Lived Experience and Family Engagement in Mental Health and Substance use Health Research: Case Profiles of Five Studies.

INTRODUCTION: People with lived and living experience (PWLLE) and family members (F) can engage in mental health and substance use health research beyond participant roles, as advisors, co-researchers, equal partners and research leads. However, implementing meaningful and effective engagement is complex. METHODS: This article profiles five research initiatives involving different lived experience engagement structures, situated in a single tertiary care teaching and research hospital. RESULTS: The profiled projects feature various study designs and stages, ranging from initial priority setting to implementation efforts. The levels of engagement range from consultation to PWLLE/F leadership. Across diverse populations, all embody high-quality engagement and illustrate that PWLLE/F can have an important impact on a wide range of mental health and substance use health research. CONCLUSIONS: Engagement can be implemented flexibly within a single research institution to meet a wide range of needs and preferences of researchers and PWLLE/F. PATIENT AND PUBLIC CONTRIBUTION: Each of the research initiatives profiled was conducted with substantial lived experience engagement, as described herein. People with lived and living experience from each research initiative are also included in the authorship team and contributed to this manuscript.

Systematic Review: Measurement Properties of Patient-Reported Outcome Measures Used to Measure Depression Symptom Severity in Adolescents With Depression.

OBJECTIVE: To systematically evaluate the measurement properties of 12 patient-reported outcome measures (PROMs) used to measure depression symptom severity in adolescents with depression. Depression symptom severity was chosen as the outcome of focus given its importance as an outcome to measure in adolescents with depression across clinical trials and/or care. METHOD: MEDLINE, PsycInfo, Embase, Scopus, CINAHL, and Cochrane were searched from year of inception up to December 7, 2023. Study appraisal (ie, risk of bias), evaluation of measurement properties, and evidence synthesis followed the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. Included studies evaluated at least 1 of 9 measurement properties as detailed in the COSMIN taxonomy within a reported sample or subgroup of youth ages 12 to 24 years, with at least 40% meeting criteria for any depressive disorder. RESULTS: Of the 15,560 records identified, 31 studies for 7 PROMs were included in the COSMIN appraisal. Although several PROMs have the potential to accurately measure depression symptom severity in adolescents with depression, at this time none of the PROMs can be recommended for use without further evaluative work. High-quality evidence was generally lacking, largely due to few or inconsistent findings, small sample sizes, and other methodological concerns. CONCLUSION: This systematic review of the measurement properties of 12 PROMs used to measure depression symptom severity in adolescents with depression found that none of the PROMs can be recommended for use until further evaluative work is conducted. Clinicians and researchers should proceed with caution when using these PROMs. DIVERSITY AND INCLUSION STATEMENT: One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented racial and/or ethnic groups in science. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented sexual and/or gender groups in science. We actively worked to promote sex and gender balance in our author group. We actively worked to promote inclusion of historically underrepresented racial and/or ethnic groups in science in our author group. The author list of this paper includes contributors from the location and/or community where the research was conducted who participated in the data collection, design, analysis, and/or interpretation of the work.

Discriminative validity and interpretability of the mood and feelings questionnaire.

BACKGROUND: Using the Mood and Feelings Questionnaire (MFQ) to differentiate between depression severity levels remains unexplored. We explored the discriminative validity of the MFQ to identify an optimal cut-off MFQ score to distinguish between subthreshold-to-mild and moderate-to-severe depression severity levels. METHODS: An observational cross-sectional design was used in a sample (N = 67) of help-seeking youth (ages 13 to 18, inclusive) experiencing depressive symptoms. The MFQ was administered verbatim to youth by a research analyst over the phone. Youth were then grouped into subthreshold-to-mild or moderate-to-severe depression severity categories based on scores received on the Kiddie Schedule for Affective Disorders and Schizophrenia-Depression Rating Scale. Receiver Operating Characteristic curve analyses were conducted, with area under the curve (AUC) and Youden Index (J) as primary indices. We hypothesized that the lower limit of the 95 % confidence interval for the area under the curve would be ≥0.70. RESULTS: The primary analysis yielded an AUC of 0.85 (95 % CI: 0.763-0.947) and an optimal cut-off of ≥43 (J = 0.60, positive predictive value = 91.4 %, negative predictive value = 62.5 %, sensitivity = 72.7 %, specificity = 87.0 %). LIMITATIONS: Our study collected a small sample, and as such cannot identify how subgroup classification (e.g., based on race or gender) may moderate outcomes. Further, unknown measurement error of the predictor and reference variable measures can bias the estimates. CONCLUSIONS: Our preliminary findings highlight the potential for the MFQ to support clinical decision-making relevant to adolescents experiencing varying severities of depressive symptoms in secondary care settings.

