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 https://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: snowk@mail.nih.gov 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: milopez@acf.dhhs.gov 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: gail.houle@ed.gov 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: denise_bradley@hhs.gov 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: stretchr@mail.nih.gov 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: baileyd@mail.nih.gov 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: snowk@mail.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 https://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. 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: https://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: https://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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://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 https://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 https://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 https://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 https://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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