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1.  The challenges of real-world implementation of web-based shared care software: the HopSCOTCH Shared-Care Obesity Trial in Children 
Background
E-health initiatives hold promise to improve shared-care models of health care. In 2008–2011 we developed and trialled web-based software to facilitate a randomised trial of a shared-care approach for childhood obesity involving General Practitioners (GPs) working with tertiary specialists. We describe the software’s development, implementation and evaluation, and make recommendations for future e-health initiatives. The web-based software was designed with the goals of allowing both GPs and specialists to communicate and review patient progress; integrating with existing GP software; and supporting GPs to deliver the structured intervention. Specifically, we aimed to highlight the challenges inherent in this process, and report on the extent to which the software ultimately met its implementation and user aims.
Methods
The study was conducted at the Royal Children’s Hospital and 22 general practices across Melbourne, Australia. Participants comprised 30 GPs delivering the shared-care intervention. Outcomes included the following. (1) GPs’ pre-specified software requirements: transcribed from two focus groups and analysed for themes using content analysis. (2) Software implementation and performance based on the experience of the research team and GPs. (3) GP users’ evaluation collected via questionnaire. (4) Software usage collected via GP questionnaire and qualified through visual inspection of the software meta-data.
Results
Software implementation posed difficult and at times disabling technological barriers (e.g. out-dated hardware, poor internet connections). The software’s speed and inability to seamlessly link with day-to-day software was a source of considerable frustration. Overall, GPs rated software usability as poor, although most (68%) felt that the structure and functionality of the software was useful. Recommendations for future e-health initiatives include thorough scoping of IT systems and server speed, testing across diverse environments, automated pre-requisite checks and upgrades of processors/memory where necessary, and user-created usernames and passwords.
Conclusions
GPs are willing to embrace novel technologies to support their practice. However, implementation remains challenging mainly for technical reasons, and this precludes further evaluation of potential user-specific barriers. These findings could inform future e-health ventures into shared-care, and highlight the need for an appropriate infrastructure.
Trial registration
Australian New Zealand Clinical Trials Registry: ACTRN126080000553.
doi:10.1186/1472-6947-14-61
PMCID: PMC4115470  PMID: 25056431
Software; Patient care team; Electronic health records; Pediatric obesity; Primary health care; Tertiary healthcare
2.  Sleep well—be well study: improving school transition by improving child sleep: a translational randomised trial 
BMJ Open  2013;3(10):e004009.
Introduction
The transition to primary school appears crucial for a child's future academic and psychological well-being. Addressing conditions which negatively affect children during this period, such as poor sleep, may improve these outcomes. Sleep problems are common and in a previous efficacy randomised controlled trial, we demonstrated that sleep problems can be identified and improved using school-based screening followed by a brief behavioural intervention. This trial will determine whether the same intervention is beneficial and cost-effective when delivered by an existing school-based health workforce.
Methods/design
We will recruit 334 children with sleep problems from approximately 40 schools after screening for behavioural sleep problems in the first year of formal education (Grade Prep). Schools in Melbourne, Australia will be invited to participate from a randomly ordered list of eligible schools and we will approach all caregivers of Grade Prep children. Children who have a parent-reported moderate or severe sleep problem will be randomised into either ‘usual care’ or ‘intervention’ groups. Trained nurses from the Primary School Nursing programme will deliver the sleep intervention programme. Intervention: Two to three contacts between the nurse and the parent; initial 45 min face-to-face meeting or phone call, 15 min phone call 2 weeks later and an optional second 30 min face-to-face meeting. Follow-up: 6 and 12 months postrandomisation using parent and teacher surveys and child face-to-face assessments. Primary outcome: child psychosocial functioning at 6 months. Secondary outcomes: child psychosocial functioning at 12 months and child sleep, behaviour, working memory, academic achievement and parent mental health at 6 and 12 months. Cost-effectiveness analysis will compare incremental costs to difference in child psychosocial functioning at 6 months.
Registration
International Standard Randomised Controlled Trial Number Register (ISRCTN92448857).
doi:10.1136/bmjopen-2013-004009
PMCID: PMC3816243  PMID: 24165031
3.  Study protocol: the Childhood to Adolescence Transition Study (CATS) 
BMC Pediatrics  2013;13:160.
Background
Puberty is a multifaceted developmental process that begins in late-childhood with a cascade of endocrine changes that ultimately lead to sexual maturation and reproductive capability. The transition through puberty is marked by an increased risk for the onset of a range of health problems, particularly those related to the control of behaviour and emotion. Early onset puberty is associated with a greater risk of cancers of the reproductive tract and cardiovascular disease. Previous studies have had methodological limitations and have tended to view puberty as a unitary process, with little distinction between adrenarche, gonadarche and linear growth. The Childhood to Adolescence Transition Study (CATS) aims to prospectively examine associations between the timing and stage of the different hormonally-mediated changes, as well as the onset and course of common health and behavioural problems that emerge in the transition from childhood to adolescence. The initial focus of CATS is on adrenarche, the first hormonal process in the pubertal cascade, which begins for most children at around 8 years of age.