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.

Economic evaluations of treatment of depressive disorders in adolescents: Protocol for a scoping review.

AIM: Depressive disorders in adolescents are common and impairing. Evidence-based treatments are available; however, at a cost. In the context of the COVID-19 pandemic, we anticipate increased demand for treatment services for adolescents with depression. We also anticipate that economic resources will be strained. Identifying cost-effective strategies to optimally treat depression in adolescents is imperative. This protocol for a scoping review aims to describe the literature with respect to economic evaluations of treatments for depression in adolescents. METHODS: We will conduct a scoping review using established methods and reporting guidelines. MEDLINE, Embase, PsyclNFO, Econlit, and the International HTA Database will be searched from inception to June 13, 2023, with an update closer to time of manuscript submission, while the NHS Economic Evaluation Database archives will be searched from inception to December 2014. Publications that contain economic evaluations, in the context of a clinical trial or a model-based study, testing a treatment of depression in adolescents will be selected for inclusion. Extracted data items will include: economic evaluation perspectives, health outcome variables and costs used in economic evaluations, types of analyses performed, as well as quality of reporting and methodology. RESULT: A narrative synthesis with summary tables will be used to describe our findings. CONCLUSION: Our findings will help identify gaps in the literature with respect to economic analyses for the treatment of depression such that these gaps can be filled with future research. Policy-makers, funders and administrators may also use our findings to inform their decisions around provision of various treatments for depression in adolescents. REGISTRATION: osf.io/5fteb (note that information on this link will be updated upon acceptance for publication based on reviewer comments).

Worldwide Prevalence and Disability From Mental Disorders Across Childhood and Adolescence: Evidence From the Global Burden of Disease Study.

Importance: The period from childhood to early adulthood involves increased susceptibility to the onset of mental disorders, with implications for policy making that may be better appreciated by disaggregated analyses of narrow age groups. Objective: To estimate the global prevalence and years lived with disability (YLDs) associated with mental disorders and substance use disorders (SUDs) across 4 age groups using data from the 2019 Global Burden of Disease (GBD) study. Design, Setting, and Participants: Data from the 2019 GBD study were used for analysis of mental disorders and SUDs. Results were stratified by age group (age 5 to 9, 10 to 14, 15 to 19, and 20 to 24 years) and sex. Data for the 2019 GBD study were collected up to 2018, and data were analyzed for this article from April 2022 to September 2023. Exposure: Age 5 to 9 years, 10 to 14 years, 15 to 19 years, and 20 to 24 years. Main Outcomes and Measures: Prevalence rates with 95% uncertainty intervals (95% UIs) and number of YLDs. Results: Globally in 2019, 293 million of 2516 million individuals aged 5 to 24 years had at least 1 mental disorder, and 31 million had an SUD. The mean prevalence was 11.63% for mental disorders and 1.22% for SUDs. For the narrower age groups, the prevalence of mental disorders was 6.80% (95% UI, 5.58-8.03) for those aged 5 to 9 years, 12.40% (95% UI, 10.62-14.59) for those aged 10 to 14 years, 13.96% (95% UI, 12.36-15.78) for those aged 15 to 19 years, and 13.63% (95% UI, 11.90-15.53) for those aged 20 to 24 years. The prevalence of each individual disorder also varied by age groups; sex-specific patterns varied to some extent by age. Mental disorders accounted for 31.14 million of 153.59 million YLDs (20.27% of YLDs from all causes). SUDs accounted for 4.30 million YLDs (2.80% of YLDs from all causes). Over the entire life course, 24.85% of all YLDs attributable to mental disorders were recorded before age 25 years. Conclusions and Relevance: An analytical framework that relies on stratified age groups should be adopted for examination of mental disorders and SUDs from childhood to early adulthood. Given the implications of the early onset and lifetime burden of mental disorders and SUDs, age-disaggregated data are essential for the understanding of vulnerability and effective prevention and intervention initiatives.

Outcomes among youth attending inpatient treatment for co-occurring disorders.

AIM: An emerging body of research is identifying effective outpatient integrated treatment approaches for youth with co-occurring psychiatric and substance use disorders, though few studies exist examining inpatient treatment. The current study aimed to address this gap by examining response to treatment during admission to, and in the year following discharge from, a specialized inpatient program for youth with co-occurring disorders. METHODS: A single-cohort longitudinal design examined change in adaptive functioning, mental health symptoms, and substance use frequency among N = 142 youth (69.1% female) aged 14-21 (M = 16.9, SD = 1.5) attending the program. Participants completed self-report measures at admission, discharge, and 1-, 6- and 12-months post-discharge. RESULTS: Analyses indicated significant improvements in adaptive functioning, internalizing and externalizing symptoms, and substance use frequency during admission. There was some loss of gains in adaptive functioning over the 12-months post-discharge. Improvements were maintained in internalizing symptoms and substance use frequency, and improvements in externalizing symptoms continued over the 12-months post-discharge. There was no significant interaction between change in functioning and internalizing symptoms at admission or type of substance use disorder diagnosis. There was a significant interaction with externalizing symptoms, such that those with clinically significant levels of externalizing symptoms at admission experienced greater improvement in functioning, though the groups ended treatment with comparable functioning scores. CONCLUSIONS: The results provide preliminary support for integrated treatment for co-occurring disorders delivered in an inpatient setting. However, the results also reflect the significant needs of youth with co-occurring disorders and the importance of ongoing care post-discharge from intensive treatment settings.

The Toronto Adolescent and Youth Cohort Study: Study Design and Early Data Related to Psychosis Spectrum Symptoms, Functioning, and Suicidality.

BACKGROUND: Psychosis spectrum symptoms (PSSs) occur in a sizable percentage of youth and are associated with poorer cognitive performance, poorer functioning, and suicidality (i.e., suicidal thoughts and behaviors). PSSs may occur more frequently in youths already experiencing another mental illness, but the antecedents are not well known. The Toronto Adolescent and Youth (TAY) Cohort Study aims to characterize developmental trajectories in youths with mental illness and understand associations with PSSs, functioning, and suicidality. METHODS: The TAY Cohort Study is a longitudinal cohort study that aims to assess 1500 youths (age 11-24 years) presenting to tertiary care. In this article, we describe the extensive diagnostic and clinical characterization of psychopathology, substance use, functioning, suicidality, and health service utilization in these youths, with follow-up every 6 months over 5 years, including early baseline data. RESULTS: A total of 417 participants were enrolled between May 4, 2021, and February 2, 2023. Participants met diagnostic criteria for an average of 3.5 psychiatric diagnoses, most frequently anxiety and depressive disorders. Forty-nine percent of participants met a pre-established threshold for PSSs and exhibited higher rates of functional impairment, internalizing and externalizing symptoms, and suicidality than participants without PSSs. CONCLUSIONS: Initial findings from the TAY Cohort Study demonstrate the feasibility of extensive clinical phenotyping in youths who are seeking help for mental health problems. PSS prevalence is much higher than in community-based studies. Our early data support the critical need to better understand longitudinal trajectories of clinical youth cohorts in relation to psychosis risk, functioning, and suicidality.

Neuroimaging and Biosample Collection in the Toronto Adolescent and Youth Cohort Study: Rationale, Methods, and Early Data.

BACKGROUND: The Toronto Adolescent and Youth (TAY) Cohort Study will characterize the neurobiological trajectories of psychosis spectrum symptoms, functioning, and suicidality (i.e., suicidal thoughts and behaviors) in youth seeking mental health care. Here, we present the neuroimaging and biosample component of the protocol. We also present feasibility and quality control metrics for the baseline sample collected thus far. METHODS: The current study includes youths (ages 11-24 years) who were referred to child and youth mental health services within a large tertiary care center in Toronto, Ontario, Canada, with target recruitment of 1500 participants. Participants were offered the opportunity to provide any or all of the following: 1) 1-hour magnetic resonance imaging (MRI) scan (electroencephalography if ineligible for or declined MRI), 2) blood sample for genomic and proteomic data (or saliva if blood collection was declined or not feasible) and urine sample, and 3) heart rate recording to assess respiratory sinus arrhythmia. RESULTS: Of the first 417 participants who consented to participate between May 4, 2021, and February 2, 2023, 412 agreed to participate in the imaging and biosample protocol. Of these, 334 completed imaging, 341 provided a biosample, 338 completed respiratory sinus arrhythmia, and 316 completed all 3. Following quality control, data usability was high (MRI: T1-weighted 99%, diffusion-weighted imaging 99%, arterial spin labeling 90%, resting-state functional MRI 95%, task functional MRI 90%; electroencephalography: 83%; respiratory sinus arrhythmia: 99%). CONCLUSIONS: The high consent rates, good completion rates, and high data usability reported here demonstrate the feasibility of collecting and using brain imaging and biosamples in a large clinical cohort of youths seeking mental health care.

Cognition and Educational Achievement in the Toronto Adolescent and Youth Cohort Study: Rationale, Methods, and Early Data.

BACKGROUND: Both cognition and educational achievement in youths are linked to psychosis risk. One major aim of the Toronto Adolescent and Youth (TAY) Cohort Study is to characterize how cognitive and educational achievement trajectories inform the course of psychosis spectrum symptoms (PSSs), functioning, and suicidality. Here, we describe the protocol for the cognitive and educational data and early baseline data. METHODS: The cognitive assessment design is consistent with youth population cohort studies, including the NIH Toolbox, Rey Auditory Verbal Learning Test, Wechsler Matrix Reasoning Task, and Little Man Task. Participants complete an educational achievement questionnaire, and report cards are requested. Completion rates, descriptive data, and differences across PSS status are reported for the first participants (N = 417) ages 11 to 24 years, who were recruited between May 4, 2021, and February 2, 2023. RESULTS: Nearly 84% of the sample completed cognitive testing, and 88.2% completed the educational questionnaire, whereas report cards were collected for only 40.3%. Modifications to workflows were implemented to improve data collection. Participants who met criteria for PSSs demonstrated lower performance than those who did not on numerous key cognitive indices (p < .05) and also had more academic/educational problems. CONCLUSIONS: Following youths longitudinally enabled trajectory mapping and prediction based on cognitive and educational performance in relation to PSSs in treatment-seeking youths. Youths with PSSs had lower cognitive performance and worse educational outcomes than youths without PSSs. Results show the feasibility of collecting data on cognitive and educational outcomes in a cohort of youths seeking treatment related to mental illness and substance use.

Talking 'Bout Better outcomes for Adolescent Depression: Youth and Caregiver Perspectives on an Integrated Care Pathway for Depression.

BACKGROUND: Depression is a common condition among adolescents, with rates continuing to rise. A gap exists between evidence-based recommendations for the treatment of depression and clinical practice. Integrated Care Pathways (ICPs) can help address this gap, but to date no study has examined how young people and their caregivers experience ICPs and whether these pathways are an acceptable form of care. This study used focus groups with adolescents, caregivers, and service providers to examine experiences of an ICP. METHODS: Six individual interviews with service providers, four focus groups with youth, and two focus groups with caregivers were completed. Data was analyzed consistent with Braun & Clarke's Thematic Analysis Framework within an interpretivist paradigm. RESULTS AND CONCLUSION: The study demonstrated that ICPs are acceptable to youth and their caregivers and that ICPs facilitate shared decision making between youth/caregivers and care providers. Findings also indicated that youth are willing to engage with ICPs particularly when there is a trusted clinician involved who helps interpret and tailor the ICP to the young person's experience. Further questions include how to best integrate these into the overall system and how to further tailor these pathways to support youth with diagnostic complexity and treatment resistance.

Systematic Review: The Measurement Properties of the Suicidal Ideation Questionnaire and Suicidal Ideation Questionnaire-Jr.

OBJECTIVE: The Suicidal Ideation Questionnaire (SIQ) and the Suicidal Ideation Questionnaire-Junior (SIQ-Jr) were designed to capture suicidal ideation in adolescents and are often used in clinical trials. Our aim was to identify and appraise the published literature with respect to the validity, reliability, responsiveness, and interpretability of the SIQ and SIQ-Jr. METHOD: We conducted a systematic review following COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines to identify, appraise, and synthesize published literature on measurement properties and interpretability of the SIQ and SIQ-Jr. We searched MEDLINE, Embase, APA PsycINFO, CINAHL, Web of Science, and Scopus from inception to May 16, 2023, to identify sources relevant to our aim. RESULTS: We identified 15 sources meeting our eligibility criteria. The body of literature did not meet COSMIN standards to make recommendations for use with regard to these measurement instruments. CONCLUSION: Further research is needed, with a focus on content validity and structural validity, prior to recommending the SIQ and SIQ-Jr for use in clinical practice and in clinical trials. No specific grant funding was used for this review. PLAIN LANGUAGE SUMMARY: In this systematic review, authors analyzed 15 sources examining measurement properties of the Suicidal Ideation Questionnaire and Suicidal Ideation Questionnaire-Jr. Both measures are designed to capture suicidal ideation in adolescents and are used in clinical practice and clinical trials. The authors identified sufficient evidence for convergent validity for both measures. Authors concluded that further research is needed to support content validity, structural validity as a unidimensional scale (as they are often used) as well as their internal consistency, test-retest reliability, discriminative validity, predictive validity, and interpretability of these measures. The authors also emphasize the need to consider the limitations of these measures for researchers studying suicidal ideation and clinicians using these measures in their assessments of young people.

Development, reach, acceptability and associated clinical changes of a group intervention to improve caregiver-adolescent relationships in the context of adolescent depression.

Background: Adolescents with depression often experience relationship problems with their caregivers, which predict poorer treatment outcomes. Personalising interventions by targeting factors associated with poor treatment outcomes may enhance the effectiveness of interventions. We report the development and initial evaluation of an intervention designed to target caregiver-adolescent relationship problems in the context of adolescent depression. Methods: Following a literature search to identify established caregiver interventions, we developed a new group intervention for caregivers through an iterative process including six rounds of the group with n = 53 caregivers of adolescents age 13-18 in the context of an integrated care pathway for adolescent depression. Caregivers rated their family functioning at the beginning and end of the program and provided anonymous satisfaction ratings. Enrolment and attendance data were examined. Youth with lived experience of depression and their caregivers provided input that was incorporated in the final version of the intervention. Results: The final intervention consists of 8 weekly, 1.5 h group sessions, delivered face-to-face, addressing: psychoeducation, the cognitive-behavioural model and caregiving, positive caregiving, listening and validation, expressing emotions effectively, and problem solving. Reach (56%), attendance (M = 63%, SD = 31%), and satisfaction (M = 92%; SD = 7%) supported the feasibility of the program. Caregivers reported significant improvements in family functioning, t(21) = 2.68, p = .014, d z = 0.56 [95% CI 0.11-1.0]. Discussion: A group intervention is acceptable to caregivers of adolescents with depression and may be associated with improved family functioning. Further research is needed, including a randomised controlled trial to test effects of the intervention on various dimensions of the caregiver-youth relationship and on youth depression outcomes.

Associations over the COVID-19 pandemic period and the mental health and substance use of youth not in employment, education or training in Ontario, Canada: a longitudinal, cohort study.

BACKGROUND: The economic shutdown and school closures associated with the COVID-19 pandemic have negatively influenced many young people's educational and training opportunities, leading to an increase in youth not in education, employment, or training (NEET) globally and in Canada. NEET youth have a greater vulnerability to mental health and substance use problems, compared to their counterparts who are in school and/or employed. There is limited evidence on the association between COVID-19 and NEET youth. The objectives of this exploratory study included investigating: longitudinal associations between the COVID-19 pandemic and the mental health and substance use (MHSU) of NEET youth; and MHSU among subgroups of NEET and non-NEET youth. METHODS: 618 youth (14-28 years old) participated in this longitudinal, cohort study. Youth were recruited from four pre-existing studies at the Centre for Addiction and Mental Health. Data on MHSU were collected across 11 time points during the COVID-19 pandemic (April 2020-August 2022). MHSU were measured using the CoRonavIruS Health Impact Survey Youth Self-Report, the Global Appraisal of Individual Needs Short Screener, and the PTSD Checklist for DSM-5. Linear Mixed Models and Generalized Estimating Equations were used to analyze associations of NEET status and time on mental health and substance use. Exploratory analyses were conducted to investigate interactions between sociodemographic characteristics and NEET status and time. RESULTS: At baseline, NEET youth were significantly more likely to screen positive for an internalizing disorder compared to non-NEET youth (OR = 1.92; 95%CI=[1.26-2.91] p = 0.002). No significant differences were found between youth with, and without, NEET in MHSU symptoms across the study time frame. Youth who had significantly higher odds of screening positive for an internalizing disorder included younger youth (OR = 1.06, 95%CI=[1.00-1.11]); youth who identify as Trans, non-binary or gender diverse (OR = 8.33, 95%CI=[4.17-16.17]); and those living in urban areas (OR = 1.35, 95%CI=[1.03-1.76]), compared to their counterparts. Youth who identify as White had significantly higher odds of screening positive for substance use problems (OR = 2.38, 95%CI=[1.72-3.23]) compared to racialized youth. CONCLUSIONS: Our findings indicate that sociodemographic factors such as age, gender identity, ethnicity and area of residence impacted youth MHSU symptoms over the course of the study and during the pandemic. Overall, NEET status was not consistently associated with MHSU symptoms over and above these factors. The study contributes to evidence on MHSU symptoms of NEET youth.

Comparing analytical strategies for balancing site-level characteristics in stepped-wedge cluster randomized trials: a simulation study.

BACKGROUND: Stepped-wedge cluster randomized trials (SWCRTs) are a type of cluster-randomized trial in which clusters are randomized to cross-over to the active intervention sequentially at regular intervals during the study period. For SWCRTs, sequential imbalances of cluster-level characteristics across the random sequence of clusters may lead to biased estimation. Our study aims to examine the effects of balancing cluster-level characteristics in SWCRTs. METHODS: To quantify the level of cluster-level imbalance, a novel imbalance index was developed based on the Spearman correlation and rank regression of the cluster-level characteristic with the cross-over timepoints. A simulation study was conducted to assess the impact of sequential cluster-level imbalances across different scenarios varying the: number of sites (clusters), sample size, number of cross-over timepoints, site-level intra-cluster correlation coefficient (ICC), and effect sizes. SWCRTs assumed either an immediate "constant" treatment effect, or a gradual "learning" treatment effect which increases over time after crossing over to the active intervention. Key performance metrics included the relative root mean square error (RRMSE) and relative mean bias. RESULTS: Fully-balanced designs almost always had the highest efficiency, as measured by the RRMSE, regardless of the number of sites, ICC, effect size, or sample sizes at each time for SWCRTs with learning effect. A consistent decreasing trend of efficiency was observed by increasing RRMSE as imbalance increased. For example, for a 12-site study with 20 participants per site/timepoint and ICC of 0.10, between the most balanced and least balanced designs, the RRMSE efficiency loss ranged from 52.5% to 191.9%. In addition, the RRMSE was decreased for larger sample sizes, larger number of sites, smaller ICC, and larger effect sizes. The impact of pre-balancing diminished when there was no learning effect. CONCLUSION: The impact of pre-balancing on preventing efficiency loss was easily observed when there was a learning effect. This suggests benefit of pre-balancing with respect to impacting factors of treatment effects.

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.

Suicidal behaviour and ideation among adolescents during the COVID-19 pandemic.

Adolescence is a period of elevated risk for suicide, and mental health professionals expressed concerns that suicidal behaviours and suicide rates may increase among this age group during the COVID-19 pandemic. Adolescent suicide rates, attempts, and ideation during the pandemic varied depending on the country, data collection methodology, and population (e.g., general population vs. emergency department). Many pre-pandemic risk factors for suicidal behaviour or ideation were identified as risk factors during the pandemic; however, there was also some evidence that certain groups were disproportionately at risk, such as girls, and adolescents identifying as Black, Asian, American Indian/Alaska Native, or Asian/Pacific Islander. Given the trend of increased adolescent suicide in many countries over the past two decades, there is an ongoing need to direct resources toward prevention programs, screening, and evidence-based interventions for suicide risk.

Study Preregistration: Measuring What Matters: Development and Dissemination of a Core Outcome Set for Pediatric Anxiety Disorders Clinical Trials.

Pediatric anxiety disorders (AD) are prevalent disorders with an impact on all aspects of a child's life and functioning.1 Although evidence supports commonly used treatments, there are notable concerns with the research to date.2 Heterogeneity in outcome selection, measurement, analysis, and reporting is a contributing factor to the hinderance of the translation of research into clinical practice.3 Recognition for outcome standardization in pediatric mental health disorders is evolving and there are several initiatives of importance, including the International Consortium for Health Outcomes Measurement (ICHOM), which has developed standardized outcome sets for use in the routine clinical mental health treatment of children and adolescents.4 Similarly, the International Alliance of Mental Health Research Funders5 advocate for use of 1 specific outcome measurement instrument (OMI) in the youth mental health research that they fund. Development of a Core Outcome Set (COS), a minimal set of outcomes that should be measured and reported in clinical trials, has been a solution in other areas of medicine to address heterogeneity in outcome selection and measurement across trials.6 The Core Outcomes and Measures in Pediatric Anxiety Clinical Trials (COMPACT) Initiative will develop a harmonized, evidence- and consensus-based COS that is meaningful to youth and families for use in future trials in pediatric AD.

Multivariable Prediction Modeling of Antidepressant Initiation in Unipolar Depressed Adolescents: A Secondary Analysis of the IMPACT Trial.

Introduction: This secondary analysis of data collected in a randomized controlled trial (RCT) for the treatment of depression in adolescents aimed to test prediction models relating antidepressant (AD) initiation to clinical variables. Methods: The primary study was an RCT where adolescents (ages 11-17) with depression were assigned one of three outpatient psychotherapies over 86 weeks. The current study tested five registered prediction models using data on adolescents not taking ADs at baseline (N = 337). Outcomes of interest included: AD initiation, change in depression severity, and self-injurious thoughts and behaviors (SITBs). Results: Findings from registered analytic strategies were not consistent with our a priori hypotheses; rather we unexpectedly observed a relationship between initiation of AD and increased risk of suicide attempts and suicidal ideation during the same time interval (p > 0.01). Sensitivity analyses found that: (1) higher depressive symptom severity and self-harm each predicted future AD initiation (p < 0.05), and (2) new-onset SITB was associated with AD initiation (p < 0.01). Conclusions: Taken together, our results suggest that depression symptoms severity and SITBs may prompt AD initiation. Researchers may wish to further explore causal pathways relevant to the association ADs between SITBs. Clinicians need to be cognizant of high-quality guideline recommendations when prescribing ADs to adolescents.