EFFECTIVENESS OF EARLY CHILDHOOD PROGRAMS, CURRICULA, AND INTERVENTIONS IN 
PROMOTING SCHOOL READINESS
 
RELEASE DATE:  January 3, 2003
 
RFA:  HD-03-003  (Reissued as RFA-HD-07-008)
 
National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov) 
Administration for Children and Families (ACF)
 (http://www.acf.dhhs.gov/)
Assistant Secretary for Planning and Evaluation (ASPE)
 (http://aspe.hhs.gov) 
Office of Special Education and Rehabilitative Services (OSERS)
 (http://www.ed.gov/offices/OSERS)

LETTER OF INTENT RECEIPT DATE:  February 26, 2003
APPLICATION RECEIPT DATE:  March 26, 2003
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

The National Institute of Child Health and Human Development (NICHD), the 
Administration for Children and Families (ACF), and the Assistant Secretary 
for Planning and Evaluation (ASPE) within the Department of Health and Human 
Services (DHHS), and the Office of Special Education and Rehabilitation 
Services (OSERS) of the U.S. Department of Education, invite research grant 
applications to develop rigorous scientific studies of the effectiveness of 
integrative early childhood interventions and programs across a variety of 
early childhood settings in promoting school readiness for children, from 
birth through age five, who are at risk of later school difficulties.  As 
defined below, integrative programs are those that include components intended 
to promote children's school readiness across multiple domains of cognitive 
and socioemotional functioning.

This RFA seeks to stimulate systematic, programmatic, multidisciplinary 
research to determine the most effective early childhood interventions in 
promoting children's school readiness.  Specifically, the co-sponsoring 
agencies seek research to increase understanding of the types of integrative 
programs and their components (individually and in combination) that promote 
child learning and development across multiple domains of early childhood 
competence, including language and communication, emergent and early literacy, 
early mathematics, early science, self-regulation of behavior, emotion, and 
attention, social competency, and motivation to learn, as well as those that 
address teacher, caregiver, or parent behaviors to promote children's 
development in these areas.  It is expected that projects will address both 
cognitive and socioemotional domains.  In addition, it is expected that 
projects will identify causal connections between specific program elements 
(alone or in combination) and specific child competencies, and include process 
evaluations that lead to understanding how the intervention was implemented 
and contributed to observed effects.  It is expected that a wide range of 
early interventions and curriculum models will be tested as they are 
implemented in the full spectrum of early childhood environments, including 
child care and/or early childhood education settings as well as home-based 
interventions.  It is expected that the research studies and programs 
stimulated by this initiative will contribute scientific data that bear 
directly on a number of public policy issues and instructional practices as 
well as informing developmental science. 
 
RESEARCH OBJECTIVES

Background

Considerable attention has been brought to issues surrounding early childhood 
through a number of federal initiatives and recent legislation.  For example, 
the No Child Left Behind Act, the Good Start, Grow Smart initiative, and the 
White House Summit on Early Childhood Cognitive Development in 2001 called 
for the development of a scientific base from which to build practice and 
policy in developing early childhood experiences that are supportive of 
school readiness and later school success.

o Brief review of key literature

Although this legislative activity is quite recent, there is a long and 
extensive history of research on early experience as it contributes to the 
development of later outcomes.  We will not repeat it here, but refer 
applicants to the recent National Research Council's (NRC) reports Eager to 
Learn and From Neurons to Neighborhoods for summaries of the role of early 
experience in development.  Additionally, there are also several summaries 
about early childhood programs and their role in preparing children for 
school, including the NRC report Eager to Learn, reports about the impact of 
Head Start and Early Head Start (reports available on-line at 
http://www.acf.dhhs.gov/programs/core/index.html), and evaluations of the 
Even Start program (available at http://www.ed.gov/offices/OUS/PES).

The primary goals of this RFA are articulated in the NRC report Eager to 
Learn.  Specifically, that expert group's recommendations (numbers 16 and 17) 
called for studies that examine the effectiveness of integrated early 
interventions in promoting children's readiness for school.  Among the 
elements of a research program called for within Recommendation 16 are the 
following:

o Development of children's capacities in the variety of cognitive and 
socioemotional areas of importance in the preschool years, and the contexts 
that enhance that development.
o The components of adult-child relationships that enhance the child's 
development during the preschool years, and experiences affecting that 
development for good or for ill.

o The implications of developmental disabilities for learning and development 
and effective approaches for working with children who have disabilities.

The committee also made a specific recommendation with regard to the type of 
research needed on early childhood programs and curricula, with a particular 
emphasis on children who are at-risk for school difficulties:  The next 
generation of research must examine more rigorously the characteristics of 
programs that produce beneficial outcomes for all children.  In addition, 
research is needed on how programs can provide more helpful structures, 
curricula, and methods for children at high risk of educational difficulties, 
including children from low-income homes and communities, children whose home 
language is not English, and children with developmental and learning 
disabilities (Recommendation 17). 

The committee further indicated that although there has been a growing body 
of evidence about the effectiveness of early interventions targeted at low-
income children, research is still needed on the effectiveness of such 
programs for children of different types of risk, as well as research that 
can identify which particular components of interventions are responsible for 
the positive outcomes that have been shown.  Finally, the committee 
recognized the need for research that examines the interplay between 
characteristics of the child, the early intervention setting (whether it be 
early education or child care setting), the home, and the larger community 
context.

The content of such interventions is suggested by a wide range of reports and 
published papers, a subset of which are included here.  Applicants are 
referred to the earlier RFA published by some of the sponsors of this RFA for 
a more thorough review (available at http://grants.nih.gov/grants/guide/rfa-
files/RFA-HD-02-005.html).  The NRC reports How People Learn and From Neurons 
to Neighborhoods and the report Off to a Good Start: Research on the Risk 
Factors for Early School Problems and Selected Federal Policies Affecting 
Children's Social and Emotional Development and Their Readiness for School 
prepared by the Foundations and Agencies Network (FAN) and partially 
supported by sponsoring agencies (see also 
http://www.nimh.nih.gov/childhp/goodstart.cfm) collectively provide a 
thorough discussion of the processes through which early learning and 
development occurs, and identifies the factors that put children at-risk for 
poor learning outcomes.  Together, these reports, and many others, recognize 
that early childhood development is not compartmentalized; children's 
literacy, language, general knowledge, math, and science skills are inter-
related in complex ways.  Indeed, the first recommendation made by the NRC 
Panel in Neurons to Neighborhoods speaks to the need to consider all aspects 
of early development, for all children:  Resources on a par with those 
focused on literacy and numerical skills should be devoted to translating the 
knowledge base on young children's emotional, regulatory, and social 
development into effective strategies   Such strategies and their widespread 
diffusion into the early childhood field must encompass young children both 
with and without special needs.

This conclusion was also drawn by the Kauffman Early Education Exchange after 
reviewing similar literature in the report Set For Success: Building A Strong 
Foundation for School Readiness Based on the Social-Emotional Development of 
Young Children.  Collectively, these documents and the bodies of research 
they represent point to the need to develop programs that focus on children's 
multiple cognitive skills, as well as their socioemotional skills to optimize 
learning.  

Finally, it is clear from both How People Learn and the FAN and Kauffman 
reports that attention needs to be paid to children from birth through the 
age of school entry in developing interventions to better prepare them for 
school.  As a result, there is a need to consider the contexts within which 
child development occurs from birth until school entry, including the home 
and child-care settings.  As with the research base regarding preschool-
specific interventions, there is a history and large body of work describing 
the importance of these environments for fostering optimal growth and 
development.  Again, without reviewing this literature in full, applicants 
are referred to the chapters on child care in From Neurons to Neighborhoods, 
and in Volume 4 of the Handbook of Child Psychology (Fifth Edition) for 
recent reviews.  Applicants are also encouraged to review the findings from 
the NICHD Study of Early Child Care and Youth Development (SECC; 
http://www.nichd.nih.gov/od/secc/index.htm).  These reviews capture the 
general conclusion that the quality of child-care environments plays a key 
role in fostering child development.  However, there is still a need to 
understand exactly what the critical features of quality are, and how they 
relate to the broad range of specific areas of child competence described in 
this RFA or, as NRC concluded, understanding how best to invest in improving 
the quality of child care.  Additionally, as NRC concluded in Neurons to 
Neighborhoods, this substantial, generally consistent literature has not been 
substantiated by high-quality experimental research, nor has research tended 
to look at the trajectories of child development starting with non-parental 
care experiences from birth through the school years.  Additionally, there is 
growing need to understand the experiences of children with disabilities in 
non-parental care.  

o Collaborative and Sponsoring Agency Goals

This solicitation is sponsored by a number of federal agencies with the 
shared goal of identifying the types of programs that are effective in 
promoting school readiness among children from birth through age five, and in 
understanding how effectiveness is influenced by child and program 
characteristics.  A goal is to provide information about process and outcomes 
that can guide federal and state investments in early childhood programs and 
guide local program efforts to maximize the effectiveness of program and 
training activities.  Agencies seek information about the cost and resources 
needed to implement any intervention found to be effective.  To orient 
applicants, this solicitation should be considered in light of a number of 
other federal research funding solicitations, as well as the role of field-
initiated research within each agency's research program.  Given the level of 
interest among federal agencies in meeting the need for scientific evidence 
for the effectiveness of early childhood programs and interventions, 
applicants are encouraged to review on-going and current federal funding 
announcements to find the most appropriate program for their work.  These are 
briefly summarized below (note that this is not intended to be an exhaustive 
list; please review the Federal Register, the NIH Guide, and agency web sites 
for up-to-date announcements):

o The Administration for Children and Families has a number of pertinent 
research programs, including the Head Start Quality Research Centers, the 
Head Start University Partnerships, the Early Head Start University 
Partnerships, the Family and Child Experiences Survey (FACES) study, and 
other activities.

o The Department of Education's Preschool Curriculum Evaluation Research 
Grants program supports research on already developed preschool curricula.

o The Interagency Education Research Initiative (IERI), sponsored by NICHD, 
the National Science Foundation, and the Institute of Education Science at 
the U.S. Department of Education may also be of interest to applicants 
working in this area.

Research Scope

This solicitation anticipates a wide range of research projects designed to 
address the effectiveness of programs in promoting school readiness in 
children birth through age five.  Studies may examine integrative early 
intervention programs, early education programs, or early childhood curricula.  
All types of early care and education settings are of interest, including 
family- or center-based child care, early Head Start, Head Start, or preschool 
classrooms, or the home.  Additionally, approaches that engage parents or 
families in promoting children's learning in concert with programs focused on 
childcare or other early education settings are encouraged.  Despite the 
expected variation in approaches, successful applications should consider the 
following basic parameters:

o  Types of Interventions to be Studied

This solicitation is intended to support rigorous studies on the effectiveness 
of integrative interventions, curricula, or programs, intended to prepare 
children for successful school entry.  Programs are considered integrative if 
they address children's developmental needs in both cognitive and 
socioemotional domains.  Cognitive domains include, but are not limited to, 
language and communication, early and emergent literacy, early mathematics, 
and early science knowledge and skills.  Socioemotional domains include, but 
are not limited to, social competency, and the regulation of attention, 
behavior, and emotion.  Designs for research programs should allow for the 
testing of causal relationships between specific program elements 
(independently or in combination) and child outcomes.  

Programs, strategies, or curricular materials must be ready for implementation 
early in the grant period, and must be available or developed during the grant 
period for potential dissemination.  Applicants should provide sufficient 
detail about the intervention, including its components and how these are 
designed to meet the specific needs and characteristics of the population for 
which they are being developed.  Applicants should include a conceptual and/or 
empirical rationale to enable reviewers to understand the potential innovation 
and impact of the program, curriculum, or intervention, as well as to 
demonstrate its specific features and components.  Additionally, applications 
should provide specific information about the types of materials and 
professional development or training opportunities offered (as applicable), 
educational level of the providers, and specific instructional practices 
employed by caregivers, teachers, or parents involved in the study.  
Applicants should describe strategies for the public dissemination of these 
materials for use in relevant early childhood settings. 

Applications should thoroughly describe the intervention context prior to 
implementation, to include child characteristics and the existing early 
childhood environment (for example, staffing and professional development, 
type and intensity of curriculum, resources).  Applicants should describe how 
the intervention enhances the existing environment.  Programs, curricula, or 
intervention strategies should be presented within a strong conceptual model 
with empirical support documented where applicable and possible.  This 
conceptual model must be grounded in evidence on what is known about early 
development and the experiences necessary to prepare young children for school 
success, with consideration given to both contextual and child 
characteristics.  Contextual factors may include, but are not limited to, 
characteristics of parents, homes, families, communities, schools, teachers, 
administrators, classrooms, and policies at multiple levels, to include 
program administrative policies or broader local, state or federal policies 
that affect intervention implementation or benefit accrued from the 
intervention.  Individual difference factors may include, but are not limited 
to, initial levels of competence, rates of learning, gender, temperament, pre-
maturity, behavioral disorder, illness, and disability.  Additionally, the 
roles of the caregivers, teachers, or parents vis-a-vis instructional 
practices must be described within the larger conceptual model.  