Methods/Design
CATS is a longitudinal population-based cohort study. All Grade 3 students (8–9 years of age) from a stratified cluster sample of schools in Melbourne, Australia were invited to take part. In total, 1239 students and a parent/guardian were recruited to participate in the study. Measures are repeated annually and comprise student, parent and teacher questionnaires, and student anthropometric measurements. A saliva sample was collected from students at baseline and will be repeated at later waves, with the primary purpose of measuring hormonal indices of adrenarche and gonadarche.
Discussion
CATS is uniquely placed to capture biological and phenotypic indices of the pubertal process from its earliest manifestations, together with anthropometric measures and assessment of child health and development. The cohort will provide rich detail of the development, lifestyle, external circumstances and health of children during the transition from childhood through to adolescence. Baseline associations between the hormonal measures and measures of mental health and behaviour will initially be examined cross-sectionally, and then in later waves longitudinally. CATS will make a unique contribution to the understanding of adrenarche and puberty in children’s health and development.
doi:10.1186/1471-2431-13-160
PMCID: PMC3852285  PMID: 24103080
Puberty; Hormones; Adrenarche; Gonadarche; Adolescent; Cohort studies; Public health; Protocol; Epidemiology
4.  Correction: Family and Neighbourhood Socioeconomic Inequalities in Childhood Trajectories of BMI and Overweight: Longitudinal Study of Australian Children 
PLoS ONE  2013;8(7):10.1371/annotation/f7e5e1f3-77f6-4c56-b0ba-53b54a86df14.
doi:10.1371/annotation/f7e5e1f3-77f6-4c56-b0ba-53b54a86df14
PMCID: PMC3761042
5.  Family and Neighbourhood Socioeconomic Inequalities in Childhood Trajectories of BMI and Overweight: Longitudinal Study of Australian Children 
PLoS ONE  2013;8(7):e69676.
Background
Socioeconomic inequalities in longitudinal patterning of childhood overweight could cause marked differentials in total burden by adulthood. This study aims to determine timing and strength of the association between socioeconomic status (SES) and children’s body mass index (BMI) in the pre- and primary school years, and to examine socioeconomic differences in overweight trajectories across childhood.
Methods
Participants were 4949 children from the Longitudinal Study of Australian Children. BMI was measured at four biennial waves starting at age 4–5 years in 2004. Developmental trajectories of childhood overweight were identified with latent class analyses. Composite variables of family and neighbourhood SES were used.
Results
Socioeconomic differences in mean BMI z-scores already present at age 4–5 more than doubled by age 10–11 years, reflecting decreasing mean BMI among advantaged rather than increasing means among disadvantaged children. Latent class analysis identified children with ‘stable normal weight’ (68%), and with ‘persistent’ (15%), ‘late-onset’ (14%), and ‘resolving’ overweight (3%). Risks of persistent and late-onset childhood overweight were highest among low SES families (e.g. most disadvantaged quintile: ORpersistent = 2.51, 95%CI: 1.83–3.43), and only partly explained by birth weight and parental overweight. Relationships with neighbourhood SES were weaker and attenuated fully on adjustment for family SES. No socioeconomic gradient was observed for resolving overweight.
Conclusions
Childhood has become the critical period when socioeconomic inequalities in overweight emerge and strengthen. Although targeting disadvantaged children with early overweight must be a top priority, the presence of childhood overweight even among less-disadvantaged families suggests only whole-society approaches will eliminate overweight-associated morbidity.
doi:10.1371/journal.pone.0069676
PMCID: PMC3720589  PMID: 23936075
6.  The Cost-Effectiveness of Universal Newborn Screening for Bilateral Permanent Congenital Hearing Impairment: Systematic Review 
Academic pediatrics  2012;12(3):171-180.
Objective
Universal newborn hearing screening for bilateral permanent congenital hearing impairment is standard practice in many developed economies, but until there is clear evidence of cost-effectiveness, it remains a controversial use of limited health care resources. We conducted a formal systematic review of studies of newborn hearing screening that considered both costs and outcomes to produce a summary of the available evidence and to determine whether there was a need for further research.
Methods
A search was conducted of medical and nursing databases and gray literature websites by the use of multiple keywords. The titles and abstracts of studies were examined for preliminary inclusion if reference was made to newborn hearing screening, and to both costs and outcomes. Studies of potential relevance were independently assessed by 2 health economists for final inclusion in the review. Studies that met inclusion criteria were appraised by the use of existing guidelines for observational studies, economic evaluations and decision analytic models, and reported in a narrative literature review.
Results
There were 22 distinct observational or modeled evaluations of which only 2 clearly compared universal newborn hearing screening to risk factor screening for bilateral permanent congenital hearing impairment. Of these, the single evaluation that examined long-term costs and outcomes found that universal newborn hearing screening could be cost-saving if early intervention led to a substantial reduction in future treatment costs and productivity losses.
Conclusions
There are only a small number of economic evaluations that have examined the long-term cost-effectiveness of universal newborn hearing screening. This is partly attributable to ongoing uncertainty about the benefits gained from the early detection and treatment of bilateral permanent congenital hearing impairment. There is a clear need for further research on long-term costs and outcomes to establish the cost-effectiveness of universal newborn hearing screening in relation to other approaches to screening, and to establish whether it is a good long term investment.
doi:10.1016/j.acap.2012.02.002
PMCID: PMC3600428  PMID: 22583631
bilateral; cost-benefit analyses; hearing loss; neonatal screening; review; systematic
8.  Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial 
BMC Pediatrics  2012;12:135.
Background
Infant colic, characterised by excessive crying/fussing for no apparent cause, affects up to 20% of infants under three months of age and is a great burden to families, health professionals and the health system. One promising approach to improving its management is the use of oral probiotics. The Baby Biotics trial aims to determine whether the probiotic Lactobacillus reuteri DSM 17938 is effective in reducing crying in infants less than three months old (<13.0 weeks) with infant colic when compared to placebo.
Methods/Design
Design: Double-blind, placebo-controlled randomised trial in Melbourne, Australia. Participants: 160 breast and formula fed infants less than three months old who present either to clinical or community services and meet Wessel’s criteria of crying and/or fussing. Intervention: Oral once-daily Lactobacillus reuteri (1x108 cfu) versus placebo for one month. Primary outcome: Infant crying/fussing time per 24 hours at one month. Secondary outcomes: i) number of episodes of infant crying/fussing per 24 hours and ii) infant sleep duration per 24 hours (at 7, 14, 21, 28 days and 6 months); iii) maternal mental health scores, iv) family functioning scores, v) parent quality adjusted life years scores, and vi) intervention cost-effectiveness (at one and six months); and vii) infant faecal microbiota diversity, viii) infant faecal calprotectin levels and ix) Eschericia coli load (at one month only). Analysis: Primary and secondary outcomes for the intervention versus control groups will be compared with t tests and non-parametric tests for continuous data and chi squared tests for dichotomous data. Regression models will be used to adjust for potential confounding factors. Intention-to-treat analysis will be applied.
Discussion
An effective, practical and acceptable intervention for infant colic would represent a major clinical advance. Because our trial includes breast and formula-fed babies, our results should generalise to most babies with colic. If cost-effective, the intervention’s simplicity is such that it could be widely taken up as a new standard of care in the primary and secondary care sectors.
Trial Registration
Current Controlled Trials ISRCTN95287767
doi:10.1186/1471-2431-12-135
PMCID: PMC3508922  PMID: 22928654
Colic; Crying; Infant; Probiotics; Randomised controlled trial; Health care costs; Postpartum depression; Mental health; Quality of life; Biota
9.  Improving outcomes of preschool language delay in the community: protocol for the Language for Learning randomised controlled trial 
BMC Pediatrics  2012;12:96.
Background
Early language delay is a high-prevalence condition of concern to parents and professionals. It may result in lifelong deficits not only in language function, but also in social, emotional/behavioural, academic and economic well-being. Such delays can lead to considerable costs to the individual, the family and to society more widely. The Language for Learning trial tests a population-based intervention in 4 year olds with measured language delay, to determine (1) if it improves language and associated outcomes at ages 5 and 6 years and (2) its cost-effectiveness for families and the health care system.
Methods/Design
A large-scale randomised trial of a year-long intervention targeting preschoolers with language delay, nested within a well-documented, prospective, population-based cohort of 1464 children in Melbourne, Australia. All children received a 1.25-1.5 hour formal language assessment at their 4th birthday. The 200 children with expressive and/or receptive language scores more than 1.25 standard deviations below the mean were randomised into intervention or ‘usual care’ control arms. The 20-session intervention program comprises 18 one-hour home-based therapeutic sessions in three 6-week blocks, an outcome assessment, and a final feed-back/forward planning session. The therapy utilises a ‘step up-step down’ therapeutic approach depending on the child’s language profile, severity and progress, with standardised, manualised activities covering the four language development domains of: vocabulary and grammar; narrative skills; comprehension monitoring; and phonological awareness/pre-literacy skills. Blinded follow-up assessments at ages 5 and 6 years measure the primary outcome of receptive and expressive language, and secondary outcomes of vocabulary, narrative, and phonological skills.
Discussion
A key strength of this robust study is the implementation of a therapeutic framework that provides a standardised yet tailored approach for each child, with a focus on specific language domains known to be associated with later language and literacy. The trial responds to identified evidence gaps, has outcomes of direct relevance to families and the community, includes a well-developed economic analysis, and has the potential to improve long-term consequences of early language delay within a public health framework.
Trial registration
Current Controlled Trials ISRCTN03981121.
doi:10.1186/1471-2431-12-96
PMCID: PMC3504523  PMID: 22776103
Language development; Mass screening; Language development disorders; Early intervention; Outcome assessment; Child development; Randomized controlled trial; Population characteristics
10.  Preventing mental health problems in children: the Families in Mind population-based cluster randomised controlled trial 
BMC Public Health  2012;12:420.
Background
Externalising and internalising problems affect one in seven school-aged children and are the single strongest predictor of mental health problems into early adolescence. As the burden of mental health problems persists globally, childhood prevention of mental health problems is paramount. Prevention can be offered to all children (universal) or to children at risk of developing mental health problems (targeted). The relative effectiveness and costs of a targeted only versus combined universal and targeted approach are unknown. This study aims to determine the effectiveness, costs and uptake of two approaches to early childhood prevention of mental health problems ie: a Combined universal-targeted approach, versus a Targeted only approach, in comparison to current primary care services (Usual care).
Methods/design
Three armed, population-level cluster randomised trial (2010–2014) within the universal, well child Maternal Child Health system, attended by more than 80% of families in Victoria, Australia at infant age eight months.
Participants were families of eight month old children from nine participating local government areas. Randomised to one of three groups: Combined, Targeted or Usual care.
The interventions comprises (a) the Combined universal and targeted program where all families are offered the universal Toddlers Without Tears group parenting program followed by the targeted Family Check-Up one-on-one program or (b) the Targeted Family Check-Up program. The Family Check-Up program is only offered to children at risk of behavioural problems.
Participants will be analysed according to the trial arm to which they were randomised, using logistic and linear regression models to compare primary and secondary outcomes. An economic evaluation (cost consequences analysis) will compare incremental costs to all incremental outcomes from a societal perspective.
Discussion
This trial will inform public health policy by making recommendations about the effectiveness and cost-effectiveness of these early prevention programs. If effective prevention programs can be implemented at the population level, the growing burden of mental health problems could be curbed.
Trial registration
ISRCTN61137690
doi:10.1186/1471-2458-12-420
PMCID: PMC3458935  PMID: 22682229
11.  A shared-care model of obesity treatment for 3–10 year old children: Protocol for the HopSCOTCH randomised controlled trial 
BMC Pediatrics  2012;12:39.
Background
Despite record rates of childhood obesity, effective evidence-based treatments remain elusive. While prolonged tertiary specialist clinical input has some individual impact, these services are only available to very few children. Effective treatments that are easily accessible for all overweight and obese children in the community are urgently required. General practitioners are logical care providers for obese children but high-quality trials indicate that, even with substantial training and support, general practitioner care alone will not suffice to improve body mass index (BMI) trajectories. HopSCOTCH (the Shared Care Obesity Trial in Children) will determine whether a shared-care model, in which paediatric obesity specialists co-manage obesity with general practitioners, can improve adiposity in obese children.
Design
Randomised controlled trial nested within a cross-sectional BMI survey conducted across 22 general practices in Melbourne, Australia.
Participants
Children aged 3–10 years identified as obese by Centers for Disease Control criteria at their family practice, and randomised to either a shared-care intervention or usual care.
Intervention
A single multidisciplinary obesity clinic appointment at Melbourne’s Royal Children’s Hospital, followed by regular appointments with the child’s general practitioner over a 12 month period. To support both specialist and general practice consultations, web-based shared-care software was developed to record assessment, set goals and actions, provide information to caregivers, facilitate communication between the two professional groups, and jointly track progress.
Outcomes
Primary - change in BMI z-score. Secondary - change in percentage fat and waist circumference; health status, body satisfaction and global self-worth.
Discussion
This will be the first efficacy trial of a general-practitioner based, shared-care model of childhood obesity management. If effective, it could greatly improve access to care for obese children.
Trial Registration
Australian New Zealand Clinical Trials Registry ACTRN12608000055303
doi:10.1186/1471-2431-12-39
PMCID: PMC3464143  PMID: 22455381
12.  Can improving working memory prevent academic difficulties? a school based randomised controlled trial 
BMC Pediatrics  2011;11:57.
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.
doi:10.1186/1471-2431-11-57
PMCID: PMC3141506  PMID: 21682929
13.  The Cool Little Kids randomised controlled trial: Population-level early prevention for anxiety disorders 
BMC Public Health  2011;11:11.
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 (cost-consequences 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.
Trial Registration
ISRCTN: ISRCTN30996662
RCH Human Research Ethics Approval
30105A
doi:10.1186/1471-2458-11-11
PMCID: PMC3027133  PMID: 21208451
14.  Improving infant sleep and maternal mental health: a cluster randomised trial 
Archives of Disease in Childhood  2006;92(11):952-958.
Objectives
To determine whether a community‐delivered intervention targeting infant sleep problems improves infant sleep and maternal well‐being and to report the costs of this approach to the healthcare system.
Design
Cluster randomised trial.
Setting
49 Maternal and Child Health (MCH) centres (clusters) in Melbourne, Australia.
Participants
328 mothers reporting an infant sleep problem at 7 months recruited during October–November 2003.
Intervention
Behavioural strategies delivered over individual structured MCH consultations versus usual care.
