and Human Services (HHS)
EXPIRED
INTERVENTIONS FOR SUICIDAL YOUTH Release Date: March 13, 2000 PA NUMBER: PA-00-077 National Institute of Mental Health National Institute on Drug Abuse THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS PA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA. PURPOSE The National Institute of Mental Health (NIMH) and the National Institute on Drug Abuse (NIDA) invite research grant applications to study interventions to reduce suicidal behaviors in youth. Although youth suicidal behavior has been recognized as a significant public health problem for several decades, there are few effective treatments or preventive interventions that have been developed and specifically tested to reduce suicidal behavior in youth. The purpose of this announcement is to support efforts to develop and test such interventions that build on both risk and protective factors. This PA identifies the need to test the effectiveness of interventions for reducing suicidal behavior from a number of approaches, ranging from broad-based community or school-based prevention efforts, to more targeted approaches that reduce suicidal behavior in youth with identified mental disorders or substance use disorders (SUD). HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Interventions for Suicidal Youth, is related to the priority areas of reducing completed suicide and suicide attempts among adolescents, and reducing drug- related deaths and proportion of youth who have used addictive substances per the Violent and Abusive Behavior, Mental Health and Mental Disorders, and Alcohol and Drugs Objectives. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) R21 and R01 grant award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed five years for an R01 application or three years for an R21. For all R21 applications and for competing R01 awards requesting up to $250,000 direct costs per year, specific application instructions have been modified to reflect MODULAR GRANT and JUST-IN-TIME streamlining efforts being undertaken at NIH. More detailed information about modular grant applications, including a sample budget narrative justification pages and a sample biographical sketch, is available via the Internet at: http://grants.nih.gov/grants/funding/modular/modular.htm. Applications that request more than $250,000 in any year must use the standard PHS 398 (rev. 4/98) application instructions. Because the R21 grants have a special application format and review criteria, applicants are strongly encouraged to consult with program staff (listed under INQUIRIES) and to obtain the appropriate additional announcements for those grant mechanisms. Individual grants are limited to 3 years and are not renewable. Special instructions and information for the NIMH R21 can be found at http://grants.nih.gov/grants/guide/pa-files/PA-99-134.html. Special instructions and information for the NIDA R21 can be found at http://grants.nih.gov/grants/guide/pa-files/PA-98-004.html. Applicants interested in applying for the Collaborative R01 award, an NIMH- specific mechanism, are strongly encouraged to consult with program staff (listed under INQUIRIES) and to obtain appropriate additional information concerning the program. PAR-98-017, Collaborative R01s for Clinical Studies of Mental Disorders, is available at http://grants.nih.gov/grants/guide/pa-files/PAR-98-017.html RESEARCH OBJECTIVES Background In 1997, suicide was the third leading cause of death for persons aged 10 to 24 years. Increases in youth suicide completion rates over the past few decades, and annual survey data that indicate that up to 7 percent of high school youth have attempted suicide, have prompted a number of calls by public health officials to improve efforts to prevent and treat suicidal behaviors in youth. Most recently, the Office of the Surgeon General issued a Call to Action to Prevent Suicide [see http://www.surgeongeneral.gov/library/calltoaction/default.htm]. This call recognizes the advances in understanding the potential precursors and risk factors for youth suicidal behavior, specifically mental and substance use disorders (SUD includes both substance dependence and substance abuse). Increased knowledge about precursors for completed adolescent suicides has come from several controlled psychological autopsies. For adolescent males, comorbid conduct disorder, mood disorder and SUD are among the most common diagnoses. For adolescent females, mood disorders predominate, with lower rates of comorbid SUD and conduct disorder compared to male suicide decedents. Epidemiologic studies of suicidal youth have also identified co-occurring mood disorders, SUD, and stressful life events as risk factors for suicidal behaviors. Certain subpopulations of youth are known to have greater risk for suicidal behavior. American Indian and Alaskan Native male youth have completed suicide rates that are ten times the U.S. average. However, there is substantial variation in suicide rates and various risk factors, such as SUD, by tribe. African American male youth had historically low suicide rates. However, between 1980 and 1996 their rates doubled, approximating the rates of their white counterparts. Increasing homicide rates, including victim-precipitated homicide (by deliberately getting in the line of fire of either gang or law enforcement activity) also highlight the critical need to address potentially specific ethnic and cultural risk and protective factors. Youth at greater risk for attempted suicide include Hispanic females, and lesbian, gay, and bisexual youth. Recent school shootings and subsequent suicidal behavior by perpetrators have resulted in the U.S. Department of