EARLY CHILDHOOD EDUCATION AND SCHOOL READINESS PLANNING GRANTS RELEASE DATE: January 7, 2002 RFA: RFA-HD-02-005 PARTICIPATING INSTITUTES AND CENTERS (ICs): National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) Administration for Children and Families (ACF) (http://www.acf.dhhs.gov) Assistant Secretary for Planning and Evaluation (ASPE) (http://www.aspe.dhhs.gov) Department of Education (http://www.ed.gov/) Letter of Intent Receipt Date: April 15, 2002 Application Receipt Date: May 14, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) 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 Participating ICs/Agencies intend jointly to stimulate sustained, multidisciplinary, programmatic research on the effectiveness and efficacy of existing, modified or newly developed comprehensive and integrative curricula or integrative curriculum modules for use with children from birth to age five to promote learning and development across domains associated with school readiness. These domains include: language and communication; emerging and early literacy; early mathematical knowledge; cognitive skills and conceptual knowledge, to include science concepts; self-regulation of attention, behavior and emotion; social competency; fine and gross motor development; motivation and positive dispositions toward learning. A special emphasis is on approaches that promote language, emerging and early literacy, early mathematical knowledge, and other aspects of cognitive development, while simultaneously developing self-regulatory and social competencies, motivation and positive dispositions toward learning, especially for children at risk for school failure. This solicitation encompasses the identification of comprehensive strategies for use with children from birth to promote the development of linguistic, social, communicative, cognitive, and perceptual- motor competencies that are the early bases of learning during the preschool years. A primary goal is to understand the complex combination of individual and contextual factors that interact with curriculum components to influence effectiveness. The research stimulated should produce knowledge that can be used systematically to educate the early childhood education and care workforce, parents, and other adults responsible for children's learning in formal and informal early childhood education and care settings. This solicitation encourages the establishment of researcher-practitioner partnerships in the context of early childhood programs developed at federal, state, and community levels, to include Head Start, Early Head Start, or other state early childhood initiatives serving populations at risk for school failure, as well as partnerships with center-based child-care, and family day care settings. This RFA will support activities necessary to prepare for a future solicitation for complex, large-scale, multi-site effectiveness trials. Obtaining a planning grant through this RFA is not required to respond to the future solicitation. RESEARCH OBJECTIVES Background During the last decade, scientists and practitioners across disciplines relevant to child development, early childhood education, and early childhood intervention have worked toward a conceptualization of school readiness intended to guide research and practice. To participate in and benefit from formal schooling, children need to be physically healthy and develop strong foundations across multiple, broadly defined domains that include: language and communication; emerging and early literacy; early mathematical knowledge; cognitive skill and conceptual knowledge; social competency; self-regulation of attention, behavior, and emotion; motivation to learn, and positive dispositions toward learning. However, at entry to kindergarten, children from poor families and minority groups often show fewer of the competencies and dispositions associated with school achievement. Early delays are quickly magnified as these children move through the early grades and become more likely than their more affluent and majority peers to score lower on tests of academic achievement, such as reading skill, receive special education, repeat school grades, and be diagnosed with mental retardation and learning disabilities. Most educators and scientists across relevant disciplines agree that early childhood is a critical time to begin preventing achievement gaps. Comprehensive services programs intended to close these gaps typically offer a combination of child-focused early childhood education, parent-focused intervention, and other health and social services. One of the highest priorities for those programs is ensuring that all children have the early experiences necessary for developing the emerging literacy, language, and cognitive skills essential for succeeding in school. However, data derived from recent evaluations of such programs underscore the need for approaches to early childhood education and care that more systematically develop this knowledge. Addressing this need is especially crucial given the rapid emergence of state initiatives for universal preschool and other programs targeting poor children from birth to five, and given the increased use of formal and informal out-of-home group care. Research indicates that to structure environments and interactions that promote learning, adults need strategies for developing positive relationships with children, and for developing children's motivation, social competency, and self-regulation of attention, behavior, and emotion, including strategies for classroom or group management that reduce aggressive and disruptive behavior. Thus, scientifically validated approaches are needed that the adults responsible for promoting children's learning and development in each early childhood education and care setting can implement reliably to develop the full range of knowledge, skills, dispositions, and behaviors essential for meeting the challenges of kindergarten and the early grades. Overview of