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Neurobiology and Treatment of Reading Disability in NF-1

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ClinicalTrials.gov Identifier: NCT00624234
Recruitment Status : Completed
First Posted : February 27, 2008
Results First Posted : April 10, 2017
Last Update Posted : November 8, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Laura Cutting, Vanderbilt University

Tracking Information
First Submitted Date  ICMJE February 25, 2008
First Posted Date  ICMJE February 27, 2008
Results First Submitted Date  ICMJE August 5, 2016
Results First Posted Date  ICMJE April 10, 2017
Last Update Posted Date November 8, 2018
Actual Study Start Date  ICMJE February 2006
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2017)
Change From Baseline in WJ-III Basic Reading Normative Update (Woodcock Johnson Psychoeducational Battery - 3rd Edition; WJ-III NU) Standard Score at 15 Hours [ Time Frame: 0 and 15 hours ]
This metric measures change in reading abilities, including word recognition and decoding, as assessed by standard educational assessments (Woodcock Johnson Psychoeducational Battery - 3rd Edition Normative Update; WJ-III NU). The scores are reported as change in age-normed standard scores (a change of 15 standard score points would represent a change of 1 standard deviation in the general population).The Basic Reading score is a normed composite of the WJ-III subtests Letter-Word Identification and Word Attack, representing word-level reading skill.
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
Improvement in basic reading skills as assessed by standard educational assessments (e.g., Woodcock Johnson Psychoeducational Battery - 3rd Edition; WJ-III) [ Time Frame: 0, 5, 10, and 15 hours ]
Change History Complete list of historical versions of study NCT00624234 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2017)
Neuroimaging Data [ Time Frame: Collected before and after intervention ]
Neuroimaging data consists of functional MRI and structural MRI measures.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neurobiology and Treatment of Reading Disability in NF-1
Official Title  ICMJE Neurobiology and Treatment of Reading Disability in Neurofibromatosis Type 1 (NF-1)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Neurofibromatosis Type 1
  • Reading Disabilities
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: NF-Tutoring Program 1
    Tutoring Program I
    Intervention: Behavioral: Tutoring Program I
  • Experimental: NF-Tutoring Program 2
    Tutoring Program II
    Intervention: Behavioral: Tutoring Program II
  • No Intervention: Typically Developing Readers
    Control group
  • Experimental: IRD-Tutoring Program 1
    Tutoring Program I
    Intervention: Behavioral: Tutoring Program I
  • Experimental: IRD-Tutoring Program 2
    Tutoring Program II
    Intervention: Behavioral: Tutoring Program II
  • No Intervention: Waitlist Control
    Intervention Control Group (RD)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2017)
184
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2008)
180
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00624234
Other Study ID Numbers  ICMJE R01NS049096( U.S. NIH Grant/Contract )
NF1-R01
R01NS049096 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified behavioral data (Woodcock Johnson-III NU scores) may be shared with other researchers upon request. De-identified T1 structural neuroimaging scans will be shared with other researchers through a neuroimaging data warehouse or consortium.
Responsible Party Laura Cutting, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Laurie E. Cutting, Ph.D. Vanderbilt University Special Education Department
Principal Investigator: Martha Bridge Denckla, M.D. Kennedy Krieger Institute, Johns Hopkins University, Johns Hopkins University School of Medicine
Principal Investigator: Sheryl L. Rimrodt, M.D. Vanderbilt University Pediatrics Department
Principal Investigator: John Gore, Ph.D. Vanderbilt University
PRS Account Vanderbilt University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP