N/A
N=89
Neurobiology and Treatment of Reading Disability in NF-1
Neurofibromatosis Type 1 · Reading Disabilities
Bottom Line
View on ClinicalTrials.gov: NCT00624234 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Change From Baseline in WJ-III Basic Reading Normative Update (Woodcock Johnson Psychoeducational Battery - 3rd Edition; WJ-III NU) Standard Score at 15 Hours — 13.50; -1.11; -.115; 5.86 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tutoring Program I (Behavioral); Tutoring Program II (Behavioral)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in WJ-III Basic Reading Normative Update (Woodcock Johnson Psychoeducational Battery - 3rd Edition; WJ-III NU) Standard Score at 15 Hours |
13.50; -1.11; -.115; 5.86; 3.06; .143 | — |
| SECONDARY Neuroimaging Data |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00624234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.