Relevant Research A large body of evidence across relevant disciplines provides a basis for addressing this need. For example, developmental sequences have been identified that specify the early content knowledge, skills, and dispositions from birth to age five that are predictors or precursors of learning and development in each domain associated with school achievement. Strategies have been identified for structuring environments and interactions with adults and peers to promote learning and development in these domains, and for encouraging engagement in and positive dispositions toward learning activities. Qualities of children's social relationships with peers and adults have been identified that influence the quality and potential effectiveness of adult-guided interactions intended to promote learning. Intensive early childhood interventions targeted toward children and families in poverty have been shown to influence a variety of school-related outcomes, including cognition and language, social competency, and regulation of emotion and behavior. The most effective interventions are implemented with strong fidelity by trained staff, include goal-oriented curricula informed by child development research, ensure that children's nutritional and other health needs are met, and often include a parent-focused component to support children's development. Despite a large relevant research base, gaps remain between current knowledge and the knowledge required to provide the education and professional development essential for structuring environments and interactions that reliably promote learning and development across all domains that are foundations of school achievement. For example, many current approaches to early childhood education and care and models for intervening with parents have a general basis in theories of development; however, specific combinations of strategies embedded in these approaches have not been evaluated to determine which components produce specific learning and development outcomes. In addition, many existing curriculum models and parent-interventions focus on only one or two content areas, typically either language and early literacy skills or social-emotional competence, although learning and development is connected across cognitive, linguistic, affective, and social domains, and despite the fact that all are essential for promoting children's preparation for school. Moreover, general styles of interacting with children often have been polarized into direct instruction and child-centered approaches each with exclusive characteristics, further separating goals for early childhood education into cognitive-linguistic and social-emotional domains. That is, direct instruction approaches have been too generally associated with directive, punitive and controlling behavior that pressures children to engage in developing knowledge and learning specific skills before reaching a level of maturity believed to be essential for benefiting from the activity. Child-centered approaches have been too generally associated with warm, responsive, nurturing care to promote social development and emotional health, and little emphasis on developing language, early literacy and cognitive skills. The most current and prevalent judgment of scientists and practitioners is that adults need a full repertoire of strategies for intentionally structuring environments and guiding interactions to meet children's individual needs for learning across all domains. Sustained, programmatic research is needed that builds upon the most rigorous scientific evidence across disciplines to identify comprehensive and integrative approaches that are enjoyable and engaging to children, that are responsive to children's individual characteristics and needs, and that develop the full range of knowledge, skills, and dispositions known to lead to early school adaptation and achievement. Research Scope To address this need, this RFA encourages planning for sustained, programmatic, multidisciplinary research to evaluate the effectiveness of existing, modified, or newly developed comprehensive and integrative curricula or integrative curriculum modules for use with children from birth to age five. The curriculum should be designed to promote learning and development in two or more of the following domains: language and communication; emerging and early literacy; early mathematical knowledge; cognitive skills and conceptual knowledge, to include science concepts. Each application should focus on one or more of the social, affective, and motivational components of school readiness to determine how implementation also facilitates (1) self-regulation of attention, behavior, and emotion, (2) social communication and competency, (3) motivation and positive dispositions toward learning. In addition to supporting the evaluation of curricula for use in center-based settings, this RFA supports planning for the evaluation of existing, modified, or newly developed, comprehensive and integrative curricula or curriculum modules intended for use by parents or other adults responsible for promoting children's learning and development in family day care and informal care settings. These may be evaluated for independent use or as a component linked to a comprehensive and integrative curriculum or curriculum module implemented in a center-based setting. For the purposes of this RFA, the term "curriculum" refers to: (1) a set of goals and objectives for the content knowledge, skills, behaviors, and attitudes to be promoted; (2) a set of benchmarks for guiding and assessing incremental progress toward attaining these goals and objectives; (3) a repertoire of strategies that adults can use in a dynamic and flexible manner to intentionally structure environments and interactions to meet curriculum goals; and (4) supporting materials to facilitate the implementation of those strategies. The term is defined broadly to encompass comprehensive strategies for intentionally