Early childhood care and education are often provided through services funded 
by local, state, or federal sources.  In many cases, these services are 
subject to mandated reporting requirements for service evaluation, service 
improvement, and continuation of funding and/or licensing.  The creation of 
partnerships between researchers and service providers is a strategy for 
producing high quality research while addressing these and other service 
delivery system needs.  As such, applicants are strongly encouraged to 
develop partnerships with service delivery systems to capitalize on and/or 
potentially inform these systems.  When such partnerships exist or will be 
developed, applicants should describe the specific programmatic or data needs 
of the service delivery system, as well as existing data collections efforts, 
how these data will be used within the design of the proposed study (if at 
all), how these data will be augmented (if at all), and/or how these data 
will enhance the overall strength of the study in informing practice and 
policy.

o  Target Populations

There is a compelling need to understand the effectiveness of programs for 
children from birth through age five in promoting school readiness among those 
most at risk of difficulty in transitioning into the early elementary school 
years.  Successful applications will include children from these groups, 
either as the entire study sample, or as meaningful sub-samples.  Where 
appropriate to the underlying theoretical or conceptual model, and 
incorporated into the data analysis model, applications may include subgroups 
composed of children not from identified risk groups.  However, applications 
must include a sample of children from identified risk groups and, when 
suitable, include appropriate control groups for all treatment groups.
Groups of special interest include:

1.  Children who are English Language Learners, whose families may or may not 
speak English at home.

2.  Children with physical, cognitive, mental, and/or social-emotional 
disabilities.  These studies must refer to the Individuals with Disabilities 
Education Act (IDEA), Part B, for definitions of disability or IDEA, Part C 
for the definition of infants and toddlers with disabilities or at-risk for 
disabilities.

3.  Children from low-income homes and communities.

o   Periods of Development to be Studied

The agencies sponsoring this RFA are interested in studies that document the 
effects of programs, interventions or educational strategies and curricula 
throughout the early years of development.  A goal is to document the 
processes responsible for change and factors that would influence the 
application of these findings to other early childhood settings and 
populations.  Although not an exhaustive list, we anticipate three possible 
strands of research:

1.  Research on the effectiveness of early intervention programs, curricula, 
and services for children from birth through age three intended to prepare 
them for school entry.  Interventions may occur in homes, childcare, or other 
early care and education settings.

2.  Research on the effectiveness of preschool programs and curricula targeted 
to children ages three through five in preparing children for school entry.  
Although these programs typically occur within classroom settings, studies of 
children from three through five in other settings are not excluded.

3.  Longitudinal research that examines the effects of early childhood or 
early intervention programs for children birth through age three in 
conjunction with programs and curricula for children ages three through five 
designed to prepare children for school entry.

o   Research Design Considerations

The goal of this RFA is to determine the characteristics of integrative 
programs (such as intensity, duration, content, and method of delivery) that 
are most effective in promoting school readiness, including the specific 
element or combination of elements of interventions or curricula, for specific 
groups of children.  As such, there is a need for scientifically rigorous 
studies that are sensitive to changes in child outcomes likely to occur as a 
result of the intervention, while simultaneously being able to control for 
random variation or variation due to factors other than those included in the 
designed intervention or curriculum.  Studies employing a range of 
methodologies and measurement models may be valid for addressing these 
questions.  The following guidelines, therefore, are suggestive and should be 
employed only when appropriate to the intervention, program, or curriculum 
under study, and scientifically feasible for the populations under study:

1.  Studies that include random assignment and/or planned variation in 
conditions are the most promising to address the goals of the RFA.  However, 
studies should use methodologies most appropriate to the nature of the 
intervention, program, or curriculum under study, the specific research 
questions and hypotheses being addressed, the populations being served, and 
the presence of potential moderating or confounding variables.  Studies may 
use mixed-methods approaches, but studies that rely solely upon descriptive 
data (whether qualitative or quantitative) are discouraged.  The research 
design must be clearly articulated and there must be a rationale for including 
specific groups and sub-groups of children in experimental and control groups 
based upon conceptual and/or empirical foundations.  

2.  In describing the research design, the term "subgroup" refers to pre-
intervention characteristics of the children (such as English language 
proficiency, risk for or presence of a disability defined by IDEA, living in 
poverty, or other characteristics of the child and/or family) used to identify 
subsamples within the study.  Applicants are encouraged to define, as 
appropriate, subgroups according to definitions used in the prevailing policy 
context (e.g., definitions of poverty) to ensure the data bear directly on 
public policy concerns.  

In describing experimental conditions, "experimental group" refers to those 
participants who receive the intervention, and "control group" refers to those 
not receiving the intervention under study.  In studies using planned 
variation designs, multiple experimental groups may be employed with a single 
control group.  However, when multiple subgroups of children are included, 
each subgroup that receives the designed intervention, program, or curriculum 
within an experimental group must have an appropriate subgroup representation 
within the control group.

3.  Studies should incorporate measures of treatment fidelity for use as 
potential mediating or confounding variables in their analyses.  For projects 
to be tested across multiple years, these measures must be sensitive to 
program development effects, and include measures of caregiver, teacher, or 
provider consistency and experience with the program, curriculum, or 
intervention approach.  For studies using multiple comparison and/or control 
groups, such measures describing the treatment must be included in the study 
design and/or data analysis plan to ensure that any differences in child 
outcomes between treatment (or experimental) groups and control groups are 
directly attributable to the treatment, and take into consideration the 
possibility of unintended spill-over effects across study groups.

4.  Studies should incorporate a suitable number of sites to provide 
sufficient variation to test relevant hypotheses.  When used, multiple sites 
should be incorporated into the research design and data analysis plans for 
the study.  Studies using single sites should provide a rationale for why a 
single site will be sufficient to meet the objectives of the research design, 
or identify the ways in which multiple sites would potentially confound the 
study and limit the investigators' abilities to test causal hypotheses.

5.  Although this solicitation is to fund research on interventions, programs, 
or curricula delivered to children from birth through age five, studies may 
employ longitudinal components to assess children and school readiness or 
success outcomes beyond the age of five.  The focus of such studies should be 
on the transition to school, but longitudinal studies of longer-term 
consequences of early intervention are also encouraged under this RFA.  Such 
longitudinal studies should be designed to identify developmental trajectories 
and the impact of the tested intervention, program, or curriculum on these 
trajectories.

o   Measurement Considerations

Because this solicitation is for projects targeting children from birth 
through age five, valid indicators of school readiness must be included in the 
study that are appropriate to the age of the children in the sample and the 
specific aims of the study.  Additionally, all measures used within the study 
(antecedent or intervention variables, moderating and mediating variables, and 
outcome measures and indicators) should be identified and appropriate 
psychometric properties provided (where possible).  While measures selected 
should take forms appropriate to the design of the study, the following 
guidelines should be observed:

1.  While some studies directed at preschool-aged children may use a range of 
school adjustment and success measures, studies focusing on younger children 
may need to select measures that are indicators of later school readiness (in 
the absence of data about actual school readiness).  In both categories of 
studies, applicants should provide appropriate validation data for all the 
planned subgroups within the sample (where available), or include plans for 
validating the measures chosen for use in the study.  

2.  In studies including non-English speaking samples, data validating the 
measures selected for use must be provided, or plans for collecting such data 
must be included in the design.  Additionally, the selection criteria for such 
measures for non-English speaking participants must be justified.  Development 
of non-English instrumentation and procedures must conform to the guidelines 
given below for instrumentation development.

3.  Although it is appropriate for applicants to propose plans for the 
validation of instrumentation, applicants may not use a grant resulting from 
this RFA solely as a means of instrument development, per se.  Additionally, 
any component of the project that focuses on instrumentation must show (1) why 
this work is necessary for the successful completion of the research to be 
supported by the grant, and (2) why the larger study is a suitable framework 
within which to determine various psychometrics of the measures to be tested.  
The development of non-English versions of validated, English-only instruments 
may be incorporated into the research design, but such work must be completed 
sufficiently early in the grant cycle to allow for refinement or replacement 
of the measure in the research design.

4.  Once grant awards are made, Principal Investigators (PI) will be 
encouraged and supported to work collaboratively to use common, cross-study 
measures and procedures, where appropriate, to assess children's experiences 
and outcomes.  Common measures will maximize the potential for cross-study 
analyses, and improve the ability to draw conclusions about the effectiveness 
of comparable interventions, or the effectiveness of interventions on 
comparable populations.  Sponsoring agency staff will support efforts to 
develop common measures through a variety of activities, including planning PI 
meetings, and providing information about measures used in on-going large- and 
small-scale projects.  The decision to utilize specific measures will lie with 
individual investigative teams, and be supported by federal program staff.

MECHANISM OF SUPPORT
 
This RFA will use NIH Research Project Grant (R01) award mechanism.  As an 
applicant you will be solely responsible for planning, directing, and 
executing the proposed project.  This RFA is a one-time solicitation.  Future 
unsolicited, competing continuation applications based on this project will 
compete with all investigator-initiated applications and will be reviewed 
according to the customary peer review procedures.  The anticipated award 
date is September 2003.

FUNDS AVAILABLE
 
The co-sponsors intend to commit approximately $9.4 million in total costs 
[Direct plus Facilities and Administrative (F & A) costs] in FY 2003 to fund 
eight to ten new and/or competing continuation 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 $750,000 per year.  Because the nature and 
scope of the proposed research will vary from application to application, it 
is anticipated that the size and duration of each award will also vary.  
Although the financial plans of the co-sponsors 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. 
 
ELIGIBLE INSTITUTIONS
 
You may submit an application 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.   
 
SPECIAL REQUIREMENTS
 
Kick-off Meeting for Principal Investigators

Because of the importance of cross-project communication and collaboration in 
this research effort, sponsoring agencies will convene a kick-off meeting in 
Washington, D.C. within two months of the grants being awarded.  PIs from 
projects funded through this RFA will be expected to attend this initial 
meeting to share research approaches and discuss strategies for developing 
core instrumentation and/or common measurement strategies across multiple 
projects as appropriate and/or possible.  The first meeting is expected to 
take place in November 2003.  Requests for funds for travel to this two-day 
meeting for the PI and up to two additional research team members (for 
example, co-PIs, the team's research methodologist) should be included in the 
application budget and budget justification.

Twice-Yearly Principal Investigators Meeting

The sponsoring agencies anticipate conducting a meeting of PIs twice yearly to 
address areas of technical need and to provide a forum for sharing approaches 
and findings.  Applications should include plans for two one-and-one-half day 
meetings of PIs to be held in Washington, D.C. each year in all years of the 
grant award (including the kick-off meeting described above) in their budgets 
and budget justifications.  Although not identified as a formal network, 
Federal program staff will work with PIs to establish and maintain an informal 
network to facilitate problem solving, share common strategies, and synthesize 
findings as they emerge.

Advisory Boards

Funded grants will be required to establish an Advisory Board of outside 
experts, stakeholders, and others that can inform the development and 
implementation of the program, curriculum, or intervention under study.  The 
specific function and constitution of the Board is dependent upon the needs of 
the investigative team, and should be appropriate to the expertise present 
among the PI or co-PIs.  The role of the Board should enhance the design of 
the study (for example, by including a participating care-provider, parent, or 
child as a member).  The specific areas of expertise of members, size of the 
Board, and plan for meetings and consultations should be identified in the 
grant application.  However, specific individuals should not be named, 
selected, or contacted until after the grant award is made.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

Kyle L. Snow, Ph.D.
Director, Program in Early Learning and School Readiness
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B05, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-2307
FAX:  (301) 480-7773
Email:  [email protected]

Michael L. Lopez, Ph.D.
Lead Social Science Research Analyst
Child Outcomes Research & Evaluation
Office of Planning, Research, and Evaluation
Administration for Children & Families
370 L'Enfant Promenade SW
Washington, DC  20447
Telephone:  (202) 205-8212
FAX:  (202) 205-3598
Email:  [email protected]

Gail R. Houle, Ph.D.
Associate Division Director, Early Childhood Programs
Office of Special Education Programs
U.S. Department of Education
330 C Street SW, Room 3524
Washington, D.C. 20202
Telephone:  (202) 205-9045
FAX:  (202) 205-8105
Email:  [email protected]

