ANZCTR search results

The objective of the current study is to develop and evaluate an emotion regulation (ER) child and parental treatment program for children and adolescents (aged 6 to 14 years) who are experiencing ER difficulties as evidenced by recurring emotional/anger outbursts and impulsive maladaptive behaviours. Specifically, the objective is to conduct a proof-of-concept, pilot ER intervention study for at-risk youth of developing chronic internalising and/or externalising disorders. Primary Aim: To develop and test the efficacy of an individual, 6-session, ER child and parental program using an A-B design with a one-month follow-up. The manualized intervention will comprise a) parental training specific components (initial/ session 1 and final/booster Session 6) and child/ adolescent with active parental dyadic intervention phase (4 sessions; conducted weeks 2 to 5).

This study will investigate the safety and tolerability of sodium selenate in patients with behavioural variant frontotemporal dementia. All participants will be given sodium selenate for 52 weeks, and assessed regularly to investigate any negative reactions to the drug, as well as any positive effects on the symptoms of their dementia, as measured by biological samples, cognitive tests and brain scans.

Aim The aim of this study is to determine the effectiveness of a lymphoedema exercise protocol in individuals recovering from head and neck cancer treatment. Who is it for? You may be eligible to join this study if you are aged 18 years or above, treated for head and neck cancer at the Sir Charles Gardiner Hospital and experiencing head and neck cancer related lymphoedema. Study details Participants in this study are randomly allocated (by chance to one of two groups. Participants in one group will receive a complete decongestive therapy protocol (usual treatment) for 6 weeks, whilst participants in the other group will receive an exercise protocol in addition to usual treatment for 6 weeks. Assessments (stage and amount of lymphoedema; body image; swallowing; health and wellbeing) will administered pre-intervention (0 weeks) and at post intervention (6 weeks). The proposed study will expand the limited knowledge of lymphoedema for people recovering from head and neck cancer and determine the effectiveness of complete decongestive therapy in conjunction with an exercise protocol.

Background and purpose: Attention deficit hyperactivity disorder (ADHD), a neurodevelopmental disorder, which has relatively high prevalence and incidence of comorbidity among children. Medication is usually the first-line treatment for ADHD; however, the adverse effects of medication may cause other medical issues. Healthy lifestyle pattern (diet, physical activities, reducing screening time) may ameliorate disease severity. To discover suitable interventions, comprehensive investigations of lifestyle patterns will be conducted in both western and eastern countries among primary school children with or without ADHD. The aims of present studies are: to compare the lifestyle patterns in children with ADHD and typically developing children, to determine cultural differences of children with ADHD in western and eastern countries, and to develop a suitable lifestyle modification program for children with ADHD. Methods: The first phase of this study will investigate the lifestyle patterns in Australian and Taiwanese children with or without ADHD. All participants and their parents will be given a series of questionnaires to examine: dietary pattern, physical activity, sleep quality, screening time, demographic data, disease severity, and pressure of their caregiver. These data will be using multiple regression methods to determine the best predictors of the symptoms of ADHD.

A cluster randomised controlled trial will be conducted in secondary schools in New South Wales to reduce sugar sweetened beverage (SSB) consumption in students. The aim of this study is to assess the efficacy of a school based nutrition intervention targeting sugar sweetened beverages in reducing daily sugar sweetened beverage consumption and daily percentage energy from sugar sweetened beverages of secondary school students. We hypothesise that a school based nutrition intervention targeting sugar sweetened beverages will be effective in these aims. Convenience sampling methods will be used for recruitment whereby information letters will be sent out to invite principals to participate. A week will be given to the principal to consider the matter and then a phone call will be made to verbally invite the principal to participate their school in the program. A meeting will be arranged to explain the intervention to school staff should the school consent. The trial will run for two school terms and consists of a whole school approach towards encouraging the students to reduce SSB consumption in up to four intervention schools compared to an identical ratio of control schools that will continue with their usual school activities. The intervention is guided by the Health Promoting Schools framework and consists of five evidence-based practices designed to address student barriers to reducing SSB. These practises include nutritional education to students, building peer support, school guidelines, school nutrition environment modifications, and providing information to parents. More specifically, the intervention will involve providing nutritional education and notifications to students, a schoolwide challenge to reduce SSB consumption, implementing school guidelines to limit access to SSB, canteen and vending machine changes in the school, adding water refill stations in each school, and parental involvement through newsletters and notifications. Primary outcomes are daily SSB consumption in students and daily percentage energy contributed from SSB in students' diet. Secondary outcomes include investigating the average daily SSB consumption of students in school, average daily energy intake of students, and changes in mean student BMI. An additional outcome that will be evaluation is the acceptability of the intervention. Data collection involves anthropometric measurements for BMI, a validated online food frequency questionnaire (Australian Child and Adolescent Eating Survey) and online student, parent and staff surveys. Process evaluation: Regular audits will be conducted via observation at intervention schools to ensure the fidelity of the intervention.