Education assisting schools to prepare for crisis situations, including early identification of behaviors or warning signs among youth at risk [see http://www.ed.gov/offices/OSERS/OSEP/earlywrn.html]. Many of the early warning signs for later violent behavior have also been found to be correlates and precursors of suicidal behavior. Runaway and homeless youth are at greater risk for suicidal behavior relative to their counterparts who attend school. Incarcerated youth, as well as those in residential treatment for mental and substance abuse disorders, also have multiple risk factors for suicidal and other self-harming behaviors, such as drug use and unprotected sex, that increase injury and illness. Despite advances in knowledge about putative risk and protective factors, and correlates of suicidal behavior in youth, few preventive or treatment interventions have been developed and tested to determine their efficacy, effectiveness, safety, and utility for the various groups of youth at risk. For example, interventions developed and tested in emergency room settings indicate that few youth and their families adhere to follow-up treatment. In addition to the clinical challenges found in treating high risk youth and their families, there are other reasons for the limited research on this topic. Suicidal behaviors, in particular completed and attempted suicide, are relatively rare phenomena, and few studies have been adequately designed with sufficient power to determine the efficacy of interventions. A third reason is that high risk youth are often excluded from clinical trials. Most treatment trials of youth with mental disorders or SUD have excluded those with a history of suicide attempts, as well as those youth perceived to be a current or future risk for suicide. A common rationale offered for these exclusions was that the capability of the investigators and the design of the treatments were not adequate for monitoring and treating suicidal crises. Thus exclusion of youth with suicidal histories or risk for future suicidal behavior was justified based on patient safety and perceived liability risks to investigators and/or sponsors of research. NIMH is expanding its efforts to include more representative samples in intervention trials with youth who have mental disorders and comorbid SUD. NIH policies on the inclusion of children have also led to adult intervention studies lowering the age of inclusion to enroll younger subjects. It is likely that a subgroup of the youth enrolled in these trials will either have a history of suicidal behavior, or exhibit suicidal behavior during the course of an intervention. With appropriate informed consent, clinical expertise, and adequate monitoring and safety protocols, it should be possible in future intervention studies to include a greater proportion of youth who have either been suicidal in the past, or may become suicidal during trials. A review of reliable and valid measures for youth suicidal behavior, as well as general guidelines for the development of informed consent, safety monitoring, crisis protocols, and adequate follow-up of suicidal patients are available at http://www.nimh.nih.gov/research/suicide.htm. However, the implementation and further testing of these measures and guidelines in treatment trials is critically needed for high risk youth for a number of conditions and settings. To expand the knowledge base of effective and safe approaches to preventing and treating youth suicidal behavior, applications pertaining to the following research topics are encouraged. However, these topics should be considered illustrative, and not restrictive. o Secondary analyses of previously conducted prevention, intervention, or service system studies to assess their effectiveness in reducing suicidal behavior in youth is encouraged. Such interventions may have targeted depression, anxiety, attention-deficit hyperactivity, aggressive and violent behavior, serious emotional disturbances, SUD or substance use in youth. Examples: Do SUD prevention efforts also reduce suicidal behaviors, and if so, for which children? Does greater enforcement of under-age drinking laws reduce youth suicide rates? Are treatments effective for reducing anxiety in youth also effective in reducing suicidal behavior? Do the increased availability and/or utilization of mental health insurance coverage reduce suicidal behavior in youth? o Interventions designed specifically to reduce self-destructive behavior and suicide attempts among youth who suffer from severe mental illness, including schizophrenia, major depression and bipolar disorders, obsessive-compulsive disorder, conduct disorder, as well as behavior disturbances, and/or SUD are needed. o Innovative interventions designed to reduce future morbidity and enhance future functioning of suicidal youth presenting to ERs are critically needed. The application of reliable and valid assessment of youth suicidal behavior in ER settings could also help document service needs, use and outcomes. o A number of school-based suicide awareness, risk screening and referral, and post-vention efforts have been developed, but few are adequately evaluated to determine their effectiveness. The development and testing of theory driven, school-based preventive interventions for depression and SUD, with suicidality as a key outcome, are needed. o Incorporation of measures of suicidality in school-based interventions designed to reduce violence and aggressive behavior would add to the knowledge base of effective treatments for suicidality in youth. Development of school- based screening approaches, crisis protocol, referral/intervention and services for youth at risk for