PA-03-088: TREATMENT OF ADOLESCENTS WITH ALCOHOL USE DISORDERS

Department of Health
and Human Services (HHS)

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TREATMENT OF ADOLESCENTS WITH ALCOHOL USE DISORDERS RELEASE DATE: April 2, 2003 PA NUMBER: PA-03-088 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Parent R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates thereafter. Applications relating to R33 and R34 activities must be in response to NIH Institute/Center (IC)-specific announcements. EXPIRATION DATE: This announcement expires on March 15, 2006, unless re-issued. National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.273 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations o References PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks research grant applications to develop and assess efficacious behavioral and pharmacological treatments for adolescents with alcohol use disorders (AUD). NIAAA's adolescent treatment research program has developed rapidly since its initiation in 1998. There still remain, however, important research issues that need to be addressed. The purpose of this program announcement (PA) is to invite applications for adolescent treatment research projects that will illuminate and resolve concerns in five areas: more effective treatments for adolescent alcohol use disorders (AUD); more effective treatments for AUD adolescents with psychiatric comorbidity; improved maintenance of recovery through extensive relapse prevention interventions; identification of contextual effects on treatment response and outcomes; and ways to narrow the gap between efficacy research and practice. Three types of research design are encouraged under this PA: (1) pilot studies to develop and test research protocols for novel interventions or new combinations of existing interventions; (2) randomized clinical trials to evaluate the efficacy of either (a) novel interventions or combinations of interventions developed in pilot studies or (b) extensions and enhancements of existing interventions; and (3) natural history studies to assess the impact of understudied influences (e.g., developmental and contextual effects) on the long term course of adolescent alcohol use disorders and associated problem behaviors. RESEARCH OBJECTIVES Background Alcohol remains the major drug of choice for America's youth. Based on data collected by SAMHSA's National Household Survey on Drug Abuse (NHSDA) in 2001, an estimated 10.1 million youth, ages 12 to 20, had consumed alcohol during the previous month. The NHSDA data further indicate that an estimated 6.8 million (19%) of youth these ages had engaged in binge drinking and 2.1 million (6%) had engaged in heavy drinking. Binge drinking is defined by the NHSDA as five or more drinks on a single occasion within the past 30 days and heavy drinking as five or more binge drinking occasions within the past 30 days. Among the nearly 148,000 adolescents entering substance abuse treatment in 1998, 24% had primary alcohol problems and 61% had primary, secondary, or tertiary alcohol problems (SAMHSA's Office of Applied Studies' Treatment Episode Data Set [TEDS] for 1998) (Stevens & Morral 2002). Epidemiologic and treatment research on adolescent alcohol problems has shown that the earlier the age of alcohol use onset, and the more chronic and severe the course of alcohol use, the more likely the manifestation of additional concurrent problem behaviors. These include other drug use, antisocial behavioral disorders, other mental health disorders such as post traumatic stress syndrome and affective disorders, and social dysfunction in school, family, and peer contexts. These findings indicate that the appropriate theoretical matrix for developing efficacious treatments for adolescent alcohol use disorders will be a translational one that seeks to explain and beneficially influence multiple biological and social dimensions that mediate and moderate adolescent health, behavior, and social functioning. In recognition of the widespread problems associated with adolescent alcohol abuse and dependence, and the paucity of effective evidence-based interventions to treat them, the NIAAA, in collaboration with SAMHSA's Center for Substance Abuse Treatment (CSAT), issued in 1998 a joint Request for Applications (RFA) for research on the treatment of adolescent alcohol abuse and dependence. The RFA issued a general call for randomized controlled clinical trials to develop and assess developmentally appropriate treatments for adolescents with a primary diagnosis of alcohol abuse or dependence. Because the knowledge base was so narrow at that time, applicants were encouraged to explore a wide range of treatment types and settings, and subtypes of adolescent subjects. The program has succeeded in meeting this goal. Ten projects have been funded that assess the effectiveness of a broad range of therapies (family, motivational, cognitive behavioral, and guided self-change) tailored specifically for delivery to adolescents with alcohol problems in a variety of community settings (schools, homes, clinics, shelters for runaways, and juvenile justice systems). This research grant program will be concluded in 2003 with final results available one or two years later. In addition, NIAAA is funding an ongoing longitudinal treatment outcome study as well as projects to assess the effectiveness of school-based substance abuse programs, approaches to adolescent aftercare, brief motivational interventions, and three pharmacological trials (fluoxetine to treat comorbid depression, buproprion to treat comorbid attention deficit hyperactivity disorder, and naltrexone to reduce craving and alcohol use). Despite this plethora of recent NIAAA adolescent treatment research activity, it has become clear that a number of important questions on how best to address adolescent treatment needs and how to further improve treatment outcomes remain to be answered. It is the purpose of this PA to delineate these current research issues. Specific Areas of Interest Research participants with alcohol use disorders (AUDs) who are recruited to projects awarded under this PA may include "diagnostic orphans" (Pollack and Martin 1999) in addition to participants who meet DSM IV criteria for alcohol abuse or dependence. Diagnostic orphans meet only one or two criteria of alcohol dependence as compared with the three criteria required for a diagnosis of alcohol dependence. Diagnostic orphans were found by Pollack and Martin to be similar in substance use patterns and problems to adolescents with DSM-IV alcohol abuse disorder and to have significantly greater substance use and related problems than adolescent who were regular drinkers but had no symptoms of alcohol abuse or dependence. There is a general expectation that interventions delivered to adolescents early in the development of clinically significant alcohol problems will be more successful than the same interventions delivered to adolescents with more severe and multiple clinical problems. Diagnostic orphans provide an opportunity to assess the validity of this assumption. Adolescents recruited into treatment studies may also include those who have concurrent drug use and/or psychiatric disorders as long as measurement of those conditions and assessment of their relationship to the subject's AUD are included in the design. In such cases, analyses to examine differential treatment response of predominant clinical subtypes are encouraged (see Babor et al. in Dennis & Babor 2002). Applicants are also encouraged to measure nicotine and marijuana use, using measures comparable in nature and detail to the alcohol consumption measures, because these are the two most commonly used substances by adolescents with primary alcohol disorders. Research objectives include, but are not limited to: 1. Develop More Effective Adolescent Treatment Interventions Evidence from recently completed clinical trials indicate that treatment effects, while showing improvement over earlier studies are still modest with respect to long-term outcomes. There is thus a need to continue the search for more effective therapies. This can be achieved, in part, by extending and refining promising existing therapies and, in part, by identifying and developing new and innovative therapies. Examples: - Derive new therapies from promising findings in basic behavioral and cognitive research, from interventions found to be effective in changing associated problem behaviors, and from theory-driven models in the sciences of behavior and human development. - Develop and test behavioral techniques to improve engagement and retention of adolescents in treatment. Treatment providers consistently state that, from their perspective, research that improves retention in treatment should be a number one priority. - Develop and assess techniques to improve adolescent compliance with treatment, considered a key determinant of treatment outcomes. - Develop and evaluate skills training for adolescents who may benefit from training in impulse control, anger management, stress management, or problem solving. - Assess the relative efficacy of AUD interventions for different clinical subtypes (see Babor et al. in Dennis & Babor 2002). - Assess the effects of gender on treatment engagement, response, and outcomes. 2. Develop and Test Treatments for Concurrent Disorders Adolescents who present for treatment of alcohol abuse and dependence include youth who exhibit high levels of psychiatric comorbidity and developmental impairment as compared with the general population of alcohol-using adolescents. The next wave of alcohol-focused adolescent treatment research needs to identify and develop specific, combined, or stepped treatment modalities that are effective in subgroups of adolescents who manifest these more severe problem clusters. This subgroup includes adolescents who have concurrent psychiatric comorbidity, polydrug use, and/or developmental problems. Examples of research projects: - Design specialized treatments for adolescents with psychiatric disorders such as conduct disorder, anxiety, depression, or post-traumatic stress disorder (see Clark & Scheid 2002). In general, pharmacological treatment of concurrent disorders is best limited to those adolescents with more severe disorders; for example, those who are recalcitrant to behavioral interventions or who still manifest symptoms after eight weeks of abstinence (ibid.), who experienced onset of symptoms prior to or concurrent with AUD onset, or those who have a history of previous treatment for the comorbid condition(s). - Develop and evaluate treatment components to assess and treat developmental problems such as deficits in cognitive or social functioning. - Design a clinical trial to determine the optimal combination and sequencing of behavioral and pharmacological interventions that target particular constellations of co-occurring disorders and problem behaviors. - Determine the impact of therapies for concurrent disorders in AUD adolescents on the developmental trajectory of alcohol and other associated behavior problems. - Identify patterns of gender-based comorbidity and assess the effects of gender on treatment engagement, response, and outcomes. 