The primary objective of this study is to evaluate the impact of a social participation and engagement tool on community participation and quality of life of community aged care clients. It is hypothesised that the implementation of the ACPQ and ICECAP-O (social participation and engagement tools) as part of routine assessment for community aged care services will improve social engagement and quality of life for clients. The aims of this study are: (i) ascertain the levels of social participation and engagement, and quality of life for a sample of community aged care clients; (ii) measure the association between the delivery of community aged care services, social participation and engagement, and quality of life; (iii) utilise the findings to provide recommendations of potential strategies that could be implemented in the future to improve social participation and engagement. A mixed method design will be utilised for this study, involving the collection of both quantitative and qualitative data to achieve the study objectives. The study will be conducted over two years with one of Australia's largest aged care providers.

The purpose of the proposed study is to evaluate effectiveness and cost effectiveness of heat therapy and/or massage in addition to standard care in people with chemotherapy induced peripheral neuropathy. Who is it for? You may be eligible to join this study if you aged 18 years or over and meet study definition of chemotherapy induced peripheral neuropathy. Study details Patients will be assigned on a 'chance' basis, (like flipping a coin) to receive standard care or an intervention of standard care and heat therapy treatment for four weeks. If after four weeks the intervention decreases CIN nervous system symptoms then the intervention will continue for another 4 weeks. If symptoms do not improve, then the patient will be assigned on a chance basis to receive an alternative intervention of standard care and heat therapy, standard care and massage or standard care, heat therapy and massage. The second intervention will then be received for four weeks. Chemotherapy induced peripheral neuropathy has become a significant health issue which can cause treatment delays and affect functional abilities and quality of life. There are currently no pharmacological interventions that effectively prevent or manage CIN.

The link between carotid artery disease and stroke is well defined in severe carotid artery stenosis. The link between carotid artery disease, cerebral perfusion, and cognitive function, is less well characterised, particularly in the absence of clinical stroke. Characterising the relationship between carotid stenosis, cerebral perfusion, and cognitive function is relevant to 1). understanding the role of carotid intervention in improving cerebral perfusion and cognitive function and, thereby, dementia prevention; 2). reconsidering the threshold for intervention in those patients who are judged ‘asymptomatic’ by current criteria (whereby indications for intervention are based on stroke risk reduction); and 3). examining whether the two distinct forms of intervention for carotid stenosis (carotid endarterectomy and carotid artery stenting) have different impacts on cognitive function. Alongside our study of the impact of intervention for carotid stenosis and cognition, we will also examine relationships between changes in cognition and quality of life. If improvement in cerebral perfusion and cognitive function in patients treated for asymptomatic carotid artery stenosis can be demonstrated, this would impact significantly on decision making and treatment for these patients with respect to the prevention of cognitive decline. The overarching aim of this research is to determine whether changes in cognitive function occur in older adults following intervention for carotid artery stenosis. The primary objectives are to investigate whether: 1) carotid endarterectomy (CEA) improves cognitive function in patients with symptomatic and asymptomatic carotid artery stenosis, 2) changes in cognitive function following CEA are related to changes in cerebral blood flow and cerebrovascular reserve (CVR) in patients with symptomatic and asymptomatic carotid artery stenosis, 4) changes in cognitive function following CEA are related to findings on MRI, and specifically, on arterial spin-labelled cerebral perfusion imaging, 5) changes in cognitive function following CEA are independent of changes in mood scores, 6) changes in cognitive function following CEA are related to changes in quality of life.

This study will examine the emotional responses to a series of emotional film clips before and after the administration of a single dose of oxytocin. The emotional film clips presented will including positive (i.e., happy) and negative (i.e., fearful or painful) scenarios, and the study offers insight into the role of oxytocin in emotional responding behaviour for both positive and negative emotions.

Background: An enhanced recovery strategy involves various pre, intra, and postoperative steps to reduce the normal stress response and organ dysfunction associated with surgical insult, with the ultimate aim of reducing time to full recovery. Preoperative carbohydrate administration is one of the components of an enhanced recovery strategy. However, preoperative carbohydrate treatment for pregnant women undergoing elective caesarean section has the potential to cause rebound hypoglycaemia in the newborn infant. The glycaemic control of newborn infants born to mothers receiving preoperative carbohydrate loading, as a part of an enhanced recovery strategy has not previously been studied. Methods: We propose a pilot randomized controlled clinical trial to investigate the effect of preoperative carbohydrate loading in pregnant women undergoing elective caesarean section, on the glycaemic control of newborn infants. One hundred pregnant women scheduled for an elective caesarean section will be recruited after informed consent. They will be randomised to either intervention or control arm, and receive preoperative carbohydrate loading or no carbohydrate loading respectively. The remainder of their peri-operative management will be as per King Edward Memorial Hospital (KEMH) protocol for enhanced recovery. Newborn infants will be monitored for the risk of hypoglycaemia using KEMH neonatal unit guidelines for “infants at risk of hypoglycaemia”. Outcomes: The primary outcomes will be blood glucose concentration in newborn infant at four and ten hours of life, and the requirement for admission to newborn nursery for the management of hypoglycaemia. Secondary outcomes will include maternal blood glucose concentration during caesarean section, maternal medication requirement for postoperative nausea, and length of hospital stay. Significance: If the study shows that should this pilot study show that pre caesarean section carbohydrate does not increase risk of hypoglycaemia in newborn infants, we can safely introduce this component to our enhanced recovery protocol. Pre caesarean section carbohydrate loading has the potential to enhance maternal recovery and decrease length of hospital stay resulting in financial saving.