violence, both self- and other-directed, are also needed. o Shelters that provide health and counseling services to runaway and homeless youth are in need of crisis protocol development, triage, and intervention development to reduce suicidal behavior. Gay, lesbian and bisexual youth are often over-represented in these settings. The application of reliable and valid assessment to document risk factors and service needs and outcomes are also encouraged. o Similarly, incarcerated youth have high rates of mental disorders, SUDs, and life events that increase their risk for suicidal behavior. Approaches to screening, crisis protocol development, triage, intervention development and effective intervention implementation are needed for incarcerated youth. o Several uncontrolled community interventions appear to have reduced suicide contagion and other risk factors for suicidal behavior. More systematic evaluation of the effectiveness of community interventions is needed, including the identification of protective factors, to help refine and identify the most potent intervention components. Replications of interventions are also needed to determine their generalizability to other communities. o Further specification and utilization of gender-, ethnic- and culturally- specific risk and protective factors in the testing and implementation of interventions is encouraged. SPECIAL REQUIREMENTS This PA poses a number of issues related to human subjects that must be addressed. 1) Prior research has suggested that some interventions using school-based suicide awareness programs as a key approach have had untoward effects, such as increasing distress in vulnerable youth. Efforts to minimize or avoid such untoward effects must be addressed. 2) Despite the presence of multiple risk factors, some youth may not become suicidal. Applications should address how research subjects will be identified, how subjects and their families will be approached about research involvement, and reasons for maintaining or breaking confidentiality. 3) Clinical trials that include high risk youth must address, in detail, consent procedures, safety monitoring, and crisis protocols. Since suicide attempts are relatively rare, adequately powered interventions are likely to be multi-site in nature. Thus operationalization of crisis protocols and other procedures for multi-site studies is critical to ensure comparable treatments as well as safety for patients. Anticipated circumstances, decision points and procedures regarding breaking clinical blinds and making treatment referrals outside of trial protocols, should be described. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applicants are strongly encouraged to contact the program contacts listed under INQUIRIES with any questions regarding their proposed project and the goals of this PA. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: [email protected]. Applications are also available on the World Wide Web at: http://grants.nih.gov/grants/forms.htm. SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations, o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the Institute staff that the Institute will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html Any application subject to this policy that does not contain the required information in a cover letter sent with the application will be returned to the applicant without review. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and five signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues of intervention development and treatment adherence can be directed to: Editha D. Nottelmann, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6200 MSC 9617 Bethesda, MD 20892-9617 Telephone: (301) 443-9734 FAX: (301) 480-4415 Email: [email protected] Direct inquiries regarding programmatic issues of application/testing of existing interventions, provisions for inclusion of suicidal youth in clinical trials, and crisis protocol development for clinical trials and services to: Jane Pearson, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7160, MSC 9635 Bethesda, MD 20892-9635 Telephone: (301) 443-3598 FAX: (301) 594-6784 Email: [email protected] Inquiries regarding drug abuse interventions can be directed to: Jacques Normand, Ph.D. Division of Epidemiology, Services and Prevention Research National Institute on Drug abuse 6001 Executive Boulevard Bethesda, MD 20892-9589 Telephone: (301) 443-6720 Email: [email protected] Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: [email protected] Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Blvd., Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX : (301) 594-6847 E-mail: [email protected] The Substance Abuse and Mental Health Services Administration supports demonstration programs in the prevention and treatment of mental and substance abuse disorders, including suicide prevention. Information on funding opportunities can be found at http://www.samhsa.gov/GRANT/GFA_KDA.HTM Inquiries can be directed to: Department of Program Development Special Population and Projects 5600 Fishers Lane, Room 17C-26 Rockville, MD 20857 Telephone: (301) 443-2940 FAX: (301) 443-5479 The National Center for Injury Prevention and Control (NCIPC) of Centers for Disease Control and Prevention supports research on the prevention of suicide in youth. Information about current requests for proposals can be found on the NCIPC internet site http://www.cdc.gov/ncipc/ncipchm.htm. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242 (NIMH) and 93.279 (NIDA). Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, and portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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