Clinical Trials Directory

Trials / Completed

CompletedNCT00624234

Neurobiology and Treatment of Reading Disability in NF-1

Neurobiology and Treatment of Reading Disability in Neurofibromatosis Type 1 (NF-1)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
184 (actual)
Sponsor
Vanderbilt University · Academic / Other
Sex
All
Age
8 Years – 17 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTutoring Program ITutoring 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.
BEHAVIORALTutoring Program IITutoring 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.

Timeline

Start date
2006-02-01
Primary completion
2013-03-01
Completion
2017-01-01
First posted
2008-02-27
Last updated
2025-07-08
Results posted
2017-04-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00624234. Inclusion in this directory is not an endorsement.