Adverse event monitoring and reporting in pediatric neuromodulatory studies: A systematic review.

Neuromodulatory interventions are relatively novel and approaches to studying harms and tolerability have varied. Using a checklist based on guidelines from Good Clinical Practice and the Harms Extension of the CONSORT (Consolidated Standards of Reporting Trials) Statement, we identified how adverse events are measured, assessed, and reported in studies evaluating neuromodulation for the treatment of mental and neurodevelopmental disorders among children and adolescents. A systematic literature review identified 56 experimental and quasi-experimental studies evaluating transcranial magnetic stimulation (TMS), transcranial alternating (tACS) or direct (tDCS) current stimulation, transcranial pulse stimulation (TPS), and vagus or trigeminal nerve stimulation (VNS or TNS). For 22 studies (39%), the types of adverse events to be monitored were identified, and for 31 studies (55%), methods for collecting adverse event data were described. Methods for assessing adverse events were less commonly described with 23 studies (41%) having details on assessing event severity, and 11 studies (20%) having details on assessing event causality. Among 31 studies with reported results, headache, skin irritation, and general pain or discomfort were the most reported across studies. Seizure, untoward medical occurrences, and intracranial bleeding, edema, or other intracranial pathology were considered serious events, but these events were not reported as occurring in any results-based papers. Taken together, the findings from this review indicate that most studies of pediatric neuromodulatory interventions did not include descriptions of adverse event monitoring and evaluation. Comprehensive event monitoring and reporting across studies can significantly augment the current knowledge base.

An Integrated Care Pathway for depression in adolescents: protocol for a Type 1 Hybrid Effectiveness-implementation, Non-randomized, Cluster Controlled Trial.

INTRODUCTION: Our group developed an Integrated Care Pathway to facilitate the delivery of evidence-based care for adolescents experiencing depression called CARIBOU-2 (Care for Adolescents who Receive Information 'Bout OUtcomes, 2nd iteration). The core pathway components are assessment, psychoeducation, psychotherapy options, medication options, caregiver support, measurement-based care team reviews and graduation. We aim to test the clinical and implementation effectiveness of the CARIBOU-2 pathway relative to treatment-as-usual (TAU) in community mental health settings. METHODS AND ANALYSIS: We will use a Type 1 Hybrid Effectiveness-Implementation, Non-randomized Cluster Controlled Trial Design. Primary participants will be adolescents (planned n = 300, aged 13-18 years) with depressive symptoms, presenting to one of six community mental health agencies. All sites will begin in the TAU condition and transition to the CARIBOU-2 intervention after enrolling 25 adolescents. The primary clinical outcome is the rate of change of depressive symptoms from baseline to the 24-week endpoint using the Childhood Depression Rating Scale-Revised (CDRS-R). Generalized mixed effects modelling will be conducted to compare this outcome between intervention types. Our primary hypothesis is that there will be a greater rate of reduction in depressive symptoms in the group receiving the CARIBOU-2 intervention relative to TAU over 24 weeks as per the CDRS-R. Implementation outcomes will also be examined, including clinician fidelity to the pathway and its components, and cost-effectiveness. ETHICS AND DISSEMINATION: Research ethics board approvals have been obtained. Should our results support our hypotheses, systematic implementation of the CARIBOU-2 intervention in other community mental health agencies would be indicated.

The genetic architecture of youth anxiety: a study protocol.

BACKGROUND: Anxiety disorders are the most common psychiatric problems among Canadian youth and typically have an onset in childhood or adolescence. They are characterized by high rates of relapse and chronicity, often resulting in substantial impairment across the lifespan. Genetic factors play an important role in the vulnerability toward anxiety disorders. However, genetic contribution to anxiety in youth is not well understood and can change across developmental stages. Large-scale genetic studies of youth are needed with detailed assessments of symptoms of anxiety disorders and their major comorbidities to inform early intervention or preventative strategies and suggest novel targets for therapeutics and personalization of care. METHODS: The Genetic Architecture of Youth Anxiety (GAYA) study is a Pan-Canadian effort of clinical and genetic experts with specific recruitment sites in Calgary, Halifax, Hamilton, Toronto, and Vancouver. Youth aged 10-19 (n = 13,000) will be recruited from both clinical and community settings and will provide saliva samples, complete online questionnaires on demographics, symptoms of mental health concerns, and behavioural inhibition, and complete neurocognitive tasks. A subset of youth will be offered access to a self-managed Internet-based cognitive behavioral therapy resource. Analyses will focus on the identification of novel genetic risk loci for anxiety disorders in youth and assess how much of the genetic risk for anxiety disorders is unique or shared across the life span. DISCUSSION: Results will substantially inform early intervention or preventative strategies and suggest novel targets for therapeutics and personalization of care. Given that the GAYA study will be the biggest genomic study of anxiety disorders in youth in Canada, this project will further foster collaborations nationally and across the world.

Emergency department visits and hospital admissions for suicidal ideation, self-poisoning and self-harm among adolescents in Canada during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic had profound effects on the mental wellbeing of adolescents. We sought to evaluate pandemic-related changes in health care use for suicidal ideation, self-poisoning and self-harm. METHODS: We obtained data from the Canadian Institute for Health Information on emergency department visits and hospital admissions from April 2015 to March 2022 among adolescents aged 10-18 years in Canada. We calculated the quarterly percentage of emergency department visits and hospital admissions for a composite outcome comprising suicidal ideation, self-poisoning and self-harm relative to all-cause emergency department visits and hospital admissions. We used interrupted time-series methods to compare changes in levels and trends of these outcomes between the prepandemic (Apr. 1, 2015-Mar. 1, 2020) and pandemic (Apr. 1, 2020-Mar. 31, 2022) periods. RESULTS: The average quarterly percentage of emergency department visits for suicidal ideation, self-poisoning and self-harm relative to all-cause emergency department visits was 2.30% during the prepandemic period and 3.52% during the pandemic period. The level (0.08%, 95% confidence interval [CI] -0.79% to 0.95%) or trend (0.07% per quarter, 95% CI -0.14% to 0.28%) of this percentage did not change significantly between periods. The average quarterly percentage of hospital admissions for the composite outcome relative to all-cause admissions was 7.18% during the prepandemic period and 8.96% during the pandemic period. This percentage showed no significant change in level (-0.70%, 95% CI -1.90% to 0.50%), but did show a significantly increasing trend (0.36% per quarter; 95% 0.07% to 0.65%) during the pandemic versus prepandemic periods, specifically among females aged 10-14 years (0.76% per quarter, 95% CI 0.22% to 1.30%) and females aged 15-18 years (0.56% per quarter, 95% CI 0.31% to 0.81%). INTERPRETATION: The quarterly change in the percentage of hospital admissions for suicidal ideation, self-poisoning and self-harm increased among adolescent females in Canada during the first 2 years of the COVID-19 pandemic. This underscores the need to promote public health policies that mitigate the impact of the pandemic on adolescent mental health.

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review.

BACKGROUND: Adverse event monitoring in studies of psychotherapy is crucial to clinical decision-making, particularly for weighing of benefits and harms of treatment approaches. In this systematic review, we identified how adverse events are defined, measured, and reported in studies of psychosocial interventions for children with mental disorders. METHOD: Medline, PsycINFO, Embase, ProQuest Dissertations and Theses Global, and the Cochrane Library were searched from January 2011-January 2023, and Google Scholar from January 2011-February 2023. English language experimental and quasi-experimental studies that evaluated the efficacy or effectiveness of psychosocial interventions for childhood mental disorders were included. Information on the definition, assessment, and report of adverse events was extracted using a checklist based on Good Clinical Practice guidelines. RESULTS: In this review, 117 studies were included. Studies most commonly involved treating anxiety disorders or obsessive-compulsive disorder (32/117; 27%); 44% of the experimental interventions tested (52/117) were cognitive behavioral therapies. Adverse events were monitored in 36 studies (36/117; 31%) with a protocol used in 19 of these studies to guide monitoring (19/36; 53%). Twenty-seven different events were monitored across the studies with hospitalization the most frequently monitored (3/36; 8%). Event severity was fully assessed in 6 studies (17%) and partially assessed in 12 studies (33%). Only 4/36 studies (11%) included assessing events for cause. CONCLUSIONS: To date, adverse events have been inconsistently defined, measured and reported in psychosocial intervention studies of childhood mental health disorders. Information on adverse events is an essential knowledge component for understanding the potential impacts and risks of therapeutic interventions.

An evaluation of satisfaction with emergency department care in children and adolescents with mental health concerns.

OBJECTIVES: We hypothesized that an association exists between satisfaction with ED mental health care delivery and patient and system characteristics. Primary: To evaluate overall satisfaction with ED mental health care delivery. Secondary: To explore aspects of ED mental health care delivery associated with general satisfaction, and patient and ED visit characteristic associated with total satisfaction scores and reported care experience themes. METHODS: We enrolled patients < 18 years of age presenting with a mental health concern between February 1, 2020 and January 31, 2021, to two pediatric EDs in Alberta, Canada. Satisfaction data were collected using the Service Satisfaction Scale, a measure of global satisfaction with mental health services. Association of general satisfaction with ED mental health care was evaluated using Pearson's correlation coefficient and variables associated with total satisfaction score was assessed using multivariable regression analyses. Inductive thematic analysis of qualitative feedback identified satisfaction and patient experience themes. RESULTS: 646 participants were enrolled. 71.2% were Caucasian and 56.3% female. Median age was 13 years (IQR 11-15). Parents/caregivers (n = 606) and adolescents (n = 40) were most satisfied with confidentiality and respect in the ED and least satisfied with how ED services helped reduce symptoms and/or problems. General satisfaction was associated with perceived amount of help received in the ED (r = 0.85) and total satisfaction with evaluation by a mental health team member (p = 0.004) and psychiatrist consultation (p = 0.05). Comments demonstrated satisfaction with ED provider attitudes and interpersonal skills and dissatisfaction with access to mental health and addictions care, wait time, and the impact of COVID-19. CONCLUSIONS: There is a need to improve ED mental health care delivery, with a focus on timely access to ED mental health providers. Access to outpatient/community-based mental health care is needed to complement care received in the ED and to provide continuity of care for youth with mental health concerns.

RéSUMé: OBJECTIFS: Nous avons émis l'hypothèse qu'il existe un lien entre la satisfaction à l'égard de la prestation de soins de santé mentale aux urgences et les caractéristiques des patients et du système. Primaire : Évaluer la satisfaction globale à l'égard de la prestation des soins de santé mentale aux urgences. Secondaire : Explorer les aspects de la prestation des soins de santé mentale aux urgences associés à la satisfaction générale, et les caractéristiques du patient et de la visite aux urgences associées aux scores de satisfaction totale et aux thèmes d'expérience de soins signalés. MéTHODES: Nous avons inscrit des patients de moins de 18 ans présentant un problème de santé mentale entre le 1er février 2020 et le 31 janvier 2021 à deux services d'urgence pédiatriques en Alberta, au Canada. Les données relatives à la satisfaction ont été recueillies à l'aide de l'échelle de satisfaction du service, une mesure de la satisfaction globale à l'égard des services de santé mentale. L'association entre la satisfaction générale et les soins de santé mentale dispensés aux urgences a été évaluée à l'aide du coefficient de corrélation de Pearson et les variables associées au score total de satisfaction ont été évaluées à l'aide d'analyses de régression multivariables. L'analyse thématique inductive des commentaires qualitatifs a permis d'identifier des thèmes liés à la satisfaction et à l'expérience des patients. RéSULTATS: 646 participants ont été inscrits. 71,2 % étaient de race blanche et 56,3 % de sexe féminin. L'âge médian était de 13 ans (IQR, 11-15). Les parents/aidants (n = 606) et les adolescents (n = 40) étaient les plus satisfaits de la confidentialité et du respect à l'urgence et les moins satisfaits de la façon dont les services d'urgence ont contribué à réduire les symptômes et/ou les problèmes. La satisfaction générale était associée à la perception de l'aide reçue aux urgences (r = 0,85) et à la satisfaction totale à l'égard de l'évaluation par un membre de l'équipe de santé mentale (p = 0,004) et de la consultation d'un psychiatre (p = 0,05). Les commentaires ont fait état d'une satisfaction à l'égard des attitudes et des compétences interpersonnelles des prestataires de soins d'urgence et d'une insatisfaction à l'égard de l'accès aux soins de santé mentale et de toxicomanie, du temps d'attente et de l'impact de l'étude COVID-19. CONCLUSIONS: Il est nécessaire d'améliorer la prestation des soins de santé mentale aux urgences, en mettant l'accent sur l'accès en temps opportun aux fournisseurs de services de santé mentale des services d'urgence. L'accès à des soins de santé mentale en consultation externe ou en milieu communautaire est nécessaire pour compléter les soins reçus aux urgences et pour assurer la continuité des soins aux jeunes ayant des problèmes de santé mentale.

Visits to Alberta Emergency Departments for Child Mental Health Concerns During the COVID-19 Pandemic: An Examination of Visit Trends in Relation to School Closures and Reopenings.

OBJECTIVE: We examined emergency department (ED) mental health visit trends by children in relation to periods of school closure and reopening during the COVID-19 pandemic in Alberta, Canada. METHODS: Mental health visits by school-aged children (5 to <18 years) were extracted from the Emergency Department Information System, a province-wide database, from March 11, 2020, to November 30, 2021 (pandemic period; n = 18,997) and March 1, 2019, to March 10, 2020 (1-year, prepandemic comparator period; n = 11,540). We calculated age-specific visit rates and compared rate differences between periods of school closure (March 15-June 30, 2020; November 30, 2020-January 10, 2021; April 22-June 30, 2021) and reopening (September 4-November 29, 2020; January 11-April 21, 2021; September 3-November 30, 2021) to matched prepandemic periods. We used a ratio of relative risk to examine the risk of a visit during closures versus reopenings. RESULTS: The cohort included 11,540 prepandemic visits and 18,997 pandemic visits. Compared with prepandemic periods, ED visit rates increased across all ages during the first (+85.53%; 95% confidence interval [CI], 73.68% to 100.41%) and third (+19.92%; 95% CI, 13.28% to 26.95%) school closures, and decreased during the second closure (-15.37%; 95% CI, -22.22% to -7.92%). During school reopenings, visit rates decreased across all ages during the first reopening (-9.30%; 95% CI, -13.94% to -4.41%) and increased during the third reopening (+13.59%; 95% CI, 8.13% to 19.34%); rates did not change significantly during the second reopening (2.54%; 95% CI, -3.45% to 8.90%). The risk of a visit during school closure versus reopening was only higher for the first closure with 2.06 times the risk (95% CI, 1.88 to 2.25). CONCLUSIONS: Emergency department mental health visit rates were highest during the first school closure of the COVID-19 pandemic, and the risk of a visit during this closure period was twice compared with when schools first reopened.

Review: Patient engagement in child, adolescent, and youth mental health care research - a scoping review.

BACKGROUND: Youth and children's lived experiences are rarely considered in studies seeking to improve or evaluate their mental health care. We conducted a scoping review to identify approaches to child, adolescent, and youth engagement in mental health studies as well as study-reported barriers, constraints, and facilitators to engagement. METHOD: We systematically searched six electronic databases for literature. We included studies of mental health care service design, development, or evaluation that involved engagement of children, adolescents, and/or youth with mental disorders or who intentionally self-harm. Studies could be of any design as long as patient engagement was used at any point during its design and/or conduct. Engagement could include co-designing health services/interventions and/or participating as a co-researcher. We assessed the reporting of patient engagement using the Guidance for Reporting Involvement of Patients and the Public 2 Long-Form (GRIPP2-LF) checklist and used the Experience Based Co-design (EBCD) framework to guide data extraction and analysis. RESULTS: Sixteen articles were included in the review. Most studies used engagement to develop or adapt a mental health service (75%) and utilized a participatory or co-design approach (69%). Participants were namely adolescents and youth (aged 10-24 years) with some studies including young adults (up to 29 years old). Most studies followed less than 50% of the EBCD framework, and the commonly reported study barriers were related to aspects addressed in EBCD: time restrictions, recruitment, and generalizability. Frequently reported study facilitators included study methodology, youth engagement, and having a diverse participant sample. CONCLUSIONS: Findings from this review suggest that the EBCD framework is not commonly used to guide patient engagement in studies of mental health care services. Future initiatives should consider following the framework to ensure meaningful evaluation and improvements to youth and children's mental health care services.

Parents as Agents of Change in Managing Pediatric Obesity: A Randomized Controlled Trial Comparing Cognitive Behavioral Therapy versus Psychoeducation Interventions.

Background: Obesity interventions for parents of children with obesity can improve children's weight and health. This randomized controlled trial (RCT) evaluated whether a parent-based intervention based on cognitive behavioral therapy (CBT) principles was superior to a parent-based intervention based on a psychoeducation program (PEP) in improving children's obesity. Methods: This study was a pragmatic, two-armed, parallel, superiority RCT. Conducted at a Canadian outpatient pediatric obesity management clinic (September 2010-January 2014), this trial included families with children 8-12 years with an age- and sex-specific BMI ≥85th percentile. The 16-week manualized interventions were similar in content and delivered to parents exclusively, with different theoretical underpinnings. The primary outcome was children's BMI z-score at postintervention (4 months). Secondary outcomes included anthropometric, lifestyle, psychosocial, and cardiometabolic variables. Data were collected at preintervention (0 months), postintervention (4 months), 10, and 16 months. Intention-to-treat analysis using linear mixed models was used to assess outcomes. Results: Among 52 randomly assigned children, the mean age (standard deviation) was 9.8 (1.7) years and BMI z-score was 2.2 (0.3). Mean differences in BMI z-score were not significantly different between the CBT (n = 27) and PEP (n = 25) groups from 0 to 4-, 10-, and 16-month follow-up. At 4 months, the mean difference in BMI z-score from preintervention between the CBT (-0.05, 95% CI = -0.09 to 0.00) and PEP (-0.04, 95% CI = -0.09 to 0.01) groups was -0.01 (95% CI = -0.08 to 0.06, p = 0.80). Similar results were found across all secondary outcomes. Conclusions: Our CBT-based intervention for parents of children with obesity was not superior in reducing BMI z-score vs. our PEP-based intervention.

The application and reporting of motivational interviewing in managing adolescent obesity: A scoping review and stakeholder consultation.

Motivational interviewing (MI) is an evidence-based counseling approach that can help individuals make positive behavioral and cognitive changes for managing obesity. We conducted a scoping review to summarize evidence on fidelity and key elements of MI-based interventions for managing adolescent obesity and examine the reporting of these interventions. Ten electronic databases and gray literature were searched systematically and included literature from January 1983 to February 2022, and 26 studies were included. Data on MI features, delivery context, training, and fidelity to treatment were summarized. Fidelity was assessed using an assessment grid with five domains-theory, training, implementation, treatment receipt, and treatment enactment. The last step of the review involved stakeholder consultation with clinician-scientists and researchers with experience in MI and managing adolescent obesity. Thirteen stakeholders were interviewed about our review findings on MI and treatment fidelity. Our analyses revealed that MI-based interventions for managing adolescent obesity had "low treatment fidelity"; no studies had "high treatment fidelity" across all five domains. Fidelity strategies adhered to the most was theory, and treatment enactment was the lowest. Stakeholders mentioned that "low treatment fidelity" may be due to increased time to complete fidelity assessments and increased cost associated with treatment fidelity. These findings have implications for planning, implementing, and evaluating MI-based interventions for managing adolescent obesity.

A randomized controlled trial evaluating the effect of an internet-based cognitive-behavioral program on anxiety symptoms in a community-based sample of adolescents.

Adolescents' use of online resources to self-manage anxiety is growing. The objective of the current trial was to assess the effectiveness of an online, primarily self-led cognitive behavioral therapy (CBT) program in reducing anxiety symptoms compared to an active comparator, access to anxiety resources on a static website. A total of 563 adolescents (13-19 years) with self-identified anxiety concerns were enrolled. Self-reported anxiety symptoms were assessed pre- and post-intervention (6 weeks). Adolescents were further assessed 3 months post-intervention. Other outcomes assessed at the three time-points were quality of life (QOL) and healthcare utilization. Both interventions reduced anxiety symptoms after use. Group differences in symptom change were not significant post-intervention (p = 0.16), but were at 3 months (favouring online CBT; p = 0.04) with male participants reporting more symptom change (p = 0.03). Across time-points, as anxiety symptoms decreased, QOL increased (p < 0.001). Among participants that provided healthcare utilization before and after intervention use, the greatest changes in use were among online CBT users particularly for mental health provider visits (psychiatrist, -41.0 % vs. +18.5 %; social worker, -42.5 % vs. -22.1 %), hospital-based care (emergency department visits, -80.0 % vs. +79.4 %; hospital admissions, -76.1 % vs. +42.9 %), and use of self-help or alternative treatments (-60.0 % vs. +6.6 %). Results suggest that, over time, use of online CBT by adolescents can result in improved anxiety symptoms and fewer use of other healthcare resources compared to traditional online information seeking.

How safe are paediatric emergency departments? A national prospective cohort study.

BACKGROUND: Despite the high number of children treated in emergency departments, patient safety risks in this setting are not well quantified. Our objective was to estimate the risk and type of adverse events, as well as their preventability and severity, for children treated in a paediatric emergency department. METHODS: Our prospective, multicentre cohort study enrolled children presenting for care during one of 168 8-hour study shifts across nine paediatric emergency departments. Our primary outcome was an adverse event within 21 days of enrolment which was related to care provided at the enrolment visit. We identified 'flagged outcomes' (such as hospital visits, worsening symptoms) through structured telephone interviews with patients and families over the 21 days following enrolment. We screened admitted patients' health records with a validated trigger tool. For patients with flags or triggers, three reviewers independently determined whether an adverse event occurred. RESULTS: We enrolled 6376 children; 6015 (94%) had follow-up data. Enrolled children had a median age of 4.3 years (IQR 1.6-9.8 years). One hundred and seventy-nine children (3.0%, 95% CI 2.6% to 3.5%) had at least one adverse event. There were 187 adverse events in total; 143 (76.5%, 95% CI 68.9% to 82.7%) were deemed preventable. Management (n=98, 52.4%) and diagnostic issues (n=36, 19.3%) were the most common types of adverse events. Seventy-nine (42.2%) events resulted in a return emergency department visit; 24 (12.8%) resulted in hospital admission; and 3 (1.6%) resulted in transfer to a critical care unit. CONCLUSION: In this large-scale study, 1 in 33 children treated in a paediatric emergency department experienced an adverse event related to the care they received there. The majority of events were preventable; most were related to management and diagnostic issues. Specific patient populations were at higher risk of adverse events. We identify opportunities for improvement in care.

A randomized trial of ketorolac and metoclopramide for migraine in the emergency department.

OBJECTIVE: The objective of this study was to assess the efficacy and safety of a common monotherapy (intravenous [iv] metoclopramide) compared to a combination strategy (adding iv ketorolac to metoclopramide) in children presenting for acute treatment of migraine headache in the emergency department (ED). METHODS: Children aged 5-17 years presenting for acute treatment of migraine headache at two pediatric EDs were enrolled in a double-blind randomized controlled trial. Children were randomly assigned to receive iv metoclopramide 0.2 mg/kg) and placebo or iv metoclopramide (0.2 mg/kg) and ketorolac (0.5 mg/kg). The primary outcome was a mean change in pain from baseline to 120 min via a 100 mm Visual Analog Scale (VAS). Follow-up was conducted 24-h after discharge. RESULTS: Fifty-three children were randomized and included in the analysis (monotherapy group [metoclopramide + placebo], n = 27; and ketorolac group [metoclopramide + ketorolac], n = 26); mean age was 12.9 ± 2.7 years and baseline pain severity on VAS was 67.3 ± 2.7 mm. The mean change in pain intensity at 120 min was -44 mm (SD: 24; 95% confidence interval [CI]: 32-57) for the monotherapy group and -36 mm (SD: 24; 95% CI: 23-49) for the ketorolac group, with a mean difference between groups of 8 mm (95% CI: -9-25; p = 0.360). Seventeen percent of the children (9/53; 95% CI: 7-27%) were pain-free at discharge. There was no difference in headache recurrence or adverse events between groups. CONCLUSIONS: The approach of combining iv metoclopramide with ketorolac failed to improve pain scores in children presenting for acute treatment of migraine headache in the ED compared to metoclopramide monotherapy. Most patients were discharged with residual pain. Further comparative studies are needed to test alternative ED treatments for migraine in children or adolescents.

An Innovative Model of Pediatric Emergency Department Mental Health Care: Protocol for a Multicenter Type 1 Effectiveness-Implementation Cluster Randomized Trial.

Over the past decade, visits to American and Canadian emergency departments (EDs) for child and youth mental health care have increased substantially.1,2 Acute mental health crises can occur as a result of a variety of concerns, including those that are life threatening (eg, suicide attempts), pose safety concerns (eg, suicidal intentions, aggressive behaviors, alcohol and other drug use), and are physically distressing to the child or youth (eg, panic attacks). ED health care providers play a vital role in assessing the safety and well-being of the child or youth and referring them to services for ongoing care.3,4 During the ED visit, assessment and care should pinpoint risks, inform treatment, and consider family needs and preferences as part of a patient-centered approach. Yet, this approach to care is not widely adopted in EDs. Most EDs do not require the use of pediatric-specific mental health tools to guide assessments or have patient-centered procedures in place to guide the care of patients with mental health emergencies.5-7 Our team believes these limitations have led to the provision of acute mental health care that can lack sufficient quality and efficiency. This study protocol describes a trial designed to evaluate if a novel mental health care bundle that was co-designed with parents and youth results in greater improvements in the well-being of children and youth 30 days after seeking ED care for mental health and/or substance misuse concerns compared with existing care protocols. We hypothesize that the bundle will positively impact child and youth well-being, while also providing cost-effective health care system benefits.

Metabolically healthy obesity in children enrolled in the CANadian Pediatric Weight management Registry (CANPWR): An exploratory secondary analysis of baseline data.

Our study purpose was to determine the prevalence of metabolically healthy obesity (MHO) and examine factors associated with MHO in children with obesity. This cross-sectional study was a secondary, exploratory analysis of data that included 2-17 years old with a body mass index (BMI) ≥85th percentile from the CANadian Pediatric Weight management Registry. Children were classified as having MHO or metabolically unhealthy obesity (MUO) using consensus-based criteria. Those with MHO had normal triglycerides, high-density lipoprotein cholesterol, blood pressure, and fasting glucose. Logistic regression was used to examine factors associated with MHO, which included calculating odds ratios (ORs) and 95% confidence intervals (CIs). In total, 945 children were included (mean age: 12.3 years; 51% female). The prevalence of MHO was 31% (n = 297), with lower levels across increasing age categories (2-5 years [n = 18; 43%], 6-11 years [n = 127; 35%], 12-17 years [n = 152; 28%]). Children with MHO were younger, weighed less, and had lower BMI z-scores than their peers with MUO (all p < 0.01). MHO status was positively associated with physical activity (OR: 1.18; 95% CI: 1.01-1.38), skim milk intake (OR: 1.10; 95% CI: 1.01-1.19), and fruit intake (OR: 1.12; 95% CI: 1.01-1.24) and negatively associated with BMI z-score (OR: 0.69; 95% CI: 0.60-0.79), total screen time in hours (OR: 0.79; 96% CI: 0.68-0.92), and intake of fruit flavoured drinks (OR: 0.91; 95% CI: 0.84-0.99). These findings may help guide clinical decision-making regarding obesity management by focusing on children with MUO who are at relatively high cardiometabolic risk.

"It's Very Stressful for Children": Elementary School-Aged Children's Psychological Wellbeing during COVID-19 in Canada.

Emerging evidence suggests that the COVID-19 pandemic and associated public health measures, including lockdowns and school closures, have been negatively affecting school-aged children's psychological wellbeing. To identify supports required to mitigate the negative impacts of the COVID-19 pandemic, we gathered in-depth information on school-aged children's and parents' lived experiences of COVID-19 and perceptions of its impact on psychological wellbeing in grade 4-6 students in Canada. In this qualitative study, we conducted telephone-based semi-structured interviews with parents (n = 15) and their children (n = 16) from six schools in small and mid-sized northern prairie communities in Canada. Interviews were analyzed through thematic analysis. Three interrelated themes have emerged. First, the start of COVID-19 brought sudden and stressful changes to children's lives. Second, disruptions to daily life led to feelings of boredom and lack of purpose. Third, limited opportunities for social interaction led to loneliness and an increase in screen time to seek social connection with peers. Results underscore the need for resilience building and the promotion of positive coping strategies to help school-aged children thrive in the event of future health crises or natural disasters.

Establishing a Working Definition of User Experience for eHealth Interventions of Self-reported User Experience Measures With eHealth Researchers and Adolescents: Scoping Review.

BACKGROUND: Across eHealth intervention studies involving children, adolescents, and their parents, researchers have measured user experience to assist with intervention development, refinement, and evaluation. To date, no widely accepted definitions or measures of user experience exist to support a standardized approach for evaluation and comparison within or across interventions. OBJECTIVE: We conduct a scoping review with subsequent Delphi consultation to identify how user experience is defined and measured in eHealth research studies, characterize the measurement tools used, and establish working definitions for domains of user experience that could be used in future eHealth evaluations. METHODS: We systematically searched electronic databases for published and gray literature available from January 1, 2005, to April 11, 2019. We included studies assessing an eHealth intervention that targeted any health condition and was designed for use by children, adolescents, and their parents. eHealth interventions needed to be web-, computer-, or mobile-based, mediated by the internet with some degree of interactivity. We required studies to report the measurement of user experience as first-person experiences, involving cognitive and behavioral factors reported by intervention users. We appraised the quality of user experience measures in included studies using published criteria: well-established, approaching well-established, promising, or not yet established. We conducted a descriptive analysis of how user experience was defined and measured in each study. Review findings subsequently informed the survey questions used in the Delphi consultations with eHealth researchers and adolescent users for how user experience should be defined and measured. RESULTS: Of the 8634 articles screened for eligibility, 129 articles and 1 erratum were included in the review. A total of 30 eHealth researchers and 27 adolescents participated in the Delphi consultations. On the basis of the literature and consultations, we proposed working definitions for 6 main user experience domains: acceptability, satisfaction, credibility, usability, user-reported adherence, and perceived impact. Although most studies incorporated a study-specific measure, we identified 10 well-established measures to quantify 5 of the 6 domains of user experience (all except for self-reported adherence). Our adolescent and researcher participants ranked perceived impact as one of the most important domains of user experience and usability as one of the least important domains. Rankings between adolescents and researchers diverged for other domains. CONCLUSIONS: Findings highlight the various ways in which user experience has been defined and measured across studies and what aspects are most valued by researchers and adolescent users. We propose incorporating the working definitions and available measures of user experience to support consistent evaluation and reporting of outcomes across studies. Future studies can refine the definitions and measurement of user experience, explore how user experience relates to other eHealth outcomes, and inform the design and use of human-centered eHealth interventions.

Utility of MyHEARTSMAP in Youth Presenting to the Emergency Department with Mental Health Concerns.

OBJECTIVES: To evaluate the utility of a digital psychological self-assessment tool, MyHEARTSMAP (scores on 10 sections: home, education and activities, alcohol and drugs, relationships and bullying, thoughts and anxiety, safety, sexual health, mood, abuse, and professional resources), in youth presenting to the pediatric emergency department (ED) with a mental health concern. STUDY DESIGN: We conducted a prospective cohort study in 2 tertiary care pediatric EDs from December 2017 to October 2019. Youth 10-17 years old triaged for a mental health concern were screened and enrolled to complete MyHEARTSMAP on a mobile device. A clinician blinded to the MyHEARTSMAP assessment conducted their own assessment which was used as the reference standard. Utility was quantified as the sensitivity and specificity of MyHEARTSMAP in detecting psychiatric, social, youth health, and functional concerns. RESULTS: Among 379 eligible youth, 351 were approached and 233 (66.4%) families were enrolled. Sensitivity for youth MyHEARTSMAP self-assessments ranged from 87.4% in the youth health domain to 99.5% in the psychiatric domain for identifying any concern, and 33.3% in the social domain to 74.6% in the psychiatric domain for severe concerns. Specificity ranged from 66.7% in the psychiatric domain to 98.2% in the youth health domain for no or only mild concerns. CONCLUSIONS: Youth and guardian MyHEARTSMAP assessments are sensitive for detecting psychosocial concerns requiring follow-up beyond pediatric ED evaluation. Specificity for no or only mild concerns was high in the nonpsychiatric domains.

Adverse events in the paediatric emergency department: a prospective cohort study.

BACKGROUND: Understanding adverse events among children treated in the emergency department (ED) offers an opportunity to improve patient safety by providing evidence of where to focus efforts in a resource-restricted environment. OBJECTIVE: To estimate the risk of adverse events, their type, preventability and severity, for children seen in a paediatric ED. METHODS: This prospective cohort study examined outcomes of patients presenting to a paediatric ED over a 1-year period. The primary outcome was the proportion of patients with an adverse event (harm to patient related to healthcare received) related to ED care within 3 weeks of their visit. We conducted structured telephone interviews with all patients and families over a 3-week period following their visit to identify flagged outcomes (such as repeat ED visits, worsening symptoms) and screened admitted patients' health records with a validated trigger tool. For patients with flagged outcomes or triggers, three ED physicians independently determined whether an adverse event occurred. RESULTS: Of 1567 eligible patients, 1367 (87.2%) were enrolled and 1319 (96.5%) reached in follow-up. Median patient age was 4.34 years (IQR 1.5 to 10.57 years) and most (n=1281; 93.7%) were discharged. Among those with follow-up, 33 (2.5%, 95% CI 1.8% to 3.5%) suffered an adverse event related to ED care. None experienced more than one event. Twenty-nine adverse events (87.9%, 95% CI 72.7% to 95.2%) were deemed preventable. The most common types of adverse events (not mutually exclusive) were management issues (51.5%), diagnostic issues (45.5%) and suboptimal follow-up (15.2%). CONCLUSION: One in 40 children suffered adverse events related to ED care. A high proportion of events were preventable. Management and diagnostic issues warrant further study.