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Neurobiology and Treatment of Reading Disability in NF-1

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Laura Cutting, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00624234
First received: February 25, 2008
Last updated: April 11, 2017
Last verified: April 2017
Results First Received: August 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions: Neurofibromatosis Type 1
Reading Disabilities
Interventions: Behavioral: Tutoring Program I
Behavioral: Tutoring Program II

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period was 2006-2012 and was done via NF organizations and NF clinics, as well as the community recruitment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusions: Incomplete Data (n=31), NF without Reading Difficulty (n=11), Age (n=13; excluded CNT and RD age 15yr and over because no NF-RD over 14yr), Low IQ (n=2), Ineligible (n=12; did not fit criteria for either RD or CNT group), Prior to Intervention Change (n=26; enrolled prior to an NIH-approved change in study design regarding intervention)

Reporting Groups
  Description
NF-Tutoring Program 1

Tutoring Program I

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.

NF-Tutoring Program 2

Tutoring Program II

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.

Typically Developing Readers Control group--children who do not have reading problems
IRD- Tutoring Program 1

These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I

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.

IRD-Tutoring Program 2

These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II

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.

Waitlist Control These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.

Participant Flow:   Overall Study
    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 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants both with and without NF1 were determined by researcher-administered assessments as having Reading Difficulties or typically developing reading skills.

Reporting Groups
  Description
NF-Tutoring Program 1

Tutoring Program I

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.

NF-Tutoring Program 2

Tutoring Program II

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.

Typically Developing Readers Control group--children who do not have reading problems
IRD- Tutoring Program 1

These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I

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.

IRD-Tutoring Program 2

These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II

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.

Waitlist Control These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
Total Total of all reporting groups

Baseline Measures
   NF-Tutoring Program 1   NF-Tutoring Program 2   Typically Developing Readers   IRD- Tutoring Program 1   IRD-Tutoring Program 2   Waitlist Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   9   26   14   18   14   89 
Age 
[Units: Years]
Mean (Standard Deviation)
 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 
[Units: Participants]
Count of Participants
             
Female      5  62.5%      1  11.1%      13  50.0%      6  42.9%      9  50.0%      3  21.4%      37  41.6% 
Male      3  37.5%      8  88.9%      13  50.0%      8  57.1%      9  50.0%      11  78.6%      52  58.4% 
Woodcock Johnson Achievement Tests [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 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) 
[1] This metric measures reading abilities (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 age-normed standard scores, with higher scores reflecting better performance on the measure (mean=100, standard deviation=15, such that a score >130 would be very superior and a score <70 would be very low). The Basic Reading score is a normed composite of the WJ-III subtests Letter-Word Identification and Word Attack, representing word-level reading skill.


  Outcome Measures

1.  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   [ Time Frame: 0 and 15 hours ]

2.  Secondary:   Neuroimaging Data   [ Time Frame: Collected before and after intervention ]
Results not yet reported.   Anticipated Reporting Date:   01/2018  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size; Different group sizes; Random assignment to treatment group (along with small sample size) produced some asymmetry of pretest score by treatment group, such that the NF-Tutoring Program 2 started with a higher group mean score.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Laurie Cutting
Organization: Vanderbilt University
phone: 615-875-1054
e-mail: Laurie.Cutting@Vanderbilt.Edu



Responsible Party: Laura Cutting, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00624234     History of Changes
Other Study ID Numbers: R01NS049096 ( U.S. NIH Grant/Contract )
NF1-R01
Study First Received: February 25, 2008
Results First Received: August 5, 2016
Last Updated: April 11, 2017