3. Develop Interventions for Adolescents Comorbid for Alcohol or Drug Disorders and Fetal Alcohol Syndrome (FAS) or Alcohol Related Neurodevelopmental Disorder (ARND) Research has demonstrated that in utero exposure to maternal alcohol consumption may lead to lifelong impairment from FAS or from the more subtle impairments of alcohol related neurodevelopmental disorder (ARND). The organic damage caused by maternal drinking is expressed by a range of disabilities. In adolescence, alcohol related effects may be manifested as specific types of learning disabilities, impulsive behavior, poor executive functioning, deficits in social and communication skills, emotional instability, and psychiatric disorders. Fetal alcohol exposure is a risk factor for later development of adolescent alcohol disorders as shown in longitudinal follow-ups (e.g., Baer et al. 1998). The multiple disabilities of these adolescents may complicate treatment and worsen prognosis. Thus, there is an important need for research to determine if specialized interventions are needed to increase the likelihood of successful substance abuse treatment outcomes. Examples of relevant research include: - Develop methodology and procedures to screen and identify adolescents in the community or in substance abuse treatment settings who may have FAS or ARND and who require treatment for substance abuse problems. - Design and test interventions for adolescents with confirmed developmental impairments related to fetal alcohol exposure who need treatment for alcohol or other substance abuse problems. 4. Maintain Recovery Through Relapse Prevention Interventions Although initiation of abstinence in treatment is common among adolescents, sobriety is frequently challenged as soon as they return to the pre-treatment environment. Some adolescent treatment outcome studies report that as many as 70 percent of adolescents may still have significant substance abuse problems at 12 months after treatment. Thus, there appears to be a need to develop long-term programs that integrate developmentally appropriate primary and aftercare interventions and, when feasible, provide recovering adolescents with prosocial alternatives in the post-treatment environment. See, for example, the assertive continuing care model and adolescent community reinforcement approach developed and assessed by Godley et al. (2002). Other examples: - For more severely affected AUD adolescents, develop and assess the efficacy of long-term care models of relapse prevention that integrate theoretically consistent primary treatment and aftercare components. - Develop and test the efficacy of behavioral aftercare interventions tailored to the range of challenges faced by adolescents in recovery; for example, compare reinforcement of coping responses that target specific types of challenges versus more generalizable coping responses. - Compare the efficacy of two types of aftercare: (1) guided self- maintenance and relapse prevention via mail, web site, or computerized telephone versus (2) a periodic therapist-delivered interactive aftercare intervention, by phone or in person. - Design and test environmental aftercare interventions that stimulate positive lifestyle change and integrate the adolescent in a prosocial community network; for example, test the efficacy of contingency management strategies to engage youth in prosocial activities (Godley et al. 2002). - Assess the differential response of three subtypes of AUD adolescents (alcohol abusers, alcohol dependent, and diagnostic orphans) to relapse prevention interventions of varying types and intensities. - Develop and evaluate a continuing care, school-based intervention program for adolescents with alcohol and drug abuse disorders in the maintenance and recovery phases. 5. Identify Contextual Effects on Treatment Response and Outcomes There are many factors, independent of treatment, in adolescents' environments that can influence their engagement in treatment and its long-term effectiveness. As a research subject, contextual effects represent a largely untapped area of potential salient factors that may shape adolescent treatment outcomes and post-treatment functioning. Constructs such as "neighborhood," "social network," and "social support" are well developed and productive research subjects but ones which have not yet been applied to treatment of adolescents with alcohol problems. Social context factors which are known to predict the future emergence of substance abuse problems (e.g., Gil, Vega & Turner 2002) may also serve to reinforce alcohol abuse and associated problems when they occur in a post- treatment environment. Because the post-treatment social environment of adolescents can continue to have profound influences on their behavior, it will be important to identify those contextual factors which have the greatest impact on adolescent treatment outcomes, and ultimately to design interventions to positively moderate or mediate these environmental influences. Because much of the research to identify and modify contextual effects will be exploratory, most projects will need to be designed as pilot studies. Examples of studies on contextual effects: - Identify which, if any, familial attitudes and behaviors and adolescent school and delinquency behaviors are associated with successful treatment outcomes and whether baseline values for any of these social contextual effects improve in response to treatment. See Gil et al. (2002) for examples of measures. - Develop a treatment intervention designed to reduce the influence of social context factors that have strong negative effects on adolescent behavior in recovery. - Identify social and cultural factors that influence motivation for treatment, adherence to treatment, and treatment outcomes. Develop interventions that are culturally convergent with such factors and determine whether such interventions are more efficacious. - Develop and test in a pilot study a treatment intervention or adjunct designed to augment or enhance hypothesized beneficial sociocultural mediators or moderators of treatment outcome. 6. Enhance Transport of Efficacy Research From Science to Service Research-based treatments for alcohol abuse and alcoholism have not been widely adopted by practitioners. The very nature of efficacy research, based on establishing the internal validity of a particular intervention under highly controlled conditions, is such that it often can not be directly applied to practice. The best example of this is the restriction of most AUD research to individually-delivered treatments and avoidance of the group milieu, in part, because of the uncontrolled influences on outcomes that may be introduced by group-level influences. In practice, however, group treatment is one of the major types of substance abuse treatment provided, both for therapeutic and cost reasons. There are several steps that efficacy researchers can take to make research results more immediately intelligible and possibly transportable to practice: - Develop efficacy studies that compare outcomes of individualized evidence-based treatment, such as motivational enhancement therapy (MET), with outcomes of treatment based on the translation of MET principles into a group format that is developmentally appropriate for adolescents (Foote et al.1999; O'Leary et al.2002; Walters, Ogle & Martin 2002). Take into account in the design the potential for an iatrogenic effect of certain types of adolescent groups (see Brown and O'Leary in O'Leary et al.2002 and Poulin, Dishion and Burraston 2001). - Design and evaluate efficacy studies to extend knowledge on adolescent treatment interventions already adopted by practice. For example, develop a randomized controlled clinical trial to test the efficacy in a primary AUD population of: (1) one of the five interventions developed and assessed in the CSAT-funded Cannabis Youth Treatment study (CYT) (Dennis & Babor 2002) or (2) one of ten exemplary substance abuse treatment models identified in a CSAT-funded National Evaluation Study (Stevens & Morral 2002). - Develop and evaluate specialized treatment components (for example, treatment of depression co-occurring with AUD) that can be more easily adopted as adjuncts to treatment-as-usual than can new total treatments offered in place of existing ones. - Identify and operationalize the active ingredients of treatment for the different phases of adolescent treatment. Develop and test transportable modules designed to enhance specific active ingredients of treatment (e.g., a module to enhance the therapeutic alliance in early treatment as a means to increase treatment engagement and retention). - Add to the assessment battery alcohol and drug questions from assessment instruments familiar to practitioners in order to compare data from research and practice settings on drinking behavior at baseline, 6 and 12 months after treatment. Examples of two widely used instruments in practice are the Global Appraisal of Individual Needs (GAIN) (Dennis 1999) and the Teen Addiction Severity Index (the T-ASI; Kaminer 1999). For efficacy investigators seeking sources of patients and services funding, collaborative opportunities for coordinated NIAAA/CSAT funding are available under several SAMHSA/CSAT initiatives such as the Adolescent Residential Treatment Program (ART) and the Effective Adolescent Treatment Program (EAT). Further information is available from the CSAT program officer, Randy Muck (rmuck@samhsa.gov or 301-443-6574). MECHANISM(S) OF SUPPORT This PA will use the NIH research project grant (R01) small grant (R03) and Exploratory/developmental grant (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Applications for R01s may request support for up to 5 years. Facilities and Administrative (F&A) costs will be awarded based on the negotiated rate at the time of the award. Under the NIAAA Small Grant mechanism (R03) applicants may request either $25,000 or $50,000 in direct costs per year for up to two years. These awards are not renewable; however, a no-cost extension of up to one year may be granted to the grantee institution prior to expiration of the project period. Before completion of the R03, investigators are encouraged to seek continuing support for research through a research project grant (R01). (See Program Announcement PAR-99-098, "NIAAA Small Grant Program," http://grants.nih.gov/grants/guide/pa-files/PAR-99-098.html, for a complete description of the R03 mechanism.) NIAAA Exploratory/developmental grants (R21) are limited to 3 years for up to $100,000/year for direct costs. (See Program Announcement PA-99-131, "NIAAA Exploratory/Developmental Grant Program," http://grants.nih.gov/grants/guide/pa-files/PA-99-131.html, for a complete description of the R21 mechanism.) Exploratory/Developmental Grants and Small Grants cannot be renewed: however, a no-cost extension of up to one year may be granted prior to expiration of the project period. Investigators are encouraged to seek continued support after completing an Exploratory/Developmental Grant project or a Small Grant project through a Research Project Grant (R01). This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Cherry Lowman, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 For express mail use: Rockville, MD 20852) Telephone: (301) 443-0637 Fax: (301) 443-8774 Email: clowman@NIAAA.nih.gov o Direct your questions about financial or grants management matters to: Judy Fox (formerly Simons) Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 (For express mail use: Rockville, MD 20852) Telephone: (301) 443-2434 Email: jsimons@niaaa.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIAAA staff member who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: 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) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Institute on Alcohol Abuse and Alcoholism National Advisory Council. 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 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? 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? 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? 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)? 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: 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. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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: The NIH maintains a policy 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 is available at . 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. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 PA 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.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 a 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 PA 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. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.273, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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. REFERENCES Baer, J.S., Barr, H., Bookstein, F.L., Simpson, P.D. and Streissguth, A.P. (1998) Prenatal alcohol exposure and family history of alcoholism in the etiology of adolescent alcohol problems. Journal of Studies on Alcohol, 59, 533-543. Clark, D.B. & Scheid, J. (2002) Comorbid mental disorders in adolescents with substance use disorders. In Hubbard, J.R., Ed., Substance Abuse in the Mentally and Physically Disabled, New York: Marcel Dekker, Inc., pp. 133-167. Dennis, M.L. (1999) Global Appaisal of Individual Needs (GAIN), Administration guide for the GAIN and related measures (Version 1299). Bloomington, IL: Chestnut Health Systems. Retrieved from http://www.chestnut.org/LI/gain/. Dennis, M.L. & Babor, T.F., Guest editors (2002) Treatment of Marijuana Disorders, Addiction 97 (Supplement 1), December. Foote, J., DeLuca, A., Magura, S., Warner, A., Grand, A., Rosenblum, A. & Stahl, S. (1999) A group motivational treatment for chemical dependency, Journal of Substance Abuse Treatment, 17, 181-192. Gil, A.G., Vega, W.A. & Turner, R.J. (2002) Early and mid-adolescence risk factors for later substance abuse by African Americans and European Americans. Public Health Reports 117, Supplement 1, S1-S29. Godley, M.D., Godley, S.H., Dennis, M.L., Funk, R. & Passetti, L.L. (2002) Preliminary outcomes from the assertive continuing care experiment for adolescents discharged from residential treatment. Journal of Substance Abuse Treatment, 23, 21-32. Kaminer, Y.K. (1991) Teen Addiction Severity Index (T-ASI); Rationale and reliability. International Journal of Addiction, 26, 219-226. Morral, AR, Eds. (2002) Adolescent Substance Abuse Treatment in the United States, New York: The Haworth Press, 296 p. O'Leary, T.A., Brown, S.A., Colby, S.M., Cronce, J.M., D'Amico, E.J., Fader, J.S., Geisner, I.M., Larimer, M.E., Maggs, J.L., McCrady, B., Palmer, R.S., Schulenberg, J. & Monti, P.M. (2002) Treating adolescents together or individually? Issues in adolescent substance abuse interventions. Alcoholism: Clinical and Experimental Research, 26, 890-899. Pollack, NK & Martin, CS (1999) Diagnostic orphans: adolescents with alcohol symptoms who do not qualify for DSM-IV abuse or dependence diagnoses. The American Journal of Psychiatry, 156, 897-901. Poulin, F, Dishion, TJ & Burraston, B (2001). 3-Year iatrogenic effects associated with aggregating high-risk adolescents in cognitive-behavioral preventive interventions. Applied Developmental Science, 5, 214-224. Walters, ST, Ogle, R & Martin, JE (2002) Perils and possibilities of group-based motivational interviewing. In Miller, WR & Rollnick, S, Eds., Motivational Interviewing: Preparing People for Change, 2nd edition, New York: The Guilford Press, pp. 377-390.

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