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BACKGROUND: Few population-based data sources fully recognise the intersections between stressful events, social health issues, and cannabis use in pregnancy, and little is known about sequelae for women's mental health. METHODS: We draw on two waves of population-based data for 344 families participating in the Aboriginal Families Study longitudinal cohort. We examine women's mental health in the first year postpartum and when children were aged 5-9 years in context with life experiences and use of cannabis in pregnancy. OUTCOMES: One in five women (19·5%) used cannabis during pregnancy (with or without co-use of tobacco). Within this group of women, 88·3% experienced 3 or more (3+) stressful events or social health issues. Psychological distress (Kessler-5 scale, K-5) in the year postpartum was substantially higher amongst women who had used cannabis or experienced 3+ stressful events or social health issues. High proportions of women met criteria for support and referral for depression and/or anxiety (52·5% of women who had used cannabis compared to 20·9% amongst women who had neither used cannabis nor tobacco; 43·2% of women who had experienced 3+ stressful events or social health issues compared to 15·6% amongst women who had not indicated these experiences). Similar patterns of psychological distress, depressive (9-item adapted Personal Health Questionnaire, aPHQ-9) and anxiety symptoms (7-item Generalised Anxiety Disorder score, GAD-7) were evident when the study children were aged 5-9 years. INTERPRETATION: Amongst women who had used cannabis in pregnancy, a high burden of psychological distress, depression, and anxiety is evident in the postpartum period and as their children turn 5-9 years. The overlay of stressful events and social health issues and the high proportion of women meeting criteria for referral for mental health assessment and support indicate an urgent need to offer women opportunities for safe disclosure of cannabis use and opportunities to

OBJECTIVE: This study aimed to examine social gradients in ADHD during late childhood (age 9-11 years) using absolute and relative relationships with socioeconomic status exposure (household income, maternal education) during early childhood (<5 years) in seven cohorts from six industrialised countries (UK, Australia, Canada, The Netherlands, USA, Sweden). METHODS: Secondary analyses were conducted for each birth cohort. Risk ratios, pooled risk estimates, and absolute inequality, measured by the Slope Index of Inequality (SII), were estimated to quantify social gradients in ADHD during late childhood by household income and maternal education measured during early childhood. Estimates were adjusted for child sex, mother age at birth, mother ethnicity, and multiple births. FINDINGS: All cohorts demonstrated social gradients by household income and maternal education in early childhood, except for maternal education in Quebec. Pooled risk estimates, relating to 44,925 children, yielded expected gradients (income: low 1.83(CI 1.38,2.41), middle 1.42(1.13,1.79), high (reference); maternal education: low 2.13(1.39,3.25), middle 1.42(1.13,1.79)). Estimates of absolute inequality using SII showed that the largest differences in ADHD prevalence between the highest and lowest levels of maternal education were observed in Australia (4% lower) and Sweden (3% lower); for household income, the largest differences were observed in Quebec (6% lower) and Canada (all provinces: 5% lower). CONCLUSION: Findings indicate that children in families with high household income or maternal education are less likely to have ADHD at age 9-11. Absolute inequality, in combination with relative inequality, provides a more complete account of the socioeconomic status and ADHD relationship in different high-income countries. While the study design precludes causal inference, the linear relation between early childhood social circumstances and later ADHD suggests a potential role for policies that

BACKGROUND/OBJECTIVES: This study analysed the relationship between early childhood socioeconomic status (SES) measured by maternal education and household income and the subsequent development of childhood overweight and obesity. SUBJECTS/METHODS: Data from seven population-representative prospective child cohorts in six high-income countries: United Kingdom, Australia, the Netherlands, Canada (one national cohort and one from the province of Quebec), USA, Sweden. Children were included at birth or within the first 2 years of life. Pooled estimates relate to a total of N = 26,565 included children. Overweight and obesity were defined using International Obesity Task Force (IOTF) cut-offs and measured in late childhood (8-11 years). Risk ratios (RRs) and pooled risk estimates were adjusted for potential confounders (maternal age, ethnicity, child sex). Slope Indexes of Inequality (SII) were estimated to quantify absolute inequality for maternal education and household income. RESULTS: Prevalence ranged from 15.0% overweight and 2.4% obese in the Swedish cohort to 37.6% overweight and 15.8% obese in the US cohort. Overall, across cohorts, social gradients were observed for risk of obesity for both low maternal education (pooled RR: 2.99, 95% CI: 2.07, 4.31) and low household income (pooled RR: 2.69, 95% CI: 1.68, 4.30); between-cohort heterogeneity ranged from negligible to moderate (p: 0.300 to < 0.001). The association between RRs of obesity by income was lowest in Sweden than in other cohorts. CONCLUSIONS: There was a social gradient by maternal education on the risk of childhood obesity in all included cohorts. The SES associations measured by income were more heterogeneous and differed between Sweden versus the other national cohorts; these findings may be attributable to policy differences, including preschool policies, maternity leave, a ban on advertising to children, and universal free school meals.

Child dental caries (i.e., cavities) are a major preventable health problem in most high-income countries. The aim of this study was to compare the extent of inequalities in child dental caries across four high-income countries alongside their child oral health policies. Coordinated analyses of data were conducted across four prospective population-based birth cohorts (Australia, n = 4085, born 2004; Québec, Canada, n = 1253, born 1997; Rotterdam, the Netherlands, n = 6690, born 2002; Southeast Sweden, n = 7445, born 1997), which enabled a high degree of harmonization. Risk ratios (adjusted) and slope indexes of inequality were estimated to quantify social gradients in child dental caries according to maternal education and household income. Children in the least advantaged quintile for income were at greater risk of caries, compared to the most advantaged quintile: Australia: AdjRR = 1.18, 95%CI = 1.04-1.34; Québec: AdjRR = 1.69, 95%CI = 1.36-2.10; Rotterdam: AdjRR = 1.67, 95%CI = 1.36-2.04; Southeast Sweden: AdjRR = 1.37, 95%CI = 1.10-1.71). There was a higher risk of caries for children of mothers with the lowest level of education, compared to the highest: Australia: AdjRR = 1.18, 95%CI = 1.01-1.38; Southeast Sweden: AdjRR = 2.31, 95%CI = 1.81-2.96; Rotterdam: AdjRR = 1.98, 95%CI = 1.71-2.30; Québec: AdjRR = 1.16, 95%CI = 0.98-1.37. The extent of inequalities varied in line with jurisdictional policies for provision of child oral health services and preventive public health measures. Clear gradients of social inequalities in child dental caries are evident in high-income countries. Policy related mechanisms may contribute to the differences in the extent of these inequalities. Lesser gradients in settings with combinations of universal dental coverage and/or fluoridation suggest these provisions may ameliorate inequalities through additional benefits for socio-economically disadvantaged groups of children.

ObjectivesTo investigate the additional programme cost and cost-effectiveness of ‘right@home’ Nurse Home Visiting (NHV) programme in relation to improving maternal and child outcomes at child age 3 years compared with usual care.DesignA cost–utility analysis from a government-as-payer perspective alongside a randomised trial of NHV over 3-year period. Costs and quality-adjusted life-years (QALYs) were discounted at 5%. Analysis used an intention-to-treat approach with multiple imputation.SettingThe right@home was implemented from 2013 in Victoria and Tasmania states of Australia, as a primary care service for pregnant women, delivered until child age 2 years.Participants722 pregnant Australian women experiencing adversity received NHV (n=363) or usual care (clinic visits) (n=359).Primary and secondary outcome measuresFirst, a cost–consequences analysis to compare the additional costs of NHV over usual care, accounting for any reduced costs of service use, and impacts on all maternal and child outcomes assessed at 3 years. Second, cost–utility analysis from a government-as-payer perspective compared additional costs to maternal QALYs to express cost-effectiveness in terms of additional cost per additional QALY gained.ResultsWhen compared with usual care at child age 3 years, the right@home intervention cost $A7685 extra per woman (95% CI $A7006 to $A8364) and generated 0.01 more QALYs (95% CI −0.01 to 0.02). The probability of right@home being cost-effective by child age 3 years is less than 20%, at a willingness-to-pay threshold of $A50 000 per QALY.

Background Many current research needs can only be addressed using very large cohorts. In such studies, traditional one-on-one phone, face-to-face, or paper-based engagement may not be feasible. The only realistic mechanism for maintaining engagement and participation at this scale is via digital methods. Given the substantial investment being made into very large birth cohort studies, evidence for optimal methods of participant engagement, participation, and retention over sustained periods without in-person contact from researchers is paramount. Objective This study aims to provide an overview of systematic reviews and meta-analyses evaluating alternative strategies for maximizing participant engagement and retention rates in large-scale studies using digital methods. Methods We used a rapid review method by searching PubMed and Ovid MEDLINE databases from January 2012 to December 2019. Studies evaluating at least 1 e-engagement, participation, or retention strategy were eligible. Articles were screened for relevance based on preset inclusion and exclusion criteria. The methodological quality of the included reviews was assessed using the AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews 2) measurement tool, and a narrative synthesis of the data was conducted. Results The literature search yielded 19 eligible reviews. Overall, 63% (n=12) of these reviews reported on the effectiveness of e-engagement or participation promotion strategies. These evaluations were generally not conducted within very large observational digital cohorts. Most of the contributing reviews included multipurpose cohort studies (with both observational and interventional elements) conducted in clinical and research settings. Email or SMS

ObjectiveParenting sensitivity and mutual parent-child attunement are key features of environments that support children’s learning and development. To-date, observational measures of these constructs have focused on children aged 2–6 years and are less relevant to the more sophisticated developmental skills of children aged 7–8 years, despite parenting being equally important at these ages. We undertook a rigorous process to adapt an existing observational measure for 7–8-year-old children and their parents. This paper aimed to: (i) describe a protocol for adapting an existing framework for rating parent-child interactions, (ii) determine variations in parents’ sensitive responding and parent-child mutual attunement (‘positive mutuality’) by family demographics, and (iii) evaluate the psychometric properties of the newly developed measure (i.e., inter-rater reliability, construct validity).MethodParent-child dyads completed one home visit, including a free-play observation and parent questionnaire. Dyads were provided with three toy sets: LEGO® Classic Box, Classic Jenga®, and animal cards. The Coding of Attachment-Related Parenting (CARP) was adapted for use with 7–8-year-old children, and rating procedures were streamlined for reliable use by non-clinician/student raters, producing the SCARP:7–8 Years. Trained staff rated video-recorded observations on 11 behaviors across two domains (five for parents’ sensitive responding, six for parent-child positive mutuality).ResultsData were available for 596 dyads. Consistently strong inter-rater agreement on the 11 observed behaviors was achieved across the 10-week rating period (average: 87.6%

AIM: To examine associations between patterns of language use and early adolescent well-being. METHODS: Participants were 1763 Australian 11- to 12-year-olds in the Child Health CheckPoint. Six patterns of language use were identified from a writing activity using Linguistic Inquiry and Word Count and factor analysis: Acting in the present and future, Positive emotion, Gender and relationships, Self-aware, Inquisitive and time focused, and Confident. Well-being measures represented a spectrum from negatively to positively framed psychosocial health. Associations between language use and well-being were estimated using linear regression adjusted for age, sex and social disadvantage. RESULTS: Positive emotion (high emotional tone, positive emotion) was associated with better general well-being (standardised regression coefficient (SRC) 0.05; 95% confidence interval 0.00 to 0.11; p = 0.04), life satisfaction (0.06; 0.01 to 0.11; p = 0.03), psychosocial health (0.07; 0.02 to 0.12; p = 0.01) and quality of life (QoL) (0.06; 0.01 to 0.11; p = 0.02). Similarly, Self-aware (high first person singular pronouns, authentic, low clout) was associated with better general well-being, life satisfaction and psychosocial health (SRC 0.05, 0.09, 0.08), but Confident (high clout, first person plural pronouns, affiliation) was associated with worse life satisfaction, psychosocial health and QoL (SRC -0.06, -0.09, -0.06). CONCLUSION: If replicated in 'real-world' settings (e.g., social media), language patterns could provide naturalistic insights into early adolescents' well-being.

OBJECTIVES: To investigate the additional programme cost and cost-effectiveness of 'right@home' Nurse Home Visiting (NHV) programme in relation to improving maternal and child outcomes at child age 3 years compared with usual care. DESIGN: A cost-utility analysis from a government-as-payer perspective alongside a randomised trial of NHV over 3-year period. Costs and quality-adjusted life-years (QALYs) were discounted at 5%. Analysis used an intention-to-treat approach with multiple imputation. SETTING: The right@home was implemented from 2013 in Victoria and Tasmania states of Australia, as a primary care service for pregnant women, delivered until child age 2 years. PARTICIPANTS: 722 pregnant Australian women experiencing adversity received NHV (n=363) or usual care (clinic visits) (n=359). PRIMARY AND SECONDARY OUTCOME MEASURES: First, a cost-consequences analysis to compare the additional costs of NHV over usual care, accounting for any reduced costs of service use, and impacts on all maternal and child outcomes assessed at 3 years. Second, cost-utility analysis from a government-as-payer perspective compared additional costs to maternal QALYs to express cost-effectiveness in terms of additional cost per additional QALY gained. RESULTS: When compared with usual care at child age 3 years, the right@home intervention cost $A7685 extra per woman (95% CI $A7006 to $A8364) and generated 0.01 more QALYs (95% CI -0.01 to 0.02). The probability of right@home being cost-effective by child age 3 years is less than 20%, at a willingness-to-pay threshold of $A50 000 per QALY. CONCLUSIONS: Benefits of NHV to parenting at 2 years and maternal health and well-being at 3 years translate into marginal maternal QALY gains. Like previous cost-effectiveness results for NHV programmes, right@home is not cost-effective at 3 years. Given the relatively high up-front costs of NHV, long-term follow-up is needed to assess the accrual of health and economic benefits over time. TRIAL REGIST

Background and Purpose: Becoming a parent can be an exciting and also challenging transition, particularly for parents who have experienced significant hurt in their own childhoods, and may be experiencing ‘complex trauma.’ Aboriginal and Torres Strait Islander (Aboriginal) people also experience historical trauma. While the parenting transition is an important time to offer support for parents, it is essential to ensure that the benefits of identifying parents experiencing complex trauma outweigh any risks (e.g., stigmatization). This paper describes views of predominantly Aboriginal stakeholders regarding (1) the relative importance of domains proposed for complex trauma assessment, and (2) how to conduct these sensitive discussions with Aboriginal parents. Setting and Methods: A co-design workshop was held in Alice Springs (Central Australia) as part of an Aboriginal-led community-based participatory action research project. Workshop participants were 57 predominantly Aboriginal stakeholders with expertise in community, clinical, policy and academic settings. Twelve domains of complex trauma-related distress had been identified in existing assessment tools and through community consultation. Using story-telling and strategies to create safety for discussing complex and sensitive issues, and delphi-style methods, stakeholders rated the level of importance of the 12 domains; and discussed why, by whom, where and how experiences of complex trauma should be explored. Main Findings: The majority of stakeholders supported the importance of assessing each of the proposed complex trauma domains with Aboriginal parents. However, strong concerns were expressed regarding where, by whom and how this should occur. There was greater emphasis and consistency regarding ‘qualities’ (e.g., caring), rather than specific ‘attributes’ (e.g., clinician). Six critical overarching themes emerged: ensuring emotional and cultural safety; establishing relationships and trust; having capaci

Tablet-adapted measures provide an efficient, accurate method of data collection for large-scale studies. The Castles and Coltheart Reading Test 2 (CC2) is a standardized paper-and-pencil measure of children’s reading ability. In the current study, the CC2 was administered to 603 children aged 7–8 years via iPad using electronic data capture software. Results indicate the tablet-adapted measure could be reliably administered by non-clinical staff and showed quantitative equivalence, i.e., comparable score distributions, to CC2 normative data. Internal consistency was good for regular and non-word lists. Findings suggest that the tablet-adapted CC2 is a viable tool for large research studies.

BACKGROUND AND PURPOSE: Becoming a parent can be an exciting and also challenging transition, particularly for parents who have experienced significant hurt in their own childhoods, and may be experiencing 'complex trauma.' Aboriginal and Torres Strait Islander (Aboriginal) people also experience historical trauma. While the parenting transition is an important time to offer support for parents, it is essential to ensure that the benefits of identifying parents experiencing complex trauma outweigh any risks (e.g., stigmatization). This paper describes views of predominantly Aboriginal stakeholders regarding (1) the relative importance of domains proposed for complex trauma assessment, and (2) how to conduct these sensitive discussions with Aboriginal parents. SETTING AND METHODS: A co-design workshop was held in Alice Springs (Central Australia) as part of an Aboriginal-led community-based participatory action research project. Workshop participants were 57 predominantly Aboriginal stakeholders with expertise in community, clinical, policy and academic settings. Twelve domains of complex trauma-related distress had been identified in existing assessment tools and through community consultation. Using story-telling and strategies to create safety for discussing complex and sensitive issues, and delphi-style methods, stakeholders rated the level of importance of the 12 domains; and discussed why, by whom, where and how experiences of complex trauma should be explored. MAIN FINDINGS: The majority of stakeholders supported the importance of assessing each of the proposed complex trauma domains with Aboriginal parents. However, strong concerns were expressed regarding where, by whom and how this should occur. There was greater emphasis and consistency regarding 'qualities' (e.g., caring), rather than specific 'attributes' (e.g., clinician). Six critical overarching themes emerged: ensuring emotional and cultural safety; establishing relationships and trust; having capaci

Tablet-adapted measures provide an efficient, accurate method of data collection for large-scale studies. The Castles and Coltheart Reading Test 2 (CC2) is a standardized paper-and-pencil measure of children's reading ability. In the current study, the CC2 was administered to 603 children aged 7-8 years via iPad using electronic data capture software. Results indicate the tablet-adapted measure could be reliably administered by non-clinical staff and showed quantitative equivalence, i.e., comparable score distributions, to CC2 normative data. Internal consistency was good for regular and non-word lists. Findings suggest that the tablet-adapted CC2 is a viable tool for large research studies.

OBJECTIVES: Snack foods-typically high in salt, sugar, fat and/or energy-are likely important to the obesity epidemic. In the context of a population-based health assessment involving parent-child dyads at child age 11-12 years, we report cross-generational concordance in intake at a controlled snack food observation. DESIGN: Cross-sectional study (Child Health CheckPoint), nested within the Longitudinal Study of Australian Children. SETTING: Assessment centres in seven Australian cities, February 2015-March 2016. PARTICIPANTS: Of all participating CheckPoint families (n=1874), 1299 children (50.3% girls) and 1274 parents (85.9% mothers) with snack data were included. Survey weights and methods were applied to account for the clustered multistage sample design. OUTCOME MEASURES: Partway through the 3.5-hour assessment, parents and children attended Food Stop separately for a timed 15 min 'snack break'. One of four standardised box size/content combinations was randomly provided to all participants on any given day. Total food mass, energy, nutrients and sodium consumed was measured to the nearest 1 g. Pearson's correlation coefficients and adjusted multivariable linear regression models assessed parent-child concordance in each variable. RESULTS: Children consumed less grams (151 g [SD 80] vs 165 g [SD 79]) but more energy (1393 kJ [SD 537] vs 1290 kJ [SD 658]) than parents. Parent-child concordance coefficients were small, ranging from 0.07 for sodium intake to 0.17 for carbohydrate intake. Compared with children with parents' energy intake on the 10th centile, children whose parents were on the 90th centile ate on average 227 kJ more. If extrapolated to one similar unsupervised snack on a daily basis, this equates to an additional 83 050 kJ per year, which could have a cumulative impact on additional body fat. CONCLUSIONS: Although modest at an individual level, this measured parent-child concordance in unsupervised daily snack situations could account for substan

INTRODUCTION: Child maltreatment and other traumatic events can have serious long-term physical, social and emotional effects, including a cluster of distress symptoms recognised as 'complex trauma'. Aboriginal and Torres Strait Islander (Aboriginal) people are also affected by legacies of historical trauma and loss. Trauma responses may be triggered during the transition to parenting in the perinatal period. Conversely, becoming a parent offers a unique life-course opportunity for healing and prevention of intergenerational transmission of trauma. This paper outlines a conceptual framework and protocol for an Aboriginal-led, community-based participatory action research (action research) project which aims to co-design safe, acceptable and feasible perinatal awareness, recognition, assessment and support strategies for Aboriginal parents experiencing complex trauma. METHODS AND ANALYSIS: This formative research project is being conducted in three Australian jurisdictions (Northern Territory, South Australia and Victoria) with key stakeholders from all national jurisdictions. Four action research cycles incorporate mixed methods research activities including evidence reviews, parent and service provider discussion groups, development and psychometric evaluation of a recognition and assessment process and drafting proposals for pilot, implementation and evaluation. Reflection and planning stages of four action research cycles will be undertaken in four key stakeholder workshops aligned with the first four Intervention Mapping steps to prepare programme plans. ETHICS AND DISSEMINATION: Ethics and dissemination protocols are consistent with the National Health and Medical Research Council Indigenous Research Excellence criteria of engagement, benefit, transferability and capacity-building. A conceptual framework has been developed to promote the application of core values of safety, trustworthiness, empowerment, collaboration, culture, holism, compassion and reciprocit

OBJECTIVE: To examine health outcomes in Australian Aboriginal and Torres Strait Islander children experiencing perinatal risk and identify protective factors in the antenatal period. METHODS: Baby/Child cohorts of the Longitudinal Study of Indigenous Children, born 2001-2008, across four annual surveys (aged 0-8 years, N = 1483). Children with 'mild' and 'moderate-to-high' perinatal risk were compared to children born normal weight at term for maternal-rated global health and disability, and body-mass-index measured by the interviewer. RESULTS: Almost one third of children had experienced mild (22%) or moderate-to-high perinatal risk (8%). Perinatal risk was associated with lower body-mass-index z-scores (regression coefficients adjusted for pregnancy and environment factors: mild = -0.21, 95% CI = -0.34, -0.07; moderate-to-high = -0.42, 95% CI = -0.63, -0.21). Moderate-to-high perinatal risk was associated with poorer global health, with associations becoming less evident in models adjusted for pregnancy and environment factors; but not evident for disability. A range of protective factors, including cultural-based resilience and smoking cessation, were associated with lower risk of adverse outcomes. CONCLUSIONS: Perinatal risks are associated with Australian Aboriginal and Torres Strait children experiencing adverse health particularly lower body weight. Cultural-based resilience and smoking cessation may be two modifiable pathways to ameliorating health problems associated with perinatal risk.

OBJECTIVES: 'Growing Up in Australia: The Longitudinal Study of Australian Children' (LSAC) is Australia's only nationally representative children's longitudinal study, focusing on social, economic, physical and cultural impacts on health, learning, social and cognitive development. LSAC's first decade collected wide-ranging repeated psychosocial and administrative data; here, we describe the Child Health CheckPoint, LSAC's dedicated biophysical module. DESIGN, SETTING AND PARTICIPANTS: LSAC recruited a cross-sequential sample of 5107 infants aged 0-1 year and a sample of 4983 children aged 4-5 years in 2004, since completing seven biennial visits. CheckPoint was a cross-sectional wave that travelled Australia in 2015-2016 to reach LSAC's younger cohort at ages 11-12 years between LSAC waves 6 and 7. Parent-child pairs participated in comprehensive assessments at 15 Assessment Centres nationwide or, if unable to attend, a shorter home visit. MEASURES: CheckPoint's intergenerational, multidimensional measures were prioritised to show meaningful variation within normal ranges and capture non-communicable disease (NCD) phenotype precursors. These included anthropometry, physical activity, fitness, time use, vision, hearing, and cardiovascular, respiratory and bone health. Biospecimens included blood, saliva, buccal swabs (also from second parent), urine, hair and toenails. The epidemiology and parent-child concordance of many measures are described in separate papers. RESULTS: 1874 (54% of eligible) parent-child pairs and 1051 second parents participated. Participants' geographical distribution mirrored the broader Australian population; however, mean socioeconomic position and parental education were higher and fewer reported non-English-speaking or Indigenous backgrounds. Application of survey weights partially mitigates that the achieved sample is less population representative than previous waves of LSAC due to non-random attrition. Completeness was uniformly high

AIM: Cardiovascular disease and mental illness commonly co-occur in later life, but it is unknown how early these associations arise. We aimed to determine the extent to which: (i) childhood mental health is associated with functional and structural cardiovascular risk phenotypes and adiposity in late childhood/adolescence, and (ii) associations between mental health and cardiovascular phenotypes may be explained by differential body mass index. METHODS: This cross-sectional study drew on three longitudinal community-based cohort studies (two enriched for overweight/obesity) in metropolitan Melbourne, Australia, with harmonized follow-up in 2014. Mental health exposures included emotional and behavioural problems (Strength and Difficulties Questionnaire) and psychosocial health and general well-being (Pediatric Quality of Life Inventory (PedsQL)), which were assessed by self- and parent-proxy report. Cardiovascular risk phenotypes and adiposity measures included mean arterial pressure, pulse wave velocity, carotid artery intima-media thickness, retinal arterioleto-venule ratio, waist circumference, % body fat, and BMI z-score. We used multivariable linear regression models, adjusting for age, sex and neighbourhood disadvantage, to examine associations. RESULTS: Of the 364 participants (mean age 14.7, standard deviation 2.0, years), 30% were overweight and 16% obese. All adiposity indicators were positively associated with higher behavioural/emotional problems and poorer psychosocial health and negatively associated with better ratings of positive general well-being, as reported by parents and children (all P ≤ 0.03). However, there was little evidence that cardiovascular functional or structural phenotypes varied by mental health. CONCLUSIONS: By late childhood/adolescence, mental health is strongly associated with adiposity but not with cardiovascular structure or function. This suggests that the known relationship between these constructs may not develop until ear

BACKGROUND: Targeted interventions during early childhood can assist families in providing strong foundations that promote children's health and wellbeing across the life course. There is growing recognition that longer follow-up times are necessary to assess intervention outcomes, as effects may change as children develop. The Early Home Learning Study, or 'EHLS', comprised two cluster randomized controlled superiority trials of a brief parenting intervention, smalltalk, aimed at supporting parents to strengthen the early childhood home learning environment of infants (6-12 months) or toddlers (12-36 months). Results showed sustained improvements in parent-child interactions and the home environment at the 32 week follow-up for the toddler but not the infant trial. The current study will therefore follow up the EHLS toddler cohort to primary school age, with the aim of addressing a gap in literature concerning long-term effects of early childhood interventions focused on improving school readiness and later developmental outcomes. METHODS: 'EHLS at School' is a school-aged follow-up study of the toddler cluster randomized controlled trial (n = 1226). Data will be collected by parent-, child- and teacher-report questionnaires, recorded observations of parent-child interactions, and direct child assessment when children are aged 7.5 years old. Data linkage will provide additional data on child health and academic functioning at ages 5, 8 and 10 years. Child outcomes will be compared for families allocated to standard/usual care (control) versus those allocated to the smalltalk program (group program only or group program with additional home coaching). DISCUSSION: Findings from The Early Home Learning Study provided evidence of the benefits of the smalltalk intervention delivered via facilitated playgroups for parents of toddlers. The EHLS at School Study aims to examine the long-term outcomes of this initiative to determine whether improvements in the quality of the

BACKGROUND: Universal newborn hearing screening (UNHS) targets moderate or greater hearing loss. However, UNHS also frequently detects children with mild loss that results in many receiving early treatment. The benefits of this approach are not yet established. We aimed to (i) compare language and psychosocial outcomes between four hearing loss detection systems for children aged 5-8 years with congenital mild-moderate hearing loss; (ii) determine whether age of detection predicts outcomes; and (iii) compare outcomes between children identified via well-established UNHS and the general population. METHODS: Linear regression adjusted for potential confounding factors was used throughout. Via a quasi-experimental design, language and psychosocial outcomes were compared across four population-based Australian systems of hearing loss detection: opportunistic detection, born 1991-1993, n = 50; universal risk factor referral, born 2003-2005, n = 34; newly established UNHS, born 2003-2005, n = 41; and well-established UNHS, born 2007-2010, n = 21. In pooled analyses, we examined whether age of detection predicted outcomes. Outcomes were similarly compared between the current well-established UNHS system and typically developing children in the Early Language in Victoria Study, born 2003, n = 1217. RESULTS: Age at diagnosis and hearing aid fitting fell steadily across the four systems. For moderate losses, mean expressive language (P for trend .05) and receptive vocabulary (P for trend .06) improved across the four systems, but benefit was not obvious for mild losses. In pooled analyses, diagnosis before age six months predicted better language outcomes for moderate losses. Children with mild-moderate losses exposed to well-established UNHS continue to experience expressive language scores well below children in the general population (adjusted mean difference -8.9 points, 95% CI -14.7 to -3.1). CONCLUSIONS: Treatment arising from UNHS appears to be clearly benefitting chil

BACKGROUND: Adaptive working memory training is being implemented without an adequate understanding of developmental trajectories of working memory. We aimed to quantify from Grade 1 to Grade 3 of primary school (1) changes in verbal and visuospatial working memory and (2) whether low verbal and visuospatial working memory in Grade 1 predicts low working memory in Grade 3. METHOD: The study design includes a population-based longitudinal study of 1,802 children (66% uptake from all 2,747 Grade 1 students) at 44 randomly selected primary schools in Melbourne, Australia. Backwards Digit Recall (verbal working memory) and Mister X (visuospatial working memory) screening measures from the Automated Working Memory Assessment (M = 100; SD = 15) were used to assess Grades 1 and 3 (ages 6-7 and 8-9 years) students. Low working memory was defined as ≥1 standard deviation below the standard score mean. Descriptive statistics addressed Aim 1, and predictive parameters addressed Aim 2. RESULTS: One thousand seventy (59%) of 1802 Grade 1 participants were reassessed in Grade 3. As expected for typically developing children, group mean standard scores were similar in Grades 1 and 3 for verbal, visuospatial, and overall working memory, but group mean raw scores increased markedly. Compared to "not low" children, those classified as having low working memory in Grade 1 showed much larger increases in both standard and raw scores across verbal, visuospatial, and overall working memory. Sensitivity was very low for Grade 1 low working memory predicting Grade 3 low classifications. CONCLUSION: Although mean changes in working memory standard scores between Grades 1 and 3 were minimal, we found that individual development varied widely, with marked natural resolution by Grade 3 in children who initially had low working memory. This may render brain-training interventions ineffective in the early school year ages, particularly if (as population-based programmes usually mandate) selectio

Language disorder (LD) and social-emotional and behavioural (SEB) difficulties are common childhood problems that often co-occur. While there is clear evidence of these associations from clinical samples, less is known about community samples. This paper examines these associations in children aged 4-7 years from a community-based longitudinal study. 771 families provided questionnaire and assessment data at 4, 5 and 7 years. Parent-reported SEB difficulties were measured at each point (SDQ). Child language was directly assessed at 4 (CELF-P2), 5 and 7 years (CELF-4). Linear regression analysis was used to compare cross-sectional differences in mean SDQ scores between children with and without LD at each time point. Linear regression was then used to examine how patterns of language development (language disordered at three time points; never disordered; disordered at one or two time points, i.e. 'unstable' group) related to SEB difficulties at each age, adjusted for potential confounders, as in the previous analyses. Higher hyperactivity/inattention scores were associated with LD at each age. In fully adjusted models, there was little difference in mean emotional symptoms scores between children with and without LD. The 'never' LD group had lower mean SDQ scores at each time point than the 'unstable' group. Findings highlight that children with persistent LD from preschool to early primary school may be more likely to have concomitant SEB difficulties, particularly behavioural difficulties. Those with unstable LD may also have co-occurring SEB difficulties, showing a need for education and health professionals to monitor early language and SEB development.

Infant colic is a distressing condition of unknown etiology. An aberrant gastrointestinal microbiota has been associated, and Lactobacillus reuteri supplementation has been shown to reduce crying and/or fussing time ('crying time') in some infants with colic. The relationship between L. reuteri gut colonization and crying time has not been examined. We investigated the relationship between L. reuteri colonization and fecal microbiota (microbial diversity and Escherichia coli), intestinal inflammation, and crying time in infants with colic, using a subset of 65 infants from the Baby Biotics trial, which randomized healthy term infants aged <13 weeks with infant colic to receive probiotic L. reuteri DSM 17938 (1 × 108 colony forming units) or placebo daily for 28 days. We observed an overall reduction in median crying time, regardless of L. reuteri colonization status (n = 14 colonized). There were no differences in E. coli colonization rates or densities, microbial diversity or intestinal inflammation by L. reuteri colonization status. We found that L. reuteri density positively correlated with crying time, and E. coli density negatively correlated with microbial diversity. As density of L. reuteri was associated with increased crying time, L. reuteri supplementation may not be an appropriate treatment for all infants with colic.

OBJECTIVES: To describe 24-hour time-use patterns and their association with health-related quality of life (HRQoL) in early adolescence. METHODS: The Child Health CheckPoint was a cross-sectional study nested between Waves 6 and 7 of the Longitudinal Study of Australian Children. The participants were 1455 11- to 12-year-olds (39% of Wave 6; 51% boys). The exposure was 24-hour time use measured across 259 activities using the Multimedia Activity Recall for Children and Adolescents. "Average" days were generated from 1 school and 1 nonschool day. Time-use clusters were derived from cluster analysis with compositional inputs. The outcomes were self-reported HRQoL (Physical and Psychosocial Health [PedsQL] summary scores; Child Health Utility 9D [CHU9D] health utility). RESULTS: Four time-use clusters emerged: "studious actives" (22%; highest school-related time, low screen time), "techno-actives" (33%; highest physical activity, lowest school-related time), "stay home screenies" (23%; highest screen time, lowest passive transport), and "potterers" (21%; low physical activity). Linear regression models, adjusted for a priori confounders, showed that compared with the healthiest "studious actives" (mean [SD]: CHU9D 0.84 [0.14], PedsQL physical 86.8 [10.8], PedsQL psychosocial 79.9 [12.6]), HRQoL in "potterers" was 0.2 to 0.5 SDs lower (mean differences [95% confidence interval]: CHU9D -0.03 [-0.05 to -0.00], PedsQL physical -5.5 [-7.4 to -3.5], PedsQL psychosocial -5.8 [-8.0 to -3.5]). CONCLUSIONS: Discrete time-use patterns exist in Australian young adolescents. The cluster characterized by low physical activity and moderate screen time was associated with the lowest HRQoL. Whether this pattern translates into precursors of noncommunicable diseases remains to be determined.

AIM: We aim to describe health service (HS) use in the first 6 months post-partum and to examine the associations between service costs, infant behaviour and maternal depressive symptoms. METHODS: Participants were 781 infants and mothers in Melbourne, Australia. Mothers reported infant feeding, sleeping and crying problems, depressive symptoms and health service use. Costs were valued in 2012 Australian dollars. RESULTS: The most common services used were maternal child health nurses, general practitioners (GP) and allied health. Infant feeding problems were associated with increased costs for services relevant to infant behaviour including maternal child health nurses (P = 0.007), GP (P = 0.008) and paediatricians (P = 0.03). Maternal depressive symptoms were associated with increased costs for services relevant to depressive symptoms including parenting centres (P = 0.04), GP (P = 0.004), psychiatrists (P = 0.02) and psychologists (P = 0.001). Mothers who completed high school had higher service costs for infant problems than those with lower education (P = 0.02). Single mothers had higher costs for services used for their depressive symptoms than partnered mothers (P < 0.001). Mothers with English as a second language had lower service costs for their depressive symptoms (P = 0.02). CONCLUSIONS: Infant feeding problems and maternal depressive symptoms are associated with higher costs for health services relevant to these conditions. Cost-effective strategies to manage these conditions are needed with accessibility being ensured for mothers who are experiencing social adversity.

OBJECTIVES: Indigenous women continue to experience rates of stillbirth, preterm birth and low birth weight, two to three times higher than other women in high-income countries. The reasons for disparities are complex and multifactorial. We aimed to assess the extent to which adverse birth outcomes are associated with maternal cannabis use and exposure to stressful events and social health issues during pregnancy. DESIGN/SETTING: Cross-sectional, population-based survey of women giving birth to Aboriginal babies in South Australia, July 2011-June 2013. Data include: maternal cannabis use, exposure to stressful events/social health issues, infant birth weight and gestation. PARTICIPANTS: 344 eligible women with a mean age of 25 years (range 15-43 years), enrolled in the study. Participants were representative in relation to maternal age, infant birth weight and gestation. RESULTS: 1 in 5 women (20.5%) used cannabis during pregnancy, and 52% smoked cigarettes. Compared with mothers not using cannabis or cigarettes, mothers using cannabis had babies on average 565 g lighter (95% CI -762 to -367), and were more likely to have infants with a low birth weight (OR=6.5, 95% CI 3.0 to 14.3), and small for gestational age (OR=3.8, 95% CI 1.9 to 7.6). Controlling for education and other social characteristics, including stressful events/social health issues did not alter the conclusion that mothers using cannabis experience a higher risk of negative birth outcomes (adjusted OR for odds of low birth weight 3.9, 95% CI 1.4 to 11.2). CONCLUSIONS: The findings provide a compelling case for stronger efforts to address the clustering of risk for adverse outcomes in Aboriginal and Torres Strait Islander communities, and point to the need for antenatal care to address broader social determinants of adverse perinatal outcomes. Integrated responses--collaboratively developed with Aboriginal communities and organisations--that focus on constellations of risk factors, and a holistic appro

BACKGROUND: Many calorie-rich dietary components contribute to obesity. However, the contribution of confectionery to obesity in children and adolescents has not been well established. OBJECTIVE: In this systematic review and meta-analysis, we hypothesized that higher total, chocolate, and nonchocolate confectionery consumption would be associated with higher odds of overweight, obesity, and other obesity-related outcomes [body mass index (BMI), BMI z score, body composition, waist circumference, and percentage body fat] in children and adolescents. DESIGN: We searched Scopus, PubMed, and reference lists of pertinent reviews, supplemented by expert contact, for randomized controlled trials (RCTs) and observational studies published between 1990 and 31 March 2015, and we conducted separate meta-analyses for categorical and continuous ORs and for total, chocolate, and nonchocolate confectioneries with the use of a random-effects model. RESULTS: A total of 19 studies were included in the systematic review, and the cross-sectional results of 11 studies (∼177,260 participants) were included in the meta-analysis. In the meta-analysis, which examined the combined outcome of overweight and obesity, the odds of overweight or obesity were 18% lower (OR: 0.82; 95% CI: 0.69, 0.97) for subjects in the highest category of consumption than for a reference category of consumption. Thus, a 1-time/wk or a 1-U increase in consumption was associated with a 13% (OR: 0.87; 95% CI: 0.85, 0.88) decrease in the odds of overweight or obesity. Associations were similarly inverse for chocolate and nonchocolate confectioneries. In the longitudinal studies and the RCT included in the review, no associations were observed between confectionery consumption and overweight, obesity, or obesity-related outcomes. CONCLUSIONS: Instead of overweight and obese children and adolescents having higher confectionery intakes, this review shows the reverse effect. This result might reflect a true inverse assoc

Parenting behaviors are commonly targeted in early interventions to improve children's language development. Accurate measurement of both parenting behaviors and children's language outcomes is thus crucial for sensitive assessment of intervention outcomes. To date, only a small number of studies have compared parent-reported and directly measured behaviors, and these have been hampered by small sample sizes and inaccurate statistical techniques, such as correlations. The Bland-Altman Method and Reduced Major Axis regression represent more reliable alternatives because they allow us to quantify fixed and proportional bias between measures. In this study, we draw on data from two Australian early childhood cohorts (N = 201 parents and slow-to-talk toddlers aged 24 months; and N = 218 parents and children aged 6-36 months experiencing social adversity) to (1) examine agreement and quantify bias between parent-reported and direct measures, and (2) to determine socio-demographic predictors of the differences between parent-reported and direct measures. Measures of child language and parenting behaviors were collected from parents and their children. Our findings support the utility of the Bland-Altman Method and Reduced Major Axis regression in comparing measurement methods. Results indicated stronger agreement between parent-reported and directly measured child language, and poorer agreement between measures of parenting behaviors. Child age was associated with difference scores for child language; however, the direction varied for each cohort. Parents who rated their child's temperament as more difficult tended to report lower language scores on the parent questionnaire, compared to the directly measured scores. Older parents tended to report lower parenting responsiveness on the parent questionnaire, compared to directly measured scores. Finally, speaking a language other than English was associated with less responsive parenting behaviors on the videotaped observati

Evidence is required as to when and where to focus resources to achieve the greatest gains for children's language development. Key to these decisions is the understanding of individual differences in children's language trajectories and the predictors of those differences. To determine optimal timing we must understand if and when children's relative language abilities become fixed. To determine where to focus effort we must identify mutable factors, that is those with the potential to be changed through interventions, which are associated with significant differences in children's language scores and rate of progress.

AIM: Behavioral sleep problems are ideally measured using a combination of objective and subjective measures. However, this is not always feasible. Thus, a global subjective measure has been used to assess sleep problems in children with attention deficit hyperactivity disorder (ADHD), yet it is unclear how this relates to more detailed multidimensional measures of sleep problems. In children with ADHD, parent report of a global measure of sleep problem severity (classified no/mild versus moderate/severe) is compared with the following: (1) a 7-Day Sleep Log and (2) the validated Children's Sleep Habits Questionnaire (CSHQ). METHOD: This study recruited 392 children with ADHD (aged 5-13 years) from 50 pediatric practices across Victoria, Australia. All caregivers completed the CSHQ, and 257 children prospectively completed the 7-Day Sleep Logs. RESULTS: Sleep log data identified distinct sleep patterns according to parent-reported sleep problem severity; children with moderate/severe sleep problems slept 30 min less per day, took longer to fall asleep, and experienced more night awakenings. This pattern was also repeated across the CSHQ, where children with moderate/severe sleep problems experienced more problematic sleep symptoms across all domains (effect sizes: 0.5-1.1; all p < 0.001). CONCLUSION: A subjective, global measure of sleep problem severity appears to be a useful tool for the initial assessment of sleep problems in children with ADHD when more extensive measures are not feasible, as it is reflective of well-established multidimensional measures. However, further research is required to determine its validity.

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

INTRODUCTION: Children with attention-deficit/hyperactivity disorder (ADHD) commonly experience behavioural sleep problems, yet these difficulties are not routinely assessed and managed in this group. Presenting with similar symptoms to ADHD itself, sleep problems are complex in children with ADHD and their aetiology is likely to be multifactorial. Common internalising and externalising comorbidities have been associated with sleep problems in children with ADHD; however, this relationship is yet to be fully elucidated. Furthermore, limited longitudinal data exist on sleep problems in children with ADHD, thus their persistence and impact remain unknown. In a diverse sample of children with ADHD, this study aims to: (1) quantify the relationship between sleep problems and internalising and externalising comorbidities; (2) examine sleep problem trajectories and risk factors; and (3) examine the longitudinal associations between sleep problems and child and family functioning over a 12-month period. METHODS AND ANALYSIS: A prospective cohort study of 400 children with ADHD (150 with no/mild sleep problems, 250 with moderate/severe sleep problems) recruited from paediatric practices across Victoria, Australia. The children's parents and teacher provide data at baseline and 6-month and 12-month post enrolment. KEY MEASURES: Parent report of child's sleep problem severity (no, mild, moderate, severe); specific sleep domain scores assessed using the Child Sleep Habits Questionnaire; internalising and externalising comorbidities assessed by the Anxiety Disorders Interview Schedule for Children IV/Parent version. ANALYSES: Multiple variable logistic and linear regression models examining the associations between key measures, adjusted for confounders identified a priori. ETHICS AND DISSEMINATION: Ethics approval has been granted. Findings will contribute to our understanding of behavioural sleep problems in children with ADHD. Clinically, they could improve the assessment an

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: OR(persistent) = 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.

OBJECTIVES: In Australian 0-7-year olds with and without sleep problems, to compare (1) type and costs to government of non-hospital healthcare services and prescription medication in each year of age and (2) the cumulative costs according to persistence of the sleep problem. DESIGN: Cross-sectional and longitudinal data from a longitudinal population study. SETTING: Data from two cohorts participating in the first two waves of the nationally representative Longitudinal Study of Australian Children. PARTICIPANTS: Baby cohort at ages 0-1 and 2-3 (n=5107, 4606) and Kindergarten cohort at ages 4-5 and 6-7 (n=4983, 4460). MEASUREMENTS: Federal Government expenditure on healthcare attendances and prescription medication from birth to 8 years, calculated via linkage to Australian Medicare data, were compared according to parent report of child sleep problems at each of the surveys. RESULTS: At both waves and in both cohorts, over 92% of children had both sleep and Medicare data. The average additional healthcare costs for children with sleep problems ranged from $141 (age 5) to $43 (age 7), falling to $98 (age 5) to $18 (age 7) per child per annum once family socioeconomic position, child gender, global health and special healthcare needs were taken into account. This equates to an estimated additional $27.5 million (95% CI $9.2 to $46.8 million) cost to the Australian federal government every year for all children aged between 0 and 7 years. In both cohorts, costs were higher for persistent than transient sleep problems. CONCLUSIONS: Higher healthcare costs were sustained by infants and children with sleep problems. This supports ongoing economic evaluations of early prevention and intervention services for sleep problems considering impacts not only on the child and family but also on the healthcare system.

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. 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 c