NCT03695068

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
840

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

3.8 years

First QC Date

September 30, 2018

Last Update Submit

May 20, 2022

Conditions

Keywords

Learning DisabilitiesDyslexiaReading

Outcome Measures

Primary Outcomes (1)

  • Change in Reading Comprehension after two years of treatment (Gates MacGinitie Passage Comprehension)

    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.

    Measured May of year 2 (end of year 2 of treatment)

Secondary Outcomes (5)

  • Change in word reading after two years of treatment (Kaufman Test of Education Achievement, Third Edition, Letter Word Recognition).

    Measured May of year 2 (end of year 2 of treatment)

  • Change in word reading after one year of treatment (Kaufman Test of Education Achievement, Third Edition, Letter Word Recognition).

    Measured May of year 1 (end of year 1 of treatment)

  • Change in reading fluency after two years of treatment (Kaufman Test of Education Achievement, Third Edition, Word Recognition Fluency).

    Measured May of year 2 (end of year 2 of treatment)

  • Change in reading fluency after one year of treatment (Kaufman Test of Education Achievement, Third Edition, Word Recognition Fluency).

    Measured May of year 1 (end of year 1 of treatment)

  • Change in Reading Comprehension after one year of treatment (Gates MacGinitie Passage Comprehension)

    Measured May of year 1 (end of year 1 of treatment)

Study Arms (2)

RISE Intervention

EXPERIMENTAL

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

Business as Usual Comparison Condition

NO INTERVENTION

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.

Interventions

Described in Arms description.

RISE Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

University of Houston

Houston, Texas, 77024, United States

RECRUITING

MeSH Terms

Conditions

Learning DisabilitiesDyslexia

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersLanguage DisordersSpecific Learning Disorder

Study Officials

  • Jack M Fletcher, Ph.D.

    University of Houston

    PRINCIPAL INVESTIGATOR
  • Sharon Vaughn, Ph.D.

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jack M Fletcher, Ph.D.

CONTACT

Jeremy R Miciak, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors are not aware of intervention assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hugh Roy and Lillie Cranz Cullen Distinguished Professor

Study Record Dates

First Submitted

September 30, 2018

First Posted

October 3, 2018

Study Start

September 1, 2018

Primary Completion

June 15, 2022

Study Completion

June 15, 2022

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations