An interventional study of Tutoring Program I and Tutoring Program II in Neurofibromatosis Type 1 and Reading Disabilities, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 8 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Treatment
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.
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.
176 studies on the registry are indexed under Neurofibromatosis 1; 43 are open to participants now.
This study's enrollment of 184 is above the median of 35 across 114 interventional studies indexed under Neurofibromatosis 1.
Browse Neurofibromatosis 1 studies →Vanderbilt University is the lead sponsor of 522 studies on the registry; 20 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tutoring Program I
Behavioral: Tutoring Program I
Tutoring Program II
Behavioral: Tutoring Program II
Control group
Tutoring Program I
Behavioral: Tutoring Program I
Tutoring Program II
Behavioral: Tutoring Program II
Intervention Control Group (RD)
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.
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.
Change From Baseline in WJ-III Basic Reading Normative Update (Woodcock Johnson Psychoeducational Battery - 3rd Edition; WJ-III NU) Standard Score at 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.
Time frame: 0 and 15 hours
Neuroimaging Data
Neuroimaging data consists of functional MRI and structural MRI measures.
Time frame: Collected before and after intervention
Recruitment period was 2006-2012 and was done via NF organizations and NF clinics, as well as the community recruitment.
| Milestone | NF-Tutoring Program 1 | NF-Tutoring Program 2 | Typically Developing Readers | IRD- Tutoring Program 1 | IRD-Tutoring Program 2 | Waitlist Control |
|---|---|---|---|---|---|---|
| Started | 8 | 9 | 26 | 14 | 18 | 14 |
| Completed | 8 | 9 | 26 | 14 | 18 | 14 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| units on a scale | NF-Tutoring Program 1 | NF-Tutoring Program 2 | Typically Developing Readers | IRD- Tutoring Program 1 | IRD-Tutoring Program 2 | Waitlist Control |
|---|---|---|---|---|---|---|
| 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 ± 13.61 | -1.11 ± 6.94 | -.115 ± 5.13 | 5.86 ± 9.31 | 3.06 ± 9.93 | .143 ± 7.97 |
Neuroimaging data consists of functional MRI and structural MRI measures.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NF-Tutoring Program 1 | — | 0/8 (0%) | 0/8 (0%) |
| NF-Tutoring Program 2 | — | 0/9 (0%) | 0/9 (0%) |
| Typically Developing Readers | — | 0/26 (0%) | 0/26 (0%) |
| IRD-Tutoring Program 1 | — | 0/14 (0%) | 0/14 (0%) |
| IRD-Tutoring Program 2 | — | 0/18 (0%) | 0/18 (0%) |
| Waitlist Control | — | 0/14 (0%) | 0/14 (0%) |
Participants both with and without NF1 were determined by researcher-administered assessments as having Reading Difficulties or typically developing reading skills.
| Age, Continuous(years) | NF-Tutoring Program 1 | NF-Tutoring Program 2 | Typically Developing Readers | IRD- Tutoring Program 1 | IRD-Tutoring Program 2 | Waitlist Control | Total |
|---|---|---|---|---|---|---|---|
| Mean | 9.62 ± 1.13 | 11.06 ± 1.48 | 9.70 ± 1.53 | 10.08 ± 1.63 | 10.33 ± 2.12 | 10.72 ± 2.25 | 10.18 ± 1.79 |
| Sex: Female, Male(Participants) | NF-Tutoring Program 1 | NF-Tutoring Program 2 | Typically Developing Readers | IRD- Tutoring Program 1 | IRD-Tutoring Program 2 | Waitlist Control | Total |
|---|---|---|---|---|---|---|---|
| Female | 5 | 1 | 13 | 6 | 9 | 3 | 37 |
| Male | 3 | 8 | 13 | 8 | 9 | 11 | 52 |
| Woodcock Johnson Achievement Tests(units on a scale) | NF-Tutoring Program 1 | NF-Tutoring Program 2 | Typically Developing Readers | IRD- Tutoring Program 1 | IRD-Tutoring Program 2 | Waitlist Control | Total |
|---|---|---|---|---|---|---|---|
| Mean | 78.25 ± 9.05 | 85.78 ± 7.24 | 103.81 ± 7.41 | 77.57 ± 13.47 | 79.67 ± 9.59 | 79.64 ± 9.66 | 86.88 ± 14.48 |
Plan to share: Yes — 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.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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