Main outcome measures
Maternal report of infant sleep problem, depression symptoms (Edinburgh Postnatal Depression Scale (EPDS)), and SF‐12 mental and physical health scores when infants were 10 and 12 months old. Costs included MCH sleep consultations, other healthcare services and intervention costs.
Results
Prevalence of infant sleep problems was lower in the intervention than control group at 10 months (56% vs 68%; adjusted OR 0.58 (95% CI: 0.36 to 0.94)) and 12 months (39% vs 55%; adjusted OR 0.50 (0.31 to 0.80)). EPDS scores indicated less depression at 10 months (adjusted mean difference −1.4 (−2.3 to −0.4) and 12 months (−1.7 (−2.6 to −0.7)). SF‐12 mental health scores indicated better health at 10 months (adjusted mean difference 3.7 (1.5 to 5.8)) and 12 months (3.9 (1.8 to 6.1)). Total mean costs including intervention design, delivery and use of non‐MCH nurse services were £96.93 and £116.79 per intervention and control family, respectively.
Conclusions
Implementing this sleep intervention may lead to health gains for infants and mothers and resource savings for the healthcare system.
Trial registration
Current Controlled Trial Registry, number ISRCTN48752250 (registered November 2004).
doi:10.1136/adc.2006.099812
PMCID: PMC2083609  PMID: 17158146
15.  New directions in childhood obesity research: how a comprehensive biorepository will allow better prediction of outcomes 
Background
Childhood obesity is associated with the early development of diseases such as type 2 diabetes and cardiovascular disease. Unfortunately, to date, traditional methods of research have failed to identify effective prevention and treatment strategies, and large numbers of children and adolescents continue to be at high risk of developing weight-related disease.
Aim
To establish a unique 'biorepository' of data and biological samples from overweight and obese children, in order to investigate the complex 'gene × environment' interactions that govern disease risk.
Methods
The 'Childhood Overweight BioRepository of Australia' collects baseline environmental, clinical and anthropometric data, alongside storage of blood samples for genetic, metabolic and hormonal profiles. Opportunities for longitudinal data collection have also been incorporated into the study design. National and international harmonisation of data and sample collection will achieve required statistical power.
Results
Ethical approval in the parent site has been obtained and early data indicate a high response rate among eligible participants (71%) with a high level of compliance for comprehensive data collection (range 56% to 97% for individual study components). Multi-site ethical approval is now underway.
Conclusions
In time, it is anticipated that this comprehensive approach to data collection will allow early identification of individuals most susceptible to disease, as well as facilitating refinement of prevention and treatment programs.
doi:10.1186/1471-2288-10-100
PMCID: PMC2984501  PMID: 20969745
16.  Outcomes and costs of primary care surveillance and intervention for overweight or obese children: the LEAP 2 randomised controlled trial 
Objective To determine whether ascertainment of childhood obesity by surveillance followed by structured secondary prevention in primary care improved outcomes in overweight or mildly obese children.
Design Randomised controlled trial nested within a baseline cross sectional survey of body mass index (BMI). Randomisation and outcomes measurement, but not participants, were blinded to group assignment.
Setting 45 family practices (66 general practitioners) in Melbourne, Australia.
Participants 3958 children visiting their general practitioner in May 2005-July 2006 were surveyed for BMI. Of these, 258 children aged 5 years 0 months up to their 10th birthday who were overweight or obese by International Obesity Taskforce criteria were randomised to intervention (n=139) or control (n=119) groups. Children who were very obese (UK BMI z score ≥3.0) were excluded.
Intervention Four standard consultations over 12 weeks targeting change in nutrition, physical activity, and sedentary behaviour, supported by purpose designed family materials.
Main outcomes measures Primary measure was BMI at 6 and 12 months after randomisation. Secondary measures were mean activity count/min by 7-day accelerometry, nutrition score from 4-day abbreviated food frequency diary, and child health related quality of life. Differences were adjusted for socioeconomic status, age, sex, and baseline BMI.
Results Of 781 eligible children, 258 (33%) entered the trial; attrition was 3.1% at 6 months and 6.2% at 12 months. Adjusted mean differences (intervention − control) at 6 and 12 months were, for BMI, −0.12 (95% CI −0.40 to 0.15, P=0.4) and −0.11 (−0.45 to 0.22, P=0.5); for physical activity in counts/min, 24 (−4 to 52, P=0.09) and 11 (−26 to 49, P=0.6); and, for nutrition score, 0.2 (−0.03 to 0.4, P=0.1) and 0.1 (−0.1 to 0.4, P=0.2). There was no evidence of harm to the child. Costs to the healthcare system were significantly higher in the intervention arm.
Conclusions Primary care screening followed by brief counselling did not improve BMI, physical activity, or nutrition in overweight or mildly obese 5-10 year olds, and it would be very costly if universally implemented. These findings are at odds with national policies in countries including the US, UK, and Australia.
Trial registration ISRCTN 52511065 (www.isrctn.org)
doi:10.1136/bmj.b3308
PMCID: PMC2737607  PMID: 19729418
17.  Universal parenting programme to prevent early childhood behavioural problems: cluster randomised trial 
BMJ : British Medical Journal  2008;336(7639):318-321.
Objective To determine whether a parenting programme, offered universally in primary care, can prevent behavioural problems in children and improve parenting and maternal mental health.
Design Cluster randomised trial.
Setting 40 primary care nursing centres (clusters) in Victoria, Australia.
Participants 733 English speaking mothers of 8 month old children sequentially recruited from well child appointments; 656 retained at 24 months.
Intervention Structured three session programme at age 8-15 months, co-led by well child providers and a parenting expert. The programme covered normal development and behaviour, strategies to increase desired behaviour, and strategies to reduce unwanted behaviour.
Main outcome measures Maternal report of child externalising behaviour (child behavior checklist 1½-5 year old), parenting (parent behavior checklist), and maternal mental health (depression anxiety stress scales) at 18 and 24 months.
Results At 18 months, child behaviour and parenting scores were similar in the two groups. At 24 months, externalising scores in the intervention and control groups were similar (mean 11.9 (SD 7.2) v 12.9 (7.4)); however, on the parent behavior checklist subscale scores, intervention group parents were less likely to report harsh/abusive parenting (mean 38.9 (SD 7.7) v 40.5 (8.8); adjusted mean difference −1.83, 95% confidence interval −3.12 to −0.55) and unreasonable expectations of child development (40.9 (9.9) v 42.7 (9.6); −2.18, −3.74 to −0.62). Mean scores for nurturing parenting and maternal mental health were similar in the two groups at both times.
Conclusions A universal parenting programme resulted in modest improvement in parenting factors that predict behavioural problems in children but did not reduce externalising behavioural problems or affect maternal mental health at 2 years.
Trial registration ISRCTN 77531789.
doi:10.1136/bmj.39451.609676.AE
PMCID: PMC2234515  PMID: 18244958
18.  Stability of television viewing and electronic game/computer use in a prospective cohort study of Australian children: relationship with body mass index 
Background
While much cross-sectional data is available, there have been few longitudinal investigations of patterns of electronic media use in children. Further, the possibility of a bi-directional relationship between electronic media use and body mass index in children has not been considered. This study aimed to describe longitudinal patterns of television viewing and electronic game/computer use, and investigate relationships with body mass index (BMI).
Methods
This prospective cohort study was conducted in elementary schools in Victoria, Australia. 1278 children aged 5–10 years at baseline and 8–13 years at follow-up had their BMI calculated, from measured height and weight, and transformed to z-scores based on US 2000 growth data. Weight status (non-overweight, overweight and obese) was based on international BMI cut-off points. Weekly television viewing and electronic game/computer use were reported by parents, these were summed to generate total weekly screen time. Children were classified as meeting electronic media use guidelines if their total screen time was ≤14 hrs/wk.
Results
Electronic media use increased over the course of the study; 40% met guidelines at baseline but only 18% three years later. Television viewing and electronic game/computer use tracked moderately and total screen time was positively associated with adiposity cross-sectionally. While weaker relationships with adiposity were observed longitudinally, baseline z-BMI and weight status were positively associated with follow-up screen time and baseline screen time was positively associated with z-BMI and weight status at follow-up. Children who did not meet guidelines at baseline had significantly higher z-BMI and were more likely to be classified as overweight/obese at follow-up.
Conclusion
Electronic media use in Australian elementary school children is high, increases with age and tracks over time. There appears to be a bi-directional association suggesting that interventions targeting reductions in either screen time or adiposity may have a positive effect on both screen time and adiposity.
doi:10.1186/1479-5868-4-60
PMCID: PMC2228322  PMID: 18021422
19.  How should activity guidelines for young people be operationalised? 
Background
If guidelines regarding recommended activity levels for young people are to be meaningful and comparable, it should be clear how they are operationalised. It is usually open to interpretation whether young people are required to meet activity and screen time targets (1) all days of the week, (2) on most days of the week, (3) on average across all days, or (4) whether compliance should be understood as the probability that a randomly selected young person meets the guidelines on a randomly selected day. This paper studies this question using data drawn from the Australian Health of Young Victorians study.
Methods
The subjects for this study were 885 13–19 year olds who recalled four days of activities using a computerised use-of-time instrument, the Multimedia Activity Recall for Children and Adolescents (MARCA). Daily minutes of moderate-to-vigorous physical activity (MVPA) and screen time were calculated. The prevalence of compliance to Australian guidelines (≥ 60 min/day of MVPA and ≤ 120 min/day of screen time outside of school hours) was calculated using the four methods.
Results
The four methods resulted in significantly different prevalence estimates for compliance to the MVPA guideline (20–68%), screen guideline (12–42%) and both guidelines (2–26%). Furthermore, different individuals were identified as compliant by the different methods.
