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Trial record 56 of 101 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Texas, United States ) | NIH, U.S. Fed

Efficacy of a Two-Year Intensive Reading Intervention for Middle School English Learners With Reading Difficulties (TCLD)

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ClinicalTrials.gov Identifier: NCT03695068
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : October 3, 2018
Sponsor:
Collaborators:
University of Texas at Austin
The University of Texas Health Science Center, Houston
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Jack Fletcher, University of Houston

Brief Summary:

This study investigates the efficacy of a reading comprehension intervention for English learners in Grades 6 and 7 with reading difficulties. Building on previous intervention studies conducted with students in Grades 4 through 8 over the past 10 years, the investigators utilize a longitudinal, double-cohort design utilizing a randomized control trial assigning students to supplemental reading intervention (RISE) or a no intervention "business as usual" (BAU) comparison condition (i.e., Cohort 1 - Years 1 and 2; 205 students in treatment and 205 in control condition; Cohort 2 - Years 3 and 4; 205 students in treatment and 205 in control condition; total 410 in each condition). Students in each cohort will be treated for 2 years (i.e., 6th and 7th grades or 7th and 8th grades). The primary outcome is reading comprehension.

The investigators hypothesize that participants receiving the RISE intervention will outperform those receiving BAU instruction across reading-related elements, including word reading, fluency, and comprehension at end of year two of treatment.


Condition or disease Intervention/treatment Phase
Learning Disorders Dyslexia Behavioral: RISE Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are randomly assigned to one of two arms: (1) the reading instruction for students who are English learners with reading difficulties (RISE) intervention or (2) a business as usual comparison condition.
Masking: Single (Outcomes Assessor)
Masking Description: Assessors are not aware of intervention assignment.
Primary Purpose: Treatment
Official Title: Integrating Attention and Self-Regulation Into an Intensive Intervention for Middle School English Learners With Persistent Reading Difficulties
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : June 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RISE Intervention
Reading Instruction for Students who are English Learners (El) with Reading Difficulties (RISE): The RISE intervention is a multi-phase treatment that first accelerates basic skills through an emphasis on word reading (e.g., multi-syllable words, morphology, high-frequency words commonly misread; Phase 1), and then provides a longer-term emphasis on fluency and comprehension through systematically varying text difficulty and genre (Phase 2). To assure that students have minimal loss during the summer, RISE adds a summer Book Club that includes provision of books with comprehension activities for students in the RISE intervention arm (Phase 3). This entire approach takes two full academic years and two summers to be replicated across two cohorts.
Behavioral: RISE Intervention
Described in Arms description.

No Intervention: Business as Usual Comparison Condition
Participants assigned to the Business as Usual (BAU)or comparison condition will participate in an elective class that includes such options as music, cooking, film, study time, or high stakes test preparation.



Primary Outcome Measures :
  1. Change in Reading Comprehension after two years of treatment (Gates MacGinitie Passage Comprehension) [ Time Frame: Measured May of year 2 (end of year 2 of treatment) ]
    The Gates MacGinitie Passage Comprehension subtest is a group-administered, untimed test of reading comprehension. It consists of 11 passages with 48 multiple choice questions that target the following areas: inference making, summarization, main idea, literal questions about text, and vocabulary. Internal consistency exceeds 0.90 for students of this age range.


Secondary Outcome Measures :
  1. Change in word reading after two years of treatment (Kaufman Test of Education Achievement, Third Edition, Letter Word Recognition). [ Time Frame: Measured May of year 2 (end of year 2 of treatment) ]
    Kaufman Test of Educational Achievement, Third Edition, Letter & Word Recognition (KTEA-3) is an individually-administered assessment of the examinee's ability to read words and letters accurately. Split-half reliabilities for ages 13-15 are 0.96-0.97.

  2. Change in word reading after one year of treatment (Kaufman Test of Education Achievement, Third Edition, Letter Word Recognition). [ Time Frame: Measured May of year 1 (end of year 1 of treatment) ]
    Kaufman Test of Educational Achievement, Third Edition, Letter & Word Recognition (KTEA-3) is an individually-administered assessment of the examinee's ability to read words and letters accurately. Split-half reliabilities for ages 13-15 are 0.96-0.97.

  3. Change in reading fluency after two years of treatment (Kaufman Test of Education Achievement, Third Edition, Word Recognition Fluency). [ Time Frame: Measured May of year 2 (end of year 2 of treatment) ]
    The KTEA-3 Word Recognition Fluency subtest is an individually-administered test of word reading fluency

  4. Change in reading fluency after one year of treatment (Kaufman Test of Education Achievement, Third Edition, Word Recognition Fluency). [ Time Frame: Measured May of year 1 (end of year 1 of treatment) ]
    The KTEA-3 Word Recognition Fluency subtest is an individually-administered test of word reading fluency

  5. Change in Reading Comprehension after one year of treatment (Gates MacGinitie Passage Comprehension) [ Time Frame: Measured May of year 1 (end of year 1 of treatment) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants are enrolled in 6th or 7th grade at a participating school.
  • Participants are currently identified as English Learners (designated by school as limited English proficient) or were previously identified as limited English proficient and were redesignated as English proficient within the last 3 years by their school.
  • A parent reported that Spanish was spoken at home at initial school entry.
  • The participant failed the state level reading comprehension test the previous school year

Exclusion Criteria:

  • The potential participant has a sensory disorder that precludes participation int he assessment and intervention protocols.
  • The potential participant participates in an alternative curriculum (i.e., life skills course) due to moderate to severe learning disorders.
  • The potential participant received a score of Beginner (Level 1) on the Texas English Language Proficiency Assessment System (TELPAS) listening and speaking subtest, indicating limited opportunity to learn English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695068


Contacts
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Contact: Jack M Fletcher, Ph.D. 832-842-2004 jmfletch@central.uh.edu
Contact: Jeremy R Miciak, Ph.D. 832-842-2044 jeremy.miciak@times.uh.edu

Locations
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United States, Texas
University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Sharon Vaughn, Ph.D.    512-232-2320    srvaughn@austin.utexas.edu   
Contact: Phil Capin, Ph.D.    512-471-8577    pcapin@utexas.edu   
University of Houston Recruiting
Houston, Texas, United States, 77024
Contact: Jack M Fletcher, Ph.D.    832-842-2004    jmfletch@central.uh.edu   
Contact: Jeremy R Miciak, Ph.D.    832-842-2044    jeremy.miciak@times.uh.edu   
Sponsors and Collaborators
University of Houston
University of Texas at Austin
The University of Texas Health Science Center, Houston
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Jack M Fletcher, Ph.D. University of Houston
Principal Investigator: Sharon Vaughn, Ph.D. University of Texas at Austin

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Responsible Party: Jack Fletcher, Hugh Roy and Lillie Cranz Cullen Distinguished Professor, University of Houston
ClinicalTrials.gov Identifier: NCT03695068     History of Changes
Other Study ID Numbers: FWA00005994
P50HD052117 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jack Fletcher, University of Houston:
Learning Disabilities
Dyslexia
Reading

Additional relevant MeSH terms:
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Dyslexia
Learning Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders