VALIDATION OF CHILD MENTAL HEALTH DIAGNOSTIC MEASURES

Release Date:  August 13, 2001

RFA:  RFA-MH-02-005

National Institute of Mental Health
 (http://www.nimh.nih.gov/)

Letter of Intent Receipt Date:  November 14, 2001
Application Receipt Date:       December 14, 2001

THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. USE THE MODULAR 
BUDGET INSTRUCTIONS THAT BEGIN ON PAGE 13 IN THE PHS 398 (REVISION 5/2001) 
AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html.  THE 
INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS MUST BE USED WHEN RESPONDING TO 
THIS RFA.

PURPOSE

The purpose of this Request For Applications (RFA) is to invite applications 
examining the psychometric characteristics of existing diagnostic instruments 
for assessing the mental health of children and adolescents.  Valid and 
reliable diagnostic tools are essential in order to document the prevalence of 
mental disorders in child and adolescent populations and to describe the 
clustering and comorbidity of symptomatology in key developmental stages.  A 
number of assessment instruments have been developed which include structured 
and semi-structured diagnostic interviews and dimensional measures of 
psychopathology.  State-of-the-art validation studies of these instruments are 
needed to provide accurate psychometric data on their performance in clinical 
as well as community-based research studies. Applications for studies that 
examine the usefulness of mental health screening instruments and studies that 
expand on ongoing clinical or community-based samples are particularly 
encouraged. 
 
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, Validation of Child Mental 
Health Diagnostic Measures, 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.  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 
grant (R01) award mechanism.  Responsibility for the planning, direction, and 
execution of the proposed project will be solely that of the applicant.  The 
total project period for an application submitted in response to this RFA many 
not exceed five years.  This RFA is 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 July 2002.  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

The NIMH intends to commit approximately $1 million in FY 2002 to fund three 
to five new grants in response to this RFA.  An applicant may request a 
project period of up to five years and a budget for direct costs of up to 
$350,000 per year.  Because the nature and scope of the research proposed may 
vary, it is anticipated that the size of each award will also vary.  Although 
the financial plans of the NIMH 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.  At this time, it 
is not known if this RFA will be reissued.

RESEARCH OBJECTIVES

Background

In the absence of biological markers, which could help define the exact nature 
of a mental disorder and disentangle issues of comorbid symptomatology, 
diagnostic procedures have emphasized naming symptom clusters and identifying 
criteria for syndromes and mental disorders.  It is essential that valid and 
reliable assessment instruments are available to study the prevalence and 
clustering of these symptoms and syndromes in child and adolescent 
populations. These instruments should also accurately assess external criteria 
for disorder, such as service use or need, and impairment and deficits in 
functioning at home, in school, and with peers. This information is needed 
from early childhood through adolescence in order to more accurately define 
the nosology for child and adolescent disorders while taking into account key 
periods in child development.

Over the last 20 years, the confluence of advances in the nosology of mental 
disorders, interview design, computer technology and survey methods led to the 
construction of a variety of diagnostic measures for use with children and 
adolescents.  These include fully-structured and semi-structured instruments 
such as the Children’s Assessment Schedule (CAS), the Diagnostic Interview for 
Children and Adolescents (DICA), the Diagnostic Interview Schedule for 
Children (DISC), the Interview Schedule for Children (ISC), the Child and 
Adolescent Psychiatric Assessment (CAPA), and the Schedule for Affective 
Disorders and Schizophrenia for School-Age Children (K-SADS).  Assessment 
tools, such as these, offer the promise that the research field can describe 
the distribution of the major mental disorders for children and adolescents 
and improve the accuracy of the identification of risk factors for the 
occurrence and maintenance of those disorders. These instruments are also used 
to identify children who may need specialized mental health treatment, and it 
is imperative that they provide an accurate measure of the child’s 
symptomatology.  

The development of these instruments encountered a variety of methodological 
challenges that affect reliability and validity of diagnosis.  These include:  
(1) the child’s developmental stage and ability to understand the meaning of 
questions about emotions and behaviors; (2) ongoing developmental changes in 
the child and in the child’s diagnostic-relevant behaviors which may or may 
not be part of normal development; (3) discrepant reports about the child’s 
behavior offered by parents, teachers, and the child; (4) the lack of a 
diagnostic gold standard with which to make precise comparisons of 
instruments; and (5) changes in the diagnostic criteria for child and 
adolescent disorders from editions III, IIIR, to IV of the American 
Psychiatric Association’s Diagnostic and Statistical Manual of Mental 
Disorders (DSM).  

Diagnostic validity of mental disorders is difficult to assess.  Applicants 
may wish to address the different types of validity in their proposals: 
content validity, predictive validity, construct validity, and discriminant 
validity. Of particular interest are proposals which provide innovative and 
creative methods to move the research field forward in ascertaining validity 
of diagnosis, diagnostic criteria and dimensional measures of child and 
adolescent psychopathology.  In order to distinguish between the validity of a 
disorder and the criteria that define it, applicants may wish to propose the 
identification of independent measures for disorders, which are distinct from 
phenomenological criteria.  

Research Themes and Questions

Listed below are examples of research topic areas that focus on the 
documentation of the psychometric properties of diagnostic instruments for 
assessing the mental health of children and adolescents.  The list of examples 
is illustrative, not exhaustive; it is expected that additional topics will be 
identified by researchers who respond to this RFA.

o  Predictive validity of diagnoses and dimensional measures of behavior with 
measures of clinical status, service use or need, functioning and impairment 
(at home, school, and with peers), and with severity/chronicity of mental 
disorder

o  Studies of the content, predictive, and construct validation of diagnostic  
instruments in understudied populations including young children, children or 
adolescents from diverse socioeconomic, racial/ethnic backgrounds, or 
geographical settings (i.e., rural/urban)

o  Assessments of the content, predictive, and construct validation of mental 
health screening instruments in relation to full instrument/assessment 
batteries which have adequate psychometric data

o  Studies that expand on existing clinical or community-based research to  
examine the validity of child and adolescent mental health instruments and 
diagnostic status over time taking into account treatment status and treatment 
effects 

o  Studies that examine the construct validity of instruments that include 
assessing competencies and impairments associated with mental disorders and 
syndromes

o  Examination of the congruence and divergence between and among structured 
and semi-structured mental health diagnostic interviews, dimensional measures, 
check-lists, and rating-scales across child developmental periods, and for 
children from diverse backgrounds and ethnic groups

o  Develop optimum methods for determining diagnosis or clinical status as a 
function of different informants (e.g., parent, child, teacher, social worker, 
clinician) or modalities (e.g., interview, paper-pencil, computer, behavioral 
observation

o  Studies that examine factors that can affect interpretation of diagnostic 
classifications such as developmental mental status, measures of age-related 
competencies, temperament, adaptive health, and personality.

o  Comparing and validating alternative rules, criteria sets and diagnostic 
algorithms for combining and scoring information to establish diagnoses, level 
of functioning, severity and clinical significance

SPECIAL REQUIREMENTS

It is anticipated that investigators receiving these awards will attend a 
two-day annual meeting in Bethesda, Maryland, to discuss project progress and 
results.  Proposed budgets should reflect these costs for the principal 
investigator.

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 biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are 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 research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html).  
A complete copy of the updated Guidelines is available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH defined Phase III clinical trials and require:  a) all 
applications or proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report 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.

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.

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.

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.

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 NIMH staff 
to estimate the potential review workload and plan the review.

The letter of intent is to be sent to Karen H. Bourdon, MA, at the address 
shown under INQUIRIES, by the letter of intent receipt date listed.

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in 
applying for these grants.  This version of the PHS 398 is available in an 
interactive, searchable PDF format.  Although applicants are strongly 
encouraged to begin using the 5/2001 revision of the PHS 398 as soon as 
possible, the NIH will continue to accept applications prepared using the 
4/1998 revision until January 9, 2002.  Beginning January 10, 2002, however, 
the NIH will return applications that are not submitted on the 5/2001 version.  
For further assistance contact GrantsInfo, Telephone 301/435-0714, Email: 
GrantsInfo@nih.gov.

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 beginning on page 
13 of the application instructions.  Applicants are permitted, however, to use 
the 4/1998 revision of the PHS 398 for scheduled application receipt dates 
until January 9, 2002.  If you are preparing an application using the 4/1998 
version, please refer to the step-by-step instructions for Modular Grants 
available at http://grants.nih.gov/grants/funding/modular/modular.htm.

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:

Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609

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 NIMH staff.  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 the NIMH 
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 Mental Health 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 the application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered in assigning the overall score, 
weighting them as appropriate for each application.  Note that the application 
does not need to be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  For example, an 
investigator may propose to carry out important work that, by its nature, is 
not innovative, but is essential to move a field forward.

(1) Significance:  Does this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that drive 
this field?

(2) Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

(3) Innovation:  Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative?  Does the project challenge existing 
paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?

(5) Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research.

o  The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project  
proposed in the application.

o  The adequacy of the proposed plan to share data, if appropriate.

Schedule

Letter of Intent Receipt Date:    November 14, 2001
Application Receipt Date:         December 14, 2001
Peer Review Date:                 March 2002
Council Review:                   May, 2002
Earliest Anticipated Start Date:  July, 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

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or answer questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Karen H. Bourdon, MA
Division of Mental Disorders, Behavioral Research, and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6198, MSC 9617
Bethesda, MD  20892-9617
Telephone:  (301) 443-5944
FAX:  (301) 480-4415
Email:  kbourdon@nih.gov

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email:  Diana_Trunnell@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.242.  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.


Return to Volume Index

Return to NIH Guide Main Index


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.