The Cool Little Kids randomised controlled trial population-level early prevention for anxiety disorders

Background: The World Health Organization predicts that by 2030 internalising problems (e.g. depression and anxiety) will be second only to HIV/AIDS in international burden of disease. Internalising problems affect 1 in 7 school aged children, impacting on peer relations, school engagement, and later mental health, relationships and employment. The development of early childhood prevention for internalising problems is in its infancy. The current study follows two successful ‘efficacy’ trials of a parenting group intervention to reduce internalising disorders in temperamentally inhibited preschool children. Cool Little Kids is a population-level randomised trial to determine the impacts of systematically screening preschoolers for inhibition then offering a parenting group intervention, on child internalising problems and economic costs at school entry.
Methods/Design: This randomised trial will be conducted within the preschool service system, attended by more than 95% of Australian children in the year before starting school. In early 2011, preschool services in four local government areas in Melbourne, Australia, will distribute the screening tool. The ≈16% (n≈500) with temperamental inhibition will enter the trial. Intervention parents will be offered Cool Little Kids, a 6-session group program in the local community, focusing on ways to develop their child’s bravery skills by reducing overprotective parenting interactions. Outcomes one and two years post-baseline will comprise child internalising diagnoses and symptoms, parenting interactions, and parent wellbeing. An economic evaluation (costconsequences framework) will compare incremental differences in costs of the intervention versus control children to incremental differences in outcomes, from a societal perspective. Analyses will use the intention-to-treat principle, using logistic and linear regression models (binary and continuous outcomes respectively) to compare outcomes between the trial arms.
Discussion: This trial addresses gaps for internalising problems identified in the 2004 World Health Organization Prevention of Mental Disorders report. If effective and cost-effective, the intervention could readily be applied at a population level. Governments consider mental health to be a priority, enhancing the likelihood that an effective early prevention program would be adopted in Australia and internationally.

Can improving working memory prevent academic difficulties? a school based randomised controlled trial

Background: Low academic achievement is common and is associated with adverse outcomes such as grade repetition, behavioural disorders and unemployment. The ability to accurately identify these children and intervene before they experience academic failure would be a major advance over the current ‘wait to fail’ model. Recent research suggests that a possible modifiable factor for low academic achievement is working memory, the ability to temporarily store and manipulate information in a ‘mental workspace’. Children with working memory difficulties are at high risk of academic failure. It has recently been demonstrated that working memory can be improved with adaptive training tasks that encourage improvements in working memory capacity. Our trial will determine whether the intervention is efficacious as a selective prevention strategy for young children at risk of academic difficulties and is cost-effective.

Methods/Design: This randomised controlled trial aims to recruit 440 children with low working memory after a school-based screening of 2880 children in Grade one. We will approach caregivers of all children from 48 participating primary schools in metropolitan Melbourne for consent. Children with low working memory will be randomised to usual care or the intervention. The intervention will consist of 25 computerised working memory training sessions, which take approximately 35 minutes each to complete. Follow-up of children will be conducted at 6, 12 and 24 months post-randomisation through child face-to-face assessment, parent and teacher surveys and data from government authorities. The primary outcome is academic achievement at 12 and 24 months, and other outcomes include child behaviour, attention, health-related quality of life, working memory, and health and educational service
utilisation.

Discussion: A successful start to formal learning in school sets the stage for future academic, psychological and economic well-being. If this preventive intervention can be shown to be efficacious, then we will have the potential to prevent academic underachievement in large numbers of at-risk children, to offer a ready-to-use intervention to the Australian school system and to build international research partnerships along the health education interface, in order to carry our further studies of effectiveness and generalisability.

Video capture : pre-service teacher reflection, assessment or both

This paper reports on a small trial with 6 pre-service teachers who videoed their own teaching practices. The pre-service teachers used the tool to reflect on practice and to enhance their own understandings of themselves as teachers. The initial footage was used to by the pre-service teachers to gauge quite specific elements of their teaching: for example, were they asking effective questions, or were they responding appropriately to questions children asked and as always, what management strategies seemed to be working? Critical feedback from other students was initially „less than critical‟, but again over time, this also appeared to sharpen as they had more opportunity to use the technology. Initial embarrassment of being on screen was replaced with a professional approach to seeing the video as a tool for providing the opportunity to systematically deconstruct practices and for providing concrete feedback for improvement. Used in conjunction with teaching preparation courses, the videoed segments of teaching practice could be used to highlight exemplars, to show what actually happens in classrooms and to explain certain practices. Cunningham and Benedetto (2002) state “Recent developments in digital video technologies permit teacher candidates to collect, review, and manipulate video to demonstrate their growth as a professional and as a reflective practitioner.” However, in the development of the trial, the issue was raised by the pre-service teachers that they would be interested in keeping the videos as evidence of their teaching competence to be used in applications for teaching positions. In the small trial, ethics permission had not been gained for that to happen, but it is certainly a valid and viable possibility for the future. Currently prospective employers have to rely on paper applications which respond to selection criteria, evidence from pre-service teachers‟ teaching rounds and the subjective impressions of an interview. If students were able to present a 5 minute segment of them teaching, it might count for much more than any other evidence. Video capture of teaching practice would provide potential employers with an indication of a pre-service teacher‟s management strategies, relationships with children and a snapshot of a pre-service teacher‟s instructional practice. The idea of video-capture as a tool for pre-service teachers to illustrate teaching capabilities will be more fully investigated in this paper.

A study protocol of a randomised controlled trial incorporating a health economic analysis to investigate if additional allied health services for rehabilitation reduce length of stay without compromising patient outcomes

Background
Reducing patient length of stay is a high priority for health service providers. Preliminary information suggests additional Saturday rehabilitation services could reduce the time a patient stays in hospital by three days. This large trial will examine if providing additional physiotherapy and occupational therapy services on a Saturday reduces health care costs, and improves the health of hospital inpatients receiving rehabilitation compared to the usual Monday to Friday service. We will also investigate the cost effectiveness and patient outcomes of such a service.
Methods/Design A randomised controlled trial will evaluate the effect of providing additional physiotherapy and occupational therapy for rehabilitation. Seven hundred and twelve patients receiving inpatient rehabilitation at two metropolitan sites will be randomly allocated to the intervention group or control group. The control group will receive usual care physiotherapy and occupational therapy from Monday to Friday while the intervention group will receive the same amount of rehabilitation as the control group Monday to Friday plus a full physiotherapy and occupational therapy service on Saturday. The primary outcomes will be patient length of stay, quality of life (EuroQol questionnaire), the Functional Independence Measure (FIM), and health utilization and cost data. Secondary outcomes will assess clinical outcomes relevant to the goals of therapy: the 10 metre walk test, the timed up and go test, the Personal Care Participation Assessment and Resource Tool (PC PART), and the modified motor assessment scale. Blinded assessors will assess outcomes at admission and discharge, and follow up data on quality of life, function and health care costs will be collected at 6 and 12 months after discharge. Between group differences will be analysed with analysis of covariance using baseline measures as the covariate. A health economic analysis will be carried out alongside the randomised controlled trial.
Discussion This paper outlines the study protocol for the first fully powered randomised controlled trial incorporating a health economic analysis to establish if additional Saturday allied health services for rehabilitation inpatients reduces length of stay without compromising discharge outcomes. If successful, this trial will have substantial health benefits for the patients and for organizations delivering rehabilitation services.

Integrated depression management: a proposed trial of a new model of care in a low vision rehabilitation setting

Purpose:
Depression is a common problem among people with visual impairment and contributes to functional decline. This article presents a study protocol to evaluate a new model of care for those patients with depressive symptoms in which psychological treatment is integrated into low vision rehabilitation services. Low vision staff will be trained to deliver "problem solving therapy for primary care" (PST-PC), an effective psychological treatment developed specifically for delivery by non-mental health care staff. PST-PC is delivered in 8 weekly telephone sessions of 30-45 minutes duration and 4 monthly maintenance sessions. We predict this new integrated model of care will significantly reduce depressive symptoms and improve the quality of life for people with visual impairment.

