MODIFYING AND TESTING EFFICACIOUS BEHAVIORAL THERAPIES TO MAKE THEM MORE COMMUNITY FRIENDLY Release Date: December 6, 2001 RFA: RFA-DA-02-006 National Institute on Drug Abuse (http://www.nida.nih.gov) Letter of Intent Receipt Date: March 11, 2002 Application Receipt Date: April 11, 2002 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute on Drug Abuse (NIDA) is committed to the development of behavioral therapies that will be utilized in community treatment settings. The purpose of this initiative is to support studies that will adapt existing, efficacious behavioral therapies for community treatment settings, or prepare for such adaptation by identifying key components of efficacious therapies to be retained in adapted therapies. 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 RFA, Modifying and Testing Efficacious Behavioral Therapies to Make Them More Community Friendly, is related to one or more of the priority areas. 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. Faith-based organizations are eligible to apply for these grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project (R01), small grant (R03), and exploratory/developmental grant (R21) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2002. The exploratory/developmental (R21) grants are limited to 3 years and small grants (R03) are limited to 2 years. Both are non-renewable and limited in direct cost amount per year (R03, $50,000; R21, $100,000). The R03 mechanism (http://grants.nih.gov/grants/guide/pa-files/PAR-00-059.html) is intended for newer, less experienced investigators, for investigators at institutions without well-developed research traditions and resources, or for experienced investigators wishing to change research directions or test new methods or techniques. The R21 mechanism (http://grants.nih.gov/grants/guide/pa-files/PA-01-012.html) is intended to encourage exploratory research projects with sound methodology and strong rationales in underdeveloped research areas of drug abuse, such as the areas covered in this RFA. Investigators may also choose to include methods development as one component within any of the other mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE NIDA intends to commit approximately $2 million in FY 2002. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. It is anticipated that approximately 8-10 awards will be made under this announcement. Although the financial plans of NIDA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. RESEARCH OBJECTIVES Background and Rationale A heterogeneous group of public and private treatment programs, including small local clinics and large complex programs sponsored by medical centers and managed care organizations, comprise the community-based drug and alcohol treatment system in the United States. A 1998 study by the Institute of Medicine devoted to bridging the gap between drug abuse treatment providers and researchers determined that despite the availability of a number of efficacious behavioral treatments, established research-based treatments have not been adopted widely in clinical practice. A major barrier to the adoption of research-based, efficacious behavioral treatments by community treatment providers is that these treatments may not be "community friendly." For instance, treatments may be too lengthy, costly, complex, or difficult to integrate with usual care to be considered feasible in a community setting, where resources are limited. A variety of research activities are needed to make efficacious behavioral therapies more community friendly. One activity involves identifying essential components and/or key mechanisms of efficacious therapies so that these can be preserved when therapies are adapted for a community setting. Examples of this activity include, but are not limited to: 1) studies that test the components of multicomponent therapies alone and in combination with one another (i.e., dismantling studies); 2) studies that test the required dose and timing of efficacious components; and 3) studies testing theory- driven hypotheses regarding the mechanisms of action of a behavioral treatment. Although theories exist about why behavioral therapies work, more systematic studies are needed to identify the key components and mechanisms of behavioral therapies so that these can be retained in the process of adapting them for community settings. Such activities may allow a therapy to be streamlined making it more community friendly by paring the treatment down to reduce the staff, time, or cost required. Streamlining may be appropriate when behavioral treatments have multiple components, some of which may not be necessary, or when the length or intensity of treatment can be reduced without diminishing efficacy. Another way that an efficacious therapy can be modified is by altering the modality of the therapy from individual to group treatment. Group treatment is a particularly attractive modality of treatment in community settings because of its apparent efficiency and lower cost. More studies are needed to develop manualized group therapies, to identify key components of group treatment, and to test for whom different group treatments are appropriate. Developing therapy modules that can be delivered independently or as adjuncts to usual care also can modify an efficacious therapy. Behavioral treatment that can be delivered as stand-alone or not necessarily sequential modules may be especially useful to community providers given the need to respond to revolving admissions. Additionally, therapy modules allow community providers to target specific patient needs as adjuncts to usual care. More studies are needed of the appropriateness of creating modules from traditionally sequential therapies or therapies with multiple components or foci. Modifying the method of therapy from in-person to telephone, computer, mail, etc. is another alternative for making efficacious therapies more community friendly. Behavioral therapies that can be conducted across remote sites, or that utilize web-based services, may be especially useful for community treatment settings, and studies of the development and manualization of such approaches to patient care are needed. These are only some of the ways in which efficacious behavioral treatments might be adapted to be more community friendly. Innovative and creative studies on therapy adaptation are encouraged. For more information on efficacious behavioral treatments, please see Principles of Drug Addiction Treatment: A Research-Based Guide at http://165.112.78.61/PODAT/PODATindex.html. Conceptual Framework for Modifying Efficacious Behavior Therapies NIDA is committed to a comprehensive program of treatment research to ensure that science-based treatments are developed and ultimately used in the community. This RFA should be understood in the context of NIDA's Behavioral Therapies Development Program Announcement (PA NUMBER: PA-99-107). NIDA's Behavioral Therapies Development Program delineates three stages of behavioral therapy research. Stage I, the earliest stage of behavioral therapy development research, is viewed as an iterative process involving identifying promising clinical, behavioral, and cognitive science relevant to treatment, generating new behavioral therapies, operationally defining the therapies in manuals, and pilot testing and refining the therapies. Stage II research consists of efficacy testing of promising therapies and investigation of the mechanisms and key components of behavioral therapies. Stage III research is aimed at understanding if and how an efficacious therapy may be transported to the community, including testing the utility of training procedures and techniques. This RFA is intended for two kinds of proposals. Stage I proposals will adapt existing efficacious interventions into new community-friendly behavioral treatments, operationally defining the therapies in manuals and pilot testing and refining the therapies. Stage II proposals will identify mechanisms and/or key components of efficacious behavioral treatments in preparation for adaptation to be community friendly. Areas of Interest: This RFA is intended to support behavioral therapy development. This initiative targets for funding, in a systematic way, essential research needed for adapting existing efficacious treatments for use in community drug clinics and by other community-based providers who treat drug abusers including private practitioners and primary care physicians. This includes, in particular, critical areas of research that have been overlooked in the past. Illustrative examples of research described below serve as a guide and are not meant to subsume all research topics that would be appropriate under this RFA. Examples of STAGE I activities: o Research streamlining an existing treatment to include only hypothesized key components. o Studies that adapt a traditionally individual intervention to a group format. o Research modifying a traditionally sequential treatment for administration as free-standing modules. o Studies that adapt an existing treatment for a mixed gender group to single sex groups for conduct in clinics which traditionally serve a single gender, i.e., adapting a treatment for use in a women's clinic. o Research translating efficacious treatment to administration via computer, videotape, telephone, mail, etc. o Studies aimed at modifying efficacious therapies to make them appropriate for use in the community with particular racial or ethnic groups. o Research to modify efficacious therapies to make them less complex to administer and/or less complex to train. o Research modifying efficacious treatment for rural settings, or patients with transportation limitations, utilizing real-time technologies such as private Internet chat sessions or streamlining video. o Studies that modify behavioral treatments to improve adherence to medications in programs combining behavioral and medication treatment. o Research that adapts existing treatments by reducing time required for administration. For example, converting a standard-length treatment to an extremely brief treatment for use in settings that do not traditionally provide extensive behavioral treatment (e.g., some methadone clinics, primary care settings, recovery houses, etc.). o Studies that test the required dose and timing of efficacious behavioral therapies. o Research that modifies efficacious behavioral treatments for drug abuse to incorporate HIV/AIDS risk reduction modules. Examples of STAGE II activities: o Studies which identify key components and underlying mechanisms of a treatment (i.e., dismantling studies). o Studies identifying differential mechanisms of action for various populations. 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 sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of the Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at http://www.nida.nih.gov/ under Funding or may be obtained by calling (301) 443-2755. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDA staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the letter of intent receipt date listed to: Director Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for courier or express delivery) Telephone: (301) 443-2755 APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/435-0714, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS 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 NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Submit a signed, typewritten original of the application, including the Checklist, and three 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) At the time of submission, two additional copies of the application must be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-2755 FAX: (301) 443-0538 Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA in accordance with the review criteria stated below. 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council on Drug Abuse. 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? Are the goals and objectives of the application relevant to the RFA? (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 that will meet the goals of the RFA? 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 (including data safety monitoring plans), animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Schedule Letter of Intent Receipt Date: March 11, 2002 Application Receipt Date: April 11, 2002 Peer Review Date: June/July 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 30, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. INQUIRIES Potential applicants are strongly encouraged to contact the appropriate staff for additional information and specific application procedures or to clarify any issues. Direct inquiries regarding programmatic issues to: Cecelia L. McNamara, Ph.D. Division of Treatment Research and Development Behavioral Treatment Development Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room, MSC 9551 Bethesda, MD 20892-9551 Telephone: (301) 402-1488 FAX: (301) 443-6814 Email: cmcnamara@mail.nih.gov Direct inquiries regarding review matters to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Blvd., MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 443-6847 Email: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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 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, any 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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