Reading ProblemNCT04511065
Computer Based Newsletter and Literacy Engagement of Middle-school Students
A study testing Newsletter using a virtual mode of delivery in people with Reading Problem, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The purpose of this study is to improve motivation for reading by implementing a computer-based newsletter and examine the effects on the literacy engagement and reading achievement of middle school-aged students. Research questions to be answered: 1. Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Reading Problem
- What is being tested?
- Newsletter using a virtual mode of delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2020to 14 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants must be in After-school participants ages 10-13 years old and in grades 6-8.
- Have access to a computer: laptop, Chromebook, or desktop.
- Can identify and press all keys on a keyboard.
- Can use a mouse to navigate on a computer.
- Have internet access at home or center.
- Computer system has the capability to download Zoom.
Show all 9Show fewer
- One grade equivalent or more below in areas of: fluency, rate, accuracy, or comprehension on Gray Oral Reading Test 5 (GORT 5).
- Standard score in the below average range on the Test of Orthographic Competence (TOC).
- Participants must speak, read, and write in English
Who cannot join
- 1. Students who do not have access to a computer, internet, and Zoom access at home.
- 2. Students who do not speak, read, and write in English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Use of a Computer-based Newsletter, Using a Virtual Delivery of Intervention, on Literacy Engagement and Reading Achievement of Middle School-aged Students
The purpose of this study is to improve motivation for reading by implementing a computer-based newsletter and examine the effects on the literacy engagement and reading achievement of middle school-aged students. Research questions to be answered: 1. Does the provision of a computer-based newsletter intervention improve literacy engagement on middle school students in comparison to their pretest scores? 2. Does the provision of computer-based newsletter intervention improve the reading achievement of middle school students in comparison to their pretest scores?
Read the detailed description
For children where consent was provided by a parent or legal guardian, an assent form will be completed by the child for the child to also consent to participate in the study. Once consent and assent have been received, the student's reading skills will be assessed using the Gray Oral Reading Test 5 (GORT 5) and Test of Orthographic Competence (TOC). The student will also be assessed using a modified Inventory of Reading Occupations (IRO) to determine their access to reading materials and their perceived proficiency with the reading tasks. From the results of the GORT 5 and TOC, inclusion criteria will be used to determine if students will be included in the study. Once the inclusion criteria have been determined for all students, students will be randomly placed in either a control or intervention group.
The intervention group will be provided with a survey to determine areas of interest to guide the 7-week literacy intervention plan of completing a newsletter. Students will complete the newsletter virtually using secure Zoom meetings 2x per week for 30 minutes per session. The results of the Gray Oral Reading Tets 5 (GORT 5) and Test of Orthographic Competence (TOC) will be used to determine the baseline reading skills of the students and each researcher will use the results of the assessments to guide the intervention with the newsletter topic that is chosen by the student. For example, if the GORT 5 notes a deficiency in reading accuracy, the focus of the intervention will be ensuring that reading accuracy is a focus of the summary that is crafted by the student for the newsletter.
At the end of 7-weeks, the control group and intervention group will be re-administered the Gray Oral Reading Test 5 and Test of Orthographic Competence to determine reading skills. Students will also be provided with the modified Inventory of Reading Occupations (IRO). The control and intervention group's GORT 5, TOC, and modified IRO scores will be analyzed to find out the differences between the groups in reading skills (using the GORT 5 and TOC) and reading interest/perceived reading proficiency (using the modified IRO).
- Conditions
- Reading Problem
- Being tested
- Newsletter using a virtual mode of delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newsletter using a virtual mode of deliveryOther
Newsletter creation where topics in the newsletter are chosen by participants in the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will be provided with a survey to determine areas of interest to guide the 7-week literacy intervention plan of completing a newsletter. Students will complete the newsletter virtually using secure Zoom meetings 2x per week for 30 minutes per session. The results of the GORT 5 and TOC will be used to determine the baseline reading skills of the students and each researcher will use the results of the assessments to guide the intervention with the newsletter topic that is chosen by the student. For example, if the GORT 5 notes deficiency with reading accuracy, the focus of the intervention will be ensuring that reading accuracy is a focus of the summary that is crafted by the student for the newsletter. Receives: Other: Newsletter using a virtual mode of delivery |
| Control Group | No intervention | The control group will not participate in the newsletter creation for the 7-week study period. These students will engage in the after-school programs at the Center, some of which may be literacy-based, but not the prescriptive model that is being followed by the researchers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading Skills of Middle-School Aged Children
Reading skills will be assessed using the Gray Oral Reading Test 5 (GORT 5) and the Test of Orthographic Competency (TOC). The Gray Oral Reading Test 5 assesses oral reading skills of individuals ages 6-23 years old, in the areas of rate, accuracy, fluency, and comprehension. The Test of Orthographic Competence assesses reading skills of children ages 6-17 years old, looking at proficiency with letters, spelling, punctuation, abbreviations and special symbols.