structuring environments and interactions from the time of birth to develop early linguistic, social, communicative, perceptual-motor, cognitive skills, and conceptual knowledge that are foundations of learning during the later preschool years. The goals, objectives, and benchmarks should be justified on the basis of the most rigorous scientific knowledge concerning developmental continua, progressions or sequences, and processes and conditions for promoting children's progress in each targeted domain. Applicants must build on existing evidence across relevant disciplines to design evaluations that answer these overarching questions: o Which components of integrative curricula or integrative curriculum modules, and which combinations of associated adult-guided interactions are necessary to promote learning and development, for which children, in which settings, and under which conditions? o What education, training, and administrative or other structural supports are needed to implement the approach fully and effectively? o What education and professional development models provide the knowledge and skill required for full and effective implementation? Research Focus A major goal of this solicitation is to plan multidisciplinary, programmatic research that can specify which approaches are most or least beneficial for which children, in which circumstances, and why. Therefore, a developmental- ecological conceptual approach is strongly encouraged to guide the design of effectiveness trials that can address these questions: o What are the mediating processes through which specific curriculum components influence learning and development in each domain? o Which individual difference factors and multiple levels of contextual factors act alone or in combination to influence child outcomes, fidelity of implementation, or replication and generalization of the results? 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. Applicants are especially encouraged to consider what adaptations to the approach are necessary for children with disabilities to participate in and benefit from the curriculum. Though promoting physical health is not a necessary component of the interventions solicited by this RFA, all applicants should consider that factors such as good prenatal care, adequate nutrition, protection from disease and infection, lack of exposure to toxins and early detection of biological/physiological impairments have the potential to facilitate early learning and moderate the effectiveness of interventions intended to promote school readiness. o What education and professional development are required to meet the needs of diverse populations, to include children with disabilities and children from varied minority, ethnic and cultural backgrounds? How do potential discrepancies between home and school environments concerning goals for and approaches to promoting children's learning and development affect implementation and effectiveness of the intervention? o What are the social competencies, regulatory behaviors, motivational dispositions and qualities of children's social relationships with adults and peers that promote or impede the effectiveness of approaches intended to promote the development of language, emerging literacy, early mathematical knowledge, and other aspects of cognitive development? What education, professional development, and structural supports are needed to help adults establish and maintain the positive relationships with children and parents that are essential for implementing the curriculum effectively? Within the context of these planning activities, applicants may focus on the early assessment and diagnosis of emotional and behavioral problems, and mental disorders that may affect social and emotional development and readiness for school, and risk or resilience for mental disorder. Applications with this focus should distinguish components of the curriculum that may be effective for the prevention and/or treatment of emotional and behavioral problems in young children, and mental disorders that affect early school functioning such as anxiety, depression, inattention, hyperactivity, and impulsivity, and pervasive developmental disorders. These applications should be responsive to recommendations of the National Advisory Mental Health Council in the report "A Blueprint for Change: Research on Child and Adolescent Mental Health" (see http://www.nimh.nih.gov/childhp/blueprint.cfm), and should consider the report entitled " 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" (see http://www.nimh.nih.gov/childhp/goodstart.cfm), that was commissioned in part by the co-sponsors of this initiative. This list is not exclusive or exhaustive, and it is not expected that each application will address the entire range of issues discussed in this RFA. However, applicants must plan proposals and establish the multidisciplinary expertise required to: (1) answer each overarching question listed under Research Scope, and (2) identify and develop conceptual models, research designs, and methodological approaches appropriate for specifying the components, processes, and conditions responsible for the short- and long- term effectiveness of the intervention. Activities to be Supported This RFA will support activities necessary to prepare for large multidisciplinary individual research projects or coordinated multiple project approaches to complex, large-scale, multi-site effectiveness trials. Specific activities supported include, but are not limited to: o Establishment of multidisciplinary scientific collaborations; o Identification of sites and establishment of researcher-practitioner collaborations; o Ascertainment of research populations and identification of appropriate sampling strategies; o Selection, validation, development, and piloting of relevant instrumentation, especially for use with diverse populations, to include children with disabilities; o Development of detailed conceptual models to guide research