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The Pediatric Adverse Event Rating Scale (PAERS) measured adverse events of children aged 6–12 years with ADHD and emotional dysregulation in the Micronutrients for ADHD in Youth (MADDY) study, an eight week multi-site randomized clinical trial of a broad-spectrum multinutrient treatment. Treatment sensitivity of the PAERS was assessed by calculating the treatment difference in change of the item scores from baseline to end of the RCT. Principal component analysis retained 14 "adverse events" (out of 43 in the PAERS) that reflected ADHD symptoms and emotional dysregulation and was used to group the variables of interest. A combined score ranging from 0 to 5 was created based on symptom presence, functional impairment, and severity. Mean score change was calculated from baseline to week 8 by treatment (multinutrient vs placebo) with intention-to-treat and per-protocol samples. The study has been registered on clinicaltrials.gov as Micronutrients for ADHD in Youth (MADDY) Study, trial registration # NCT03252522 (). The 126 children in the ITT sample had a mean age of 9.8 (SD = 1.7), with majority (73%) male, and 72% diagnosed with ADHD prior to the study screening. Baseline presence of PAERS symptoms was similar between treatment groups: the highest proportion was ADHD symptoms, followed by Irritable symptoms. The micronutrient group showed a greater decrease (improvement) in the mean anxiety combined score than the placebo group with a between-group difference in change of −0.36 (95% CI: −0.67, −0.04; p =.03) with ITT data and −0.48 (95% CI: −0.81, −0.15; p =.005) with per-protocol (n = 93) data. The multinutrient supplement did not result in more adverse events than placebo, suggesting it is a safe intervention. In addition to assessing actual adverse events, the PAERS may be a useful adjunct outcome measure for ADHD behaviors. [ABSTRACT FROM AUTHOR]

Background: Parents' lived experiences of having a child with ADHD may shape their decision making regarding ADHD treatment options for their child. The aim of this study was to explore parents' experiences of living with a child with ADHD in the family and how their experiences influence their perspectives on treatment preferences and priorities. Methods: A phenomenological qualitative design was used. Semistructured interviews were conducted with parents of children with ADHD who were enrolled in a multisite randomized controlled trial. Interviews were transcribed verbatim, and transcripts at each site were double coded. Initial codes were derived directly from the text. Qualitative data were analysed with an inductive approach. Results: Twenty‐three parents were interviewed: eight from Alberta, Canada; eight from Portland, Oregon, USA; and seven from Columbus, Ohio, USA. Among the parents, 69% were married, 86% completed college education and 52% reported household income over $80,000. Among the children, the mean age was 9.6 years (SD = 1.8 years), 78% were boys and 48% were never medicated for their ADHD. Two major themes emerged from the analysis. Theme 1 was 'impact of ADHD on families within and outside the home' with the following subthemes: 'reconfiguring the home life', 'trial‐and‐error of accommodations at school' and 'responding to social pressures to fit in'. Theme 2 was 'enabling appropriate and accessible treatments for families' with the following subthemes: 'finding the "right fit" with professionals and treatments' and 'factors influencing inequitable access to treatments'. Conclusions: Parents described shared experiences and identified similar barriers, preferences and priorities for ADHD treatments regardless of demographic differences by site. Families desired access to family‐centred, multimodal approaches to ADHD treatment. Further research is needed to identify the specific structural changes to healthcare, services and policies that will better support this approach. [ABSTRACT FROM AUTHOR]

Purpose: To describe the trends in the prevalence and incidence of children with psychiatric disorders, the types of medication prescribed, and the type of physician providing the prescriptions.Method: This retrospective study linked six population-based administrative databases (2008-2015) in Alberta, Canada.Results: The prevalence of paediatric psychiatric disorders increased from 12.6 per 100 population in 2008 to 15.0 per 100 population in 2015, while the incidence rate increased from 2.0 per 100 population to 2.2 per 100 population in the same period. The proportion of patients dispensed any psychiatric medication increased from 21.4% in 2008 to 28.2% in 2015. Over the same period, dispensations for antidepressants increased from 7.0% to 11.2% and stimulants to treat ADHD, from 11.9% to 15.9%. For antidepressants, general practitioners (GPs) wrote the highest proportion of prescriptions (44.3% in 2011-48.1% in 2015), while paediatricians wrote the lowest proportion (8.7% in 2011-11.0% in 2015) and the proportion by psychiatrists decreased from 33.4% in 2011 to 27.2% in 2015. For stimulants to treat ADHD, paediatricians were the most frequent prescribers (36.9% in 2011-39.3% in 2015) followed by GPs as the second most frequent (33.1% in 2011-33.5% in 2015), while psychiatrists were the least likely to prescribe stimulants for ADHD.Conclusion: The increasing trend of psychiatric diagnoses and medication prescriptions in the paediatric population is evident using population-based administrative databases. The lack of safety and adverse consequences of medication use in this cohort warrants additional monitoring data. [ABSTRACT FROM AUTHOR]

