Technical Assistance Webinar: Approaches to Identifying Preteen Suicide Risk and Protective Factors
ERIC MURPHY: Thank you, everybody, for coming to this technical assistance webinar on approaches to identifying pre-teen suicide risk and protective factors. The new RFA's that were recently published. As you can see in the chat box, we will be allowing the chat to stay open so that questions can come in during the discussion, but we will have a dedicated Q&A at the end of the presentation, both for the R01 and for the U24 mechanism. So you can also wait until then if you have specific questions. And I guess we can get started. So can we go to the next slide? All right. So just a brief overview of what I'll be presenting today. First, I will be introducing the NIMH members that will be joining on this call and may be available for questions as necessary. Then I will be giving an overview of the RFA's, the scope of the R01 and U24 mechanisms, including the application process and the review criteria and areas of interest within each of those mechanisms. And as mentioned, there will be a Q& A session available after both the discussion of the R01 and the U24. Next slide, please.
ERIC MURPHY: All right. So with us today, we have Jane Pearson, the senior advisor to the director of NIMH on suicide research and Joel Sherrill, the deputy division director of the Division of Services and Intervention Research, both of whom were instrumental in the writing of these RFA's. We also have Nick Gaiano, who is the chief of the extramural review branch. We have Heather Weiss and Rita Cisco, who are both lead grants management specialists who are filling in on this call for Tamara Kees, who is the contact grant management specialist for this RFA. And they can answer questions on technicalities regarding the application process. And then I am Eric Murphy. I'm the chief of the developmental depression and suicide risk program and the scientific contact for the RFA's. Next slide, please.
ERIC MURPHY: So just to give a little bit of background on how these came into being, in early 2021, NIMH convened a four-part virtual research roundtable series: risk, resilience, and trajectories in pre-teen suicide. And among the many topics that came up, one that was discussed at great length was a lack of consensus around optimal methods of assessing suicidal thoughts and behaviors and relevant risk and protective factors, including instruments and sampling strategies that are developmentally and culturally appropriate for kids at these ages. So these RFA's were designed to refine assessment approaches that are either currently in use or being considered for use in the field, and to identify measures that could be integrated into a core assessment battery for pre-teen youth in future research. Next slide.
ERIC MURPHY: So the overarching design of the R01 and U24 components is that the R01 projects will be submitted independently by different groups with plans to collect independent prospective samples. These groups, though, will be expected to create a consortium among themselves upon funding to identify and incorporate common data elements across the studies that could inform a core assessment battery. And these will work to optimize assessment protocols, including feasibility, acceptability, psychometric properties, safety, and predictive utility of various assessment approaches. The U24 project will be used to create a data coordinating center, which will work with the R01 sites to harmonize data and assessment measures between them, including working with the NDA, the NIMH Data Archive, to ensure that data structures match that allow them for interim analyses across project data and to ensure that all the data are interoperable. Next slide, please.
ERIC MURPHY: For the R01, the scope and objectives state that the initiative supports four-year longitudinal studies that seek to refine protocols for the assessment of pre-teen suicidal thoughts and behaviors and associated risk and protective factors and/or define risk trajectories in pre-teen youth with consideration for identification of novel targets, future development of prevention and intervention efforts. And for the purposes of this announcement, pre-teen is defined as ages 8 to 12. Next slide. An emphasis is being placed on efforts that will enhance our knowledge of suicide risk among youth from subpopulations at higher risk for suicidal thoughts and behaviors, or in which suicide death rates have been rising at significant rates, particularly those typically underrepresented in suicide research. Applications are expected to define and justify the sampling strategy of the proposed research in terms of risk and associated burden, including the number of affected individuals, the associated level of suicide risk, and/or overall burden associated with unmet mental health needs and to anchor the assessment of risk and protective factors in the relevant developmental and cultural context. Next.
ERIC MURPHY: The scope of the proposed research may include optimizing existing assessment instruments to ensure that they're developmentally and culturally appropriate, developing and validating new or adapted measures to assess STVs and risk or resilience constructs that may have high predictive value for risk in pre-teens, examining the acceptability and utility of new or existing assessment methods, and developing and testing methods for characterizing risk trajectories. Next. Among the approaches encouraged, we encourage multilevel translational assessment approaches to categorize core constructs, domains of functioning, and relevant cognitive or affective processes that are associated with preteen suicide risk. Applicants should provide the empirical justification for the selection of constructs, measures, and assessment schedules. Consideration should also be given to the environmental, social, and developmental factors that have been empirically linked with suicide risk states, and are relevant to the project's empirically grounded assessment strategy, for example, exposure to early adversity or economic hardship, geographic location or neighborhood context, familial or social context and support, developmental stage, victimization or bullying, experiences of discrimination, or digital media exposure. Next slide.
ERIC MURPHY: Translational assessment approaches that are developmentally and culturally informed are encouraged, including, but not limited to, multi-level assessment of RDoC-like domains and constructs, such as negative valence, cognitive control, arousal, and regulatory systems, and social processes that can be feasibly measured via low-burden approaches that go beyond self-report, for example, mobile or sensor-based assessments, computerized or task-based assessments, exposure to social media and other digital content, measures that are feasible and practical for use in larger scale research studies and clinical practice and measures that may be included across linked sites as part of a core common assessment battery. Next slide.
ERIC MURPHY: Variety of longitudinal study designs are of interest, including cohort and accelerated longitudinal studies that facilitate the examination of risk and protective factors and their interaction over time. An emphasis is placed on the use of risk-based sampling to construct cohorts that are enriched for rates of suicidal thoughts and behavior and exposure to suicide risk factors. Risk inclusion groups may include, but are not limited to, youth with a lifetime diagnosis of a psychiatric disorder or history of suicidal thoughts and behaviors or non-suicidal self-injury, youth from subpopulations with a higher population rates or higher increase in rates over time of suicide, such as Black, American, Indian, and Alaskan native or sexual and gender minority groups, youth with increased exposure to adversity, or youth with a family history of suicide, mental illness, and/or substance abuse. Next slide.
ERIC MURPHY: Now, we do have a fairly long list of applications that would not be responsive to this FOA. So applications with the following criteria would be considered nonresponsive and would not be reviewed. Applications that are not designed to examine suicidal thoughts and behaviors during this pre-teen age range of 8 to 12; applications that do not include racially and ethnically diverse samples and planned analyses of disparities in suicidal thoughts and behaviors; applications that focus on developing or testing preventive, therapeutic, or services interventions; applications using animal research; applications that are not primarily designed to examine suicidal thoughts and behaviors and focus only on non-suicidal self-injury, depression, anxiety, or PTSD; applications that involve qualitative measures exclusively, or applications that involve the use of existing data without plans to prospectively collect data. Next slide.
ERIC MURPHY: In terms of the research plan and review criteria, which have been combined here, in terms of the significance of the project, you will be evaluated on how well the proposed approach will yield developmentally and culturally and formed and valid methods for operationalizing suicidal thoughts and behaviors and non-suicidal self-injury and characterizing suicide risk and protective factors across multiple domains and in pre-teen youth. As appropriate, just how is the stakeholder-informed risk-based sampling strategy used? And how will this strategy facilitate the enrollment of high-risk participants from sub-populations typically underrepresented in suicide risk research? And describe how the proposed research would aid in the developmentally and culturally informed assessment or identification of mutable factors that could represent potential targets for intervening on risk. Next, please.
ERIC MURPHY: For the investigators, you'll want to detail how the research team includes expertise on suicide research, developmental psychopathology, minority mental health and health disparities, and community-engaged research, as well as expertise relevant to the project's methodological approach. Please describe plans for the inclusion of community stakeholders. For innovation, highlight how the proposed methods overcome existing barriers to the developmentally and culturally appropriate assessment of suicidal thoughts and behaviors, non-suicidal self-injury, and/or suicide risk and protective factors, particularly in some populations that experience health disparities. And as relevant, describe the use of innovative approaches for assessing social determinants of health that may interact with biological or behavioral factors to uniquely confer or mitigate risk for suicide. Next slide.
ERIC MURPHY: In the approach, describe how the constructs that are going to be assessed as well as the proposed assessment battery, assessment schedule, longitudinal design, and inclusion criteria are justified in terms of the relevant empirical literature regarding suicide risk and protective factors. Include relevant literature relating the developmental time course of suicide risk, minority mental health and health disparities, and epidemiological findings. As appropriate, describe the methods and model specifications for longitudinal assessment that will be used to identify risk and protective factors. Characterize risk factor trajectories, and understand imminent risk and the transition from ideation to behavior in diverse pre-teen youth. As relevant, when translational assessment approaches are proposed, describe the inclusion of surrogate measures that are feasible and practical for use in larger-scale research studies and clinical practice. For studies proposing the use of mixed methods - provide the rationale for the use of mixed methods in the selected design, including an explanation for why alternative designs would be inappropriate or inadequate. Describe the quantitative and qualitative components, procedures, and sequence of activities that will be used to achieve the study aims. For each method, specify and justify the sampling approach, sample size, and analysis plans. And describe plans for integrating the proposed quantitative and qualitative methods. Indicate how they will work in tandem and how the qualitative data will complement and inform the quantitative approach. Next slide.
ERIC MURPHY: So that was certainly a lot. So we're now going to open it up for any questions specific to the R01 mechanism. And these can either go into the chat or the Q&A, or you can raise a hand, and we can call on you live here. I'm going to give it a minute. Okay. I will then keep going. All right. Next slide. All right. The basic application process for both of these-- I'm just going to put this right here. The due date is November 9th, and this will take only new submissions. So no resubmissions from other announcements. And a letter of intent is not required, but it is encouraged to inform review requirements. And I really can't emphasize enough that these letters of intent are really useful for you, the applicants, because it is letting us know the type of research that you're proposing and what type of expertise we should be looking for and putting together a review panel that will be able to adequately evaluate the proposals that you're putting in.
ERIC MURPHY: So you are doing this to help yourselves. And to the extent possible, ask us questions earlier rather than later. All right. Next. All right. For the U24, the scope and objectives of the U24, the data coordinating center will assist the R01 consortium through data coordination, data monitoring and analysis, and administrative, logistical, and meeting support. And it will also facilitate the development of best practice guidelines and the dissemination of research results. Next slide.
ERIC MURPHY: For the research strategy for the U24, this section must include the following key attributes: first, the leadership structure and organization of The Coordinating Center; the plans for tracking data collection, cleaning, and sharing data collection and submission process-- progress, excuse me, across funded research sites; plans for facilitating communications among the research projects related to the development of common data elements, and necessary data harmonization for purposes of data sharing and interim cross-site analyses; plans for collaborating with NIMH Data Archive, the NDA, to facilitate the harmonization of study data; plans for disseminating and sharing best practices and other consortium-generating tools and products for wider use by the broader research community, such as through an outward-facing website; a description of how the proposed Data Coordinating Center structure will facilitate effective collaboration and research activities; and, within the biosketch, detail the research team capacity and expertise for providing support for longitudinal transdisciplinary research programs, facilitating cross-site collaboration on projects using innovative data collection methods, harmonizing data across multiple multi-site projects, such as deriving latent variables for key constructs of interest that were not directly assessed, and managing innovative community-engaged research projects. Next slide.
ERIC MURPHY: Again we do encourage you to ask us questions early. If not on this chat, these are the contact information for each of us. This is on the RFA as well. So I am the scientific research contact. So if you have questions specific to the scientific premise or the design that you're interested in submitting, I'm happy to give some basic feedback on that. If you have questions specific to the review or questions around that, Nick Gaiano is the person to contact. And if you have questions about the financial aspect or other grants management questions that are not specifically scientific but perhaps more logistical, Tamara Kees is the person to email. And again, these are all on the RFA's. Next slide. Just a note that we are all government employees, and so we are able to answer emails when the government is open. So if you are planning to email us in the next month or so, just keep an eye on that to make sure that we will be around to answer your emails. Now, if anyone has any questions specific to the U24 or in general, we are happy to entertain them. Okay. I see in the chat, do R01s have to have common measurements, since it's not a U, but rather an R, they may not be the same, and they may not be binding to common elements, even in terms of measurements and outcomes.
ERIC MURPHY: So yes, this is part of the consortium agreement. So for the applications of the individual R01s, you can certainly suggest measurements that you think may be useful for inclusion as part of common data elements, but these will possibly be hammered out by the consortium of R01 projects once projects are actually awarded. So projects will be speaking with each other. And while we will not have any top-down influence as the funders because these are independent R projects, what we are hoping is that the possibility of having harmonized measures across several sites will give us a size of data set to evaluate the utility of these measures that will really make it worthwhile to see what is available to harmonize. And it may be a lot. It may be just a few aspects, but as the groups meet, there may be opportunities to incorporate different common measures across the projects.
ERIC MURPHY: The second question I see is about the direct funding for the data coordinating center. It is limited, and that is partly due to the specific nature of the data coordinating center to harmonize and coordinate data between the R01 projects, but not to direct these projects. So this is really a center that is there to serve the needs of the consortium as they define them. So this is really going to be a scientific process that is driven by the R01 sites, and the DCC will be providing expertise in how to achieve the goals that the R01 sites agree on. I hope that was a direct answer to this. And if there's any follow-up, please let me know. Any other questions, thoughts?
ERIC MURPHY: Will the DCC be responsible for the analysis, or will each R01 be able to do that on their own data? So the DCC will not be responsible for any of the analysis, the R01s will own their own data, and they will be able to do their own individual data analysis on their projects. There will also be-- because we are hoping to have these harmonized data elements, we are hoping to have a space where the R01 projects are able to look at each other's data and work together on data that has harmonized elements so that there is essentially a much larger data set for the consortium to work with and to address some of these questions.
ERIC MURPHY: There are a few other questions relating to the relationship between the consortium and the DCC. So, again, the idea is that while these R01s would be coming in independently, there is a likelihood that there will be some aspect of assessments that will be overlapping or that will be ripe for harmonizing across at least some of the sites. This is not suggesting that every site has to finalize an exact protocol that every site has to do the exact same way. But if there are measures that these R01 consortium groups decide are worth harmonizing and coming up with a sort of standardized way of assessing, the DCC would be very helpful in ensuring that the methods are the same across the groups, that the data structures are set up such that they will be interoperable when the different sites put them into the data archives so that they are able to be analyzed together as part of this larger data set. I'm hoping that also addresses the question about the goal of the collaboration across the R01s, but if there are more specific questions, I can certainly try to address that.
ERIC MURPHY: I guess this one is slightly different. Does every study need to have the same assessment schedule and cohort duration? Not necessarily. I think that there will be different groups that are going to be coming in with different ideas about the scientifically best way to approach different types of hypotheses that may require different types of longitudinal or cohort-based approaches, or perhaps an accelerated longitudinal design. And so these would not need to be in lockstep with each other in order for these harmonized assessment measures to work across the different sites. The idea is that the DCC will help to optimize the utility of these measures by understanding what the specific needs are for each of the individual sites and how the different structures and designs of the different sites might feed into a useful set of harmonized measures.
ERIC MURPHY: I don't see other questions in the chat, but I will stay here for a little bit in case others either want to raise their hands or put additional questions in the chat. Can an institution be both an R01 site and the DCC? This sounds like a grants management question. One of you want to pick this one up there. Heather Weiss or Rita if you're on.
RITA CISCO: Yes. They can. They just can't have any overlap.
ERIC MURPHY: Okay. So you are able to be both an R01 site and The Coordinating Center site, but there can't be scientific overlap between the two projects? Thank you.
ERIC MURPHY: All right. We are closing in on 12 o'clock. So if we don't get additional questions, maybe that will be the time. Will the DCC be tasked with data release? And will this take place on an ongoing basis? So the data release from any NIMH projects comes through the data archive. So the DCC will be helping these individual sites with getting their data together to upload to the NIMH Data Archive. But this will not necessarily be, for example, the ABCD project, which is this giant project that regularly releases tranches of data throughout the life course of the project. This will be much more in line with a regular R01 project where data is not required to be released until, I believe, either upon publication of papers from the project or within one year of the completion of the projects. And that will be true for each of the R01 sites.
ERIC MURPHY: All right. Will the DCC be expected to release harmonized data to the data archive? So one of the DCC's roles will be to put the harmonized data in part of the data archive both for interim use for the projects during the course of the study as well as ultimately to be made available to the public at the completion of the study. So yes, part of the DCC's role would be to put this data in a usable form into the data archive. But then the actual release of the data, again, goes through the NDA itself.
ERIC MURPHY: Feel that people are still thinking about asking questions. So I don't want to end this just yet.
ERIC MURPHY: All right. I don't see more coming in. I do not see any hands raised. For any questions that you realize you wanted to ask after the fact, again, our emails are on the RFA's, and we are happy to answer your questions when we are able to. And we are recording this as you have hopefully all seen, and so we are hoping that this will be available soon in case anyone wants to go back and reference it. With that, I think we are set. So thank you all for coming, and I look forward to questions and/or applications in the future. Thanks.