Discussing the gaps in the science and practice of lived experience engagement in mental health and substance use research: results of knowledge mobilization activities.

BACKGROUND: Engaging people with lived experience of mental health or substance use challenges and family members (PWLE) improves the quality and relevance of the associated research, but it can be challenging to include them meaningfully and authentically in the work. KNOWLEDGE MOBILIZATION EVENTS: After reviewing the literature on the science of lived experience engagement, we held two knowledge mobilization events to translate the findings to relevant partners and collect their feedback to guide our future research. A total of 55 people attended, bringing the perspective of people with lived experience, family members, research staff, research trainees, and scientists, as well as attendees holding multiple roles. We presented the scoping review findings, then held discussions to solicit feedback and encourage the sharing of perspectives. ATTENDEE PERSPECTIVES: Through small and large group discussion activities, we found that our scoping review findings resonated with the attendees' personal experiences with engagement in mental health and substance use research. Among the gaps highlighted in the discussions, the two that were most emphasized were the critical importance of improving diversity in engagement work in mental health and substance use, and the importance of addressing gaps around communication, relationships, rapport, and power dynamics in engagement spaces. CONCLUSIONS: Diversity, communication, relationships, and power dynamics emerge as key areas of work needed in the near future to advance the science of PWLE engagement in mental health and substance use research. We commit to pursuing the work that is considered of greatest need by a range of partners this research engagement sphere. We call on researchers in this area to continue this line of work, with a focus on the areas of research identified by attendees.

Engaging people with lived experience of mental health or substance use challenges and family members (PWLE) improves research, but it can be challenging to do it right. We reviewed the scientific research on engaging people with lived experience in this area of research. Next, we held two community events to share our findings and brainstorm on next steps. A total of 55 people attended. They were people with lived experience, family members, research staff, research trainees, and scientists, as well as people coming from multiple perspectives. Through small and large group discussions, attendees talked about the findings and the next steps. As a whole, attendees recognized the importance of this area of work and largely agreed with the findings we presented. Among all of the material discussed, attendees emphasized 1) the importance of improving diversity in PWLE engagement, and 2) the importance of improving communication, relationships, rapport, and power dynamics. These two key issues are considered among the most important areas of work going forward to advance the science of PWLE engagement in mental health and substance use research. We commit to pursuing the work that is considered of greatest need and call on researchers in this area to continue this line of work, with a focus on the areas of research identified by attendees.

Lived experience adaptation of a psychosocial intervention for young adults with bipolar spectrum disorders: Process description and adaptation outcomes.

AIM: Lived experience adaptation of mental health interventions can help ensure that the intervention is appropriate for the target population. This paper describes a youth-led adaptation of a self-stigma reduction intervention for young adults with bipolar spectrum disorders, that is, Narrative Enhancement and Cognitive Therapy. METHODS: Standard guidelines for youth engagement were followed. A youth lived experience adaptation lead and a five-member youth lived experience advisory panel reviewed the intervention and made a number of adaptations to increase its relevance for young people with bipolar disorders. A brief evaluation of the engagement process was conducted. RESULTS: The primary adaptations made to the intervention fell into five areas: (1) wording revisions for recovery-oriented language accessible to youth with a wide variety of language and literacy levels; (2) updating and tailoring to the diagnostic category, with the addition of new quotes describing the lived experience of stigma; (3) integration of a new, engaging graphic design; (4) development of a goal-setting module, as recommended by the research team; and (5) identification of the role of a peer co-facilitator. An evaluation of the engagement process showed that the engagement was extremely meaningful for the youth engaged. CONCLUSIONS: Using a youth lived experience adaptation process, young people can make relevant, important changes to a psychosocial intervention. The resulting early intervention materials are research-ready and are hypothesized to meet the needs of young people with BD in a youth-friendly manner. Research on the acceptability, efficacy, and effectiveness of the newly adapted intervention will be required.

Exploring the impact of engagement in mental health and substance use research: A scoping review and thematic analysis.

BACKGROUND: There is growing evidence demonstrating the impact of engaging people with lived experience (PWLE) in health research. However, it remains unclear what evidence is available regarding the impact of engagement specific to mental health and substance use research. METHODS: A scoping review of three databases and thematic analysis were conducted. Sixty-one articles that described the impact of engagement in mental health and substance use research on either individual experiences or the research process were included. RESULTS: Key topics include (a) the impact of engagement on individual experiences; (b) the impact of engagement on the research process; and (c) facilitators and barriers to impactful engagement. Studies largely focused on the perceived positive impact of engagement on PWLE (e.g., personal and professional growth, empowering and rewarding experience, feeling heard and valued), researchers (e.g., rewarding experience, deeper understanding of research topic, changes to practice), and study participants (e.g., added value, fostered a safe space). Engagement activities were perceived to improve facets of the research process, such as improvements to research quality (e.g., rigour, trustworthiness, relevance to the community), research components (e.g., recruitment), and the research environment (e.g., shifted power dynamics). Facilitators and barriers were mapped onto the lived experience, researcher, team, and institutional levels. Commonly used terminologies for engagement and PWLE were discussed. CONCLUSION: Engaging PWLE-from consultation to co-creation throughout the research cycle-is perceived as having a positive impact on both the research process and individual experiences. Future research is needed to bring consistency to engagement, leverage the facilitators to engagement, and address the barriers, and in turn generate research findings that have value not only to the scientific community, but also to the people impacted by the science. PATIENT OR PUBLIC CONTRIBUTION: PWLE were engaged throughout the scoping review process, including the screening phase, analysis phase, and write-up phase.

Research evidence and implementation gaps in the engagement of people with lived experience in mental health and substance use research: a scoping review.

BACKGROUND: There is growing recognition that engaging people with lived experience (PWLE) in mental health and substance use research improves the quality of the research in terms of relevance to the population and the feasibility of the work. Engagement also provides positive opportunities for research teams and the PWLE engaged. However, there are many gaps in the research on PWLE engagement. This scoping review synthesizes the gaps in the implementation of PWLE engagement and in the research on engagement as presented by research teams engaging PWLE in their work. METHOD: A systematic electronic database search was conducted in 2022 for published articles on PWLE engagement in mental health and substance use research. Potential articles were screened for relevance. The search led to 49 final articles included in the review. The 49 articles were then coded using codebook thematic analysis to answer two research questions: (1) What are the research evidence gaps regarding the engagement of PWLE in mental health and substance use research?; and (2) What are the gaps in implementing PWLE engagement in mental health and substance use research? PWLE were engaged in the conduct of this review. RESULTS: Results showed that research evidence gaps include further work on conceptualizing engagement; developing resources, tools, and practice recommendations to support research teams; increasing diversity in evaluations of engagement; and evaluating engagement, including its impact on the research, on PWLE, and on researchers. Implementation gaps included several broader institutional gaps and gaps in the day-to-day practice of engagement. CONCLUSIONS: Despite progress in PWLE engagement in mental health and substance use research in recent years, research evidence and implementation gaps remain. Research teams are encouraged to consider these gaps and conduct research and implementation activities to address them in a rigorous manner.

There is growing recognition that engaging people with lived experience (PWLE) in mental health and substance use research improves the quality of the research by making it more relevant to the population and more feasible. Engagement also provides positive opportunities for those working in this way. However, many questions remain unanswered in terms of PWLE engagement. We reviewed the published literature to identify gaps in the research on PWLE engagement and on the ways PWLE engagement is practiced in mental health and substance use research. We identified 49 articles addressing these issues. We examined each article to identify (1) research evidence gaps regarding the engagement of PWLE in mental health and substance use research; and (2) gaps in the way PWLE engagement is put into place in mental health and substance use research. We found that research evidence gaps include the need for further research work to understand what engagement and lived experience are; the need to develop resources, tools, and practice recommendations to support PWLE engagement; the need to increase the diversity of the PWLE engaged; and the need to evaluate the impact of engagement on the research, on PWLE, and on researchers. Gaps in the practice of PWLE engagement included several broader institutional gaps and gaps in the day-to-day practice. Despite progress in PWLE engagement in research in recent years, many gaps remain. Research teams are encouraged to conduct research to clarify these aspects of engagement and to implement engagement in ways that address these gaps.

Stigma as a barrier to early intervention among youth seeking mental health services in Ontario, Canada: a qualitative study.

BACKGROUND: Stigma associated with mental health challenges is a major barrier to service seeking among youth. Understanding how stigma impacts service-seeking decisions from the perspectives of youth remains underexplored. Such research is necessary to inform effective stigma reduction. OBJECTIVE: This study aims to understand how stigma influences service seeking among youth with mental health challenges. METHODS: Qualitative inquiry was taken using youth engagement, underpinned by pragmatism. Data were collected via 4 virtual focus groups with 22 purposively selected youth participants with lived experience of mental health challenges in Ontario, Canada. Focus group guides were developed collaboratively among research team members, including youth co-researchers. Data were analyzed inductively using reflexive thematic analysis. RESULTS: Three main themes were constructed from the data: point of entry into the system, being biomedicalized or trivialized, and paving the way for non-stigmatizing services. Initial contact with the mental healthcare system was seen to be affected by stigma, causing participants to delay contact or be refused services if they do not fit with an expected profile. Participants described a constant negotiation between feeling 'sick enough' and 'not sick enough' to receive services. Once participants accessed services, they perceived the biomedicalization or trivialization of their challenges to be driven by stigma. Lastly, participants reflected on changes needed to reduce stigma's effects on seeking and obtaining services. CONCLUSION: A constant negotiation between being 'sick enough' or 'not sick enough' is a key component of stigma from the perspectives of youth. This tension influences youth decisions about whether to seek services, but also service provider decisions about whether to offer services. Building awareness around the invisibility of mental health challenges and the continuum of wellness to illness may help to break down stigma's impact as a barrier to service seeking. Early intervention models of care that propose services across the spectrum of challenges may prevent the sense of stigma that deters youth from accessing and continuing to access services.

Impact Potpourri: A Multimethod Survey Study on Youth Substance Use During COVID-19.

Background: Given the important implications of youth substance use, it is essential to document and describe changes in substance use during the coronavirus disease 2019 pandemic. Methods: This multimethod survey study examines the impacts of the coronavirus disease 2019 pandemic on youth substance use among 149 Canadian youth who were using substances at a mid-pandemic period. Participants were 21.9 years of age on average (SD=2.2), including 99 girls/young women, 42 boys/young men, and 8 transgender or nonbinary individuals. The majority were Caucasian and born in Canada. Qualitative and quantitative findings are reported, with thematic analysis combined with descriptive and inferential statistical analyses. Results: Qualitatively, many youth reported increases or shifts in their substance use over the course of the pandemic. Youth reported using substances with limited numbers of peers, with family, or alone. Many reported using substances out of boredom and to cope. While legal substances remained highly accessible, illegal substances were reported to be more difficult to acquire and less trustworthy. Spending had increased. Quantitative findings suggested alcohol use has decreased, but other substance use has remained stable in the sample as a whole, although for each substance, some youth reported increases. Discussion: Despite minimal quantitative change, qualitative findings show that some youth increased their use of some substances during the pandemic, decreased others, changed their motivation to use, and decreased in safety behaviors. Youth-serving organizations should be aware of individual differences, the changing context of substance use, and the potential long-term impacts.

Contexte: Compte tenu des implications importantes de la consommation de substances chez les jeunes, il est essentiel d'identifier, documenter et décrire l'évolution de la consommation de substances pendant la pandémie de COVID-19 afin d'élaborer des stratégies de prévention et des traitements efficaces. Méthode: Cette étude d'enquête multiméthodes examine les impacts de la pandémie de COVID-19 sur la consommation de substances chez 149 jeunes canadiens qui consommaient des substances au milieu de la période de la pandémie. Les participants avaient 21,9 ans en moyenne (ET=2,2), dont 99 filles/jeunes femmes, 42 garçons/jeunes hommes et 8 personnes transgenres ou non binaires. La majorité des participants étaient caucasien et née au Canada. Les résultats qualitatifs et quantitatifs sont rapportés avec une analyse thématique combinée à des analyses statistiques descriptives et analogiques. Résultats: Sur le plan qualitatif, de nombreux jeunes qui consommaient des substances pendant la pandémie ont signalé des augmentations ou des changements dans leur consommation de substances au cours de la pandémie. Les jeunes ont déclaré consommer des substances avec un nombre limité de pairs, en famille ou seul. De nombreux jeunes ont déclaré consommer des substances par ennui et pour faire face à la situation. Alors que les substances légales sont restées très accessibles, les substances illicites sont devenues plus difficiles à acquérir et moins dignes de confiance ce qui a entraîné une augmentation des dépenses. Les résultats quantitatifs suggèrent que la consommation d'alcool a diminué pour ces jeunes, mais la consommation d'autres substances est restée stable dans l'ensemble de l'échantillon, bien que pour chaque substance, certains jeunes ont signalé des augmentations. Analyse: Malgré un changement quantitatif minime, les résultats qualitatifs montrent que chez les jeunes qui consommaient des substances au milieu de la période de la pandémie, certains jeunes ont connu une augmentation de la consommation de certaines substances pendant la pandémie, une diminution de leur consommation d'autres substances, des changements dans leur motivation à consommer des substances et une diminution des comportements sécuritaires. Les organisations au service des jeunes doivent être conscientes des différences individuelles, du contexte changeant de la consommation de substances et des impacts potentiels à long terme. Les prestataires de services devraient travailler avec les jeunes de manière centrée sur la personne pour identifier des solutions dans le contexte des expériences vécues en lien avec la COVID-19.

Embedding lived experience into mental health academic research organizations: Critical reflections.

BACKGROUND: As part of a growing emphasis on engaging people with lived experience of mental health conditions in mental health research, there are increasing calls to consider and embed lived experience throughout academic research institutes. This extends beyond the engagement of lay patients and also considers the potential roles of academic researchers with lived experience. When the lived experience of academic researchers is applied to academic work, there is the potential to improve the relevance of the research, while destigmatizing mental illness within academia. However, there are different and often contrasting perspectives on the way a lived experience academic researcher initiative should be implemented. OBJECTIVES: This article describes some of the key issues to be considered when planning an initiative that leverages and values the lived experience of academic researchers, including the advantages and disadvantages of each potential approach. DISCUSSION & RECOMMENDATIONS: Institutions are encouraged to reflect on the ways that they might support and value lived experience among academic researchers. In developing any such initiative, institutions are encouraged to be transparent about their objectives and values, undertake a careful planning process, involve researchers with lived experience from the outset and consistently challenge the stigma experienced by academic researchers with lived experience. PATIENT OR PUBLIC CONTRIBUTION: Multiple authors are academic researchers with lived experience of mental health conditions.

A Longitudinal Cohort Study of Youth Mental Health and Substance use Before and During the COVID-19 Pandemic in Ontario, Canada: An Exploratory Analysis.

BACKGROUND: Youth mental health appears to have been negatively impacted by the COVID-19 pandemic. The impact on substance use is less clear, as is the impact on subgroups of youth, including those with pre-existing mental health or substance use challenges. OBJECTIVE: This hypothesis-generating study examines the longitudinal evolution of youth mental health and substance use from before the COVID-19 pandemic to over one year into the pandemic among youth with pre-existing mental health or substance use challenges. METHOD: A total of 168 youth aged 14-24 participated. Participants provided sociodemographic data, as well as internalizing disorder, externalizing disorder, and substance use data prior to the pandemic's onset, then every two months between April 2020-2021. Linear mixed models and Generalized Estimating Equations were used to analyze the effect of time on mental health and substance use. Exploratory analyses were conducted to examine interactions with sociodemographic and clinical characteristics. RESULTS: There was no change in internalizing or externalizing disorder scores from prior to the pandemic to any point throughout the first year of the pandemic. Substance use scores during the pandemic declined compared to pre-pandemic scores. Exploratory analyses suggest that students appear to have experienced more mental health repercussions than non-students; other sociodemographic and clinical characteristics did not appear to be associated with mental health or substance use trajectories. CONCLUSIONS: While mental health remained stable and substance use declined from before the COVID-19 pandemic to during the pandemic among youth with pre-existing mental health challenges, some youth experienced greater challenges than others. Longitudinal monitoring among various population subgroups is crucial to identifying higher risk populations. This information is needed to provide empirical evidence to inform future research directions.

Unsubstantiated health claims for COVID-19 infections are led by cannabidiol: return of snake oil medicine.

BACKGROUND: The United States Food and Drug Administration (FDA) monitors, inspects, and enforces the promotion of products by companies that claim to mitigate, prevent, treat, diagnose, or cure COVID-19. The introduction of COVID-19-related diagnostics and therapeutics during the pandemic has highlighted the significance of rigorous clinical trials to ensure safety and efficacy of such interventions. The objective of this report is to provide a descriptive review of promotional violations of health products for COVID-19 infection. METHODS: Warning letters issued by the FDA's Center for Drug Evaluation and Research were retrieved over an 18 month period (March 6, 2020, to August 30, 2021) to identify promotional violations. FDA violation letters categorized as "Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)" were reviewed. A content analysis was performed for each letter to identify categories for product type, promotional venue, violation type, and country of origin. For cannabidiol-related violations, a content analysis was repeated within its own product category. RESULTS: A total of 130 letters were reported. Across all letters, cannabidiol products were the most frequent subject of violation (15/130; 11.5%). Of the cannabidiol letters, all reported the promotion of unapproved products (15/15; 100%), misbranding (15/15; 100%), and/or had claims that lacked scientific substantiation (14/15; 93.3%). All promotional violations were linked to websites (15/15; 100%), along with other mainstream venues: Facebook, Instagram, YouTube, Twitter, LinkedIn, and email. Lastly, the cannabidiol products were described to provide therapeutic benefit to COVID-19, by acting as an anti-viral (5; 33.3%), pro-inflammatory (1; 6.7%), anti-inflammatory (7; 46.7%), immune-booster (5; 40%), immune-suppressor (2; 13.3%), and/or other (2; 13.3%). CONCLUSION: Despite the urgent need for COVID-19 treatments, promotional material by companies must comply with standard regulatory requirements, namely substantiation of claims. As the pandemic persists, the FDA must continue their efforts to monitor, inspect, and enforce violative companies. Cannabidiol-related substances led the spectrum of products with unsubstantiated claims to treat COVID-19 infection. Improving awareness among the public, healthcare providers, and stakeholders highlights the value of drug approval process, while protecting public safety.

Youth Perspectives on Seeking Psychotherapy: A Concurrent Mixed Methods Study.

OBJECTIVE: Psychotherapy is the recommended first line of treatment for depression among youth; however, few youth seek professional support. This study compares barriers and facilitators to seeking psychotherapy among both youth who have and have not seen a psychotherapist. The study further explores reasons youth discontinue psychotherapy. METHODS: A concurrent mixed methods study design was used. Eligible participants completed a survey (N=104) and a subset of participants completed a semi-structured interview (N=60). The survey and interview data were analyzed concurrently using a triangulation design. RESULTS: Surveys were conducted among youth who had experienced psychotherapy (N=53) and youth who had not (N=51). The majority of participants were female. Common reasons for not seeking psychotherapy included wanting to handle their problems on their own (87.6%), thinking their problems would improve on its own (87.6%), and not knowing who to see (74.3%). Several barriers were common across the two groups, including stigma, concerns about the therapeutic relationship, and a preference for self-management. Common facilitators included improving coping skills and addressing functional impairment. There was some overlap between the barriers to seeking psychotherapy and the reasons for discontinuing, although aging out of youth-oriented service also constituted a termination factor. CONCLUSIONS: : As this study highlights the multiple factors that influence youth's psychotherapy-seeking behavior, a widespread, multi-level approach is needed to address barriers and facilitators at the individual level, but also at the community, policy, and organizational levels. Strategies such as increasing service availability and quality are needed to increase service seeking and improve retention.

OBJECTIF: La psychothérapie est le traitement de première intention recommandé pour la dépression chez les jeunes, toutefois, peu de jeunes recherchent un soutien professionnel. La présente étude compare ce qui fait obstacle et ce qui facilite la recherche de psychothérapie chez les jeunes qui ont vu ou pas un psychothérapeute. L'étude explore en outre les raisons pour lesquelles les jeunes cessent la psychothérapie. MÉTHODES: Une étude concomitante à méthodes mixtes a été utilisée. Les participants admissibles ont rempli un sondage (N = 104) et un sous-ensemble de participants a répondu à une entrevue semi-structurée (N = 60). Les données du sondage et de l'entrevue ont été analysées simultanément à l'aide d'une méthode de triangulation. RÉSULTATS: Les sondages ont été menés auprès des jeunes qui avaient l'expérience de la psychothérapie (N = 53) et des jeunes qui ne l'avaient pas (N = 51). La majorité des participants était de sexe féminin. Les raisons communes de ne pas rechercher la psychothérapie étaient notamment vouloir régler leurs problèmes par eux-mêmes (87,6 %), croire que leurs problèmes allaient se régler d'eux-mêmes (87,6 %), et ne pas savoir qui consulter (74,3 %). Plusieurs obstacles étaient partagés par les deux groupes, dont les stigmates, des préoccupations quant à la relation thérapeutique, et une préférence pour la gestion autonome. Ce qui facilitait communément était notamment améliorer les compétences d'adaptation et remédier à la déficience fonctionnelle. Il y avait un chevauchement entre les obstacles à la recherche de psychothérapie et les raisons d'y mettre fin bien que le fait de vieillir hors de la zone des services pour les jeunes constitue un facteur d'abandon. CONCLUSIONS: Comme cette étude mentionne les multiples facteurs qui influencent la recherche de thérapie chez les jeunes, il faut une approche étendue multi-niveaux pour aborder obstacles et facilitateurs au niveau individuel, mais aussi à l'échelle communautaire, politique et organisationnelle. Des stratégies comme accroître la disponibilité et la qualité des services sont nécessaires pour hausser la recherche des services et améliorer le maintien en place.

Compliance With Cannabis Act Regulations Regarding Online Promotion Among Canadian Commercial Cannabis-Licensed Firms.

Importance: As global jurisdictions shift toward cannabis legalization, 2 areas of public health importance relate to exposure to youth and to truthful promotion. Although Canada's Cannabis Act specifies many prohibitions related to cannabis promotion, no systematic monitoring or enforcement among licensed firms exists. Compliance with marketing regulations has effects beyond Canadian citizens because of the global outreach of websites and social media. Objectives: To evaluate compliance among licensed firms with the Cannabis Act and analyze trends among violations regarding promotional material. Design, Setting, and Participants: This cross-sectional study evaluated cannabis-licensed firms after cannabis legalization. Data were extracted from online public platforms, including company websites, Facebook, Instagram, and Twitter, from October 1, 2019, to March 31, 2020. Descriptive statistics, Poisson regression, and logistic regression were used to analyze the associations of covariates with promotion violations. Main Outcomes and Measures: The primary outcome was characterization of type and prevalence of promotion violations. Secondary outcomes were the role of various covariates (namely, licensed firm characteristics and online platforms) in the frequency and probability of violations. Hypotheses were formulated before data collection. Results: Among 261 licensed firms, 211 (80.8%) had an online platform, including 204 (96.7%) with websites, 128 (60.7%) with Facebook, 123 (58.3%) with Instagram, and 123 (58.3%) with Twitter. Of all licensed firms with an online platform, 182 (86.3%) had at least 1 violation. Compared with websites, the risk of violations was significantly higher on Facebook (rate ratio [RR], 1.24; 95% CI, 1.11-1.39) and Instagram (RR, 1.19; 95% CI, 1.05-1.34). The most common violations included lack of age restrictions, brand glamorization, and omission of risk information. With websites as the reference group, lack of age restrictions was approximately 15 times more likely to occur on Facebook (odds ratio [OR], 14.76; 95% CI, 8.06-27.05); the odds of an age restriction violation were also higher on Instagram (OR, 2.48; 95% CI, 1.43-4.32) and Twitter (OR, 4.03; 95% CI, 2.29-7.09). For unsubstantiated claims, the odds of violations were significantly decreased on Facebook (OR, 0.23; 95% CI, 0.11-0.48) and Instagram (OR, 0.28; 95% CI, 0.14-0.57). The odds of glamorization were associated with an increase on Instagram (OR, 2.90; 95% CI, 1.72-4.88). Conclusions and Relevance: In this cross-sectional study, widespread violations were observed in online Canadian cannabis promotion. To protect public health and safety amid legalization, decision-makers should make explicit federal regulation and enforcement regarding promotional activities of cannabis retailers. These results suggest that policy and enforcement of cannabis promotion in Canada would have an international impact, from ease of access to online media and downstream consequences of unregulated promotion.

Going virtual: youth attitudes toward and experiences of virtual mental health and substance use services during the COVID-19 pandemic.

BACKGROUND: During the COVID-19 pandemic, youth mental health and substance use services rapidly moved to virtual modalities to meet social distancing requirements. It is important to understand youth attitudes toward and experience of virtual services. OBJECTIVE: This study examined the attitudes toward and experiences of virtual mental health and substance use services among youth drawn from clinical and non-clinical samples. METHOD: Four hundred nine youth completed a survey including questions about their attitudes toward and experience of virtual services. The survey included quantitative and open-ended questions on virtual care, as well as a mental health and substance use screener. RESULTS: The majority of youth with mental health or substance use challenges would be willing to consider individual virtual services, but fewer would consider group virtual services. However, many have not received virtual services. Youth are interested in accessing a wide variety of virtual services and other supportive wellness services. Advantages and disadvantages of virtual services are discussed, including accessibility benefits and technological barriers. DISCUSSION: As youth mental health and substance use services have rapidly gone virtual during the COVID-19 pandemic, it is essential that we hear the perspectives of youth to promote service utilization among those in need. Diverse, accessible, technologically stable virtual services are required to meet the needs of different youth, possibly with in-person options for some youth. Future research, engaging youth in the research process, is needed to evaluate the efficacy of virtual services to plan for the sustainability of some virtual service gains beyond the pandemic period.

Evaluating the effectiveness of the Family Connections program for caregivers of youth with mental health challenges, part II: A qualitative analysis.

BACKGROUND: The Family Connections™ (FC) program is a 12-week support and skill-training program for caregivers of youth with mental health challenges. The intervention was originally developed with a focus on borderline personality disorder (BPD). It is important to understand the experiences of caregivers in such interventions, as well as its applicability beyond BPD, for the purposes of evaluation and ongoing program improvement. OBJECTIVE: To explore and analyse the experiences of caregivers of youth with diverse mental health challenges and who participated in FC. DESIGN: Semi-structured interviews with thirteen FC-participating caregivers of youth with mental health challenges. RESULTS: Thematic analysis uncovered three major themes regarding caregivers' experience with FC: (a) FC increased the caregivers' ability to manage their youth's mental health challenges; (b) participating in FC impacted their intra- and interpersonal spheres; and (c) improvements to the program were proposed. Following participation in FC, caregivers felt they learned a new approach to understanding themselves, their youth and mental health, and were better able to manage their youth's mental health challenges. DISCUSSION AND CONCLUSION: FC is a promising intervention for caregivers of youth with mental health challenges, beyond the traditional BPD focus. The intervention has the potential to provide broad-based benefits for caregivers and should be considered for implementation and scale-up across youth- and caregiver-serving organizations. Potential areas of intervention flexibility and improvement are discussed. PATIENT/PUBLIC CONTRIBUTION: Caregivers were involved in the program development and facilitation of FC. A person with lived experience was involved with the analysis.

'It reshaped how I will do research': A qualitative exploration of team members' experiences with youth and family engagement in a randomized controlled trial.