Background: The Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youth (MADDY) study evaluated the efficacy and safety of a multinutrient formula for children with ADHD and emotional dysregulation. The post-RCT open-label extension (OLE) compared the effect of treatment duration (8 weeks vs 16 weeks) on ADHD symptoms, height velocity, and adverse events (AEs).Children aged 6–12 years randomized to multinutrients vs. placebo for 8 weeks (RCT), received an 8–week OLE for a total of 16 weeks. Assessments included the Clinical Global Impression-Improvement (CGI-I), Child and Adolescent Symptom Inventory-5 (CASI-5), Pediatric Adverse Events Rating Scale (PAERS), and anthropometric measures (height and weight).Of the 126 in the RCT, 103 (81%) continued in the OLE. For those initially assigned to placebo, CGI-I responders increased from 23% in the RCT to 64% in the OLE; those who took multinutrients for 16 weeks increased from 53% (RCT) to 66% responders (OLE). Both groups improved on the CASI-5 composite score and subscales from week 8 to week 16 (all p–values < 0.01). The group taking 16 weeks of multinutrients had marginally greater height growth (2.3 cm) than those with 8 weeks (1.8 cm) (p = 0.07). No difference in AEs between groups was found.The response rate to multinutrients by blinded clinician ratings at 8 weeks was maintained to 16 weeks; the response rate in the group initially assigned to placebo improved significantly with 8 weeks of multinutrients and almost caught up with 16 weeks. Longer time on multinutrients did not result in greater AEs, confirming an acceptable safety profile.Methods: The Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youth (MADDY) study evaluated the efficacy and safety of a multinutrient formula for children with ADHD and emotional dysregulation. The post-RCT open-label extension (OLE) compared the effect of treatment duration (8 weeks vs 16 weeks) on ADHD symptoms, height velocity, and adverse events (AEs).Children aged 6–12 years randomized to multinutrients vs. placebo for 8 weeks (RCT), received an 8–week OLE for a total of 16 weeks. Assessments included the Clinical Global Impression-Improvement (CGI-I), Child and Adolescent Symptom Inventory-5 (CASI-5), Pediatric Adverse Events Rating Scale (PAERS), and anthropometric measures (height and weight).Of the 126 in the RCT, 103 (81%) continued in the OLE. For those initially assigned to placebo, CGI-I responders increased from 23% in the RCT to 64% in the OLE; those who took multinutrients for 16 weeks increased from 53% (RCT) to 66% responders (OLE). Both groups improved on the CASI-5 composite score and subscales from week 8 to week 16 (all p–values < 0.01). The group taking 16 weeks of multinutrients had marginally greater height growth (2.3 cm) than those with 8 weeks (1.8 cm) (p = 0.07). No difference in AEs between groups was found.The response rate to multinutrients by blinded clinician ratings at 8 weeks was maintained to 16 weeks; the response rate in the group initially assigned to placebo improved significantly with 8 weeks of multinutrients and almost caught up with 16 weeks. Longer time on multinutrients did not result in greater AEs, confirming an acceptable safety profile.Results: The Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youth (MADDY) study evaluated the efficacy and safety of a multinutrient formula for children with ADHD and emotional dysregulation. The post-RCT open-label extension (OLE) compared the effect of treatment duration (8 weeks vs 16 weeks) on ADHD symptoms, height velocity, and adverse events (AEs).Children aged 6–12 years randomized to multinutrients vs. placebo for 8 weeks (RCT), received an 8–week OLE for a total of 16 weeks. Assessments included the Clinical Global Impression-Improvement (CGI-I), Child and Adolescent Symptom Inventory-5 (CASI-5), Pediatric Adverse Events Rating Scale (PAERS), and anthropometric measures (height and weight).Of the 126 in the RCT, 103 (81%) continued in the OLE. For those initially assigned to placebo, CGI-I responders increased from 23% in the RCT to 64% in the OLE; those who took multinutrients for 16 weeks increased from 53% (RCT) to 66% responders (OLE). Both groups improved on the CASI-5 composite score and subscales from week 8 to week 16 (all p–values < 0.01). The group taking 16 weeks of multinutrients had marginally greater height growth (2.3 cm) than those with 8 weeks (1.8 cm) (p = 0.07). No difference in AEs between groups was found.The response rate to multinutrients by blinded clinician ratings at 8 weeks was maintained to 16 weeks; the response rate in the group initially assigned to placebo improved significantly with 8 weeks of multinutrients and almost caught up with 16 weeks. Longer time on multinutrients did not result in greater AEs, confirming an acceptable safety profile.Conclusion: The Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youth (MADDY) study evaluated the efficacy and safety of a multinutrient formula for children with ADHD and emotional dysregulation. The post-RCT open-label extension (OLE) compared the effect of treatment duration (8 weeks vs 16 weeks) on ADHD symptoms, height velocity, and adverse events (AEs).Children aged 6–12 years randomized to multinutrients vs. placebo for 8 weeks (RCT), received an 8–week OLE for a total of 16 weeks. Assessments included the Clinical Global Impression-Improvement (CGI-I), Child and Adolescent Symptom Inventory-5 (CASI-5), Pediatric Adverse Events Rating Scale (PAERS), and anthropometric measures (height and weight).Of the 126 in the RCT, 103 (81%) continued in the OLE. For those initially assigned to placebo, CGI-I responders increased from 23% in the RCT to 64% in the OLE; those who took multinutrients for 16 weeks increased from 53% (RCT) to 66% responders (OLE). Both groups improved on the CASI-5 composite score and subscales from week 8 to week 16 (all p–values < 0.01). The group taking 16 weeks of multinutrients had marginally greater height growth (2.3 cm) than those with 8 weeks (1.8 cm) (p = 0.07). No difference in AEs between groups was found.The response rate to multinutrients by blinded clinician ratings at 8 weeks was maintained to 16 weeks; the response rate in the group initially assigned to placebo improved significantly with 8 weeks of multinutrients and almost caught up with 16 weeks. Longer time on multinutrients did not result in greater AEs, confirming an acceptable safety profile. [ABSTRACT FROM AUTHOR]

Background One of the biggest challenges for population health studies is the recruitment of participants. Questions that investigators have asked are "who volunteers for studies?" and "does recruitment method influence characteristics of the samples?" The purpose of this paper was to compare sample characteristics of two unrelated pregnancy cohort studies taking place in the same city, in the same time period, that employed different recruitment strategies, as well as to compare the characteristics of both cohorts to provincial and national statistics derived from the Maternity Experiences Survey (MES). Methods One pregnancy cohort used community-based recruitment (e.g. posters, pamphlets, interviews with community media and face-to-face recruitment in maternity clinics); the second pregnancy cohort used both community-based and population-based (a centralized system identifying pregnant women undergoing routine laboratory testing) strategies. Results The pregnancy cohorts differed in education, income, ethnicity, and foreign-born status (p < 0.01), but were similar for maternal age, BMI, and marital status. Compared to the MES, the lowest age, education, and income groups were under-represented, and the cohorts were more likely to be primiparous. Conclusions The findings suggest that non-stratified strategies for recruitment of participants will not necessarily result in samples that reflect the general population, but can reflect the target population of interest. Attracting and retaining young, low resource women into urban studies about pregnancy may require alternate and innovative approaches. [ABSTRACT FROM AUTHOR]

Epigenetics is revealing how “nature is nurtured”, with environmental factors such as nutrition, environmental neurotoxicants, and psychological stress influencing DNA expression. In this current opinion paper, we argue that understanding the dynamic interplay between the genome acquired at conception and environmental exposures throughout life requires pregnancy and birth cohorts, and that greater Canadian national commitment to the infrastructure needed for sustaining such cohorts is warranted. We present a framework that is now being implemented in Alberta. [ABSTRACT FROM AUTHOR]