Denise Bradley, Ph.D. 
Division of Children and Youth Policy 
Office of the Assistant Secretary for Planning and Evaluation 
U.S. Department of Health and Human Services 
200 Independence Avenue, SW, Room 450G 
Washington, DC 20201 
Telephone:  (202) 401-6670 
FAX:  (202) 690-5514 
Email:  [email protected]

o Direct your questions about peer review issues to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1485
FAX:  (301) 402-4104
Email:  [email protected]

o Direct your questions about financial or grants management matters to:

Ms. Dianna Bailey
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A07E, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6978
FAX:  (301) 480-4783 
Email:  [email protected] 
 
LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

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 NICHD staff to estimate the potential review workload and 
plan the review.
 
The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Kyle L. Snow, Ph.D.
Director, Program in Early Learning and School Readiness
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B05, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-2307
FAX:  (301) 480-7773
Email:  [email protected]

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: [email protected].
 
USING THE RFA LABEL:  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.
 
SENDING AN APPLICATION TO THE NIH:  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:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service)

APPLICATION PROCESSING:  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.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NICHD.  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 NICHD in accordance with the review criteria stated below.  
As part of the initial merit review, all applications will:

o Receive a written critique
o 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 and assigned a priority score
o Receive a second level review by the National Institute of Child Health and 
Human Development 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.

(1) SIGNIFICANCE:  If the aims of the application are achieved, how will 
scientific knowledge be advanced, and what ways will practice and policy be 
informed?  Does the study as designed have the potential to inform practice 
and policy as they relate to early childhood care and education, and the 
promotion of school readiness?

(2) APPROACH:  Is the nature of the planned intervention, program, or 
curriculum described adequately?  Does the application adequately describe 
plans for a process evaluation that will provide information about how the 
intervention was implemented and how it contributed to observed effects?  
Will the project provide information about the cost and resources needed to 
implement any intervention found to be effective?  Is the approach 
integrative as specified in the RFA?  Is there a clear linkage between 
theory, previous research, and the proposed program, intervention, or 
curriculum?  Is the research design likely to provide data to test causal 
hypotheses between elements of the planned program, curriculum, or 
intervention, and child outcomes?  Is there an adequate sampling plan and 
plan for sample maintenance over time?  Is the sample justified by 
appropriate statistical power analyses?  Are the measures selected 
appropriate to the research questions, populations, and study context?  Are 
appropriate steps taken to ensure accommodation for children with special 
needs, such as those with physical, learning, or developmental disabilities, 
or for children for whom English is not a native language when these groups 
are included in the study?

(3) INNOVATION:  Does the project employ novel concepts, approaches or 
methods?  Are the aims original and innovative?  Is the linkage between 
intervention, program, or curriculum and the needs of the populations served 
particularly inventive?  Will the project result in new methodologies, 
approaches, or technologies that may be utilized in preparing children for 
school entry beyond those included in the original study?  Will the findings 
from the study contribute to the development and/or revision of existing 
policies applied to early childhood care and educational practice?

(4) INVESTIGATOR:  Is the investigator appropriately trained and well suited 
to carry out this work?  Do the proposed PI and research team have the 
complement of skills necessary to conduct the study proposed, such as 
experience in intervention or curriculum design and implementation 
evaluation?  Do the proposed PI and research team have a history of 
partnerships with project implementation sites similar to those included in 
the research plan that will be necessary for successful implementation?

(5) ENVIRONMENT:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Is the identification of 
multiple sites appropriate to the research questions and hypotheses, and 
appropriately justified within the application?

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o 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.

o 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.)

o DATA SHARING:  The adequacy of the proposed plan to share data. 

o BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

OTHER REVIEW CRITERIA:

o DISSEMINATION:  Does the application adequately describe plans to make 
materials publicly available and as appropriate, describe strategies for 
disseminating materials for use in relevant early childhood settings.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  February 26, 2003
Application Receipt Date:  March 26, 2003
Peer Review Date:  July 2003
Council Review:  September 2003
Earliest Anticipated Start Date:  September 2003

AWARD CRITERIA

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.
 
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 is 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 
http://grants.nih.gov/grants/funding/children/children.htm 

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 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.

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.  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 
RFA 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 Nos. 93.865, 93.239 and 84.324 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.

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