Methods and Design:
A randomized controlled trial of PST-PC will be implemented nationally across low vision rehabilitation services provided by Vision Australia. Clients who screen positive for depressive symptoms and meet study criteria will be randomized to receive PST-PC or usual care, consisting of a referral to their general practitioner for more detailed assessment and treatment. Outcome measures include depressive symptoms and behaviors, quality of life, coping and psychological adjustment to visual impairment. Masked assessments will take place pre- and post-intervention as well as at 6- and 12-month follow-up.

Conclusion:
We anticipate that this innovative service delivery model will lead to sustained improvements in clients' quality of life in a cost effective manner and provide an innovative service delivery model suitable for other health care areas in which depression is co-morbid.

Mothers after gestational diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial

Background:
Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals.

Methods/Design:
The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups.

Discussion:
This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population.

The impact of a team-based intervention on the lifestyle risk factor management practices of community nurses: outcomes of the community nursing SNAP trial

Background
Lifestyle risk factors like smoking, nutrition, alcohol consumption, and physical inactivity (SNAP) are the main behavioural risk factors for chronic disease. Primary health care is an appropriate setting to address these risk factors in individuals. Generalist community health nurses (GCHNs) are uniquely placed to provide lifestyle interventions as they see clients in their homes over a period of time. The aim of the paper is to examine the impact of a service-level intervention on the risk factor management practices of GCHNs.

Methods
The trial used a quasi-experimental design involving four generalist community nursing services in NSW, Australia. The services were randomly allocated to either an intervention group or control group. Nurses in the intervention group were provided with training and support in the provision of brief lifestyle assessments and interventions. The control group provided usual care. A sample of 129 GCHNs completed surveys at baseline, 6 and 12 months to examine changes in their practices and levels of confidence related to the management of SNAP risk factors. Six semi-structured interviews and four focus groups were conducted among the intervention group to explore the feasibility of incorporating the intervention into everyday practice.

Results
Nurses in the intervention group became more confident in assessment and intervention over the three time points compared to their control group peers. Nurses in the intervention group reported assessing physical activity, weight and nutrition more frequently, as well as providing more brief interventions for physical activity, weight management and smoking cessation. There was little change in referral rates except for an improvement in weight management related referrals. Nurses’ perception of the importance of ‘client and system-related’ barriers to risk factor management diminished over time.

Conclusions
This study shows that the intervention was associated with positive changes in self-reported lifestyle risk factor management practices of GCHNs. Barriers to referral remained. The service model needs to be adapted to sustain these changes and enhance referral.

Cognitive-reminiscence therapy and usual care for depression in young adults: study protocol for a randomized controlled trial

Background
Depression is a common affliction for young adults, and is associated with a range of adverse outcomes. Cognitive-reminiscence therapy is a brief, structured intervention that has been shown to be highly effective for reducing depressive symptoms, yet to date has not been evaluated in young adult populations. Given its basis in theory-guided reminiscence-based therapy, and incorporation of effective therapeutic techniques drawn from cognitive therapy and problem-solving frameworks, it is hypothesized to be effective in treating depression in this age group.

Methods and design
This article presents the design of a randomized controlled trial implemented in a community-based youth mental health service to compare cognitive-reminiscence therapy with usual care for the treatment of depressive symptoms in young adults. Participants in the cognitive-reminiscence group will receive six sessions of weekly, individual psychotherapy, whilst participants in the usual-care group will receive support from the youth mental health service according to usual procedures. A between-within repeated-measures design will be used to evaluate changes in self-reported outcome measures of depressive symptoms, psychological wellbeing and anxiety across baseline, three weeks into the intervention, post-intervention, one month post-intervention and three months post-intervention. Interviews will also be conducted with participants from the cognitive-reminiscence group to collect information about their experience receiving the intervention, and the process underlying any changes that occur.

Discussion
This study will determine whether a therapeutic approach to depression that has been shown to be effective in older adult populations is also effective for young adults. The expected outcome of this study is the validation of a brief, evidence-based, manualized treatment for young adults with depressive symptoms.

