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NIMH - National Institute of Mental Health

PROJECT SUMMARY/ABSTRACT The purpose of this Mentored Patient-Oriented Research Career Development Award is to prepare Evan Dalton, MD, MSHP for a career as an independent clinician-investigator with expertise in developing and implementing interventions that transform care delivery for hospitalized children with autism spectrum disorder (ASD) and improve their outcomes on pediatric medical units. Dr. Dalton’s proposal includes training, mentorship, and research activities that will enable him to conduct a full-scale clinical trial of a systems-level intervention for children with ASD and aggression at a pediatric medical hospital. Dr. Dalton has developed a comprehensive career development and research plan that builds on his foundation in health services and quality improvement research to: 1) obtain advanced training in participant-engaged mixed methods for intervention development and redesign, 2) enhance his knowledge of human-centered design and practice its application within the pediatric hospital work system, and 3) gain the expertise in clinical trial methodology necessary to carry out a full-scale controlled trial at a pediatric medical hospital. The prevalence of ASD has risen above 3% in the United States and children with ASD are frequently hospitalized for their co-occurring medical and psychiatric disorders. Many children with ASD have inherent sensory sensitivity, restricted interests, and repetitive behaviors that are difficult to accommodate in the medical hospital setting. In addition, few specialized psychiatric hospitals exist for children with ASD, so pediatric medical hospitals provide psychiatric care for many children with ASD. The objective of the proposed research studies is to redesign an ASD-specific care pathway, which has demonstrated effectiveness at a psychiatric hospital, for implementation with children with ASD and aggression, their caregivers, and their observers in a pediatric medical hospital. To accomplish this objective, Dr. Dalton will pursue the following specific aims: 1) identify usability challenges and adaptation needs of an ASD-specific care pathway within the pediatric hospital work system, 2) redesign and iteratively refine the ASD-specific care pathway with Advisory Board collaboration, 3) pilot test the redesigned ASD-specific care pathway in a non-randomized, single-arm trial on a pediatric medical unit. This pilot study will assess the pathway’s usability, acceptability, and feasibility, evaluate the hypothesized mechanisms (e.g., observer beliefs, comfort, and knowledge), and examine clinical outcomes including patient aggression, physical restraint use, and staff injuries. The data generated by this project will serve as the foundation for a future R01 which will test the ASD-specific care pathway in a full-scale controlled trial at a pediatric medical hospital. This proposal addresses the National Institute of Mental Health Strategic Goal 4.2.B of “building models to scale-up evidence-based practices” by adapting an evidence-based intervention with demonstrated effectiveness in a psychiatric hospital for use with patients with ASD in pediatric medical units.

Substance Abuse and Mental Health Services Adminis

The purpose of this program is to develop and implement a community-wide prevention program to prevent and reduce drug overdose deaths by expanding access to FDA-approved opioid overdose reversal medications.

NIDA - National Institute on Drug Abuse

PROJECT SUMMARY/ABSTRACT We are proposing a hybrid type I trial to assess the effectiveness and implementation determinants of an innovative peer-led court navigator program that facilitates linkage to substance use disorder treatment. The courthouse is a venue where people with behavioral health needs who are justice-involved and at various points along the sequential intercept model converge in time and space; however, despite considerable attempts to link these populations to evidence-based treatment, outside of specialty court models, courthouses themselves are underexplored as an intervention setting. We will test whether court navigator intervention, led by peer recovery specialists and implemented in county courthouses, can be an effective strategy to facilitate linkages to substance use treatment. Court navigators are civilians who provide adjunctive legal-related services to those passing through courthouses, and the investigative team published pilot data demonstrating the feasibility of treatment linkage. Peer recovery specialists (persons with lived experience of substance use recovery) have been associated with reduced substance use outcomes and are being integrated into multiple criminal-legal intercepts and settings; however, peer-led court navigation is an innovative and unexplored approach within research and an ideal fit for a Justice Community Opioid Innovation Network Phase II Innovation Hub project. The proposed hybrid type I trial of a manualized court navigation intervention delivered by certified peer recovery specialists and compare the effectiveness through a pragmatic randomized controlled trial with an information-only control in two Indiana courthouses. Guided by Social Cognitive Theory and the Consolidated Framework for Implementation Research, our aims are as follows: Aim 1: Assess the effectiveness of court navigation vs. an information-only control on linkage to substance use treatment in a randomized controlled trial; Aim 2: Assess the effectiveness of court navigation vs. an information-only control on overdose and public safety outcomes in a randomized controlled trial; Aim 3: Explore barriers and facilitators implementing peer-led court navigation in criminal-legal systems. For the clinical trial, we will randomly select times of day that the court navigator intervention will be available and enroll 600 subjects over 24 months with 12 months of follow-up data by linking statewide administrative records. We will also conduct interviews to identify barriers and facilitators for implementing the intervention (N=64). The proposed study will be led by Dr. Bradley Ray, an experienced research sociologist, and supported by an interdisciplinary investigative team of qualitative and quantitative experts with senior justice and behavioral health leaders from the Indiana Supreme Court and Indiana Division of Mental Health and Addiction. This study has the potential to identify a new setting (courthouses) and strategy (court navigation) for linking those in need to community-based behavioral health services, thereby improving public health and safety. This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions for the overdose epidemic, including opioid and stimulant use disorders. The NIH HEAL Initiative bolsters research across NIH to address the national opioid public health crisis and improve treatment for opioid misuse and addiction.

Substance Abuse and Mental Health Services Adminis

The purpose of this program is to improve local awareness among youth and young adults of the risks associated with fentanyl and provide youth and young adults with opioid use disorder and other substance use disorder prevention, treatment and recovery support services.

Substance Abuse and Mental Health Services Adminis

Preventing Youth Overdose: Treatment, Recovery, Education, Awareness and Training

NIMH - National Institute of Mental Health

Project Summary Fragile X syndrome (FXS) stands as a prominent contributor to intellectual disability and autism spectrum disorders, stemming from mutations within the FMR1 gene. These mutations lead to severe reduction or absence of the FMRP protein. Despite extensive research, effective medical interventions for FXS remain elusive, hindered by a limited understanding of its underlying mechanisms. Biochemical investigations have consistently highlighted FMRP's role in modulating mRNA translation, with its absence correlating with increased translation levels of select FMRP- interacting mRNA targets. However, emerging evidence suggests broader dysregulation, as FXS neurons exhibit heightened overall protein synthesis, hinting at elevated translation of non-FMRP interacting mRNAs. This intriguing phenomenon underscores the need for a deeper exploration into the cellular dysfunctions characterizing FXS. This research initiative aims to unravel a novel facet of FXS pathology—nucleolar hyper-function. We propose that this hyper-function contributes to aberrant ribosome biogenesis, thus augmenting the cellular capacity for translation and driving the observed global increase in protein synthesis in FXS. Aim 1 will assess neuronal and glial nucleolar function in wild-type (WT) and Fmr1 knockout (KO) mice. Aim 2 will conduct a comparative analysis of genome-wide proteomic data encompassing nucleolar proteins in WT and Fmr1 KO samples, discerning molecular alterations integral to ribosome biogenesis and assembly. Aim 3 will assess nucleolar function in the peripheral tissue in Fmr1 KO mice, establishing the hyper-functional pathological outcome as a potential clinical biomarker. The successful execution of this exploratory R21 project promises to unveil previously unexplored cellular mechanisms underlying FXS pathology. This study will also suggest nucleolus-associated abnormalities as novel molecular/cellular measures and potential biomarkers.

NIMH - National Institute of Mental Health

Project Summary As life expectancy increases in people living with HIV (PLWH), the probability of developing other chronic conditions such as type 2 diabetes (T2DM), hypertension, and cardiovascular disease also increases. PLWH live longer, develop multiple chronic conditions (MCCs), and experience polypharmacy, reinforcing a need to evaluate composite medication adherence across all chronic medications. Suboptimal medication adherence to essential treatments may limit treatment effectiveness, shorten survival, decrease overall population health, and increase health-system costs. Positioned at the nexus of therapeutic intent and success, medication adherence is influenced by myriad system, provider, and person-related factors that cannot be evaluated using claims-based studies alone. Therefore, the overarching goal of this research is to identify a taxonomy of composite medication adherence trajectories (MATs) over a 36-month observation period in older (50-99 years of age) PLWH and MCCs. The taxonomies will inform future research involving development and testing of comprehensive medication adherence interventions and clinical decision support strategies with the highest probability to positively impact medication adherence-related clinical outcomes in older PLWH and MCCs. We propose a mixed-methods explanatory sequential design by combining group-based trajectory modeling (GBTM) of medication refill data followed by 75 semi-structured interviews to fully understand the clinical, social, behavioral, cultural, structural, and economic perspectives that may influence medication adherence decision-making in PLWH and MCCs (i.e., T2DM, hypertension, and/or hyperlipidemia). We propose the following aims: 1. Apply group-based trajectory modeling of medication refill data to identify dynamic profiles of medication adherence behavior over time for older PLWH and MCCs. 2. Use qualitative, semi-structured interviews of older PLWH and MCCs to obtain in-depth understanding of social, behavioral, cultural, structural, and economic perspectives that align with each MAT profile. In contrast to disease-specific (intra-disease), dichotomous summary measures focused on antiretroviral therapy alone, this study uniquely identifies longitudinal MATs across MCCs (inter-disease). Qualitative assessment of lived medication use experiences and array of social, behavioral, cultural, structural, and economic perspectives contributing to MAT profiles advances understanding of needs for PLWH and MCCs to inform optimal, tailored interventions for unique MATs unachievable with claims-only studies.

Substance Abuse and Mental Health Services Adminis

Project AWARE (Advancing Wellness and Resiliency in Education)

Substance Abuse and Mental Health Services Adminis

The purpose of Project AWARE is to develop a sustainable framework to address mental health, substance use, and co-occurring disorders and promote the social and emotional wellbeing for school-aged youth in local or tribal education agency settings. NOTE: at least three awards will be made to a tribe or tribal organization pending sufficient volume of applications.

Substance Abuse and Mental Health Services Adminis

Promoting the Integration of Primary and Behavioral Health Care: States

Substance Abuse and Mental Health Services Adminis

The purpose of this program is to: promote full integration and collaboration in clinical practice between physical and behavioral health care; support the improvement of integrated care models for physical and behavioral health care to improve overall wellness and physical health status; promote the implementation and improvement of bidirectional integrated care services, including evidence-based or evidence-informed screening, assessment, diagnosis, prevention, treatment, and recovery services for mental and substance use disorders, and co-occurring physical health conditions and chronic diseases.

Health and Human Services Department

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Health and Human Services Department

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Advancing Violence Epidemiology in Real-Time (AVERT). The AVERT program provides funding to jurisdictions to conduct routine monitoring of Emergency Department visits related to violence-related injuries and mental health conditions, and to analyze these data in a timely manner.

NIMH - National Institute of Mental Health

PROJECT SUMMARY Postpartum depression (PPD) affects approximately one in eight women in the year following childbirth, with significant implications for maternal and child outcomes. While theoretical perspectives emphasize the importance of social support during this challenging transition, particularly from partners, current research relies heavily on self-reported measures of support that are susceptible to cognitive biases and may be confounded with depression symptoms. A critical factor that may influence maternal mental health outcomes is the actual time spent in proximity with one's partner, as these periods provide opportunities for both emotional and practical support. In the proposed project, we will examine patterns of partner proximity across pregnancy and the extended postpartum period using innovative wearable devices (TotTags) that dynamically and unobtrusively measure physical distance between partners in their daily ecological context. Our central hypothesis is that reduced partner proximity will prospectively predict increases in maternal depression symptoms (Aim 1). We will also investigate the bidirectional relationships between both partners' depression symptoms and their proximity patterns (Aim 2) and examine how infant caregiving contexts influence these dynamics (Aim 3). This project addresses a critical gap in the perinatal mental health literature by advancing our understanding of how objective measures of partner support relate to depression risk during the transition to parenthood. This study will set the foundation for future research that can inform interventions aimed at preventing postpartum depression in both mothers and fathers. Through this project, the candidate will develop specialized expertise in perinatal mental health research, ecological assessment methods, and advanced statistical approaches for analyzing dynamic social interactions, positioning them to establish an independent research program examining how partner support shapes mental health outcomes during major life transitions.

NIDA - National Institute on Drug Abuse

The rapid shift in public perception of psychedelics, coupled with the expansion of their use and policy reform across the United States, has created a unique opportunity to assess the real- world impacts of psychedelic use. Over 7,000 people in Oregon have received legal, supervised psilocybin experiences. Similar services are set to begin in Colorado in 2025, and nine other states are currently considering psychedelic services legislation. Although early phase trials suggest psilocybin may be safe and effective for treating some mental health and substance use disorders (e.g., tobacco use), it is not known whether these effects extend to community- based settings with less standardized screening and counseling support. There is an urgent need to assess the safety of these programs and their impact on substance use, before more voters and policymakers are asked to consider their merits and drawbacks. The Psilocybin Research and Implementation study for Substance use and Mental health (PRISM) study is designed to fill this gap by enrolling a cohort of individuals who use substances and receive Oregon’s state-regulated psilocybin services and comparing them to a group of people who would access these services, if they were available. Using 12 months of rigorous longitudinal surveys and qualitative interviews, PRISM will detect potential safety risks and benefits of regulated psilocybin services and identify specific substances and subpopulations that may be responsive to psilocybin’s effects. The study has three Aims: 1) Assess the impact of state- regulated psilocybin services on safety events in people who use substances, 2) Assess the impact of state-regulated psilocybin services on substance use, and 3) Elicit stakeholder views of the impact of state-regulated psilocybin services on long-term safety and changes in substance use. The PRISM study seeks to generate rigorous real-world evidence that can effectively guide state and federal decision-making. The timing of this work is critical, given the rapid expansion of psychedelic policy reform across the United States. The findings will help shape policies that maximize potential benefits of psilocybin services while minimizing risks, offering a scientifically grounded framework for public health strategies, harm reduction efforts, and future psychedelic regulations.

NYS Office of Mental Health

To provide life and employment skills for OMH inpatients to reintegrate into society

U.S. Mission to Burundi

The U.S. Department of State s Embassy Bujumbura announces an open competition to implement a program to support U.S. policy objectives and promote shared interests. Projects must promote Freedom250 and align with policy goals such as making the United States safer, stronger, and more prosperous. Specifically, the projects should showcase American leadership and excellence in sports-particularly in Basketball, and health, notably by celebrating American sports excellence during the American decade of sports. The target audience should be youth and young professionals aged 15-35 representing emerging voices, as well as opinion leaders to convey information and reach the broader population. The program shall pursue four core goals: advancing U.S. public diplomacy, strengthening people-to-people ties, capitalizing on the Decade of Sport, and promoting physical and mental health. Together, these efforts will position Sports as a catalyst for goodwill, cultural exchange, and community well-being.

NIMH - National Institute of Mental Health

Project Summary Strong, longstanding evidence points to important roles for the cerebellum in autism spectrum disorders (ASDs), yet cerebellar mechanisms remain understudied in ASDs compared to neocortical circuits. Anatomical and functional studies have pointed, in particular, to changes in the synapses of Purkinje cells, the sole output neurons of the cerebellum. Purkinje cells were reduced both in number and size in ASD cases, particularly in the cerebellar vermis and other sub-regions involved in cognition and emotional control. Genes localized to Purkinje cell synapses were down-regulated. Purkinje cell-specific conditional knockout mice for several ASD risk genes suggest direct effects of these cerebellar neurons on ASD-related behaviors and synaptic structure and function. However, cell type-specific transcriptional and epigenomic changes in the cerebellum of individuals with ASDs remain poorly characterized, and it is unknown whether the synaptic features identified in mouse models translate to the human condition. Here, we propose comprehensive multi-omic and synaptic imaging studies to address these knowledge gaps, utilizing a unique post-mortem brain tissue resource from the University of Maryland Baltimore Brain and Tissue Bank. We will generate single-nuclei multi-omic profiles of gene expression and chromatin accessibility in ~1.5 million cells from 100 ASD cases and 100 controls. In the same brain tissue samples, we will perform super-resolution confocal imaging to quantify the density, size, and nanostructure of Purkinje cell synapses. ~50% of the donors in our cohort will have known causal mutations, including multiple cases with tuberous sclerosis complex (TSC), Rett syndrome, and Fragile X syndrome, enabling us to define shared vs. unique features of ASDs with mutations in different genes. Key findings will be validated in a mouse model of TSC, Tsc1 conditional knockout mice, enabling us to determine which transcriptomic and synaptic phenotypes arise from the direct effect of this mutation in Purkinje cells.

