Full Text HD-93-09 RESEARCH ON TREATMENT EFFECTIVENESS FOR LEARNING DISABLED (LD) CHILDREN NIH GUIDE, Volume 21, Number 28, August 7, 1992 RFA: HD-93-09 P.T. 34 Keywords: National Institute of Child Health and Human Development Application Receipt Date: January 7, 1993 PURPOSE The Human Learning and Behavior Branch (HLB) of the Center for Research for Mothers and Children (CRMC) of the National Institute of Child Health and Human Development (NICHD) invites research grant applications to develop new knowledge in the area of treatment effectiveness for learning disabled children who display primary deficits in oral and written language abilities including disabilities in listening, speaking, reading, and written language skills. The research emphasis must be placed on the identification, development, and implementation of treatment/intervention conditions that have effects on specific deficits in component oral language abilities (e.g., phonology, semantics, syntax), written language abilities (e.g., word attack skills, word recognition skills, reading comprehension, spelling behavior, written expression skills), and the relationships between them (e.g., compound disabilities in phonology, word attack skills, spelling, and written expression). However, children with comorbid deficits in attention, mathematics, behavioral, and social competencies should also be studied in the process. The goal of this Request for Applications (RFA) is to encourage treatment/intervention research on children with learning disabilities who are well-defined in terms of age, gender, ethnicity, socio-economic status, primary learning disability, comorbid disabilities (e.g., ADD; mathematics disability), severity of disability(ies), intensity and duration of previous and current interventions, familial and/or genetic findings, physical/neurological findings, intellectual status, cognitive-linguistic status, neurophysiological/neuropsychological status, educational status, and social/behavioral competencies. Some of the specific research question to be addressed are: o Which single treatment/intervention model or combination of models (e.g.,individualized intervention, small-group intervention, large-group intervention, computer-assisted instruction) and which single or multimodal approaches and/or methods (e.g., direct instruction, mastery learning, phonemic awareness training, alphabetic methods, analytic phonics methods, process approaches, neurodevelopmental approaches, whole language approach); o provided in which setting or combination of settings (e.g., public school, private school, clinic,) and under what type of time-on-task conditions (intensity and duration); o have the most effective impact on well-defined domains of child functioning (e.g., academic, cognitive, social/behavioral, neurophysiological, neuropsychological); o for how long (short vs. long term); and o for what reasons (educational, environmental, behavioral, neurophysiological, psychological processes underlying change and generalization)? HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. Of the 3000 such objectives, 170 address the public health needs of children and adolescents. This RFA, Research on Treatment Effectiveness for Learning Disabled (LD) Children, specifically addresses the priorities that are related to learning problems and psychosocial interventions in children. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-474-0, or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238) ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, public and private, non-profit and for-profit organizations such as universities, colleges, hospitals, schools, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT The support mechanism for this RFA is the Individual Research Grant (R01). Policies that govern are those of the grant-in-aid award programs covered by the PHS. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed five years. FUNDS AVAILABLE The NICHD has set aside $600,000 for direct costs for the first year of support. It is anticipated that two awards will be made. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plan of the NICHD, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background The NICHD has had a long standing interest in the study of learning disabilities and disorders that adversely affect the development of listening, speaking, reading, and writing abilities in approximately 10 to 15 percent of children in the United States. Since its inception in 1963, the NICHD has funded research to delineate the basic biological and behavioral mechanisms that underlie specific deficits in attention, perception, language, cognition, and academic skills, particularly reading. In January of 1987, a National Conference on Learning Disabilities, co-sponsored by the Interagency Committee on Learning Disabilities (of which the NICHD was designated as the lead agency) and the Foundation for Children with Learning Disabilities, was held on the NIH campus. The proceedings of this conference were combined with other sources to provide a comprehensive document titled Learning Disabilities: A Report to the U.S. Congress (1987). A major recommendation included in this report called for a systematic effort to develop rigorous research strategies and intervention trials to examine the response of learning disabled children to different forms of treatment. In 1990, the NICHD supported a planning conference in Racine, Wisconsin to review ongoing NICHD-supported comprehensive longitudinal studies designed to classify and define learning disabilities. In addition, efforts