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出境医 / 临床实验 / Improving the Academic Performance of First-Grade Students With Reading and Math Difficulty

Improving the Academic Performance of First-Grade Students With Reading and Math Difficulty

Study Description
Brief Summary:
The main purpose of this clinical trials is to explore short-term effects of coordinated intervention versus the business-as-usual school program on the primary endpoints of post-intervention word-reading fluency and arithmetic fluency. The study population is students who begin 1st grade with delays in word reading and calculations. Students who meet entry criteria are randomly assigned to coordinated intervention across reading and math, reading intervention, math intervention, and a business-as-usual control group (schools' typical program). The 3 researcher-delivered interventions last 15 weeks (3 sessions per week; 30 minutes per session). Students in all 4 conditions are tested before researcher-delivered intervention begins and after it ends.

Condition or disease Intervention/treatment Phase
Reading Learning Disability Math Learning Disability Behavioral: Reading Intervention Behavioral: Math Intervention Behavioral: Coordinated Intervention Not Applicable

Detailed Description:

First-grade students who meet study entry criteria are identified near the start of the school year using a 3-stage screening process. Students who enter the study complete the pretest battery.

Then, students are randomly assigned at the individual level to coordinated intervention, reading intervention, math intervention, or a business-as-usual control group (the schools' typical classroom instruction with supplemental intervention schools choose to provide). Research staff deliver intervention in the coordinated intervention condition, in the reading intervention condition, and in the math intervention condition 1:1 for 15 weeks (three 30-min sessions per week, scheduled in line with teacher input to avoid students missing important content). Adherence to the researcher-delivered interventions is monitored via audio recordings and live observations.

The content of each researcher-delivered intervention is aligned with the school district's 1st-grade foundational reading & math learning standards; relies on explicit instruction; and incorporates fluency-building activities word reading and/or arithmetic problems; incorporates procedures designed to build engagement and perseverance. Reading intervention is designed to build skill in letter-sound associations, decoding, sight words, and contextualized reading. Math intervention provides is designed to build number knowledge, counting strategies, and arithmetic skill. Coordinated intervention addresses the same instructional objectives as reading intervention & math intervention.

When researcher-delivered intervention ends, students in all four conditions complete the posttest assessment battery. Testers are blind to students' study conditions. Adherence to testing protocols is monitored via audio recordings. The primary endpoints are posttest word-reading fluency and arithmetic fluency.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving the Academic Performance of First-Grade Students With Reading and Math Difficulty
Actual Study Start Date : November 11, 2019
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: Coordinated Reading and Math Intervention
Coordinated intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction addressing similar skills as those addressed in the reading intervention arm & similar skills as the math intervention arm.
 Behavioral: Coordinated Intervention
Coordinated intervention provides 15 weeks (30-minute sessions per week) of explicit instruction addressing the similar skills as in the reading intervention arm & similar objectives as the math intervention arm.
Active Comparator: Reading Intervention
Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction designed to build skill on letter-sound associations, decoding, sight words, & contextualized reading.
 Behavioral: Reading Intervention
Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction to build skill on letter-sound associations, decoding, sight words, & contextualized reading.
Active Comparator: Math Intervention
Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.
 Behavioral: Math Intervention
Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge & counting strategies to build arithmetic skill.
No Intervention: Business-as-usual Control
Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.
Outcome Measures
Primary Outcome Measures :
  1. Word Reading Fluency-2 (Zumeta et al., 2012) [ Time Frame: an average of 25 weeks ]
    Students have 1 min to read 60 words randomly sampled/presented in bands of 5 words from most frequent words; then from next-most frequent words; etc.). If students finish before 1 min, the score is prorated. Two alternate forms are administered.

  2. Test of Word Reading Efficiency-Sight Word Efficiency [ Time Frame: an average of 25 weeks ]
    The tester shows a word list ordered in increasing difficulty; children read as many words as they can in 45 seconds.

  3. Arithmetic Combinations Fluency - Addition (Fuchs et al., 2013) [ Time Frame: an average of 25 weeks ]
    Students have 1 minute to write answers to 25 addition items (sums 5-12).

  4. Arithmetic Combinations Fluency - Subtraction (Fuchs et al., 2013) [ Time Frame: an average of 25 weeks ]
    Students have 1 minute to write answers to 25 subtraction items (minuends 5-12).


Secondary Outcome Measures :
  1. Wide Range Achievement Test-4-Reading (WRAT4; Wilkinson, & Robertson, 2006) [ Time Frame: an average of 25 weeks ]
    Students read words ordered in difficulty (no time limit; testing ends after 10 consecutive errors).

  2. WRAT-4-Arithmetic (Wilkinson, & Robertson, 2006) [ Time Frame: an average of 25 weeks ]
    Children complete calculation problems of increasing difficulty (10 minutes).


Other Outcome Measures:
  1. Comprehensive Test of Phonological Processing (CTOPP; Wagner et al., 2013)-Elision [ Time Frame: an average of 25 weeks ]
    Students say words with a constituent part removed from the words.

  2. CTOPP-Sound Matching [ Time Frame: an average of 25 weeks ]
    Children see words and for each say which of 3 words (shown as pictures) start/end with the same sound.

  3. SWAN Attentive Behavior Rating Scale (J. Swanson, 2004) [ Time Frame: an average of 25 weeks ]
    Teachers rate 9 items from the DSM criteria for Attention Deficit Hyperactivity Disorder for inattention, each on a 7-point scale. The score is the sum of the 9 ratings.

  4. The Grit Scale (Duckworth & Quinn, 2009)-grade 1 [ Time Frame: an average of 25 weeks ]
    Students rate their own beliefs concerning perseverance in learning. The grade 1 adaptation simplifies language and situates questions entirely in terms of reading & math.

  5. Rating Scale of Effort & Motivation (Malone & Fuchs, 2014) [ Time Frame: an average of 25 weeks ]
    Teachers rate items assessing students' effort and motivation.

  6. Working Memory Test Battery for Children - Nonword List Recall (WMTB-C; Pickering & Gathercole, 2001) [ Time Frame: an average of 25 weeks ]
    Children repeat stimuli spoken by the tester in the same order. Trials correct is the score.

  7. Test of First-Grade Reading Comprehension (Fuchs, Fuchs, Craddock, & Lehman, 2017). [ Time Frame: an average of 25 weeks ]
    Children read short passages aloud and answer open-ended literal and inferential questions. Number correct is the score.

  8. Test of First-Grade Math Word Problems (Fuchs, Seethaler, & Craddock, 2009) [ Time Frame: an average of 25 weeks ]
    Children listen words problem read aloud to them, while they see the text, and find solutions.Number correct is the score.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Attends a participating school in the Metropolitan-Nashville Public Schools
  • Is a member of a first-grade classroom whose teacher has agreed to let his/her students participate
  • Has the available school schedule to participate
  • Has adequate English proficiency to be reliably assessed in English on study entry screening measures
  • Scores at or below the 25th percentile on the study's screening math test
  • Scores at or below the 25th percentile on the study's screening reading test
  • Scores at or above the 7th percentile on at least one of the study's two measures of cognitive performance

Exclusion Criterion:

  • Does not attend a participating school in the Metropolitan-Nashville Public Schools
  • Is not a member of a first-grade classroom whose teacher has agreed to let his/her students participate
  • Does not have the available school schedule to participate
  • Does not have adequate English proficiency to be reliably assessed in English on study entry screening measures
  • Scores above the 25th percentile on the study's screening math test
  • Scores above the 25th percentile on the study's screening reading test
  • Scores below the 7th percentile on both of the study's two measures of cognitive performance
Contacts and Locations

Locations
Layout table for location information
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University
Investigators
Layout table for investigator information
Principal Investigator: Douglas Fuchs, Ph.D. Vanderbilt University
Tracking Information
First Submitted Date  ICMJE June 13, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date April 14, 2021
Actual Study Start Date  ICMJE November 11, 2019
Estimated Primary Completion Date August 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Word Reading Fluency-2 (Zumeta et al., 2012) [ Time Frame: an average of 25 weeks ]
    Students have 1 min to read 60 words randomly sampled/presented in bands of 5 words from most frequent words; then from next-most frequent words; etc.). If students finish before 1 min, the score is prorated. Two alternate forms are administered.
  • Test of Word Reading Efficiency-Sight Word Efficiency [ Time Frame: an average of 25 weeks ]
    The tester shows a word list ordered in increasing difficulty; children read as many words as they can in 45 seconds.
  • Arithmetic Combinations Fluency - Addition (Fuchs et al., 2013) [ Time Frame: an average of 25 weeks ]
    Students have 1 minute to write answers to 25 addition items (sums 5-12).
  • Arithmetic Combinations Fluency - Subtraction (Fuchs et al., 2013) [ Time Frame: an average of 25 weeks ]
    Students have 1 minute to write answers to 25 subtraction items (minuends 5-12).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Wide Range Achievement Test-4-Reading (WRAT4; Wilkinson, & Robertson, 2006) [ Time Frame: an average of 25 weeks ]
    Students read words ordered in difficulty (no time limit; testing ends after 10 consecutive errors).
  • WRAT-4-Arithmetic (Wilkinson, & Robertson, 2006) [ Time Frame: an average of 25 weeks ]
    Children complete calculation problems of increasing difficulty (10 minutes).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 17, 2019)
  • Comprehensive Test of Phonological Processing (CTOPP; Wagner et al., 2013)-Elision [ Time Frame: an average of 25 weeks ]
    Students say words with a constituent part removed from the words.
  • CTOPP-Sound Matching [ Time Frame: an average of 25 weeks ]
    Children see words and for each say which of 3 words (shown as pictures) start/end with the same sound.
  • SWAN Attentive Behavior Rating Scale (J. Swanson, 2004) [ Time Frame: an average of 25 weeks ]
    Teachers rate 9 items from the DSM criteria for Attention Deficit Hyperactivity Disorder for inattention, each on a 7-point scale. The score is the sum of the 9 ratings.
  • The Grit Scale (Duckworth & Quinn, 2009)-grade 1 [ Time Frame: an average of 25 weeks ]
    Students rate their own beliefs concerning perseverance in learning. The grade 1 adaptation simplifies language and situates questions entirely in terms of reading & math.
  • Rating Scale of Effort & Motivation (Malone & Fuchs, 2014) [ Time Frame: an average of 25 weeks ]
    Teachers rate items assessing students' effort and motivation.
  • Working Memory Test Battery for Children - Nonword List Recall (WMTB-C; Pickering & Gathercole, 2001) [ Time Frame: an average of 25 weeks ]
    Children repeat stimuli spoken by the tester in the same order. Trials correct is the score.
  • Test of First-Grade Reading Comprehension (Fuchs, Fuchs, Craddock, & Lehman, 2017). [ Time Frame: an average of 25 weeks ]
    Children read short passages aloud and answer open-ended literal and inferential questions. Number correct is the score.
  • Test of First-Grade Math Word Problems (Fuchs, Seethaler, & Craddock, 2009) [ Time Frame: an average of 25 weeks ]
    Children listen words problem read aloud to them, while they see the text, and find solutions.Number correct is the score.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Improving the Academic Performance of First-Grade Students With Reading and Math Difficulty
Official Title  ICMJE Improving the Academic Performance of First-Grade Students With Reading and Math Difficulty
Brief Summary The main purpose of this clinical trials is to explore short-term effects of coordinated intervention versus the business-as-usual school program on the primary endpoints of post-intervention word-reading fluency and arithmetic fluency. The study population is students who begin 1st grade with delays in word reading and calculations. Students who meet entry criteria are randomly assigned to coordinated intervention across reading and math, reading intervention, math intervention, and a business-as-usual control group (schools' typical program). The 3 researcher-delivered interventions last 15 weeks (3 sessions per week; 30 minutes per session). Students in all 4 conditions are tested before researcher-delivered intervention begins and after it ends.
Detailed Description

First-grade students who meet study entry criteria are identified near the start of the school year using a 3-stage screening process. Students who enter the study complete the pretest battery.

Then, students are randomly assigned at the individual level to coordinated intervention, reading intervention, math intervention, or a business-as-usual control group (the schools' typical classroom instruction with supplemental intervention schools choose to provide). Research staff deliver intervention in the coordinated intervention condition, in the reading intervention condition, and in the math intervention condition 1:1 for 15 weeks (three 30-min sessions per week, scheduled in line with teacher input to avoid students missing important content). Adherence to the researcher-delivered interventions is monitored via audio recordings and live observations.

The content of each researcher-delivered intervention is aligned with the school district's 1st-grade foundational reading & math learning standards; relies on explicit instruction; and incorporates fluency-building activities word reading and/or arithmetic problems; incorporates procedures designed to build engagement and perseverance. Reading intervention is designed to build skill in letter-sound associations, decoding, sight words, and contextualized reading. Math intervention provides is designed to build number knowledge, counting strategies, and arithmetic skill. Coordinated intervention addresses the same instructional objectives as reading intervention & math intervention.

When researcher-delivered intervention ends, students in all four conditions complete the posttest assessment battery. Testers are blind to students' study conditions. Adherence to testing protocols is monitored via audio recordings. The primary endpoints are posttest word-reading fluency and arithmetic fluency.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Reading Learning Disability
  • Math Learning Disability
Intervention  ICMJE
  • Behavioral: Reading Intervention
    Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction to build skill on letter-sound associations, decoding, sight words, & contextualized reading.
  • Behavioral: Math Intervention
    Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge & counting strategies to build arithmetic skill.
  • Behavioral: Coordinated Intervention
    Coordinated intervention provides 15 weeks (30-minute sessions per week) of explicit instruction addressing the similar skills as in the reading intervention arm & similar objectives as the math intervention arm.
Study Arms  ICMJE
  • Experimental: Coordinated Reading and Math Intervention
    Coordinated intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction addressing similar skills as those addressed in the reading intervention arm & similar skills as the math intervention arm.
    Intervention: Behavioral: Coordinated Intervention
  • Active Comparator: Reading Intervention
    Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction designed to build skill on letter-sound associations, decoding, sight words, & contextualized reading.
    Intervention: Behavioral: Reading Intervention
  • Active Comparator: Math Intervention
    Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.
    Intervention: Behavioral: Math Intervention
  • No Intervention: Business-as-usual Control
    Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 17, 2019) 		334
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2024
Estimated Primary Completion Date August 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Attends a participating school in the Metropolitan-Nashville Public Schools
  • Is a member of a first-grade classroom whose teacher has agreed to let his/her students participate
  • Has the available school schedule to participate
  • Has adequate English proficiency to be reliably assessed in English on study entry screening measures
  • Scores at or below the 25th percentile on the study's screening math test
  • Scores at or below the 25th percentile on the study's screening reading test
  • Scores at or above the 7th percentile on at least one of the study's two measures of cognitive performance

Exclusion Criterion:

  • Does not attend a participating school in the Metropolitan-Nashville Public Schools
  • Is not a member of a first-grade classroom whose teacher has agreed to let his/her students participate
  • Does not have the available school schedule to participate
  • Does not have adequate English proficiency to be reliably assessed in English on study entry screening measures
  • Scores above the 25th percentile on the study's screening math test
  • Scores above the 25th percentile on the study's screening reading test
  • Scores below the 7th percentile on both of the study's two measures of cognitive performance
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03991234
Other Study ID Numbers  ICMJE 180633
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Research staff will make de-identified data sets electronically available to external users under a data-sharing agreement providing the user's commitment to use data for the research purposes described in the user's request; assurance that no research participant will be identified for any purpose; a commitment to securing the data; a commitment to not transferring data to other users & destroying the data after analyses are complete; & guarantees publications are credited to grant/agency and entered in PubMed. Once the user signs and returns the Agreement Form, a database with the variables of interest and codebook are provided, and staff provide relevant, de-identified data and segments of the code book with variable names/values, notes clarifying scoring/data-reduction methods not otherwise available, and a technical report describing the sample, study, and procedures.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame:

The de-identified (stripped) primary outcome data set will become available no later than acceptance for publication of the main findings from the final data set and remain accessible for 3 years following the closeout of this grant. This time frame for data accessibility will be reviewed at the proposed project's completion and revised as needed.

If all Investigators leave or become unavailable, the last remaining Investigator will assume responsibility for identifying a Vanderbilt faculty member to undertake these responsibilities.
Access Criteria: The user submits a request describing variables of interest, research aims, & quantitative methods and signs a user agreement form (see Plan Description).
Responsible Party Lynn Fuchs, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Douglas Fuchs, Ph.D. Vanderbilt University
PRS Account Vanderbilt University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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