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| Sponsors and Collaborators: |
Kennedy-Krieger Research Institute National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
| ClinicalTrials.gov Identifier: | NCT00624234 |
Purpose
The goal of this trial is to determine if children with neurofibromatosis type 1 who have reading disabilities respond the same way—both behaviorally and neurobiologically—to specialized treatment programs as children with idiopathic reading disabilities do, and to determine which intervention is best for particular learner profiles.
| Condition | Intervention |
|---|---|
|
Neurofibromatosis Type 1 Reading Disabilities |
Behavioral: Tutoring Program I Behavioral: Tutoring Program II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study |
| Official Title: | Neurobiology and Treatment of Reading Disability in Neurofibromatosis Type 1 (NF-1) |
| Estimated Enrollment: | 180 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Tutoring Program I
|
Behavioral: Tutoring Program I
Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design.
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2: Experimental
Tutoring Program II
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Behavioral: Tutoring Program II
Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity.
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3: No Intervention
Control group
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The most common concern of parents of children with neurofibromatosis type 1 (NF-1) is learning disabilities (LD). Approximately one half of all children with NF-1 have LD—the most debilitating and common of which are reading disabilities.
The purpose of this study is to determine if children with NF-1 who have reading disabilities respond the same way—both behaviorally and neurobiologically—to specialized treatment programs known to improve the decoding deficits in children with idiopathic reading disabilities. The trial will also determine which intervention is best for particular learner profiles. The overall purpose of this research is to gain a deeper understanding of the characteristics and treatment of reading disabilities in NF-1.
In the trial, researchers will compare children with NF-1 who show weaknesses in reading to children with reading disabilities of no known cause (idiopathic) using two different interventions and behavioral and neurobiological measures. Both interventions focus on teaching sound-symbol relationships, but vary in terms of relative emphasis on verbal versus visual methods of teaching.
Scientists hope findings from the trial will advance knowledge about the best therapies for LD in children with NF-1. And, by further refining how children with NF-1 who have reading disabilities are similar (or different) to children with idiopathic reading disabilities, the researchers may be able to learn if reading interventions that address areas other than decoding will also benefit children with NF-1. Also, by understanding the similarities and/or differences in the neuropsychological and neurobiological profiles of children with NF-1 who have reading disabilities, and those without, scientists will be able to refine the cognitive phenotype and neurobiological characteristics of NF-1, which will further understanding of central nervous system abnormalities in NF-1.
Eligibility| Ages Eligible for Study: | 8 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
This study will be open to all individuals, ages 8 to 17 years, who meet eligibility criteria regardless of race, gender, or socioeconomic status.
Exclusion Criteria:
Any child, regardless of which group he/she is recruited for, will be excluded if he/she meets any of the following criteria (determined during phone screening, medical review, and during testing):
Contacts and Locations| Contact: Lindsay Goldberg | 443-923-9326 | readingresearch@kennedykrieger.org |
| United States, Maryland | |
| Kennedy Krieger Institute, F. M. Kirby Research Center for Functional Brain Imaging | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Contact: Laurie E. Cutting, Ph.D. 443-923-9250 cutting@kennedykrieger.org | |
| Contact: Martha Bridge Denckla 443-923-9250 | |
| Principal Investigator: Laurie E. Cutting, Ph.D. | |
| Principal Investigator: Martha Bridge Denckla, M.D. | |
| Principal Investigator: Sheryl L. Rimrodt, M.D. | |
| Principal Investigator: | Laurie E. Cutting, Ph.D. | Kennedy Krieger Institute, Johns Hopkins University, Johns Hopkins University School of Medicine |
| Principal Investigator: | Martha Bridge Denckla, M.D. | Kennedy Krieger Institute, Johns Hopkins University, Johns Hopkins University School of Medicine |
| Principal Investigator: | James J. Pekar, Ph.D. | Kennedy Krieger Institute, Johns Hopkins University School of Medicine, F. M. Kirby Research Center for Functional Brain Imaging |
| Principal Investigator: | Sheryl L. Rimrodt, M.D. | Kennedy Krieger Institute, Johns Hopkins University, Johns Hopkins University School of Medicine |
More Information
| Responsible Party: | Kennedy Krieger Institute ( Laurie E. Cutting, Ph.D., Principal Investigator, F. M. Kirby Research Center for Functional Brain Imaging ) |
| Study ID Numbers: | R01NS49096, NF1-R01 |
| Study First Received: | February 25, 2008 |
| Last Updated: | August 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00624234 |
| Health Authority: | United States: Federal Government |
|
neurofibromatosis type 1 reading disabilities NF-1 learning disabilities tutoring intervention |
|
Benzocaine Neurodegenerative Diseases Neurofibromatosis 1 Neurofibromatosis type 1 Methamphetamine Neoplastic Syndromes, Hereditary Heredodegenerative Disorders, Nervous System Neurofibroma |
Genetic Diseases, Inborn Neuromuscular Diseases Peripheral Nervous System Diseases Neurofibromatoses Amphetamine Nerve Sheath Neoplasms Neurocutaneous Syndromes |
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Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neoplasms, Nerve Tissue |