design and hypothesis testing; o Design of protocols for well-controlled randomized experiments and/or quasi-experiments, to include identification of feasible strategies for achieving randomization; establishing criteria for matching comparison groups; strategies for minimizing selective attrition; and strategies for maintaining and evaluating fidelity of the intervention. o Development of plans for data analysis to include identification of quantitative expertise required for analyzing complex multivariate data sets and using state of the art techniques for measuring change; o Development of plans to specify complete costs of implementing the intervention in additional settings, including all materials and professional development, and plans to conduct cost-benefit analyses as appropriate; o Identification of administrative facilities, procedures, and on-site and off-site personnel. Application Considerations Each applicant should ensure that the application includes plans to address the following methodological and organizational issues: o Research Population This RFA especially encourages the establishment of researcher-practitioner partnerships with early childhood education and care settings that have been developed at federal, state, or community levels, including but not limited to Head Start, Early Head Start, or other state early childhood initiatives for younger children, center-based child care, family day care and informal child-care that include populations at risk for school failure. It is anticipated that samples will include large numbers of individuals who are from minority groups and/or lower socio-economic levels to ensure that findings will be useful for addressing educational disparities that exist for these groups. Applications may include focused study of subgroups that meet the definition of preschoolers with disabilities under Part B of the Individuals with Disabilities Education Act (IDEA) and infants and toddlers who are served under Part C of IDEA. Applicants are encouraged to select a core research population that provides the opportunity to conduct longitudinal analyses on subgroups of samples large enough to test complex interactions among individual and contextual factors that promote or impede intervention effectiveness. o Selection Criteria To facilitate complete and independent replication, applicants must plan to rigorously define samples and subgroups using clear operational definitions, and to describe and justify subject selection criteria with respect to sample characteristics that include, but are not limited to, age, gender, ethnicity, socioeconomic status, geographic region, and disability. Applicants are expected to plan to identify detailed eligibility and exclusion criteria for participants and research sites. Applications should include plans to thoroughly describe all relevant structural and process features of the intervention setting. These features include but are not limited to staff configuration, availability of various services or resources, education and training backgrounds of those responsible for implementing the intervention, and existing approaches to providing education and care. o Approaches to Integration Current approaches to integration differ in the explicitness and degree of integration both within a single domain, such as language, or literacy, or math, and across cognitive-linguistic and social-emotional domains. One intention of this program is to encourage multidimensional approaches to promoting and evaluating the full set of knowledge, skills, and dispositions within each domain, from the onset of initial foundational competencies in each domain through the development of advanced forms. Therefore,, existing curricula targeting one or more of the cognitive-linguistic domains may be further developed, implemented, and evaluated with consideration of how the implementation facilitates one or more of the following: (1) self-regulation of attention, behavior, and emotion, (2) social communication and competency, (3) motivation and positive dispositions toward learning. Likewise, approaches that currently target social-emotional competence may be further expanded to target two or more of the cognitive-linguistic domains. Further development and evaluation of other widely used and advocated, but understudied, approaches to integration also are encouraged. For example, goals for learning across two or more distinct domains, such as literacy and math, or literacy, language, and fine and gross motor development, are sometimes incorporated into a single curriculum module. Such approaches include but are not limited to project or theme-based approaches, typically implemented with the intention of building on a child's expressed interest in a particular area. This initiative encourages further development and evaluation of these curricula, under the condition that the approach is consistent with the definition of "curriculum" and all other requirements provided under Research Scope, above. These examples of integrative approaches are neither inclusive nor exhaustive. Applicants should provide, define, and justify their particular approach to integration in detail on the basis of the most rigorous and relevant scientific evidence supporting its potential for effectively promoting early school achievement. o Research Methodology and Approaches Applicants should design randomized experiments and/or well-controlled quasi- experiments, combined as appropriate with detailed observational, micro- genetic, survey, and qualitative methodologies. Qualitative methodologies are encouraged as a complement to quantitative methodologies to aid in the identification of factors that explain intervention effectiveness or ineffectiveness, to include factors that affect the fidelity of implementation, or the replication and generalization of intervention effects. Applicants may establish criteria for evaluating the trustworthiness and credibility of data obtained with qualitative methods, the transferability of the data, and adequacy of the data for testing the hypothesis. Systematic planned variations are encouraged to test the value-added contribution that each intervention component makes to children's outcomes. Therefore, applicants may consider designs that specify, as appropriate to the focus of the project, the unique contribution to outcomes made by (1) each component embedded within the curriculum module, (2) each curriculum module embedded within the comprehensive curriculum, and (3) each parent- implemented intervention linked to a comprehensive integrative curriculum or integrative curriculum module offered in a center-based setting. Longitudinal designs or combinations of cross-sectional and longitudinal designs will be necessary to meet the overarching objective of this research. The use of recently developed statistical methodologies is encouraged for analyzing how individual and contextual factors interact with intervention components to influence individual developmental trajectories that identify individual rates and patterns of change. Designs should allow evaluation of how the duration, intensity, and timing of children's participation in the intervention influence short- and long-term outcomes. One goal of this RFA is to support plans for longitudinal studies that evaluate long-term outcomes as children transition from preschool into kindergarten and enter formal schooling. Applications with this focus should include plans to identify appropriate functional measures of children's school adaptation and achievement to distinguish which components of the early childhood intervention predict specific school-related outcomes. Characteristics of kindergarten and early elementary school environments should be evaluated to determine how these potentially moderate long-term outcomes. All applications are not required to plan for following children through the period of transition to formal schooling. An equally important focus is on the conditions under which the purposeful structuring of environments and interactions with infants and toddlers provide foundations for developing the knowledge, skills, attitudes, and behaviors that are the basis for learning and development during the later preschool years. Applicants are encouraged to consider that the implementation of a curriculum designed to produce specific outcomes can have unintended positive and negative effects. For example, some approaches to integration may result in enjoyable activities for children but not meet the goal of developing the specific knowledge or skills essential for early school achievement and for which the approach was designed. However, highly structured approaches with a very narrow focus, such as learning the alphabet, can have unintended negative consequences, such as a reduction in the use of diverse and complex language that research shows is crucial for learning and development. Therefore, applicants are encouraged to evaluate outcomes within and across domains both to identify the full range of positive, intended effects and to identify any probable unintended outcomes of the implementation. o Measurement Applicants may propose to identify, further validate, and/or develop essential instrumentation for evaluating intervention effects on children's learning and development. Applicants should select multiple measures of child development and learning from multiple perspectives to include parent and teacher report as well as direct observations and assessments, which should be included whenever appropriate and possible. Applicants should select and/or develop instrumentation linked directly to operationally defined curriculum goals for learning and development. Direct observations and individual assessments may be developed that measure transitions in learning and development from the onset of initial competencies through more advanced forms. Appropriate instrumentation may be unavailable either because data do not exist to judge appropriate usage or because instruments have unacceptable psychometric properties for subgroups expected to participate in future large-scale trials. In this case, applicants may plan to validate existing measures of children's learning and development for use with diverse populations, to include direct assessments and observations as well as parent and teacher reports. Standard observation assessments may be developed for intended use by trained adults to evaluate each child's progress and to adjust implementation strategies to meet curriculum goals. In addition, applicants may identify or develop standard observational assessments to evaluate the fidelity of implementation. MECHANISM OF SUPPORT This RFA will use the NIH Exploratory/Developmental Research Grant (R21) 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. Plans developed via support from this RFA can inform future solicited and unsolicited applications that propose large-scale randomized trials and quasi-experiments that meet the objectives of this research initiative. The anticipated award date is September 2002. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, all applications with direct costs in each year of $250,000 or less must use the modular format. FUNDS AVAILABLE The participating ICs and agencies intend to commit approximately $2.5 million (total costs) in FY 2002 to fund 10 to 12 new grants in response to this RFA: NICHD, $1 million; ACF, $1 million; ASPE, $250,000; and NIMH $250,000. An applicant may request a project period of one year and a budget for direct costs of up to $125,000. Although the financial plans of the ICs and agencies 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 organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any established researcher 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. If research organizations involve curriculum developers or distributors in the project, objectivity of the evaluation must not be jeopardized. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Meeting for Investigators Principal Investigators of projects funded through this RFA will be expected to attend one meeting to share conceptual frameworks, to share approaches to developing and implementing comprehensive and integrative curricula, and to establish core instrumentation intended to maximize the systematic collection of converging data across projects. Requests for funds for travel to this meeting should be included in the application budget request. 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: Melissa K. Welch-Ross, Ph.D. Child Development and Behavior Branch 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 E-mail: rossm@mail.nih.gov Michael L. Lopez, Ph.D. Director, Commissioner's Office of Research & Evaluation Administration on Children, Youth & Families 330 C Street, SW, Room 2128 Washington, DC 20447 Telephone: (202) 205-8212 FAX: (202) 205-9721 E-mail: milopez@acf.dhhs.gov Cheryl A. Boyce, Ph.D. Developmental Psychopathology and Prevention Research Branch Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Blvd., Room 6200, MSC 9617 Bethesda, MD 20892-9617 Telephone: (301) 443-0848 FAX: (301) 480-4415 E-mail: cboyce@nih.gov o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Acting Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 FAX: (301) 402-4104 E-mail: stretchr@mail.nih.gov o Direct your questions about financial or grants management matters to: Ms. Mary Daley Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1305 FAX: (301) 402-0915 E-mail: md74u@nih.gov Ms. Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 E-mail: Diana_Trunnell@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 IC 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: Melissa K. Welch-Ross, Ph.D. Child Development and Behavior Branch 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 E-mail: rossm@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, E-mail: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at https://grants.nih.gov/grants/funding/modular/modular.htm. 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. Acting Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Blvd., Room 5E03, 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 participating ICs and agencies. 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 NICHD 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, will the investigation contribute conceptual frameworks, methods, assessments, and/or products that have potential to advance both scientific knowledge and practice? (2) APPROACH: o Has the applicant provided a thorough description of the curriculum and approach to integration? Is the potential merit of these for supporting early school readiness adequately justified on the basis of rigorous scientific evidence across relevant disciplines? o Are there plans to identify and develop detailed conceptual models, research designs and methodological approaches most useful for identifying the components, processes, and conditions responsible for the short- and long-term effectiveness of the curriculum? o Do plans include strategies for ascertaining and maintaining subjects from subgroups at risk for school failure? o Are there an adequate justification and explanation of why the proposed planning activities are essential before beginning large-scale, multi-site evaluations that are responsive to this RFA? To what degree will the specific activities proposed facilitate the conceptualization, design or implementation of studies that can address each overarching research question under Research Scope, and as appropriate, the central questions under Research Focus, above? (3) INNOVATION: Will the project that planning activities will support result in the development of new conceptual models, methodological approaches, measurements, assessments, technologies, or products? (4) INVESTIGATOR: Do the investigators have the appropriate training and expertise needed to conduct the large-scale, multi-site trials that planning activities will support? Does the application include a thorough evaluation of the additional multidisciplinary content and methodological expertise required to design, execute, and evaluate the intervention, and a description of plans to secure such expertise during the planning period? (5) ENVIRONMENT: o How adequate and/or appropriate are the established sites and/or potential research sites to be secured during the planning period? Have the applicants provided a thorough evaluation of barriers in the research environment that may affect the successful conduct of the research? Have they described actions that will be taken to remove or reduce these barriers during the planning period? Have they thoroughly described all other activities that will be undertaken to ensure that the environments contribute to the probability of success? o Are approaches proposed for establishing relationships with research sites and implementers of the intervention both feasible and adequate for supporting all aspects of the project (e.g., subject recruitment, provision of adequate professional development, evaluation of implementation fidelity, assessment of outcomes, etc.)? o Do the investigators plan to take advantage of unique features of the research environment and to secure all essential and useful collaborative arrangements? Is there evidence of institutional support, to include support for establishing essential researcher-practitioner collaborations? 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 BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: April 15, 2002 Application Receipt Date: May 14, 2002 Peer Review Date: July 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 2002 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 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 are 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 (NICHD) and 93.242 (NIMH) 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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