Study protocol for a randomised controlled trial of internet-based cognitive-behavioural therapy for obsessive-compulsive disorder.

Obsessive-Compulsive Disorder (OCD) is a common chronic psychiatric disorder that constitutes a leading cause of disability. Although Cognitive-Behaviour Therapy (CBT) has been shown to be an effective treatment for OCD, this specialised treatment is unavailable to many due to access issues and the social stigma associated with seeing a mental health specialist. Internet-based psychological treatments have shown to provide effective, accessible and affordable treatment for a range of anxiety disorders, and two Randomised Controlled Trials (RCTs) have demonstrated the efficacy and acceptability of internet-based CBT (iCBT) for OCD, as compared to waitlist or supportive therapy. Although these initial findings are promising, they do not isolate the specific effect of iCBT. This paper details the study protocol for the first randomised control trial evaluating the efficacy of therapist-assisted iCBT for OCD, as compared to a matched control intervention; internet-based therapist-assisted progressive relaxation training (iPRT). It will aim to examine whether therapist-assisted iCBT is an acceptable and efficacious treatment, and to examine how effectiveness is influenced by patient characteristics.

A progress report on a prospective randomised trial of open and robotic prostatectomy

A randomised trial of robotic and open prostatectomy commenced in October 2010 and is progressing well. Clinical and quality of life outcomes together with economic costs to individuals and the health service are being examined critically to compare outcomes.

Individualised, flexible postnatal care: a feasibility study for a randomised controlled trial

Abstract
Background:
Postnatal care in hospital is often provided using defined care pathways, with limited opportunity for more refined and individualised care. We explored whether a tertiary maternity service could provide flexible, individualised early postnatal care for women in a dynamic and timely manner, and if this approach was acceptable to women.
Methods: A feasibility study was designed to inform a future randomised controlled trial to evaluate an alternative approach to postnatal care. English-speaking women at low risk of medical complications were recruited around 26 weeks gestation to explore their willingness to participate in a study of a new, flexible model of care that involved antenatal planning for early postpartum discharge with additional home-based postnatal care. The earlier women were discharged from hospital, the more home-based visits they were eligible to receive. Program uptake was measured, women’s views obtained by a postal survey sent at eight weeks postpartum and clinical data collected from medical records.
Results: Study uptake was 39% (109/277 approached). Most women (n=103) completed a postnatal care plan during pregnancy; 17% planned to leave hospital within 12 hours of giving birth and 36% planned to stay 48 hours. At eight weeks postpartum most women (90%) were positive about the concept and 88% would opt for the same program again. Of the 28% who stayed in hospital for the length they had planned, less than half (43%) received the appropriate number of home visits, and only 41% were given an option for the timing of the visit. Most (62%) stayed in hospital longer than planned (probably due to clinical complications); 11% stayed shorter than planned.
Conclusions: Women were very positive about individualised postnatal care planning that commenced during pregnancy. Given the hospital stay may be impacted by clinical factors, individualised care planning needs to continue into the postnatal period to take into account circumstances which cannot be planned for during pregnancy. However, individualised care planning during the postnatal period which incorporates a high level of flexibility may be challenging for organisations to manage and implement, and a randomised controlled trial of such an approach may not be feasible.

Is cost effectiveness sustained after weekend inpatient rehabilitation? 12 month follow up from a randomized controlled trial