Conclusion
Clarification of how compliance to guidelines should be operationalised would assist in comparisons between studies, and in consistency in determining correlates of compliance.
doi:10.1186/1479-5868-4-43
PMCID: PMC2045661  PMID: 17883875
20.  Population health and wellbeing: Identifying priority areas for Victorian children 
Background
Population health information, collected using soundly-designed methodologies, is essential to inform policy, research, and intervention programs. This study aimed to derive policy-oriented recommendations for the content of a health and wellbeing population survey of children 0–12 years living in Victoria, Australia.
Results
Qualitative interviews were conducted with 54 academic and policy stakeholders, selected to encompass a wide breadth of expertise in areas of public health and inter-sectoral organisations relevant to child health outcomes, including universities, government and non-government agencies across Victoria. These stakeholders were asked to provide advice on strategic priorities for child health information (data) using a structured interview technique. Their comments were summarised and the major themes were extracted. The priority areas of health and wellbeing recommended for regular collection include obesity and its determinants, pregnancy and breastfeeding, oral health, injury, social and emotional health and wellbeing, family environment, community, health service utilisation, illness, and socioeconomic position. Population policy questions for each area were identified.
Conclusion
In contrast to previous population survey programs nationally and internationally, this study sought to extract contemporary policy-oriented domains for inclusion in a strategic program of child health data collection, using a stakeholder consultation process to identify key domains and policy information needs. The outcomes are a rich and relevant set of recommendations which will now be taken forward into a regular statewide child health survey program.
doi:10.1186/1743-8462-2-16
PMCID: PMC1180818  PMID: 16029511
22.  Outcomes of population based language promotion for slow to talk toddlers at ages 2 and 3 years: Let’s Learn Language cluster randomised controlled trial 
Objective To determine the benefits of a low intensity parent-toddler language promotion programme delivered to toddlers identified as slow to talk on screening in universal services.
Design Cluster randomised trial nested in a population based survey.
Setting Three local government areas in Melbourne, Australia.
Participants Parents attending 12 month well child checks over a six month period completed a baseline questionnaire. At 18 months, children at or below the 20th centile on an expressive vocabulary checklist entered the trial.
Intervention Maternal and child health centres (clusters) were randomly allocated to intervention (modified “You Make the Difference” programme over six weekly sessions) or control (“usual care”) arms.
Main outcome measures The primary outcome was expressive language (Preschool Language Scale-4) at 2 and 3 years; secondary outcomes were receptive language at 2 and 3 years, vocabulary checklist raw score at 2 and 3 years, Expressive Vocabulary Test at 3 years, and Child Behavior Checklist/1.5-5 raw score at 2 and 3 years.
Results 1217 parents completed the baseline survey; 1138 (93.5%) completed the 18 month checklist, when 301 (26.4%) children had vocabulary scores at or below the 20th centile and were randomised (158 intervention, 143 control). 115 (73%) intervention parents attended at least one session (mean 4.5 sessions), and most reported high satisfaction with the programme. Interim outcomes at age 2 years were similar in the two groups. Similarly, at age 3 years, adjusted mean differences (intervention−control) were −2.4 (95% confidence interval −6.2 to 1.4; P=0.21) for expressive language; −0.3 (−4.2 to 3.7; P=0.90) for receptive language; 4.1 (−2.3 to 10.6; P=0.21) for vocabulary checklist; −0.5 (−4.4 to 3.4; P=0.80) for Expressive Vocabulary Test; −0.1 (−1.6 to 1.4; P=0.86) for externalising behaviour problems; and −0.1 (−1.3 to 1.2; P=0. 92) for internalising behaviour problems.
Conclusion This community based programme targeting slow to talk toddlers was feasible and acceptable, but little evidence was found that it improved language or behaviour either immediately or at age 3 years.
Trial registration Current Controlled Trials ISRCTN20953675.
doi:10.1136/bmj.d4741
PMCID: PMC3191855  PMID: 21852344
23.  Shared care obesity management in 3-10 year old children: 12 month outcomes of HopSCOTCH randomised trial 
Objective To determine whether general practice surveillance for childhood obesity, followed by obesity management across primary and tertiary care settings using a shared care model, improves body mass index and related outcomes in obese children aged 3-10 years.
Design Randomised controlled trial.
Setting 22 family practices (35 participating general practitioners) and a tertiary weight management service (three paediatricians, two dietitians) in Melbourne, Australia.
Participants Children aged 3-10 years with body mass index above the 95th centile recruited through their general practice between July 2009 and April 2010.
Intervention Children were randomly allocated to one tertiary appointment followed by up to 11 general practice consultations over one year, supported by shared care, web based software (intervention) or “usual care” (control). Researchers collecting outcome measurements, but not participants, were blinded to group assignment.
Main outcome measures Children’s body mass index z score (primary outcome), body fat percentage, waist circumference, physical activity, quality of diet, health related quality of life, self esteem, and body dissatisfaction and parents’ body mass index (all 15 months post-enrolment).
