ANZCTR search results

Society asks a lot of schools, including that they protect children's health and wellbeing. This trial will work out the best way of supporting schools, teachers and school communities to create and sustain school environments that protect children's physical and mental health. We will measure the impact and return on investment of this support on children's health and education outcomes as well as on the schools themselves.

For most women, childbirth is a significant life event that can be associated with a range of emotional responses, from joy and relief for some, but trauma and distress for others. A traumatic childbirth experience, sometimes referred to as ‘birth trauma’ lead to poor mental health outcomes in postpartum women, severely impacting mother-infant attachment, child development, and overall mental health of the family unit. The current project will be the first intervention for postpartum mothers with recent traumatic birth experiences, to decrease serious and persistent mental health concerns. This project will assess the feasibility and acceptability of a highly innovative telehealth group-based early intervention for this vulnerable population group.

This study is exploring how feasible it is for patients with persistent pain to test whether non-drug, self-managed activities are effective for their pain, using an app called StudyU which helps them do single case experiments. The app also produces reports for the patient and their general practitioner (GP), so they can discuss these reports to make shared decisions about the best ways to manage the patient's pain going forward.

The aim of this study is to evaluate the use of Er:YAG laser treatment as a potential treatment for women with slight to severe stress urinary inconctinence. We hypothesize that Er:YAG Laser is superior to sham therapy in women who have slight to severe stress urinary incontinence, based on the Severity Index for Urinary Incontinence in women, with subjective improvement rates defined as a Minimal Important Difference (MID) of 4 points on the ICIQ-UI-SF questionnaire.

The study will test the effectiveness and feasibility of applying silver fluoride by an Aboriginal Health Practitioner to decayed baby tooth surfaces to stop the decay process among young Aboriginal children in remote communities. The outcomes will be compared against treatments provided by dental therapists using minimally invasive approaches. the hypothesis tested is that the application of silver fluoride to decayed baby teeth will be as effective as standard minimally invasive restorative treatments in managing baby-tooth decay.

Approximately 7% of 4–17-year-olds experience anxiety disorders. Half of these children do not receive help, and waiting times for seeing psychologists extend beyond 12 months, especially in regional areas. During COVID, 1 in 5 children and adolescents experienced clinical-level anxiety. Studies have demonstrated that increasing access to internet-based Cognitive Behavioural Therapy (iCBT) for anxiety can assist with this growing health concern. However, there have been challenges in identifying an optimum digital model of care for effectively addressing anxiety in children and adolescents who reside in regional areas. Studies in iCBT suggest that while some level of therapist support is necessary to enhance motivation, address diagnostic complexity, and personalize treatment for effectively alleviating severe anxiety, it is crucial for treatment to be delivered remotely, at scale, with minimal cost, and without the long waiting times currently experienced with face-to-face services in regional areas. There is a need to develop a new digital model of care that can bridge the gap between self-help and therapist-assisted approaches, effectively reducing anxiety among children and adolescents, and be suitable for dissemination in regional areas. This project will test a new evidence-informed digital model of care for child and adolescent anxiety that combines standard, self-help iCBT program with minimal therapist support at crucial treatment stages and weekly messaging support. To date, no studies have tested such digital model of care for children and adolescent in regional areas. If this model, using self-help iCBT with minimal therapist support is more effective than self-help iCBT alone, we will have identified a scalable, easily disseminated model that is effective for alleviating anxiety among children and adolescents in regional areas. In this project, therapists will offer minimal support (2 x 30 mins sessions at pre- and mid-treatment) via telephone or video conferencing. Additionally, they will send weekly messages to young people, which can be accessed at any location and time. Therefore, this model of care can be readily disseminated and is non-intrusive to young people.

This study is investigating whether aiming to restore a healthy microbiota, gut barrier and digestion through faecal microbiota transplantation (FMT) alongside chemotherapy can effectively treat and relieve symptoms and pain in non-resectable pancreatic cancer. Who is it for? You may be eligible for this study if you are aged between 18 and 75 years of age, and have been diagnosed with non-resectable pancreatic cancer (i.e. pancreatic tumours that cannot be removed through surgery). Study details Participants will be randomly assigned to either receive FMT or placebo capsules in 2 separate treatment periods: one before chemotherapy and one 4 weeks after chemotherapy cessation. All participants will receive Folfirinox chemotherapy for either 3 or 6 months depending on the treating oncologist's review of their clinical response at 3 months. Safety, tolerability and efficacy data will be collected from participants over the course of their participation in this study. This study represents a unique opportunity to provide a novel and promising intervention for the management of pancreatic cancer and its symptoms to Australian patients to improve their health outcomes.

This study is determining if a novel co-designed therapeutic exercise program is feasible, acceptable, and potentially effective for survivors of paediatric sarcoma. Who is it for? You may be eligible for this study if you are aged between 8 - 18 years of age, diagnosed with sarcoma that required surgical resection at least 12 months earlier, but no more than 5 years prior to enrolment, not undergoing any cancer treatment, and medically able to complete the exercise program. Study details Participants will receive weekly face-to-face individualised goal-directed exercise program for 12 weeks, delivered by a physiotherapist or exercise physiologist. There will also be an accompanying home-based program three times per week. Treatment completion will be checked. Assessments of participant fitness, everyday functioning and activity levels will be at the beginning and end of the program (12-weeks), and at 6 months follow up. Test will include VO2 peak, six minute walk test, timed up and go, timed up and down stairs and pTESS] If the exercise program is shown to be feasible, acceptable, and efficacious, the program has strong potential for testing in larger studies involving more research centres and subsequent use in routine clinical practice. The study will be the first to explore the feasibility, acceptability and efficacy of therapeutic exercise to improve fitness, physical function and physical activity in survivors of childhood sarcoma; improvements in these outcomes could dramatically improve the quality of survivorship and play a major role in mitigating the significant risk of disabling secondary health conditions later in life

The purpose of this study is to examine the efficacy, feasibility, and acceptability of videoconferencing-delivered CBT for anxiety disorders in LGBTQ+ adults. A CONSORT-R compliant, two-group, randomised control feasibility trial (RCT) will examine the research questions. The hypotheses for this study are below: 1) Videoconferencing-delivered, standard CBT will result in significant reductions in symptoms with a large between-group and within-group effect size at post-treatment and three-month follow-up. 2) Videoconferencing-delivered, LGBTQ-adapted CBT will result in a similar degree of symptom reduction when compared to standard CBT. 3) Videoconferencing-delivered standard CBT and LGBTQ-adapted CBT will be feasible to deliver to LGBTQ+ adults with diagnosed anxiety 4) Videoconferencing-delivered CBT will be acceptable to LGBTQ+ adults with diagnosed anxiety disorders

Chronic Kidney Disease (CKD) Stewardship aims to identify people with mid to late stage CKD, who are admitted to hospital for any reason, to improve the proportion of patients receiving optimal guideline directed management. Patients will be enrolled from 6 different public hospitals in NSW over a period of 12 months and half will receive the CKD Stewardship intervention and half will receive usual care. This study seeks to compare the proportion of patients referred to a nephrologist, receiving appropriate medications and receiving regular kidney health testing at 12 months in the intervention group compared with the usual care group.