BACKGROUND: Engaging youth and family members as active partners in research and service design offers great promise in improving projects. In youth mental health, recent research has highlighted the value of youth and family engagement. However, research on the experience and impacts of engagement is sparse. OBJECTIVE: This study explores the project team's experience of youth and family engagement in the design and development of the YouthCan IMPACT randomized controlled trial and clinical service pathway design. DESIGN: Qualitative data collected using semi-structured interviews and a focus group as part of the YouthCan IMPACT clinical trial were analysed to understand the impacts of engagement. Twenty-eight team members were interviewed, including youth and family members. A qualitative content analysis was conducted, with a member checking process. RESULTS: Team members reported facilitators, barriers and impacts of youth and family engagement. Facilitators included a safe environment and strong procedures conducive to inclusion in co-design. Barriers included logistical, structural and institutional constraints. Overall, team members found youth and family engagement to be valuable and to positively impact the research and service design process. DISCUSSION AND CONCLUSIONS: Youth and family engagement played a critical role in research and clinical service pathway design. The team found that their involvement improved the quality of the research and service pathway through sustained and multifaceted engagement. Facilitators and barriers to engagement may serve to guide future engagement initiatives. Future research should evaluate the long-term impact of early engagement and further focus on family engagement. PATIENT/PUBLIC CONTRIBUTION: Youth and family members were engaged in the data analysis and interpretation process.

Evaluating the effectiveness of the Family Connections program for caregivers of youth with mental health challenges, part I: A quantitative analysis.

INTRODUCTION: Caregivers of youth with mental health (MH) challenges are often faced with complex problems in relation to caring for their youth. Family Connections™ (FC) is a 12-week skills training program for families of individuals with MH challenges, developed originally for Borderline Personality Disorder. Research is needed to examine the effectiveness of FC for caregivers of youth with diverse MH challenges. OBJECTIVE: To examine the effectiveness of FC for caregivers of youth with MH challenges. METHODS: A total of 94 caregivers of youth with MH challenges participated in FC, across three sites in Ontario, Canada. Assessments occurred at baseline, 6 weeks, 12 weeks and follow-up. Primary outcomes include the Burden Assessment Scale and The Stress Index for Parents of Adolescents. Secondary outcomes included the caregiver's report of child behaviour, affect, mastery, coping and grief. Linear mixed model analyses were conducted, where time and the time × site interaction were defined as the fixed effects. RESULTS: Statistically significant improvements over time were observed across outcome measures, including caregiver burden, grief, coping, and other measures. The time × site interaction was only significant for burden (P = .005). CONCLUSION: This study demonstrates the effectiveness of FC for caregivers of youth with MH challenges. Future research should focus on differences across geographical sites and facilitation models. PATIENT OR PUBLIC CONTRIBUTION: Caregivers were involved in the facilitation of FC. A person with lived experience was involved in analysing the data, reporting the results, and drafting the manuscript.

Drug Advertising Violations: A Longitudinal Trend Analysis of FDA Enforcement Letters from 2005 to 2019.

INTRODUCTION: In the United States, all pharmaceutical promotional activities must comply with regulatory standards set by the Food and Drug Administration (FDA); failure to comply may lead to receiving an FDA enforcement letter. Letters include details of the specific advertisement in violation, as well as the action that is required by the company to rectify the non-compliant promotion. OBJECTIVES: The aim of this study was to determine trends in enforcement letters from the FDA to parties responsible for pharmaceutical promotion violations from 2005 to 2019. METHODS: A longitudinal trend analysis was conducted of FDA enforcement letters sent to pharmaceutical companies from 2005 to 2019 (n = 318). Publicly available enforcement letters released by the Office of Prescription Drug Promotion were accessed and analysed online through the Center for Drug Evaluation and Research, a part of the FDA. Variables analysed included number of letters by year, violation categories, venues, intended audience, drug age and company revenues. Publicly available revenue was the major source for company revenue information. RESULTS: The total number of enforcement letters significantly decreased over time. Violations concerning risk information were significantly more prevalent than all other violation categories. Online promotional materials were most frequently cited. Proportionally, larger companies received the majority of letters in earlier years of observation, and smaller companies in later years (2013-2019). CONCLUSIONS: These trends are of value for industry and regulators alike in refining policy to ensure fair, balanced and meaningful information in pharmaceutical promotion. The frequency of violation letters has decreased in recent years; however, smaller companies have increasingly received the majority of letters. Small firms must increase their compliance around informing drug risk potential with balanced safety information across all promotional venues. Specifically, these findings are useful for pharmaceutical companies to direct educational efforts to promotional staff and their advertising agencies, especially regarding online advertising.