BACKGROUND: Our previous work showed that providing additional rehabilitation on a Saturday was cost effective in the short term from the perspective of the health service provider. This study aimed to evaluate if providing additional rehabilitation on a Saturday was cost effective at 12 months, from a health system perspective inclusive of private costs. METHODS: Cost effectiveness analyses alongside a single-blinded randomized controlled trial with 12 months follow up inclusive of informal care. Participants were adults admitted to two publicly funded inpatient rehabilitation facilities. The control group received usual care rehabilitation services from Monday to Friday and the intervention group received usual care plus additional Saturday rehabilitation. Incremental cost effectiveness ratios were reported as cost per quality adjusted life year (QALY) gained and for a minimal clinical important difference (MCID) in functional independence. RESULTS: A total of 996 patients [mean age 74 years (SD 13)] were randomly assigned to the intervention (n = 496) or control group (n = 500). The intervention was associated with improvements in QALY and MCID in function, as well as a non-significant reduction in cost from admission to 12 months (mean difference (MD) AUD$6,325; 95% CI -4,081 to 16,730; t test p = 0.23 and MWU p = 0.06), and a significant reduction in cost from admission to 6 months (MD AUD$6,445; 95% CI 3,368 to 9,522; t test p = 0.04 and MWU p = 0.01). There is a high degree of certainty that providing additional rehabilitation services on Saturday is cost effective. Sensitivity analyses varying the cost of informal carers and self-reported health service utilization, favored the intervention. CONCLUSIONS: From a health system perspective inclusive of private costs the provision of additional Saturday rehabilitation for inpatients is likely to have sustained cost savings per QALY gained and for a MCID in functional independence, for the inpatient stay and 12 months following discharge, without a cost shift into the community. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry November 2009 ACTRN12609000973213 .

Exploring child dental service use among migrant families in metropolitan Melbourne, Australia

Abstract Background This study describes and explores factors related to dental service use among migrant children. Methods A cross-sectional analysis of baseline data from Teeth Tales, an exploratory trial implementing a community based child oral health promotion intervention. The sample size and target population was 600 families with 1-4 year old children from Iraqi, Lebanese and Pakistani backgrounds residing in metropolitan Melbourne. Participants were recruited into the study using purposive and snowball sampling techniques. Results Most (88%; 550/625) children had never visited the dentist (mean (SD) age 3.06 years (1.11)). In the fully adjusted model the variable most significantly associated with child dental visiting was parent reported 'no reason for child to visit the dentist' (OR = 0.07, p < 0.001). Of those children whose parents reported their child had no reason to visit the dentist, 22% (37/165) experienced dental caries with 8% (13/165) at the level of cavitation. Conclusions Dental service use by migrant preschool children was very low. The relationship between perceived dental need and dental service use is currently not aligned. One in 10 children of select migrant background had visited a dentist, which is in the context of 1 in 3 with dental caries. To improve utilization, health services should consider organizational cultural competence, outreach and increased engagement with the migrant community.

Using clinical trial data and linked administrative health data to reduce the risk of adverse events associated with the uptake of newly released drugs by older Australians: a model process

BACKGROUND: The study was undertaken to evaluate the contribution of a process which uses clinical trial data plus linked de-identified administrative health data to forecast potential risk of adverse events associated with the use of newly released drugs by older Australian patients. METHODS: The study uses publicly available data from the clinical trials of a newly released drug to ascertain which patient age groups, gender, comorbidities and co-medications were excluded in the trials. It then uses linked de-identified hospital morbidity and medications dispensing data to investigate the comorbidities and co-medications of patients who suffer from the target morbidity of the new drug and who are the likely target population for the drug. The clinical trial information and the linked morbidity and medication data are compared to assess which patient groups could potentially be at risk of an adverse event associated with use of the new drug. RESULTS: Applying the model in a retrospective real-world scenario identified that the majority of the sample group of Australian patients aged 65 years and over with the target morbidity of the newly released COX-2-selective NSAID rofecoxib also suffered from a major morbidity excluded in the trials of that drug, indicating a substantial potential risk of adverse events amongst those patients. This risk was borne out in post-release morbidity and mortality associated with use of that drug. CONCLUSIONS: Clinical trial data and linked administrative health data can together support a prospective assessment of patient groups who could be at risk of an adverse event if they are prescribed a newly released drug in the context of their age, gender, comorbidities and/or co-medications. Communication of this independent risk information to prescribers has the potential to reduce adverse events in the period after the release of the new drug, which is when the risk is greatest.Note: The terms 'adverse drug reaction' and 'adverse drug event' have come to be used interchangeably in the current literature. For consistency, the authors have chosen to use the wider term 'adverse drug event' (ADE).