at this conference were made to conceptualize the scope, goals, and objectives for research programs to identify and/or develop treatment intervention programs that could enhance the development of oral and written language abilities in well-defined groups and subgroups of LD children. This RFA can be thought of as an expression of both the NICHDs long-standing commitment to learning disabilities in general, as well as the NICHDs specific commitment to the 1990 planning of intervention studies. Focus The specific focus of this RFA on treatment/intervention studies with LD children between the ages of six and twelve who manifest primary deficits in oral and written language, is related to the current understanding of the developmental nature of reading and writing disabilities. The past decade has seen a significant increase in knowledge related to the relationship between deficits in component oral language abilities (e.g., phonology, semantics, syntax), orthographic capabilities, and reading (e.g., word attack/decoding word recognition, comprehension) and written language (spelling, formulation/composition, expression) deficits. More specifically, a great deal is now known about which linguistic, perceptual, and word recognition (orthographic) mechanisms are related to the development of accurate and fluent reading and writing abilities. Moreover, there now exists a substantial body of information related to how best to account for the heterogeneity and levels of severity within samples of LD readers and writers. This progress will allow investigators to define their samples for study according to rigorous criteria related to critical marker variables. In addition, a review of current prevalence studies suggest that 60 to 80 percent of identified LD children manifest primary deficits in language-based reading deficits. In contrast, current knowledge related to the developmental course and diagnostic characteristics of children who display primary deficits in mathematics and/or social competencies is less well developed, and intervention research at the proposed level of complexity within this RFA must await a broadening and strengthening of the scientific footing upon which treatments for these primary domain deficits could be based. Research Population Learning Disabled children between the ages of six and twelve with primary deficits in component oral and written language abilities that are related to well-defined disabilities or combinations of disabilities in phonological skills, semantic skills, syntactic skills, word-attack skills, orthographic skills, spelling abilities, and written composition skills should constitute the population of interest for this research program. It is expected that not all children within the samples selected for study will manifest the entire range of oral and written language deficits mentioned above. More specifically, within any sample chosen for study, there are likely to be subgroups with significantly different patterns of comorbidity, levels of severity, and psychological processing deficits. As such, applicants should consider research protocols that are capable of identifying well-defined subgroups and subtypes that exist within the sample. Investigators should also consider casting the sampling net wide enough to ensure a representative number of subtypes and contrast groups within the study population. For example, of interest are subtypes of dyslexic children of varying intellectual abilities, with primary deficits in word attack/decoding and/or comprehension skills, who display a single comorbid deficit or a combination of comorbid deficits in attention, oral language, mathematics, behavioral, and social competencies; subtypes of dyslexic children without comorbid deficits, and subtypes of children with and without comorbid deficits whose reading and writing deficits are associated with known pathophysiological factors or neuroencephalopathic events (e.g., head injury, neoplasm, post surgical complications). Subject Selection Criteria The samples for study should be rigorously defined so that complete replication at another site can be accomplished. Within this context, applicants should provide clearly documented and operationalized definitions for their subject selection criteria. These definitions and criteria must be specified in an a priori manner. The selection of "school-identified" or "clinic-identified" learning disabled children is clearly discouraged unless the diagnostic characteristics in these cases matches the applicant's a priori established selection criteria. Likewise, criteria for selection of contrast group(s) should be specified in an a priori manner. All children selected for study must be defined with reference to age, gender, grade level, length of time in special education placement, type of current special education placement, previous special education placement(s) including intensity and duration, ethnicity, socio-economic status, primary learning disability, comorbid disabilities, severity of disability, familial and/or genetic findings, physical/neurological findings, intellectual status, cognitive-linguistic status, neurophysiological/neuropsychological status, levels of academic achievement in reading, mathematics, and written language, and presence or absence of attention deficit disorder. Measurement Criteria Standardized tests, laboratory tasks, observational measures, and other assessment procedures (e.g., dynamic assessment procedures) must be selected on the basis of known reliability and validity and appropriateness for the population under study. If reliability and validity characteristics are not yet known for a particular assessment or measurement procedure, the application should contain specific plans for establishing these features. The valid measurement of change over time is critical to the research called for in this RFA since treatment effectiveness is of primary concern. As such, applicants should be aware of, and utilize robust procedures for, separating treatment effects from the effects of development in general. The use of growth models and longitudinal data are encouraged as is the collection of sufficient data prior to the onset of treatment(s) to allow estimation of pre- and post-treatment growth curves. Measurement should also be carried out across several time points. Treatments Review of the literature related to dyslexia and other learning disabilities suggests that no single treatment/intervention approach or method is likely to yield clinically significant, long-term, therapeutic gains in heterogeneous groups of LD children. Likewise, even in homogeneous groups of disabled readers (dyslexics) matched on well-defined criteria such as age, IQ, socio-economic status, and opportunity to learn, members differ significantly in their development of requisite skills (e.g., phonological awareness) that are significantly related to the development of fluent and automatic basic reading and written language skills. This suggests that not all children fail to develop oral and written language skills for the same reasons and, as such, will not respond equally well to the same treatment or multi-modality approach. Unfortunately, to date, there exists scant scientific support for the use of particular treatment/interventions or combination of treatments with different types of oral and written language disabilities. There are several factors that contribute to limitations in documented treatment efficacy for LD children, and these factors should be considered in the design of subsequent treatment studies: First, many studies addressing the efficacy of different treatment/intervention methods and approaches for LD individuals have studied heterogeneous groups of children who were identified according to vague and inconsistent criteria, and who demonstrated unaccounted for differences in demographic background features, number and degree of comorbid disabilities, and severity of primary and comorbid disabilities. As such, not only have replication efforts been negated, but it has been impossible to determine specific treatment effects and outcomes due to the possible influence of uncontrolled nuisance variables. Moreover, this lack of description with respect to the children's background and academic and information processing characteristics have made it difficult to identify which treatment/intervention methods are indicated and/or contra-indicated for which children, under what conditions. Second, many studies of LD children's response to treatment models, approaches, and methods have employed intervention procedures that are poorly described and defined. For instance, few intervention studies critically describe how and why treatment/intervention stimuli are represented to the child. In addition, the type of response that the treatment/intervention procedure requires of the child is rarely defined in detail. In treatment/intervention investigations involving reading disorders, few studies have provided sufficient detail with respect to the following critical questions: What is the nature of the vocabulary? Is vocabulary controlled? On what basis were the words used in the treatment protocol selected? Do the word stimuli possess a consistent phoneme-grapheme relationship? How many meaningful nouns and verbs are used? What is the nature of the sentence structure? Is the sentence structure similar to the child's language? What is the nature of the content of the reading material? Is the material relevant to the child's background? Are the sound and word decoding strategies that are utilized analytic or synthetic in nature? Does the treatment/intervention require deductive or inductive cognitive operations, or both? Unless sufficient descriptive data are available to answer these types of questions, replication and an understanding of the critical variables necessary for positive response to treatment/intervention will be difficult to ascertain. Third, treatment/intervention studies that employ models, approaches, or methods that have several components or procedures rarely report which component or procedure or which combination of procedures are most critical to promoting gains in learning at different developmental stages during the learning process for different types of youngsters with LD. Likewise, treatment studies employing multimodal interventions frequently fail to identify how and why the different interventions are selected and the roles that the different interventions play in achieving treatment gains. This information is critical since some children with LD may require a stronger emphasis on particular components of the intervention program given their particular array of cognitive, linguistic, neuropsychological, behavioral, and attentional characteristics. Fourth, the majority of treatment/intervention studies conducted with youngsters with LD have been relatively short-term in duration. As such, when limited effects of a treatment or combination of treatments are reported, it is not clear whether the limited efficacy is due to the treatment itself or to the fact that it was employed for a duration that was too short to promote long-term change, no matter how robust the intervention. Moreover, it is likely that even the most powerful treatments or combination of treatments may not result in measurable effects during or immediately following specific durations of intervention, if such effects are assessed by static measures or within too short a timeframe. As such, measurement methodologies must be employed that are capable of assessing fine grained changes in child functioning across several domains over a well defined period of time. Fifth, many treatment studies assessing the effectiveness of different interventions may have been confounded by the effects of previous and concurrent interventions. It is unclear whether a history of a particular type of treatment(s) significantly influences response to an ongoing intervention. It is also not well understood whether concurrent interventions or programs being conducted in regular or special classroom settings influence response to ongoing experimental treatments. These issues must be addressed in order to separate specific treatment effects from contaminating practice or inhibitory effects produced by historical or concomitant interventions. Sixth, a significant number of treatment studies involving children with LD have not separated specific intervention or program effects from clinician or teacher effects. That is, limited attention has been paid to delineating those teacher and environmental variables that can account for change within any treatment program. What content, assessment, teaching and behavior management capabilities do successful clinicians and teachers possess that less successful ones do not? How do these clinician/teacher characteristics interact with the magnitude and generalization of change? Seventh, it is not clear from the existing treatment literature whether or not gains in oral and written language skills developed under highly controlled intervention conditions generalize to less controlled naturalistic settings. As such, follow-up studies of treatment benefits have typically shown a decrease in treatment gains, particularly when measurements are taken in settings that are different from those employed in the original treatment trials. Issues related to the generalization and maintenance of treatment effects should be explored. Rationale and Research Questions A critical public health task confronting the field of learning disabilities is to understand and define the treatment/intervention variables and factors that have to be considered when addressing the oral and written language needs of children with LD. There exists an immediate and compelling need to develop intervention protocols that increase the probability that individuals with well-defined LD will acquire proficient reading and written language skills as well as the skills that are related to these developmental learning processes. To this end, examples of research questions and areas that need to be addressed are provided below. These examples are illustrative but not restrictive. 1. How do deficits in information processing abilities (e.g., phonological processing, listening comprehension, visual perception, orthographic processing and memory, spatial and temporal processing) interact with well-defined treatment/interventions to develop specific skills, concepts, and/or strategies? Are certain interventions more efficacious with certain processing profiles? Can type and severity of processing deficit predict response to intervention? 2. How does comorbidity affect response to different treatment models, approaches, methods? For example, do children with dyslexia and attention deficit disorder show a different response to treatment(s) than dyslexic children without attention deficit disorder? Do children with combined deficits in oral language (e.g., phonology), written language (reading, spelling), and other academic skills (e.g., mathematics) require different types of intervention, levels of intensity, and greater duration in treatment than children without such comorbidities? 3. Are different deficits in component oral language skills (e.g., phonology, semantics, syntax) related to different reading and written language disabilities? For example, do phonological deficits predict deficits in word attack skills or word recognition skills or both? Are semantic deficits more related to word recognition deficits than are phonological deficits? Are different treatment/interventions required to produce maximum benefits with these different constellations of oral and written language deficits? 4. Is there differential treatment response by gender? By socio-economic status? By comorbidity? Do type and level of severity of processing deficit, comorbidity, SES, and gender interact with treatment response? 5. Are combined or tailored treatment/intervention approaches more efficacious than "packaged" programs? If so, with which types of children and at what age? 6. Are synthetic phonics approaches more efficacious than analytic phonics approaches in the treatment of dyslexia? Do these different approaches have different probabilities of success depending on the background, demographic, and diagnostic features of the child? 7. Are code-emphasis treatment approaches (e.g., alphabetic approaches) more efficacious than meaning-emphasis approaches (e.g., whole language approaches) in the treatment of dyslexia? If so, do different subtypes respond differentially to these approaches? Is a combination of these approaches warranted? 