Trial Outcomes & Findings for Neurobiology and Treatment of Reading Disability in NF-1 (NCT NCT00624234)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

184 participants

Primary outcome timeframe

0 and 15 hours

Results posted on

2025-07-08

Participant Flow

Recruitment period was 2006-2012 and was done via NF organizations and NF clinics, as well as the community recruitment.

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)

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	8	9	26	14	18	14
Overall Study COMPLETED	8	9	26	14	18	14
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neurobiology and Treatment of Reading Disability in NF-1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NF-Tutoring Program 1 n=8 Participants 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 n=9 Participants 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 n=26 Participants Control group--children who do not have reading problems	IRD- Tutoring Program 1 n=14 Participants 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 n=18 Participants 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 n=14 Participants These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.	Total n=89 Participants Total of all reporting groups
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	13 Participants n=5 Participants	6 Participants n=4 Participants	9 Participants n=21 Participants	3 Participants n=8 Participants	37 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants	8 Participants n=4 Participants	9 Participants n=21 Participants	11 Participants n=8 Participants	52 Participants n=8 Participants
Age, Continuous	9.62 years STANDARD_DEVIATION 1.13 • n=5 Participants	11.06 years STANDARD_DEVIATION 1.48 • n=7 Participants	9.70 years STANDARD_DEVIATION 1.53 • n=5 Participants	10.08 years STANDARD_DEVIATION 1.63 • n=4 Participants	10.33 years STANDARD_DEVIATION 2.12 • n=21 Participants	10.72 years STANDARD_DEVIATION 2.25 • n=8 Participants	10.18 years STANDARD_DEVIATION 1.79 • n=8 Participants
Woodcock Johnson Achievement Tests	78.25 units on a scale STANDARD_DEVIATION 9.05 • n=5 Participants	85.78 units on a scale STANDARD_DEVIATION 7.24 • n=7 Participants	103.81 units on a scale STANDARD_DEVIATION 7.41 • n=5 Participants	77.57 units on a scale STANDARD_DEVIATION 13.47 • n=4 Participants	79.67 units on a scale STANDARD_DEVIATION 9.59 • n=21 Participants	79.64 units on a scale STANDARD_DEVIATION 9.66 • n=8 Participants	86.88 units on a scale STANDARD_DEVIATION 14.48 • n=8 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	NF-Tutoring Program 1 n=8 Participants 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 n=9 Participants 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 n=26 Participants Control group--children who do not have reading problems	IRD- Tutoring Program 1 n=14 Participants 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 n=18 Participants 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 n=14 Participants These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
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 units on a scale Standard Deviation 13.61	-1.11 units on a scale Standard Deviation 6.94	-.115 units on a scale Standard Deviation 5.13	5.86 units on a scale Standard Deviation 9.31	3.06 units on a scale Standard Deviation 9.93	.143 units on a scale Standard Deviation 7.97

SECONDARY outcome

Timeframe: Collected before and after intervention

Neuroimaging data consists of functional MRI and structural MRI measures.

Outcome measures

Other adverse events

Adverse event data not reported

Additional Information

Dr. Laurie Cutting

Vanderbilt University

Phone: 615-875-1054

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place