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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