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NCT00085202 · OUTCOME

Reading Decoding Composite Scores in the Intervention and Standard of Care Groups

Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor · Source last updated 2024-02-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Error
Time frame
5 years postdiagnosis

What was measured

SOC is standard-of-Care control group. Patients randomly assigned to the control group received the current standard of care. RI is Reading Intervention Group. Patients randomly assigned to Reading Intervention Group which is with The Fast ForWord program. Assessment of reading decoding was completed using the Woodcock Johnson, Third Edition (WJIII) Tests of Achievement (Woodcock, McGraw, \& Mather, 2001), with particular attention given to the reading and reading-related abilities. Two subtests were completed: (1) Letter-Word Identification, and (2) Word Attack, a test requiring the patient to read phonologically regular nonwords. The combination of these two subtests provided a standardized composite score of overall reading decoding ability with a population mean of 100 and a standard deviation of 15. Scores of 90-110 are considered to be in the average range, while those 80-89 are considered low-average (refer: Journal of Pediatric Psychology 39(4) pp. 450-458, 2014).

Analysis population: Of the 126 MB patients enrolled, 41 were not eligible. This left 85 patients considered eligible for the randomization study. Of the 85 eligible patients,81 were randomized to either SOC (n= 38) or to RI (n =43). The parents of only four patients did not consent to the intervention study. Two patients randomized to the RI group, and four patients in the SOC group, were excluded due to having only a single assessment, which resulted in 75 patients (RI=41, SOC=34) over a 5-year follow-up period.

Groups in this outcome

Intervention

A COMPUTER-BASED TRAINING SYSTEM SPECIFICALLY TARGETING LANGUAGE, READING, AND LEARNING SKILLS (FAST FORWORD®, SCIENTIFIC LEARNING CORPORATION)

Standard of Care

THE CURRENT STANDARD OF CARE ON READING DECODING SKILLS

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Intervention41
Standard of Care34

Reported measurements

Baseline
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Intervention104.11.902Not reportedNot reportedNot reported
Standard of Care102.42.604Not reportedNot reportedNot reported
Change over time
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Intervention-1.510.4849Not reportedNot reportedNot reported
Standard of Care-1.170.4883Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    Change over time
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6231
    statistical Method
    t-test, 2 sided
  2. group Description
    Baseline
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5720
    statistical Method
    t-test, 2 sided
Complete source fields
analyses
  1. group Description
    Change over time
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6231
    statistical Method
    t-test, 2 sided
  2. group Description
    Baseline
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5720
    statistical Method
    t-test, 2 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.902
        value
        104.1
      2. group Id
        OG001
        spread
        2.604
        value
        102.4
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.4849
        value
        -1.51
      2. group Id
        OG001
        spread
        0.4883
        value
        -1.17
    title
    Change over time
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      34
    units
    Participants
description
SOC is standard-of-Care control group. Patients randomly assigned to the control group received the current standard of care. RI is Reading Intervention Group. Patients randomly assigned to Reading Intervention Group which is with The Fast ForWord program. Assessment of reading decoding was completed using the Woodcock Johnson, Third Edition (WJIII) Tests of Achievement (Woodcock, McGraw, \& Mather, 2001), with particular attention given to the reading and reading-related abilities. Two subtests were completed: (1) Letter-Word Identification, and (2) Word Attack, a test requiring the patient to read phonologically regular nonwords. The combination of these two subtests provided a standardized composite score of overall reading decoding ability with a population mean of 100 and a standard deviation of 15. Scores of 90-110 are considered to be in the average range, while those 80-89 are considered low-average (refer: Journal of Pediatric Psychology 39(4) pp. 450-458, 2014).
dispersion Type
Standard Error
groups
  1. description
    A COMPUTER-BASED TRAINING SYSTEM SPECIFICALLY TARGETING LANGUAGE, READING, AND LEARNING SKILLS (FAST FORWORD®, SCIENTIFIC LEARNING CORPORATION)
    id
    OG000
    title
    Intervention
  2. description
    THE CURRENT STANDARD OF CARE ON READING DECODING SKILLS
    id
    OG001
    title
    Standard of Care
param Type
MEAN
population Description
Of the 126 MB patients enrolled, 41 were not eligible. This left 85 patients considered eligible for the randomization study. Of the 85 eligible patients,81 were randomized to either SOC (n= 38) or to RI (n =43). The parents of only four patients did not consent to the intervention study. Two patients randomized to the RI group, and four patients in the SOC group, were excluded due to having only a single assessment, which resulted in 75 patients (RI=41, SOC=34) over a 5-year follow-up period.
reporting Status
POSTED
time Frame
5 years postdiagnosis
title
Reading Decoding Composite Scores in the Intervention and Standard of Care Groups
type
SECONDARY
unit Of Measure
score on a scale

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