-experienced adults with type 1 diabetes will be recruited. Following a 1 week run-in, all participants will be assigned 670G 3.1 and 670G 3.0 HCL systems in random order for a period of 7 days each, with stages separated by 1 week. Interventions aimed at challenging glycaemic control hyperglycaemia will be implemented during each of the 7 days. OUTCOME MEASURES: Glucose control including CGM time in target glucose range and time in hyperglycaemic and hypoglycaemic ranges. Safety end points including number of episodes of hypoglycaemia and ketoacidosis, and system performance

This study aims to compare post-operative pain outcomes following the placement of rectus sheath catheters by surgeons and anaesthetist. A total of 72 patients will be included in this study, with 36 in each arm. One arm will receive rectus sheath catheters placed into the pre-peritoneal space intraoperatively by the operating surgeon, while the other arm will receive rectus sheath catheters placed under ultrasound guidance by an anaesthetist into the intrafasicular space. Both arms will then receive 20mL 0.2% Ropivacaine infusion through these catheters every 4 hrs for 3 days. The post-operative pain experience will be assessed by narcotic requirements which will be documented as IV morphine equivalents.