NIMH - National Institute of Mental Health

Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive brain stimulation methodology FDA- approved for treatment of major depressive disorder (MDD). While rTMS achieves higher antidepressant efficacy than conventional treatments, reported response and remission rates are highly variable across cohorts. To reduce this variability and enhance overall remission rates, an understanding of the biological mechanisms behind rTMS’s antidepressant efficacy is needed. Recent studies have identified that rTMS works through a common biological mechanism even across multiple neurological disorders being treated: reduction of neuroinflammation, specifically, reduction in microglia activation. This is particularly relevant for MDD, as increased neuroinflammation is well-documented, on average, in groups of patients with MDD, and microglia are reported to be the cells responsible for this neuroinflammation. We and others have shown that people with MDD exhibit a range of neuroinflammation and that only those with high neuroinflammation have an antidepressant response to anti-inflammatory treatment. Taken together, this suggests that the mechanism of action of rTMS may be through the reduction of neuroinflammation (specifically, microglia density) and that the reported heterogeneity in response to rTMS may be due to the heterogeneity of neuroinflammation in MDD itself. We seek to probe this in the proposed high-risk, high-reward proof-of-concept study in n = 10 treatment- seeking participants with MDD, who will undergo rTMS as part of their standard of care – this is not a clinical trial: Aim 1. Explore the relationship between rTMS-associated reductions in depression severity and reductions in microglial density, as measured by microglia-specific [11C]PS13 positron emission tomography (PET) tracer. We expect microglia density to decrease following rTMS based on published animal literature reporting a ~23% reduction in microglia after TMS. Data from our current study examining participants with MDD receiving anti-inflammatory medication suggest that reductions in depression severity will be correlated with this reduction in neuroinflammation. Aim 2. Explore the relationship between pretreatment microglia density as measured by [11C]PS13 PET and antidepressant response to rTMS. Data from our current study suggest that greater pretreatment neuroinflammation will be associated with better response to rTMS. This high-risk, high-reward R21 will be the first study to assess rTMS’s effects on microglia in patients with MDD, advancing our understanding of its mechanism of action, providing proof of concept to support future larger studies, and stimulating the development of both novel neuroinflammation-specific therapeutics and future improvements in rTMS protocols.

NIMH - National Institute of Mental Health

Title: R-loop-induced CGG contraction as a therapeutic approach for Fragile X syndrome PROJECT SUMMARY Fragile X syndrome (FXS) is an X-linked neurodevelopmental disorder and one of the most common monogenic causes of inherited intellectual disability and autism spectrum disorders (ASD). FXS has a higher incidence among males (~1:3000) than females (~1:6000). Approximately 60% of FXS individuals demonstrate autistic features, 86% have an anxiety disorder, and almost all exhibit cognitive, motor, and developmental delays. Disease-modifying treatments have been of major pharmaceutical interest. Clinical trials have largely targeted pathways downstream of FMR1 or alternative pathways to modulate disease phenotype, such as arbaclofen and metabotropic glutamate receptor 5 (mGluR5) antagonists, with a phosphodiesterase-4D (PDE4D) allosteric inhibitor recently shown to improve cognitive function. However, because FMRP — the gene product of FMR1 — has many functions in the brain, the molecular, synaptic, and circuit dysfunctions seen in FXS may not be easily corrected by targeting a single downstream or parallel pathway. Despite intensive efforts to better understand the etiology, there remains a dearth of disease-specific treatments. It is now known that restoring FMR1 expression can at least partially rescue FXS phenotypes. Towards this goal, we recently identified a new approach that corrects the underlying genetic defect by reactivating the silenced FMR1. By investigating conditions favorable to FMR1 reactivation, we found that two compounds (“2i”) — a MEK and a BRAF inhibitor — could fully turn back on FMR1 in cellular models. We traced the mechanism to 2i-mediated DNA demethylation and formation of site-specific R-loops that then recruit endogenous DNA repair mechanisms to excise the CGG repeat. We went on to demonstrate that the CGG contraction and gene reactivation could be recapitulated by driving site-specific R-loop formation using dCas9 and an FMR1-specific gRNA. These discoveries lead to a model in which R-loops induce a positive feedback cycle comprising DNA demethylation, de novo FMR1 transcription, and reinforcement of R-loops at the CGG repeat — which in turn drive recruitment of endogenous DNA repair mechanisms to remove the aberrant RNA:DNA structure. Excision of the long CGG repeat then enables the reactivation of FMR1. We observed that repeat contraction is specific to FMR1 and fully restores production of FMRP protein. Our study thereby identifies a novel and potential method of treating FXS. In the proposed research, we aim to obtain proof-of-concept that R-loops form and induce contraction of the CGG repeat in post-mitotic neurons and that the contraction can lead to FMR1 reactivation in a human 3D disease model for FXS. If successful for FXS, the R-loop approach could be a potential therapeutic for other tandem repeat disorders as well.

NIDCR - National Institute of Dental and Craniofacial Research

PROJECT SUMMARY/ABSTRACT The US faces a mental health crisis; nearly 83 million Americans experience mental illness, but fewer than 50% of these individuals accessed past year mental health services. There is a critical need for highly disseminable, potent mental health interventions. Standalone digital interventions offer promise for improving clinical outcomes at scale; however, efficacy of these interventions to date is modest, likely due in part to insufficient personalization to patient heterogeneity and to momentary changes in mental health symptoms. The present study seeks to rapidly improve the efficacy of precision psychiatry digital health interventions by developing real-world, person-centered maintenance models for psychopathology using ecological (i.e., in patient’s daily lives) data and dynamic systems modeling. Dynamic systems modeling of repeated time series data yielded by ecological momentary assessment (EMA) and smartphone sensors will be used to evaluate the individual and interactive effects of empirical maintenance factors to understand each individual’s maintenance system for psychopathology in their daily life. Just-in-time adaptive interventions (JITAIs) are prompts delivered in-the-moment via smartphone at identified instances of risk for maladaptive behaviors. Although often evaluated in aggregate across months, JITAIs could be conceptualized as ecological quasi-experiments that induce use of specific therapeutic skills at observable times. Accordingly, this study will use micro-randomized (in which the content of the JITAI is randomly assigned in the moment) JITAIs delivered at times of elevated risk for maladaptive behavior based on the individual’s developed dynamic system to evaluate the effects and mechanisms of specific therapeutic skills on outcomes of interest, to provide granular insight into treatment mechanisms. Eating disorders are the ideal population in which to test proof-of-concept for these methods to improve efficacy of precision psychiatry digital interventions, as they are characterized by easily measurable maladaptive behaviors (i.e., dietary restriction, binge eating, compensatory behaviors), are maintained by a complex intersection of biological, psychology, and social factors, and their frontline treatment, enhanced cognitive behavioral therapy (CBT-E), is primarily comprised of behavioral skills. The aims are: 1) test the hypothesis that person-centered dynamic models will describe risk for dietary restriction, binge eating, add compensatory behaviors with ≥ 60% average goodness-of-fit, 2) test hypothesized effects and mechanisms of CBT-E skills on eating disorder behaviors and primary maintenance factors using JITAIs, and 3) characterize feasibility and acceptability of the standalone JITAIs. The study will enroll N = 170 adults with eating disorders who will complete four months of ecological data collection and receive JITAIs to use CBT-E skills at times of elevated risk for 10 weeks of the data collection period. The study will set the stage for future randomized controlled trail to evaluate the optimized, standalone JITAI system, which will have the potential to substantially improve access to evidence-based mental healthcare.

NIMH - National Institute of Mental Health

Project Summary/Abstract Amid an unprecedented youth mental health crisis, adolescents and young adults (AYA) have the most barriers to receiving mental healthcare. While digital tools are a scalable and accessible way to provide timely mental health screening and referral options, these tools have failed to engage AYA in their daily lives. This failure is driven by multiple factors, including a lack of: 1) understanding of implementation determinants for digital tools in community spaces; and 2) partnership with AYA, their caregivers, and support staff who work in key community settings where AYA spend their time. Consistent with the NIMH Strategic Plan and National Advisory Mental Health Council report, the goal of this R34 proposal is to target AYA engagement in the design and implementation of a digital low-intensity treatment for AYA in Chicago Park District (CPkD) Teen Programming. The CPkD is the largest park district in the country, and more than 40,000 youth are served daily across all 77 Chicago neighborhoods. This project harnesses on a partnership with CPkD and is grounded in the Accelerated Creation-to-Sustainment (ACTS) Model to guide the development of a technology (the “CPkD D-LITe”), as well as its service and implementation plans for CPkD sites. Aim 1 follows the first phase of the ACTS Model, Create. Human-centered design and community-engaged research methodologies will be used to collaborate with the existing CPkD Youth Advisory Board and Teen Programming participants, caregivers of AYA served by CPkD, and CPkD staff. Design activities will focus on targeting mechanisms that are believed to influence engagement: 1) individual-level barriers to care; 2) leveraging spaces where youth spend their time, including assessing determinants in these spaces; and 3) elevating key player input throughout design. The products of Aim 1 will include: an initial version of the “CPkD D-LITe” that demonstrates usability and acceptability by key players, a service protocol for integration of the “CPkD D-LITe” and potential higher clinical needs reported by AYA as a result of using the tool, and an implementation blueprint for integration into CPkD programming. Additionally, extended usability testing will pilot all trial activities to be conducted in Aim 2. In Aim 2, the second phase of the ACTS Model, Trial, will be followed by conducting a pilot randomized controlled trial in CPkD sites using an Optimization, Effectiveness, and Implementation trial methodology. The “CPkD D-LITe” will be compared to a control condition (digital workbook) across a pragmatic, rollout implementation trial. Primary outcomes include acceptability and feasibility, along with reductions of individual levels to mental healthcare, DMH use, and, secondarily, clinical outcomes (anxiety, depression). Optimization activities will occur across the trial period. In sum, the naturalistic approach of this work addresses multiple barriers to real-world digital tool engagement failures for AYA. It will provide key insights into engagement strategies, adaptations, and both service and implementation practices that will support AYA in community settings, both broadly and in a future R01 proposal.

NIMH - National Institute of Mental Health

This application proposes extensive community engagement activities to adapt and pilot test an evidence-based intervention to improve employment outcomes for young adults experiencing early psychosis in Uganda called Individual Placement and Support (IPS). Psychosis usually starts during adolescence and young adulthood, a critical developmental period, and, despite its relatively low prevalence, accounts for a disproportionate number of global disability and level of caregiver burden. People with severe mental disorders, including psychosis, are seven times more likely to be unemployed than those without a disorder. While treatment for acute episodes is important, post-acute interventions are crucial for long term recovery and improved clinical and functional outcomes. Our research has demonstrated that Ugandan youth experiencing psychosis are eager to work and complete their education, yet there are no placement or support services like IPS available to them. Because IPS has never been systematically implemented in a low- and middle-income country (LMIC) in Africa, we anticipate that adaptations will be necessary to fit the local cultural, economic, and social context. Thus, we propose a systematic process of community engagement to adapt and pilot test IPS in the newly established early psychosis services in Kampala. Aim 1. We will engage with the community to identify barriers to and facilitators of IPS implementation in Uganda. We will conduct 45 qualitative interviews and focus group discussions with young people diagnosed with early psychosis and their relatives, potential employers, local alternative healers, mental health providers, and policymakers. Aim 2. Using Aim 1 findings, we will adapt IPS to the local context by conducting a multi-day workshop with 15 key stakeholders, featuring IPS demonstrations followed by surveys and group discussions. Based on this, an adapted IPS-Uganda draft will be developed and iteratively reviewed. After integrating all feedback, we will finalize the IPS manual and create a training scheme for personnel delivering the intervention during the trial. Aim 3. We will evaluate the potential methodology for a randomized controlled trial (RCT) and pilot test the adapted IPS intervention among 60 Ugandan patients experiencing early psychosis. We will conduct a pilot RCT to examine the feasibility, costs and acceptability of IPS. Participants will be randomized to receive IPS or treatment as usual. The follow-up period will be twelve months. This proposal is a collaboration between teams in Uganda and New York to address the pressing need to increase access to post-acute evidence-based recovery-oriented interventions that improve the lives people experiencing psychosis in LMICs. This project will lay the foundation for a larger trial in the future.

Substance Abuse and Mental Health Services Adminis

Recovery Community Services Program