ANZCTR search results

Data from the 2015 Australian Government Early Developmental Index Census (AEDI; 2015) suggests that around 22% of Australian children are “developmentally vulnerable” on one or more domains at the start of school, with rates as high as 33% in disadvantaged communities. Recent advances in early childhood and brain development science highlight the importance of early identification and intervention for children at developmental risk to maximize child and family function and participation outcomes. Such opportunities are unfortunately missed in a substantial majority due to poor uptake of current surveillance programs that are voluntary with no mechanism for follow up. There is also evidence for an ‘inverse care law’, with those at highest risk (e.g., mothers born overseas, lower educational and income levels) being least likely to access developmental surveillance programs (Eapen et al., 2014). While GPs are usually the first point of contact for families, time pressures and lack of knowledge and confidence about assessments and referral pathways/support systems limit opportunities for early identification/intervention during these most critical years. We believe that by utilizing an interactive web-based tool at general appointments for children and during 18-month vaccination visit contacts at GP practices/Child and Family Health Nurse (CFHN) clinics, the uptake and coverage of current developmental surveillance programs will be significantly enhanced. This project will test the diagnostic accuracy of a web application developmental surveillance tool comprising (1) the ‘Watch Me Grow’ app (WMG app), a web-based application for parents, and (2) a GP/Health professional component that includes an algorithm with recommendations for next steps regarding review/assessments/investigations and/or referral pathways to early intervention. The project will take place over 3 phases: Phase 1. Recruitment and 18-month screening: Children (n=240) aged 18 months attending GP practices and CFHN clinics will be recruited for this study. At the clinic-based 18-month immunisation/personal health record (PHR) appointment, the parent will complete the WMG app assessment and the GP/CFHN/Practice Nurse will receive a summary of the screening results, referral considerations and parenting options through a secure messaging system (using the child’s name and date of birth) to inform their management plan. Phase 2. Comprehensive developmental assessment: All children identified at 18-months through the WMG app as being at developmental risk together with 10% of those who screen negative (to cover for any false negative results), will complete a comprehensive gold-standard developmental assessment protocol at 2 years of age. Phase 3. Comparison of numbers of children referred for more detailed developmental assessment during the study period with current “usual practice” at the participating sites..

This study is examining the efficacy and safety of a ChemoRadiation and ImmunOtherapy protocol called CIRO in unresectable skin squamous cell carcinoma. Who is it for? You may be eligible for this study if you are aged 18 or older and have an advance biopsy proven skin squamous cell carcinoma which can not be removed by surgery Study details All participants will receive the standard treatment (chemoradiation) for 7 weeks in conjunction with an immunotherapy medication called Durvalumab. CRIO stands for ChemoRadiation and ImmunOtherapy which involves the combination of radiotherapy, chemotherapy, and immunotherapy. Patients with advance skin squamous cell carcinoma which can not be removed by surgery represent a clinical challenge. These patients are often treated by radiotherapy and chemotherapy. Such approach is 50% successful in making the skin cancer disappear completely. We are hoping to improve the 50% figure to 70% by adding an immunotherapy called durvalumab.

Childhood obesity is a serious public health challenge. About one in five Australian children aged 2 to 3 years is now either overweight or obese. Early intervention is important as excess weight and fast weight gain in early childhood are related to being overweight later in life with considerable impact upon health and health services. Over the past 8 years we have developed, implemented and evaluated an early obesity intervention program funded by NHMRC. The project titled Healthy Beginnings Trial (HBT) was designed to improve infant feeding practices, eating habits, active play, and reduce TV viewing time to prevent childhood obesity in the first two years of life through staged home visiting. However, the high cost associated with home visits potentially limits population reach. To translate the successful evidence from the HBT into scaled-up practice applicable across the state with low-cost and broad-reach approaches, we commenced the CHAT study, to promote healthy infant feeding and active play using telephone support and Short Message Service (SMS). The CHAT trial is being conducted with 1155 mothers recruited from the third trimester of pregnancy providing intervention to 24 months of child age. The 24-month follow-up of the CHAT study will be an integral part of the recruitment process and baseline data collection for this new 2-arm RCT. By linking the two studies this study will add significant value to CHAT study by 1) examining the intervention effects at 2 years of age, and 2) conducting a new 2-arm RCT of an early obesity prevention program using a combined telephone support and SMS intervention for children aged 2-4 years. This study will address known gaps in universal obesity prevention strategies for children aged 0-2 years (CHAT study) and 2-4 years (this study) in the most efficient way possible. This unique opportunity of linking two studies will expedite project start up time and provide continuing support to the participants in the existing RCT.

Participating in physical activity reduces pain and improves function in knee osteoarthritis (OA) patients. Despite this, only 13% of people with knee OA meet the current physical activity guidelines, far lower than the national average. Identifying effective, low-cost, accessible, scalable and sustainable strategies to promote physical activity in knee OA patients is crucial. ‘parkrun’ is a free weekly mass community event that represents a novel setting with substantial untapped potential for physical activity promotion. The aim of this study is to assess the feasibility, acceptability and safety of parkrun for patients with knee OA. Participants will be asked to participate in four consecutive Saturday parkruns and complete quantitative and qualitative interviews about their experience. Participants will be followed-up after 6 months to assess longer-term impacts and adherence. Study findings will inform the development of a large RCT aiming to examine parkrun as a strategy to promote physical activity for knee OA and study its effectiveness compared to usual care. This will be the first study to examine parkrun as a novel physical activity promotion strategy for knee OA patients. This is a group of patients in need of innovative strategies to promote physical activity participation. Given the “parkrun phenomenon” has hit 17 countries around the world and consists of 400,000+ Australian members, this project has potential for broad national and international implementation.

The aims of the study are to examine the change in the physical activity and dietary behaviours of school staff, and assess the feasibility and acceptability of implementing a healthy workplace initiative in NSW primary schools. It is hypothesised that if school staff participate in a workplace physical activity and healthy eating program, then they will have improved physical activity levels and healthy eating behaviours. A cluster randomised controlled trial will be conducted with 20 primary schools (10 intervention: 10 control), located in the Hunter New England (HNE) region. The intervention will consist of two programs; i) the Premier’s Sporting Challenge; and ii) a Healthy eating program. To increase the extent of schools’ implementation of these programs, strategies recommended by the NSW Governments Get Healthy@Work Framework as well as those that have previously been utilised by the research team to successfully change the health promoting policies and practices of schools and other organisations will be implemented.

Our study will explore the effects of comparative feedback in improving post-operative rehab in patients undergoing total knee arthroplasty. This will be done by comparing outcomes in the study group of patients who receive feedback regarding their performance, with comparative feedback regarding the overall groups's. This will be compared to a control group, who only receive individual feedback, and are blinded to the performance of the rest of the group. Our hypothesis is that comparative feedback motivates patients to improve performance during post operative rehabilitation, thus improving their long term outcomes (e.g. improved joint range of motion, better limb strength, lower pain levels).

This study will test using a randomised controlled trial a brief online intervention (an Acceptance-Facilitation Intervention, AFI) designed to increase uptake and adherence to an online mental health program (myCompass 2). The primary hypotheses are that uptake of the program will be higher in the AFI + myCompass 2 condition relative to the myCompass 2 alone condition (H1), and that more participants will adhere to the intervention in the AFI + myCompass 2 condition relative to myCompass 2 alone (H2).

Phenylketonuria (PKU) is a rare Inborn Error of Metabolism (IEM) with an incidence of approximately 1 in 10 - 15,000. Prior to the advent of newborn screening and effective dietary treatments, PKU caused a severe neurodevelopmental phenotype marked by global developmental delay, severe intellectual impairment, and seizures. Early diagnosis from newborn screening and introductions of dietary interventions prevent these severe neurological manifestations. Despite this, neuropsychological complications of PKU are observed when control is suboptimal, which include reduced executive function, attention deficit, decreased processing speed, cognitive impairment and disturbances in emotion and behaviour. Neuro-disabilities are thus a key phenotype amongst the PKU cohort when their metabolic control is suboptimal. This project is aimed at exploring practical tools to improve our management outcomes for children and families living with this rare chronic disease. We hypothesise that participating in a brief evidence-based parenting intervention (Triple P), when compared to baseline, will improve progress towards child behaviour/parenting goals, improve children’s quality of life, decrease parent-reported use of ineffective parenting practices, increase parent self-efficacy, reduce parent-reported child behavioural problems, reduce parenting stress, and improve children’s blood Phe levels.

This pilot randomized controlled trial (RCT) aims to examine the feasibility, efficacy, and cost-effectiveness of a new risk-targeted transdiagnostic CBT telehealth program (FullFix) for comorbid alcohol and other drugs (AOD) and mental health problems in young people. The study aims to recruit 130 participants aged 16 - 25, who will be randomised to receive 4 core modules (and up to 4 additional modules) targeting transdiagnostic risk and protective factors for mental health and AOD use, or usual AOD care. Participants' AOD use, mental health, and functional outcomes will be assessed at baseline, and at 1 month, 2, 6, and 12 months post baseline.

This study aims to investigate whether a 12-week combined psychoeducation and home-based exercise intervention can improve dementia risk, mood, health knowledge, cognition, sleep, metabolic markers and brain connectivity in older adults with cognitive difficulties. The active intervention will comprise an individually prescribed, home-based exercise and psychoeducation program. Results will be compared to an active waitlist control group, who will be offered the psychoeducation program at the end of the trial.