8. How is generalization of treatment effects best accomplished across settings? What critical conditions must be in place in order to transfer skills learned in highly intensive treatment settings to less intensive settings? 9. How do affective variables relate to the acquisition of oral and written language skills? Likewise, how do motivational factors interact with response to treatment? 10. How do previous and concurrent treatments affect response to intervention? 11. What correlations exist between type of processing deficits, severity of deficits, degree of comorbidity, response to intervention, and neurophysiological and neuropsychological status? 12. Are positive responses to treatment for component oral and written language deficits accompanied by changes in neurophysiological, neuropsychological, affective, social, and attentional status? 13. What declarative and procedural knowledge must clinicians and teachers possess to maximize treatment response in children with LD? How is this knowledge best developed? 14. Are there decision making frameworks or clinical heuristics that can be used to guide treatment and to enhance efficacy? How are these frameworks best developed and implemented? 15. How can treatment success and efficacy best be measured? How are growth curves best assessed? Are static or dynamic measures best suited for the monitoring of treatment effects? 16. It is likely that treatments will involve several components. How and when are component analyses developed and used to interpret treatment effects? 17. Are well-defined treatments for oral and written language disorders manifested by children with LD equally efficacious for children whose oral and written language deficits are related to head-injury? Lower cognitive ability? SES? Lack of exposure to learning? STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS The research subjects will be boys and girls between the ages of six and twelve years-of-age. Investigators are encouraged to study male and female children varying in their racial and socio-economic background. NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on PHS form 398 (rev. 9/91). This application form is available in the business or grants and contracts office at most academic and research institutions and from the Office of Grants Inquiries, Division of Research Grants, NIH, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. The receipt deadline for applications prepared in response to this RFA is January 7, 1993. Late applications will not be accepted. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. 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, Research on Treatment Effectiveness for Learning Disabled (LD) Children, and the RFA number must be typed on line 2a of the face page of the application form and the YES box must be marked. The original and three copies of the application must be sent or delivered to: Office of Grants Inquiries Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two copies of the application must be sent under separate cover to: Laurance Johnston, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 9000 Rockville Pike Bethesda, MD 20892 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by staff of the NICHD for responsiveness to the RFA. Applications deemed non-responsive will be returned to the applicant. In the event that an application is returned, the applicant has the option to resubmit the application to the Division of Research Grants as an unsolicited application during one of the three yearly review cycles (February 1, June 1, October 1). If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been 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. Responsive applications may be evaluated by preliminary triage in a peer review group to determine the scientific merit relative to other applications received in connection with this RFA. Applications judged to be non-competitive will not be considered further. The Principal Investigator and his/her institutional business official will be notified in such instances. Those applications judged to be competitive will be further evaluated for technical and scientific merit by a peer review panel convened for this purpose by the Division of Scientific Review, NICHD. Review criteria will be those customarily used by the NIH to evaluate investigator-initiated R01 applications, including: o Thorough knowledge of the scientific literature in appropriate fields; o Scientific, technical, or medical significance and originality of the proposed research; o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o Qualifications and research experience of the Principal Investigator; o Appropriateness of the proposed budget and duration in relation to the proposed research. Following evaluation by the initial review group, all applications will be reviewed by the National Advisory Child Health and Human Development Council. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Requests for additional programmatic information may be addressed to: G. Reid Lyon, Ph.D. Human Learning and Behavior Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-6591 Direct inquiries regarding fiscal and administrative matters to: E. Douglas Shawver Office of Grants and Contracts National Institute of Child Health and Human Development 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-1303 AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42, USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. Awards are also made under authorization of PHS Act, Title V, Part B. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health System Agency review. .
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