Measured: These assessments will be administered at the start of the study and at the end of the study. Total timeframe from Time 1 to Time 2 is 7 weeks.
Secondary outcomes (1)
Literacy Engagement of Middle-School Aged Children
The researchers will also administer the modified Inventory of Reading Occupations (modified-IRO), a literacy engagement scale created by the investigators using the two standardized assessments, Inventory of Reading Occupations Pediatric version, and Inventory of Reading Occupations Adult version.
Measured: This assessment will be administered at the start of the study and at the end of the study. Total timeframe from Time 1 to Time 2 is 7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start2 Oct 2020
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Reading ProblemStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turquessa Francis, State University of New York at Buffalo
- Investigators
- Turquessa Francis, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511065
- Sponsor's protocol ID
- STUDY00004610
- Status last verified
- Jun 2022
- First submitted
- 10 Aug 2020
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
Grajo LC, Candler C, Bowyer P, Schultz S, Thomson J, Fong K. Determining the Internal Validity of the Inventory of Reading Occupations: An Assessment Tool of Children's Reading Participation. Am J Occup Ther. 2016 May-Jun;70(3):7003220010p1-9. doi: 10.5014/ajot.2016.017582.
PubMed 27089292Kim, A.-H., Vaughn, S., Klingner, J. K., Woodruff, A. L., Reutebuch, C. K., & Kouzekanani, K. (2006). Improving the reading comprehension of middle school students with disabilities through computer-assisted collaborative strategic reading. Remedial and Special Education, 27(4), 235-249. doi: 10.1177/07419325060270040401
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of a Computer-based Newsletter, Using a Virtual Delivery of Intervention, on Literacy Engagement and Reading Achievement of Middle School-aged Students
- ClinicalTrials.gov ID
- NCT04511065
- Acronym / sponsor ID
- STUDY00004610
- Conditions
- Reading Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to improve motivation for reading by implementing a computer-based newsletter and examine the effects on the literacy engagement and reading achievement of middle school-aged students. Research questions to be answered: 1. Does the provision of a computer-based newsletter intervention improve literacy engagement on middle school students in comparison to their pretest scores? 2. Does the provision of computer-based newsletter intervention improve the reading achievement of middle school students in comparison to their pretest scores?
Detailed description
For children where consent was provided by a parent or legal guardian, an assent form will be completed by the child for the child to also consent to participate in the study. Once consent and assent have been received, the student's reading skills will be assessed using the Gray Oral Reading Test 5 (GORT 5) and Test of Orthographic Competence (TOC). The student will also be assessed using a modified Inventory of Reading Occupations (IRO) to determine their access to reading materials and their perceived proficiency with the reading tasks. From the results of the GORT 5 and TOC, inclusion criteria will be used to determine if students will be included in the study. Once the inclusion criteria have been determined for all students, students will be randomly placed in either a control or intervention group.
The intervention group will be provided with a survey to determine areas of interest to guide the 7-week literacy intervention plan of completing a newsletter. Students will complete the newsletter virtually using secure Zoom meetings 2x per week for 30 minutes per session. The results of the Gray Oral Reading Tets 5 (GORT 5) and Test of Orthographic Competence (TOC) will be used to determine the baseline reading skills of the students and each researcher will use the results of the assessments to guide the intervention with the newsletter topic that is chosen by the student. For example, if the GORT 5 notes a deficiency in reading accuracy, the focus of the intervention will be ensuring that reading accuracy is a focus of the summary that is crafted by the student for the newsletter.
At the end of 7-weeks, the control group and intervention group will be re-administered the Gray Oral Reading Test 5 and Test of Orthographic Competence to determine reading skills. Students will also be provided with the modified Inventory of Reading Occupations (IRO). The control and intervention group's GORT 5, TOC, and modified IRO scores will be analyzed to find out the differences between the groups in reading skills (using the GORT 5 and TOC) and reading interest/perceived reading proficiency (using the modified IRO).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Newsletter using a virtual mode of deliveryThe intervention group will be provided with a survey to determine areas of interest to guide the 7-week literacy intervention plan of completing a newsletter. Students will complete the newsletter virtually using secure Zoom meetings 2x per week for 30 minutes per session. The results of the GORT 5 and TOC will be used to determine the baseline reading skills of the students and each researcher will use the results of the assessments to guide the intervention with the newsletter topic that is chosen by the student. For example, if the GORT 5 notes deficiency with reading accuracy, the focus of the intervention will be ensuring that reading accuracy is a focus of the summary that is crafted by the student for the newsletter. |
| Control Group | No intervention | –The control group will not participate in the newsletter creation for the 7-week study period. These students will engage in the after-school programs at the Center, some of which may be literacy-based, but not the prescriptive model that is being followed by the researchers. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Participants must be in After-school participants ages 10-13 years old and in grades 6-8.
- Have access to a computer: laptop, Chromebook, or desktop.
- Can identify and press all keys on a keyboard.
- Can use a mouse to navigate on a computer.
- Have internet access at home or center.
Key exclusion criteria (2 listed)
- 1. