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.

Increasing access to mental health supports for 12-17-year-old Indigenous youth with the JoyPop mobile mental health app: study protocol for a randomized controlled trial.

BACKGROUND: Indigenous youth in Northwestern Ontario who need mental health supports experience longer waits than non-Indigenous youth within the region and when compared to youth in urban areas. Limited access and extended waits can exacerbate symptoms, prolong distress, and increase risk for adverse outcomes. Innovative approaches are urgently needed to provide support for Indigenous youth in Northwestern Ontario. Using a randomized controlled trial design, the primary objective of this study is to determine the effectiveness of the JoyPop app compared to usual practice (UP; monitoring) in improving emotion regulation among Indigenous youth (12-17 years) who are awaiting mental health services. The secondary objectives are to (1) assess change in mental health difficulties and treatment readiness between youth in each condition to better understand the app's broader impact as a waitlist tool and (2) conduct an economic analysis to determine whether receiving the app while waiting for mental health services reduces other health service use and associated costs. METHODS: A pragmatic, parallel arm randomized controlled superiority trial will be used. Participants will be randomly allocated in a 1:1 ratio to the control (UP) or intervention (UP + JoyPop) condition. Stratified block randomization will be used to randomly assign participants to each condition. All participants will be monitored through existing waitlist practices, which involve regular phone calls to check in and assess functioning. Participants in the intervention condition will receive access to the JoyPop app for 4 weeks and will be asked to use it at least twice daily. All participants will be asked to complete outcome measures at baseline, after 2 weeks, and after 4 weeks. DISCUSSION: This trial will evaluate the effectiveness of the JoyPop app as a tool to support Indigenous youth waiting for mental health services. Should findings show that using the JoyPop app is beneficial, there may be support from partners and other organizations to integrate it into usual care pathways. TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT05898516 [registered on June 1, 2023].

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.

Understanding How Youth Search for Mental Health Information Online: A Qualitative Descriptive Study.

The objective of this study was to understand how youth search for mental health information online. Youth partners were engaged at the onset of the project and provided input throughout on the design, conduct and analysis. Individual, semi-structured interviews with Canadian youth with experience searching for mental health information online were conducted. Data collection and reflexive thematic analysis proceeded concurrently. Fourteen youth were interviewed. Four main themes related to how youth search online emerged: mind-set shapes the search process; external factors shape the search process; key attributes of helpful information; and cues affecting trustworthiness of online information. Findings can inform the development of youth-friendly online mental health information that is perceived as helpful and trustworthy by youth. Ensuring youth have access to quality online mental health information, accessible to how they search for it, is critical to the mental health and development of youth.

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.

Use of quality improvement methods to enhance implementation of a mental health care bundle in a pediatric emergency department.

OBJECTIVES: We used quality improvement methods to implement a care bundle for children presenting to a pediatric emergency department (ED) with mental health concerns. A bundle novelty was that it included an option for assessment in a partnered clinic, not in the ED, to families of children assessed as having no medical or safety concerns. The primary aim of this study was to establish successful implementation of the bundle prior to studying its impact. METHODS: The bundle included the Ask Suicide-Screening Questions to standardize risk assessment at triage, the HEADS-ED (Home, Education, Activities/Peers, Drug/Alcohol, Suicidality, Emotions/Behavior, Discharge Resources) tool for brief, scored mental health assessments, and offering an urgent appointment within 96 h for low-risk children as an alternative to ED-based assessment or as a follow-up option for patients assessed in the ED. We developed aims, driver diagrams, and outcome measures for each bundle element. Each element was introduced with small tests of change using iterative plan-do-study-act cycles. Run charts were used to determine successful completion of aims. RESULTS: Rules for special cause were met through detection of shifts in performance 5 months after bundle implementation for the Ask Suicide-Screening Questions and HEADS-ED. These bundle elements were consistently used with ≥ 80% of eligible patients, representing aim achievement. During the 6 months of providing urgent appointments, 89.3% of 159 referred families received an appointment within 96 h. CONCLUSIONS: Using quality improvement methods, we were able to successfully ensure reliable implementation of a new care bundle for pediatric patients presenting to the ED with mental health concerns and allow eligible low-risk patients to receive full assessments in a partnered clinic instead of the ED.

RéSUMé: OBJECTIFS: Nous avons utilisé des méthodes d'amélioration de la qualité pour mettre en œuvre un ensemble de soins (bundle) pour les enfants qui se présentent à un service d'urgence pédiatrique avec des problèmes de santé mentale. Une nouveauté de ce bundle était qu'il comprenait une option d'évaluation dans une clinique partenaire, et non au service des urgences, pour les familles d'enfants évalués comme n'ayant aucun problème médical ou de sécurité. L'objectif premier de cette étude était d'assurer la réussite de la mise en œuvre du bundle avant d'en étudier l'impact. MéTHODES: Le bundle comprenait le questionnaire Ask Suicide-Screening Questions pour normaliser l'évaluation du risque au triage, l'outil HEADS-ED (Home, Education, Activities/Peers, Drug/Alcohol, Suicidality, Emotions/Behavior, Discharge Resources) pour des évaluations brèves et notées de la santé mentale, et l'offre d'un rendez-vous urgent dans les 96 heures pour les enfants à faible risque comme alternative à l'évaluation à l'urgence ou comme option de suivi pour les patients évalués à l'urgence. Nous avons élaboré des objectifs, des diagrammes de pilotage et des mesures de résultats pour chaque élément du bundle. Chaque élément a été introduit avec de petits tests de changement en utilisant des cycles itératifs planifier-faire-étudier-agir. Des diagrammes de progression ont été utilisés pour déterminer la réussite des objectifs. RéSULTATS: Les règles relatives à la cause spéciale ont été respectées grâce à la détection de changements dans les performances 5 mois après la mise en œuvre de bundle pour les questions de dépistage du suicide et HEADS-ED. Ces bundles ont été systématiquement utilisés avec plus de 80 % des patients éligibles, ce qui représente un objectif atteint. Au cours des six mois pendant lesquels des rendez-vous urgents ont été proposés, 89,3 % des 159 familles référées ont obtenu un rendez-vous dans les 96 heures. CONCLUSIONS: En utilisant des méthodes d'amélioration de la qualité, nous avons réussi à assurer une mise en œuvre fiable d'un nouveau bundle de soin pour les patients pédiatriques se présentant aux urgences avec des problèmes de santé mentale et à permettre aux patients à faible risque éligibles de recevoir des évaluations complètes dans une clinique partenaire plutôt qu'aux urgences.

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.

Evaluation of parent and youth experiences in advisory groups as part of a mental healthcare clinical trial: protocol for a mixed-method study.

INTRODUCTION: Patient engagement in healthcare research is a necessity to ensure that research objectives align with priorities, outcomes and needs of the population under study, and to facilitate ease of implementation and adoption of findings. In clinical trials, there is an increasing focus on patient engagement during the planning and conduct of clinical trials due to the potential for ethical and methodological benefits. As patient engagement in clinical trials increases, there is a need to evaluate the approaches of these activities to contribute evidence on what is most appropriate and successful. The purpose of this study is to evaluate patient engagement processes and the activities of patient partners during and after a paediatric mental healthcare trial. METHODS AND ANALYSIS: Using a mixed-methods study design, we will evaluate patient partners' engagement activities across set time-points during the trial and after trial completion. In this study, the term 'patient partner' is inclusive of two groups of people with lived experience: (1) caregivers (parents, formal/informal caregivers and family), and (2) youth (aged 15-24 years). Engagement will be evaluated using the participant and project questionnaires of the Public and Patient Engagement Evaluation Tool (PPEET), followed sequentially by semi-structured interviews. Quantitative data from the PPEET questionnaire will be analysed and reported using descriptive statistics. Data from open-ended questions from the PPEET questionnaires and semi-structured interviews will be analysed using thematic analysis. ETHICS AND DISSEMINATION: Approval from Athabasca University Research Ethics Board will be obtained for this project. Findings will be disseminated at both academic and public venues whether in-person or online, and using platforms that are caregiver and youth friendly. TRIAL REGISTRATION NUMBER: NCT04902391.

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.

Microcystin Contamination and Toxicity: Implications for Agriculture and Public Health.

Microcystins are natural hepatotoxic metabolites secreted by cyanobacteria in aquatic ecosystems. When present at elevated concentrations, microcystins can affect water quality aesthetics; contaminate drinking water reservoirs and recreational waters; disrupt normal ecosystem functioning; and cause health hazards to animals, plants, and humans. Animal and human exposures to microcystins generally result from ingesting contaminated drinking water or physically contacting tainted water. Much research has identified a multitude of liver problems from oral exposure to microcystins, varying from hepatocellular damage to primary liver cancer. Provisional guidelines for microcystins in drinking and recreational water have been established to prevent toxic exposures and protect public health. With increasing occurrences of eutrophication in freshwater systems, microcystin contamination in groundwater and surface waters is growing, posing threats to aquatic and terrestrial plants and agricultural soils used for crop production. These microcystins are often transferred to crops via irrigation with local sources of water, such as bloom-forming lakes and ponds. Microcystins can survive in high quantities in various parts of plants (roots, stems, and leaves) due to their high chemical stability and low molecular weight, increasing health risks for consumers of agricultural products. Studies have indicated potential health risks associated with contaminated fruits and vegetables sourced from irrigated water containing microcystins. This review considers the exposure risk to humans, plants, and the environment due to the presence of microcystins in local water reservoirs used for drinking and irrigation. Additional studies are needed to understand the specific health impacts associated with the consumption of microcystin-contaminated agricultural plants.