Ophthalmic Findings in Aboriginal Children with High Rates of Prenatal Alcohol Exposure and Fetal Alcohol Spectrum Disorder: The Lililwan Project.

PURPOSE: To describe ophthalmic findings in an Indigenous paediatric population and the associations between fetal alcohol spectrum disorder (FASD), prenatal alcohol exposure (PAE), and eye anomalies. METHODS: Medical records were reviewed for eye problems, and eye assessments were conducted by an orthoptist or ophthalmologist in the Lililwan Project cohort, which comprised 108 (81%) of all children born between 2002 and 2003, and residing in the remote Fitzroy Valley, Western Australia in 2010. Values from ophthalmic assessments and prevalence of abnormalities were presented for the total cohort and stratified by group: FASD; PAE (no FASD); and No PAE. RESULTS: Of children, 55% had PAE and 19% FASD. Most (98%) had normal vision; 15.6% had keratometry cylinder values indicating astigmatism and potential for improved vision with glasses. Strabismus (22.3%), short palpebral fissure length (PFL; 21.3%), upslanting palpebral fissures (12.0%), follicular trachomatous inflammation (6.9%), abnormal slit lamp assessments (6.7%), retinal tortuosity (6.7%), and blepharoptosis (5.6%) were identified. Strabismus and trachoma rates were higher than in the general child population. Ophthalmic findings were similar between groups except for prevalence of short PFL (FASD > No PAE; p = 0.003); abnormal keratometry cylinder values (FASD [29.4%] and PAE (no FASD) [20.0%] > No PAE [5.3%]; p = 0.031) and blepharoptosis (FASD [9.5%] > other groups [0%]; p = 0.040). CONCLUSION: Despite the small sample, some eye abnormalities were higher in children with PAE and/or FASD. Access to eye services or assessment of vision and structural eye anomalies is essential for Indigenous children, particularly those with PAE or FASD to allow early effective treatment.

Differential effectiveness of a practice change intervention to improve antenatal care addressing alcohol consumption during pregnancy: Exploratory subgroup analyses within a randomised stepped-wedge controlled trial.

OBJECTIVE: A practice change intervention demonstrated improvements in the provision of antenatal care addressing alcohol consumption. The aim of this study was to explore whether the effectiveness of the intervention differed between subgroups of pregnant women and types and location of maternity services. DESIGN AND SETTING: Post-hoc exploratory subgroup analyses of the outcomes from a randomised stepped-wedge controlled trial conducted with all public maternity services within three sectors of a local health district in Australia. MEASUREMENTS: Two outcomes (receipt of alcohol assessment and complete care) measured at two visit types (initial and subsequent) were included in analyses. Logistic regression models explored interactions between pre-post differences and subgroups of women (age, Aboriginal origin, education level, disadvantage, gravidity and alcohol consumption in pregnancy) and services (geographic remoteness, service and provider type/s) that have been reported to be associated with variation in guideline implementation. FINDINGS: Surveys from 5694 women were included in the analyses. For the initial visit, no significant differential intervention effects between subgroups of women or type/location of services were found for either outcome. For subsequent visits, the intervention effect differed significantly only between Aboriginal origin subgroups (Aboriginal OR: 1.95; 95% CI: 0.99-3.85; non-Aboriginal OR: 5.34; 95% CI: 4.17-6.83; p<0.01) and women's alcohol consumption in pregnancy subgroups (consumed alcohol OR: 1.28; 95% CI: 0.59-2.78; not consumed alcohol OR: 5.22; 95% CI: 4.11-6.65; p<0.001) for assessment of alcohol consumption. KEY CONCLUSIONS: These exploratory results suggest that the intervention may have had similar effects between different subgroups of women and types and location of services, with the exception of women who were non-Aboriginal and women who had not consumed alcohol, for whom the intervention was potentially more effective. IMPLICATIONS FOR PRACTICE: The practice change intervention could be implemented with different maternity service and provider types to effectively support improvements in antenatal care addressing alcohol consumption. These exploratory results provide further data for hypothesis generation regarding targeted areas for the testing of additional strategies that enable Aboriginal women to benefit equally from the intervention, and to ensure those women most in need of care, those consuming alcohol during pregnancy, have their care needs met.

Eye Abnormalities in Children with Fetal Alcohol Spectrum Disorders: A Systematic Review.

PURPOSE: Although eye abnormalities are reported in fetal alcohol spectrum disorders (FASD), no systematic review based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines has been undertaken. Our aim was to document the range and prevalence of eye abnormalities reported in children with prenatal alcohol exposure (PAE) and/or FASD. METHODS: Searches of electronic databases and manual searches. Eligible articles were observational studies in children with PAE and/or FASD; peer reviewed journal articles in the English language; and studies reporting quantitative or frequency data on functional/structural eye abnormalities. Pooled prevalence, odds ratio, and mean differences were calculated. RESULTS: Of the 1,068 retrieved articles 36 were eligible, including articles on children with diagnosed fetal alcohol syndrome/FASD (N = 31); PAE (N = 3); and FASD or PAE without FASD (N = 2). Structural and functional eye abnormalities were identified, the most prevalent being short palpebral fissure length (66.1%), visual impairment (55.5%), epicanthus (53.5%), subnormal stereoacuity (53.0%), abnormal retinal tortuosity (50.5%), impaired fixation ability (33.3%), telecanthus (31.7%), optic nerve hypoplasia (30.2%), and small optic discs (27.0%). Compared to non-exposed controls, strabismus, subnormal vision, ptosis, short palpebral fissure length, microphthalmos, smaller optic disc area, and retinal vessel tortuosity were more prevalent in children with FASD. CONCLUSIONS: Examination of eyes and vision should be considered in children with PAE and suspected or diagnosed FASD to enable early identification and optimal management. This first comprehensive, systematic literature review demonstrates the variety and frequency of eye abnormalities reported in PAE/FASD.

Factors to be considered as part of a holistic assessment for fetal alcohol spectrum disorder: A scoping review.

We undertook a scoping review to identify the factors outside of current fetal alcohol spectrum disorder (FASD) diagnostic criteria to be considered as part of a holistic assessment process. This included physical, social, cultural, mental health and wellbeing factors to inform targeted recommendations and supports to improve outcomes for individuals with FASD. Evidence from this review will be used to inform the revision of the Australian Guide to the Diagnosis of FASD. Six electronic databases were searched. Studies were eligible if they included factors outside of the diagnostic criteria that cover dysmorphology, growth restriction, neurodevelopmental impairments. Data charting and content analysis were performed to synthesize the results. One hundred twenty-one studies were included that spanned 12 key areas These included physical health, sleep, adverse postnatal experiences, substance use/other risk-taking behaviors, contact with the criminal justice system, mental health, First Nations cultural considerations, transition to adult roles, involvement with the out-of-home care system, feeding and eating, strengths/interests/external resources and incontinence. Areas to be considered as part of a holistic assessment and diagnostic process spanned individual, family, and system level factors. Results provide guidance for clinicians on the wide range of factors that could influence long-term health, development, and wellbeing for individuals with prenatal alcohol exposure and FASD. In practice, this guidance can be used to inform an individualized assessment process to facilitate tailored recommendations and supports to best meet the complex needs of individuals living with FASD and their families.

Effectiveness of a practice change intervention in reducing alcohol consumption in pregnant women attending public maternity services.

BACKGROUND: The aim of this study was to examine the effect of a practice change intervention to support the implementation of guideline-recommended care for addressing alcohol use in pregnancy on self-reported alcohol use during pregnancy. METHODS: A randomized, stepped-wedge controlled trial in three clusters (sectors) within the Hunter New England Local Health District (NSW, Australia). We evaluated a practice change intervention that supported the introduction of a new model of care for reducing alcohol use in pregnancy, consistent with local and international guidelines, and implemented in random order across the sectors. Each week throughout the study period, pregnant women who attended any public antenatal services within the previous week, for a 27-28 or 35-36 week gestation visit, were randomly sampled and invited to participate in the survey. The intended intervention for all women was Brief advice (to abstain from alcohol and information about potential risks). Women identified as medium-risk alcohol consumers using the Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) were to be offered referral to a phone coaching service, and women identified as high-risk were to be offered referral to a Drug and Alcohol Service. Rates of self-reported alcohol use (AUDIT-C risk level and special occasion drinking) were summarized and compared in groups of women pre-intervention and post-intervention using multivariable logistic regression. RESULTS: Surveys were completed by 1309 women at pre-intervention and 2540 at post-intervention. The majority of women did not drink during pregnancy (pre-intervention: 89.68%; post-intervention: 90.74%). There was no change in the proportion of women classified as No risk from drinking (AUDIT-C score = 0) or Some risk from drinking (AUDIT-C score ≥ 1) pre- or post-intervention (p = 0.08). However, a significant reduction in special occasion drinking was observed (pre-intervention: 11.59%; post-intervention: 8.43%; p < 0.001). CONCLUSIONS: Special occasion drinking was reduced following implementation of guideline-recommended care. Failure to change other patterns of alcohol use in pregnancy may reflect barriers to implementing the model of care in antenatal care settings and the need to address other social determinants of alcohol use. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (registration number: ACTRN12617000882325; date: 16 June 2017).

Written information and health professionals are the information sources about alcohol use in pregnancy most often used by pregnant women.

INTRODUCTION: Alcohol use in pregnancy remains common in Australia, despite national guidelines recommending that pregnant women abstain. The aims of this study were to investigate where pregnant women obtain information about alcohol use in pregnancy and the relationship between the information source used and women's demographic characteristics and alcohol use. METHODS: In this cross-sectional survey of pregnant women attending public maternity services in the Hunter New England region (New South Wales), women were asked, 'Where did you get information to help you make decisions about alcohol use during pregnancy?'. The number and types of information sources were analysed using descriptive statistics. Associations between women's information sources, and their demographic characteristics and alcohol use in pregnancy were assessed using chi-square tests and logistic regression. RESULTS: Of 4511 pregnant women surveyed, 80.1% used at least one type of information source (range 0-5). Written/electronic information (45.4%), health providers (37.6%) and family/friends (19.5%) were the sources most reported. Higher use of written/electronic information, antenatal health providers and family/friends was associated with first pregnancy, younger age and higher education. The type of information source used was associated with alcohol use in pregnancy. Women who reported alcohol use were more likely to receive information from written/electronic sources. Almost 20% of women (older, multiparous [>1 pregnancy] and more highly educated) obtained no information regarding alcohol use in pregnancy. DISCUSSION AND CONCLUSIONS: Antenatal providers should routinely provide information on alcohol use in pregnancy, including for women least likely to access available information.

Iterative delivery of an implementation support package to increase and sustain the routine provision of antenatal care addressing alcohol consumption during pregnancy: study protocol for a stepped-wedge cluster trial.

INTRODUCTION: Antenatal care addressing alcohol consumption during pregnancy is not routinely delivered in maternity services. Although a number of implementation trials have reported significant increases in such care, the majority of women still did not receive all recommended care elements, and improvements dissipated over time. This study aims to assess the effectiveness of an iteratively developed and delivered implementation support package in: (1) increasing the proportion of pregnant women who receive antenatal care addressing alcohol consumption and (2) sustaining the rate of care over time. METHODS AND ANALYSIS: A stepped-wedge cluster trial will be conducted as a second phase of a previous trial. All public maternity services within three sectors of a local health district in Australia will receive an implementation support package that was developed based on an assessment of outcomes and learnings following the initial trial. The package will consist of evidence-based strategies to support increases in care provision (remind clinicians; facilitation; conduct educational meetings) and sustainment (develop a formal implementation blueprint; purposely re-examine the implementation; conduct ongoing training). Measurement of outcomes will occur via surveys with women who attend antenatal appointments each week. Primary outcomes will be the proportion of women who report being asked about alcohol consumption at subsequent antenatal appointments; and receiving complete care (advice and referral) relative to alcohol risk at initial and subsequent antenatal appointments. Economic and process evaluation measures will also be reported. ETHICS AND DISSEMINATION: Ethical approval was obtained through the Hunter New England (16/11/16/4.07, 16/10/19/5.15) and University of Newcastle Human Research Ethics Committees (H-2017-0032, H-2016-0422) and the Aboriginal Health and Medical Research Council (1236/16). Trial findings will be disseminated to health service decision makers to inform the feasibility of conducting additional cycles to further improve antenatal care addressing alcohol consumption as well as at scientific conferences and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trials Registry (ACTRN12622000295741).

Practice change intervention to improve antenatal care addressing alcohol consumption during pregnancy: a randomised stepped-wedge controlled trial.

BACKGROUND: Clinical guideline recommendations for addressing alcohol consumption during pregnancy are sub-optimally implemented and limited evidence exists to inform practice improvements. The aim of this study was to estimate the effectiveness of a practice change intervention in improving the provision of antenatal care addressing alcohol consumption during pregnancy in public maternity services. METHODS: A randomised stepped-wedge controlled trial was undertaken with all public maternity services in three sectors (one urban, two regional/rural) of a single local health district in New South Wales, Australia. All antenatal care providers were subject to a seven-month multi-strategy intervention to support the introduction of a recommended model of care. For 35 months (July 2017 - May 2020) outcome data were collected from randomly selected women post an initial, 27-28 weeks and 35-36 weeks gestation antenatal visit. Logistic regression models assessed intervention effectiveness. RESULTS: Five thousand six hundred ninety-four interviews/online questionnaires were completed by pregnant women. The intervention was effective in increasing women's reported receipt of: assessment of alcohol consumption (OR: 2.63; 95% CI: 2.26-3.05; p < 0.001), advice not to consume alcohol during pregnancy and of potential risks (OR: 2.07; 95% CI: 1.78-2.41; p < 0.001), complete care relevant to alcohol risk level (advice and referral) (OR: 2.10; 95% CI: 1.80-2.44; p < 0.001) and all guideline elements relevant to alcohol risk level (assessment, advice and referral) (OR: 2.32; 95% CI: 1.94-2.76; p < 0.001). Greater intervention effects were found at the 27-28 and 35-36 weeks gestation visits compared with the initial antenatal visit. No differences by sector were found. Almost all women (98.8%) reported that the model of care was acceptable. CONCLUSIONS: The practice change intervention improved the provision of antenatal care addressing alcohol consumption during pregnancy in public maternity services. Future research could explore the characteristics of pregnant women and maternity services associated with intervention effectiveness as well as the sustainment of care practices over time to inform the need for, and development of, further tailored practice change support. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (Registration number: ACTRN12617000882325; Registration date: 16/06/2017) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372985&isReview=true.

Bigiswun Kid Project: a longitudinal study of adolescents living with high rates of prenatal alcohol exposure, fetal alcohol spectrum disorder and early life trauma in remote Australian Aboriginal communities.

INTRODUCTION: The Lililwan Project was the first Australian population-based prevalence study of fetal alcohol spectrum disorder (FASD) using active case ascertainment. Conducted in 2010-2011, the study included 95% of all eligible children aged 7-9 years living in the very remote Aboriginal communities of the Fitzroy Valley, Western Australia. Women from Marninwarntikura Women's Resource Centre, a local Aboriginal-led organisation, are concerned that some participants from the study are struggling in adolescence so partnered with researchers from the University of Sydney to follow up the Lililwan cohort in 2020-2022 at age 17-19 years.The overarching aim of the Bigiswun Kid Project is to identify adolescents' needs and build knowledge to inform services to improve the health and well-being of adolescents in remote Aboriginal communities. The specific aims are to: (1) provide a voice to adolescents and their families to understand the health and well-being status of the Lililwan cohort at 17-19 years. (2) Examine relationships between exposures during pregnancy, birth characteristics, and health and neurodevelopment at 7-9 years, and positive/adverse adolescent outcomes at 17-19 years. This information will identify prenatal and early life factors that predict good health and well-being in adolescence. (3) Determine whether management plans provided in the Lililwan Project were followed, and identify past and present service gaps, support needs and barriers to service use. (4) Determine if key physical characteristics of FASD change between childhood and adolescence in this Aboriginal population. ETHICS AND DISSEMINATION: Approved by the Kimberley Aboriginal Health Planning Forum and relevant ethics committees.

Cost, cost-consequence and cost-effectiveness evaluation of a practice change intervention to increase routine provision of antenatal care addressing maternal alcohol consumption.

BACKGROUND: Implementation of antenatal clinical guideline recommendations for addressing maternal alcohol consumption is sub-optimal. There is a complete absence of evidence of the cost and cost-effectiveness of delivering practice change interventions addressing maternal alcohol consumption amongst women accessing maternity services. The study sought to determine the cost, cost-consequence and cost-effectiveness of developing and delivering a multi-strategy practice change intervention in three sectors of a health district in New South Wales, Australia. METHODS: The trial-based economic analyses compared the costs and outcomes of the intervention to usual care over the 35-month period of the stepped-wedge trial. A health service provider perspective was selected to focus on the cost of delivering the practice change intervention, rather than the cost of delivering antenatal care itself. All costs are reported in Australian dollars ($AUD, 2019). Univariate and probabilistic sensitivity analyses assessed the effect of variation in intervention effect and costs. RESULTS: The total cost of delivering the practice change intervention across all three sectors was $367,646, of which $40,871 (11%) were development costs and $326,774 (89%) were delivery costs. Labour costs comprised 70% of the total intervention delivery cost. A single practice change strategy, 'educational meetings and educational materials' contributed 65% of the delivery cost. Based on the trial's primary efficacy outcome, the incremental cost effectiveness ratio was calculated to be $32,570 (95% CI: $32,566-$36,340) per percent increase in receipt of guideline recommended care. Based on the number of women attending the maternity services during the trial period, the average incremental cost per woman who received all guideline elements was $591 (Range: $329 - $940) . The average cost of the intervention per eligible clinician was $993 (Range: $640-$1928). CONCLUSION: The intervention was more effective than usual care, at an increased cost. Healthcare funders' willingness to pay for this incremental effect is unknown. However, the strategic investment in systems change is expected to improve the efficiency of the practice change intervention over time. Given the positive trial findings, further research and monitoring is required to assess the sustainability of intervention effectiveness and whether economies of scale, or reduced costs of intervention delivery can be achieved without impact on outcomes. TRIAL REGISTRATION: The trial was prospectively registered with the Australian and New Zealand Clinical Trials Registry, No. ACTRN12617000882325 (date registered: 16/06/2017).

Predictors of alcohol use during pregnancy in Australian women.

INTRODUCTION: This paper aimed to document alcohol use during pregnancy and determine predictors of ongoing use, including knowledge and agreement with national alcohol guideline recommendations. METHODS: Pregnant women (n = 1179) attending public antenatal services in a Local Health District in NSW, Australia, were surveyed about their alcohol use before pregnancy and after pregnancy recognition, and awareness of, and agreement with, national alcohol guidelines and health-related statements. Respondent characteristics, drinking behaviour and predictors of ongoing drinking during pregnancy were assessed. RESULTS: Most women consumed alcohol before pregnancy (79.3%) but the majority (82.0%) stopped following pregnancy recognition. Half the ongoing drinkers only drank on special occasions. Most (63.6%) women were aware of the national guidelines: 78.1% knew the recommendation that consuming no alcohol in pregnancy is safest, 4.6% thought some alcohol was safe and 17.3% were unsure. Predictors [OR (95%CI)] of ongoing drinking were older age [1.11 (1.07, 1.15)]; medium [2.42 (1.46, 4.00)] or high-risk drinking pre-pregnancy [3.93 (2.35, 6.56)]; and agreement that: avoiding alcohol in pregnancy is safest [0.05 (0.006, 0.47)]; avoiding alcohol is important for baby's health [0.14 (0.06, 0.31)] and pregnancy is a good time to change alcohol use for mother's health [0.29 (0.13, 0.63)]. DISCUSSION AND CONCLUSIONS: Results emphasise the importance of asking about special occasion drinking, the link between pre-pregnancy drinking and ongoing drinking during pregnancy, and the need to understand why women disagree with the national guideline. To ensure guidelines have their intended benefit, interventions to promote behaviour change relating to alcohol consumption during pregnancy are warranted.

Ear Abnormalities Among Children with Fetal Alcohol Spectrum Disorder: A Systematic Review and Meta-Analysis.

OBJECTIVE: To systematically review and conduct meta-analysis on studies that report the type and prevalence of functional and structural ear abnormalities among children with prenatal alcohol exposure and/or fetal alcohol spectrum disorder (FASD). STUDY DESIGN: MEDLINE, PubMed, Embase, Web of Science, PsycINFO, ERIC, CINAHL, and Maternity and Infant Care were searched from 1806 through March 2021. Reference lists of relevant articles were manually searched. Studies reporting on functional and/or structural ear abnormalities among children (<18 years) with prenatal alcohol exposure and/or FASD were eligible. Data extraction and quality assessment were performed by one reviewer and independently checked by another. A random effects meta-analysis was conducted. RESULTS: A total of 31 studies met the inclusion criteria and 25 were included in the meta-analyses, representing a total of 843 children with prenatal alcohol exposure and 1653 children with FASD. Functional ear abnormalities with the highest pooled prevalence were chronic serous otitis media (88.5%; 95% CI, 70.4%-99.3%), abnormal auditory filtering (80.1%; 95% CI, 76.5%-84.3%), and unspecified conductive hearing loss (68.0%; 95% CI, 51.9%-82.2%). Structural ear abnormalities with the highest pooled prevalence were microtia (42.9%; 95% CI, 26.8%-59.7%), railroad track ear (16.8%; 95% CI, 8.1%-27.7%), and misplaced ear (12.3%; 95% CI, 7.6%-17.9%). CONCLUSIONS: Our findings highlight the importance of examining the ears during assessment for FASD, and the need for public health messaging regarding the harms of prenatal alcohol exposure.

It takes a village: Influencing policy and practice to prevent alcohol use in pregnancy and promote better outcomes for individuals living with Fetal Alcohol Spectrum Disorder.

Fetal Alcohol Spectrum Disorder (FASD) is a neurodevelopmental disorder caused by exposure to alcohol in utero. It has pervasive, lifelong impacts and is recognised as a major public health concern in many countries where alcohol is used. The FASD Research Australia Centre of Research Excellence (CRE) was funded by the National Health and Medical Research Council to generate and translate evidence to address prevention, diagnosis, and management of FASD in Australia. The current paper describes the approach to policy and practice impact taken by our CRE, including our stakeholder engagement processes and the key principles that underlie our approach. We provide examples of policy and practice influence in FASD prevention, diagnosis and management that have been achieved over the past five years and discuss challenges that are routinely faced in the translation of our work.

Antenatal care for alcohol consumption during pregnancy: pregnant women's reported receipt of care and associated characteristics.

BACKGROUND: Antenatal clinical guidelines recommend that during initial and subsequent antenatal visits all pregnant women: have their alcohol consumption assessed; be advised that it is safest not to consume alcohol during pregnancy and of the potential risks of consumption; and be offered referrals for further support if required. However, the extent to which pregnant women attending public antenatal services receive guideline recommended care at these visits, and the characteristics associated with its receipt, is unknown. The purpose of this study was to examine: 1) pregnant women's reported receipt of guideline recommended care addressing alcohol consumption during pregnancy; 2) characteristics associated with the receipt of care; and 3) pregnant women's acceptability of care. METHODS: From July 2017 - February 2018 a survey (telephone or online) was undertaken with 1363 pregnant women who had recently visited a public antenatal service in one health district in Australia. Receipt and acceptability of recommended care were assessed via descriptive statistics and associations via logistic regression analyses. RESULTS: At the initial antenatal visit, less than two thirds (64.3%) of pregnant women reported that they received an assessment of their alcohol consumption and just over one third (34.9%) received advice and referral appropriate to their self-reported level of alcohol consumption since pregnancy recognition. Less than 10% of women received such care at subsequent antenatal visits. Characteristics that significantly increased the odds of receiving all guideline elements at the initial antenatal visit included: less than university attainment (OR = 1.93; 95% CI:1.12, 3.34), not residing in an advantaged area (OR = 2.11; 95% CI:1.17, 3.79), first pregnancy (OR = 1.91; 95% CI:1.22, 2.99) and regional/rural service location (OR = 2.38; 95% CI:1.26, 4.48); and at subsequent visits: younger age (OR = 0.91; 95% CI:0.84, 0.99) and Aboriginal origin (OR = 3.17; 95% CI:1.22, 8.24). Each of the recommended care elements were highly acceptable to pregnant women (88.3-99.4%). CONCLUSIONS: Although care for alcohol consumption is both recommended by clinical guidelines and highly acceptable to pregnant women, its receipt in public antenatal services is suboptimal. There is a need and an opportunity for interventions to support antenatal care providers to routinely and consistently provide such care to all pregnant women.

A Signature of Attention-Elicited Electrocortical Activity Distinguishes Response From Non-Response to the Non-Stimulant Atomoxetine in Children and Adolescents With ADHD.

OBJECTIVE: Atomoxetine has several characteristics that make it an attractive alternative to stimulants for treating ADHD, but there are currently no tests identifying individuals for whom the medication should be a first-line option. METHOD: Within the ADHD Controlled Trial Investigation Of a Non-stimulant (ACTION) study, we examined neuro-cortical activity in 52 youth with ADHD. Baseline event-related potentials (ERP) were compared between those who subsequently responded to 6 weeks of atomoxetine versus those who did not. RESULTS: Responders were distinguished by significantly lower auditory oddball N2 amplitudes than both non-responders and typically developing controls, particularly in the right frontocentral region ( p = .002, Cohen's d = 1.1). Leave-one-out cross validation determined that N2 amplitude in this region was able to accurately predict non-responders with a specificity of 80.8%. There were no P3 differences between responders and non-responders. CONCLUSION: The N2 amplitude is a biomarker that may have utility in predicting response to atomoxetine for youth with ADHD.

A practice change intervention to improve antenatal care addressing alcohol consumption by women during pregnancy: research protocol for a randomised stepped-wedge cluster trial.

BACKGROUND: Despite clinical guideline recommendations, implementation of antenatal care addressing alcohol consumption by pregnant women is limited. Implementation strategies addressing barriers to such care may be effective in increasing care provision. The aim of this study is to examine the effectiveness, cost and cost-effectiveness of a multi-strategy practice change intervention in increasing antenatal care addressing the consumption of alcohol by pregnant women. METHODS: The study will be a randomised, stepped-wedge controlled trial conducted in three sectors in a health district in New South Wales, Australia. Stepped implementation of a practice change intervention will be delivered to sectors in a random order to support the introduction of a model of care for addressing alcohol consumption by pregnant women. A staged process was undertaken to develop the implementation strategies, which comprise of: leadership support, local clinical practice guidelines, electronic prompts and reminders, opinion leaders, academic detailing (audit and feedback), educational meetings and educational materials, and performance monitoring. Repeated cross-sectional outcome data will be gathered weekly across all sectors for the study duration. The primary outcome measures are the proportion of antenatal appointments at 'booking in', 27-28 weeks gestation and 35-36 weeks gestation for which women report (1) being assessed for alcohol consumption, (2) being provided with brief advice related to alcohol consumption during pregnancy, (3) receiving relevant care for addressing alcohol consumption during pregnancy, and (4) being assessed for alcohol consumption and receiving relevant care. Data on resources expended during intervention development and implementation will be collected. The proportion of women who report consuming alcohol since knowing they were pregnant will be measured as a secondary outcome. DISCUSSION: This will be the first randomised controlled trial to evaluate the effectiveness, cost and cost-effectiveness of implementation strategies in improving antenatal care that addresses alcohol consumption by pregnant women. If positive changes in clinical practice are found, this evidence will support health service adoption of implementation strategies to support improved antenatal care for this recognised risk to the health and wellbeing of the mother and child. TRIAL REGISTRATIONS: Australian and New Zealand Clinical Trials Registry, No. ACTRN12617000882325 (date registered: 16/06/2017).

Response inhibition and emotional cognition improved by atomoxetine in children and adolescents with ADHD: The ACTION randomized controlled trial.

Although the non-stimulant medication atomoxetine is effective for attention-deficit hyperactivity disorder (ADHD) in children and adolescents, there are still significant gaps in our knowledge about whether atomoxetine improves anxiety symptoms or cognition in children. Furthermore, while cognition has been proposed as an intermediate phenotype for ADHD dysfunction, the relationships between clinical and cognitive outcomes are not yet understood. We addressed these knowledge gaps in a controlled trial using objective assessments of both general and emotional cognitive functions implicated in ADHD and in anxiety, which commonly co-occurs with ADHD. A total of 136 children and adolescents with ADHD (ages 6-17years; 80% male; 31.6% with a comorbid anxiety disorder) were enrolled in a randomized double-blind, placebo-controlled, cross-over trial of 6-weeks treatment with atomoxetine. Of these, 109 completed the second cross-over phase. Selected cognitive domains associated with ADHD and anxiety disorders (Sustained attention, response inhibition and fearful face identification) were assessed using a normed, computerized test battery. Symptom outcomes were assessed by parent reports on the ADHD Rating Scale-IV and Conners' Anxious-Shy subscale. For completers, atomoxetine caused a greater improvement in the primary cognitive outcomes of response inhibition and fear identification compared to placebo, but not in sustained attention. Atomoxetine also improved ADHD and anxiety symptoms. Anxiety symptoms improved most for ADHD and anxiety disorder combined, but presence of an anxiety disorder did not moderate any other outcomes. Changes in cognitive and clinical outcomes were not correlated. These findings contribute to the foundations of measurement-based treatment planning and offer targets for probing the mechanisms of atomoxetine action.

Fine motor skills in a population of children in remote Australia with high levels of prenatal alcohol exposure and Fetal Alcohol Spectrum Disorder.

BACKGROUND: Many children in the remote Fitzroy Valley region of Western Australia have prenatal alcohol exposure (PAE). Individuals with PAE can have neurodevelopmental impairments and be diagnosed with one of several types of Fetal Alcohol Spectrum Disorder (FASD). Fine motor skills can be impaired by PAE, but no studies have developed a comprehensive profile of fine motor skills in a population-based cohort of children with FASD. We aimed to develop a comprehensive profile of fine motor skills in a cohort of Western Australian children; determine whether these differed in children with PAE or FASD; and establish the prevalence of impairment. METHODS: Children (n = 108, 7 to 9 years) were participants in a population-prevalence study of FASD in Western Australia. Fine motor skills were assessed using the Bruininks-Oseretsky Test of Motor Proficiency, which provided a Fine Motor Composite score, and evaluated Fine Manual Control (Fine Motor Precision; Fine Motor Integration) and Manual Coordination (Manual Dexterity; Upper-Limb Coordination). Descriptive statistics were reported for the overall cohort; and comparisons made between children with and without PAE and/or FASD. The prevalence of severe (≤ 2nd percentile) and moderate (≤16th percentile) impairments was determined. RESULTS: Overall, Fine Motor Composite scores were 'average' (M = 48.6 ± 7.4), as were Manual Coordination (M = 55.7 ± 7.9) and Fine Manual Control scores (M = 42.5 ± 6.2). Children with FASD had significantly lower Fine Motor Composite (M = 45.2 ± 7.7 p = 0.046) and Manual Coordination scores (M = 51.8 ± 7.3, p = 0.027) than children without PAE (Fine Motor Composite M = 49.8 ± 7.2; Manual Coordination M = 57.0 ± 7.7). Few children had severe impairment, but rates of moderate impairment were very high. CONCLUSIONS: Different types of fine motor skills should be evaluated in children with PAE or FASD. The high prevalence of fine motor impairment in our cohort, even in children without PAE, highlights the need for therapeutic intervention for many children in remote communities.

Behavior in Children with Fetal Alcohol Spectrum Disorders in Remote Australia: A Population-Based Study.

OBJECTIVE: To document behavior in children residing in very remote Western Australian communities as rated by parent/caregivers and teachers. We hypothesized that children with fetal alcohol spectrum disorders (FASD) would have higher rates of problematic behavior than children without FASD. METHODS: The Child Behavior Checklist (CBCL; n = 97), and Teacher Report Form (TRF; n = 106) were used in this population-based study. Raw scores, proportions scoring within "Normal/Borderline/Clinical" ranges, and frequencies of Critical items were determined. Mann-Whitney U and χ tests were used for between-group comparisons. RESULTS: Children were aged from 7.5 to 9.6 years, and 19% had FASD. Academic performance was commonly rated in the "Borderline/Clinical" range (73%). Teacher-rated scores were poorer in the FASD group on 15 scales encompassing total and internalizing problems, adaptive function, academic performance, attention, withdrawn/depressed, social problems, posttraumatic stress, thought problems, and sluggish cognitive tempo (p < .05). More children in the FASD group had scores in the "Borderline/Clinical" range on 11 TRF scales (p < .05). "Physically attacks people" was the most prevalent Critical item endorsed by teachers for the total cohort (22%). "Talks about killing self" was endorsed by teachers more often in the FASD group (14%) than the Non-FASD group (1%; p = .03). There were no significant differences between groups in parent-reported CBCL scores after adjustment for multiple comparison testing. CONCLUSION: This study demonstrates that children with FASD have more teacher-reported behavioral impairment than children without FASD. In remote Australian communities, academic performance is poor.

Prevalence and profile of Neurodevelopment and Fetal Alcohol Spectrum Disorder (FASD) amongst Australian Aboriginal children living in remote communities.

BACKGROUND: Despite multiple risk factors for neurodevelopmental vulnerability, few studies have assessed neurodevelopmental performance of Australian Aboriginal children. An important risk factor for neurodevelopmental vulnerability is prenatal alcohol exposure (PAE), which places children at risk for Fetal Alcohol Spectrum Disorder (FASD). AIMS: This study assesses neurodevelopment outcomes in a population of Australian Aboriginal children with and without PAE. METHODS AND PROCEDURES: Children born in 2002/2003, and living in the Fitzroy Valley, Western Australia between April 2010 and November 2011, were eligible (N=134). Sociodemographic and antenatal data, including PAE, were collected by interview with 127/134 (95%) consenting parents/caregivers. Maternal/child medical records were reviewed. Neurodevelopment was assessed by clinicians blinded to PAE in 108/134 (81%) children and diagnoses on the FASD spectrum were assigned. OUTCOMES AND RESULTS: Neurodevelopmental disorder was documented in 34/108 children (314.8 per 1000). Any diagnosis on the FASD spectrum was made in 21/108 (194.4 per 1000) children (95% CI=131.0-279.0). CONCLUSIONS AND IMPLICATIONS: Neurodevelopmental impairment with or without PAE is highly prevalent among children in the Fitzroy Valley. Rates of diagnoses on the FASD spectrum are among the highest worldwide. Early intervention services are needed to support developmentally vulnerable children in remote communities.