Results 118 (60 intervention, 56 control) children were recruited and 107 (91%) were retained and analysed (56 intervention, 51 control). All retained intervention children attended the tertiary appointment and their general practitioner for at least one (mean 3.5 (SD 2.5, range 1-11)) weight management consultation. At outcome, children in the two trial arms had similar body mass index (adjusted mean difference −0.1 (95% confidence interval −0.7 to 0.5; P=0.7)) and body mass index z score (−0.05 (−0.14 to 0.03); P=0.2). Similarly, no evidence was found of benefit or harm on any secondary outcome. Outcomes varied widely in the combined cohort (mean change in body mass index z score −0.20 (SD 0.25, range −0.97-0.47); 26% of children resolved from obese to overweight and 2% to normal weight.
Conclusions Although feasible, not harmful, and highly rated by both families and general practitioners, the shared care model of primary and tertiary care management did not lead to better body mass index or other outcomes for the intervention group compared with the control group. Improvements in body mass index in both groups highlight the value of untreated controls when determining efficacy.
Trial registration Australian New Zealand Clinical Trials Registry ACTRN12608000055303.
doi:10.1136/bmj.f3092
PMCID: PMC3677741  PMID: 23751902
24.  Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial 
Objective To determine whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months.
Design Double blind, placebo controlled randomised trial.
Setting Community based sample (primary and secondary level care centres) in Melbourne, Australia.
Participants 167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel’s criteria for crying or fussing: 85 were randomised to receive probiotic and 82 to receive placebo.
Interventions Oral daily L reuteri (1×108 colony forming units) versus placebo for one month.
Main outcomes measures The primary outcome was daily duration of cry or fuss at 1 month. Secondary outcomes were duration of cry or fuss; number of cry or fuss episodes; sleep duration of infant at 7, 14, and 21 days, and 1 and 6 months; maternal mental health (Edinburgh postnatal depression subscale); family functioning (paediatric quality of life inventory), parent quality adjusted life years (assessment of quality of life) at 1 and 6 months; infant functioning (paediatric quality of life inventory) at 6 months; infant faecal microbiota (microbial diversity, colonisation with Escherichia coli), and calprotectin levels at 1 month. In intention to treat analyses the two groups were compared using regression models adjusted for potential confounders.
Results Of 167 infants randomised from August 2011 to August 2012, 127 (76%) were retained to primary outcome; of these, a subset was analysed for faecal microbial diversity, E coli colonisation, and calprotectin levels. Adherence was high. Mean daily cry or fuss time fell steadily in both groups. At 1 month, the probiotic group cried or fussed 49 minutes more than the placebo group (95% confidence interval 8 to 90 minutes, P=0.02); this mainly reflected more fussing, especially for formula fed infants. The groups were similar on all secondary outcomes. No study related adverse events occurred.
Conclusions L reuteri DSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic. These findings differ from previous smaller trials of selected populations and do not support a general recommendation for the use of probiotics to treat colic in infants.
Trial registration Current Controlled Trials ISRCTN95287767.
doi:10.1136/bmj.g2107
PMCID: PMC3972414  PMID: 24690625
25.  Specific language impairment: a convenient label for whom? 
Background
The term ‘specific language impairment’ (SLI), in use since the 1980s, describes children with language impairment whose cognitive skills are within normal limits where there is no identifiable reason for the language impairment. SLI is determined by applying exclusionary criteria, so that it is defined by what it is not rather than by what it is. The recent decision to not include SLI in DSM-5 provoked much debate and concern from researchers and clinicians.
Aims
To explore how the term ‘specific language impairment’ emerged, to consider how disorders, including SLI, are generally defined and to explore how societal changes might impact on use the term.
Methods & Procedures
We reviewed the literature to explore the origins of the term ‘specific language impairment’ and present published evidence, as well as new analyses of population data, to explore the validity of continuing to use the term.
Outcomes & Results and Conclusions & Implications
We support the decision to exclude the term ‘specific language impairment’ from DSM-5 and conclude that the term has been a convenient label for researchers, but that the current classification is unacceptably arbitrary. Furthermore, we argue there is no empirical evidence to support the continued use of the term SLI and limited evidence that it has provided any real benefits for children and their families. In fact, the term may be disadvantageous to some due to the use of exclusionary criteria to determine eligibility for and access to speech pathology services. We propose the following recommendations. First, that the word ‘specific’ be removed and the label ‘language impairment’ be used. Second, that the exclusionary criteria be relaxed and in their place inclusionary criteria be adopted that take into account the fluid nature of language development particularly in the preschool period. Building on the goodwill and collaborations between the clinical and research communities we propose the establishment of an international consensus panel to develop an agreed definition and set of criteria for language impairment. Given the rich data now available in population studies it is possible to test the validity of these definitions and criteria. Consultation with service users and policy-makers should be incorporated into the decision-making process.
doi:10.1111/jlcd.1460-6984.12102
PMCID: PMC4303922  PMID: 25142091
specific language impairment; language impairment; child language

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