Neurobiology and Treatment of Reading Disability in NF-1

NCT ID: NCT00624234

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2017-01-31

Brief 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

Neurofibromatosis Type 1; Reading Disabilities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NF-Tutoring Program 1

Tutoring Program I

Group Type: EXPERIMENTAL

Tutoring Program I

Intervention Type: BEHAVIORAL

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.

NF-Tutoring Program 2

Tutoring Program II

Group Type: EXPERIMENTAL

Tutoring Program II

Intervention Type: BEHAVIORAL

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.

Typically Developing Readers

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

IRD-Tutoring Program 1

Tutoring Program I

Group Type: EXPERIMENTAL

Tutoring Program I

Intervention Type: BEHAVIORAL

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.

IRD-Tutoring Program 2

Tutoring Program II

Group Type: EXPERIMENTAL

Tutoring Program II

Intervention Type: BEHAVIORAL

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.

Waitlist Control

Intervention Control Group (RD)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• The Reading Disabilities group (including those with NF-1) is defined by scoring equal to or less than the 25th percentile on measures of basic word reading skills.
• The Control group (including those with NF1) is defined by scoring equal to or above the 40th percentile on the average of the Letter Word Identification and Word Attack subtests from the WJ-III.

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):

• is in foster care;
• previous diagnosis of mental retardation;
• known uncorrectable visual impairment;
• history of known neurological disorder (e.g., epilepsy, spina bifida, cerebral palsy, traumatic brain injury);
• documented hearing impairment greater than 25 dB loss in either ear;
• medical contraindication to MRI procedures, if participating in MRI (including exposure to metal and pregnancy);
• individuals known to have an IQ below 70;
• history or presence of a pervasive developmental disorder;
• during the DICA-IV parents indicate the presence of any severe psychiatric diagnoses or pervasive developmental disorder.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Laura Cutting

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laurie E. Cutting, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Special Education Department

Martha Bridge Denckla, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kennedy Krieger Institute, Johns Hopkins University, Johns Hopkins University School of Medicine

Sheryl L. Rimrodt, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Pediatrics Department

John Gore, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University, Vanderbilt University Institute of Imaging Science

Nashville, Tennessee, United States

Countries

United States

Related Links

https://ebrl.vkcsites.org/

Additional study information

Other Identifiers

NF1-R01

Identifier Type: -

Identifier Source: secondary_id

R01NS049096

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01NS049096

Identifier Type: NIH

Identifier Source: org_study_id

View Link