Background: Although maternal nutrient status influences all aspects of fetal development including the brain, the impact of micronutrient supplementation on the baby's mental function is a topic of debate. This systematic review assesses the effect of single and multiple micronutrient supplementation during pregnancy on offspring mental development. Methods: Eleven electronic literature databases were searched using key terms of various combinations and filter string terms. Reference lists of articles selected for review were scanned for citations fitting the same inclusion criteria. Each stage of the literature retrieval and review process was conducted independently by two reviewers. The CONSORT checklist was used to assess study quality. Results: A total of 1316 articles were retrieved from the electronic database search, of which 18 met the inclusion criteria and were evaluated. The selected studies were randomized controlled trials published from 1983 to 2010, with high variance in sample size, intervention type, and outcome measures. The median CONSORT score was 15 (range 12 - 19). Due to inconsistent interventions and outcome measures among the studies, no conclusive evidence was found that enhancing the intrauterine environment through micronutrient supplementation was associated with child mental development in a number of dimensions. There was some evidence to support n-3 fatty acids or multi-micronutrients having some positive effect on mental development, but the evidence for single nutrients was much weaker. Conclusions: The study of children's mental outcomes as a function of prenatal supplementation is still relatively new, but the results of this systematic review suggest that further work with multiple micronutrients and/or n-3 fatty acids should be conducted. [ABSTRACT FROM AUTHOR]

Background: Knowledge translation (KT) is a rapidly growing field that is becoming an integral part of research protocols.Methods: This meeting report describes one group's experience at the 2009 KT Canada Summer Institute in developing an end-of-grant KT plan for a randomized control trial proposal.Results: Included is a discussion of the process, challenges, and recommendations from the trainee's perspective in developing an end-of-grant KT plan.Conclusion: New researchers should consider developing an end-of-grant KT plan with strategies that move beyond passive dissemination to incorporate innovative means of collaboration with the end user to craft the message, package the information, and share the research findings with end users. [ABSTRACT FROM AUTHOR]

Objectives: The 8-week Micronutrients for ADHD in Youth (MADDY) randomized controlled trial (N = 126, age 6-12) of broad-spectrum multinutrients for ADHD with emotional dysregulation found 3 times as many responders with multinutrients (54%) compared to placebo (18%) by Clinical Global Impression-Improvement (CGI-I). Our primary aim for this analysis tests the hypothesis that those with poor overall diet quality at baseline benefit more. The second aim is to explore whether specific components of diet quality moderate treatment response. Methods: 124 children (69 multinutrients, 55 placebo) had diet quality assessed using the Healthy Eating Index-2015 (HEI-2015). For each potential moderator, the outcome CGI-I at week 8 (RCTend), was modeled two ways: (1) as a dichotomous variable: responder/non-responder, with responders defined by a rating of 1 or 2 'very much' or 'much improved,' all else equals nonresponder using logistic regression, and (2) as a dimensional improvement outcome from 1 = very much improved to 7 = very much worse, using linear regression. Results: HEI-2015 total score did not moderate treatment response [odds ratio = 1.00 (95% CI: 0.90,1.10), p = 0.984] or improvement [ß = -0.01 (95% CI: -0.06,0.04), p = 0.648]. However, total vegetable intake moderated level of improvement in exploratory analysis [ß = -0.48 (95% CI: -0.82, -0.13), p = 0.007]: those with higher baseline vegetable intake showed greater benefit from multinutrients compared to placebo. Conclusions: Multinutrients may benefit children with ADHD and irritability regardless of overall diet quality. The finding that higher baseline vegetable intake may improve response to multinutrients deserves further exploration, including dietary effect on gut microbiota and absorption of multinutrients and parental factors. [ABSTRACT FROM AUTHOR]

Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder with a U.S. pediatric prevalence of 8–10%. It presents with inattention and hyperactivity/impulsivity; frequently associated with emotional dysregulation (ED) symptoms common in Oppositional Defiant Disorder and Disruptive Mood Dysregulation Disorder. The etiology of ADHD is multi-factorial; symptom severity is associated with diet. This study examines the association of diet quality with ADHD and ED symptoms within a pediatric research cohort. Baseline data were analyzed for 134 children aged 6–12 years with symptoms of ADHD and ED enrolled in an RCT of multinutrient supplementation. Diet quality was based on Healthy Eating Index-2015 (HEI-2015). ADHD and ED symptoms were assessed using Child and Adolescent Symptom Inventory-5 and Strengths and Difficulties Questionnaire. Linear regression models, adjusting for covariates when necessary, determined association. The mean HEI Total Score of 63.4 (SD = 8.8) was not significantly associated with any outcome symptoms. However, after adjusting for covariates, HEI component scores for total fruit intake (β = −0.158, p =.037) and total vegetable intake (β = −0.118, p =.004) were negatively associated with inattention. The lack of association with total diet quality could be explained by the relatively good baseline diet quality and mild symptom severity in this sample, along with measurement error from dietary intake estimates and relatively small sample size. These findings suggest that dietary intake may impact inattention in children with ADHD and ED: those eating less fruits and vegetables were likely to have more severe symptoms of inattention. Causality is not established by this cross-sectional analysis. [ABSTRACT FROM AUTHOR]

Background: Small Canadian rural maternity services are struggling to maintain core staffing and remain open. Existing evidence states that having to travel to access maternity services is associated with adverse outcomes. The goal of this study is to systematically examine rural maternal and newborn outcomes across three Canadian provinces.Methods: We analyzed maternal newborn outcomes data through provincial perinatal registries in British Columbia, Alberta and Nova Scotia for deliveries that occurred between April 1st 2003 and March 31st 2008. All births were allocated to maternity service catchments based on the residence of the mothers. Individual catchments were stratified to service levels based on distance to access intrapartum maternity services or the model of maternity services available in the community. The amalgamation of analyses from each jurisdiction involved comparison of logistic regression effect estimates.Results: The number of singleton births included in the study is 150,797. Perinatal mortality is highest in communities that are greater than 4 h from maternity services overall. Rates of prematurity at less than 37 weeks gestation are higher for rural women without local access to services. Caesarean section rates are highest in communities served by general surgical models.Conclusion: Composite analysis of data from three Canadian provinces provides the strongest evidence to date demonstrating that we need to sustain small community maternity services with and without caesarean section capability. [ABSTRACT FROM AUTHOR]

Background: Postpartum depression is a serious problem for women and their offspring. Micronutrient supplements are recommended for pregnant women because of their documented protective effects for the offspring, but their potential beneficial effects on maternal mental health are unknown. This study investigated the association between prenatal micronutrient supplementation and the risk for symptoms of postpartum depression in a longitudinal pregnancy cohort from the Alberta Pregnancy Outcomes and Nutrition (APrON) study.Methods: Participants came from a cohort of the first 600 APrON women. Supplemental nutrient intake and symptoms of depression (measured with the Edinburgh Postnatal Depression Scale (EPDS)) were collected at each trimester and 12 weeks postpartum.Results: Of the 475 participants who completed the EPDS at least twice in pregnancy and at 12 weeks postpartum, 416 (88%) scored <10 and 59 (12%) scored ≥10, where an EPDS ≥10 is considered to be "at least probable minor depression". Mean nutrient intakes from supplements were higher in women with lower EPDS scores, particularly selenium (p = 0.0015) and omega-3s (p = 0.01). Bivariate analyses showed that several demographic and social/lifestyle variables were associated with EPDS ≥10: not having been born in Canada (p = 0.01), greater number of chronic conditions (p = 0.05), greater number of stressful life events during this pregnancy (p = 0.02), and lower prenatal and postnatal support (p = 0.0043 and p = 0.0001, respectively). Adjusting for covariates and nutrients known to be associated with postpartum depression, logistic regression showed that having a prenatal EPDS ≥ 10 increased the odds of postpartum depressive symptoms (second and third trimester OR = 3.29, 95% CI = 1.55 - 7.01, p = 0.004 and OR = 4.26, 95% CI = 2.05 - 8.85, p < 0.0001, respectively), while prenatal supplemental selenium (per 10 mcg, OR = 0.76, 95% CI = 0.74 - 0.78, p = 0.0019) and postnatal social support (OR = 0.87, 95% CI = 0.78 - 0.97, p = 0.0015) were protective.Conclusions: Multiple factors, including supplementary selenium intake, are associated with the risk of postpartum depressive symptoms. Future research on dietary supplementation in pregnancy with special attention to selenium intake is warranted. [ABSTRACT FROM AUTHOR]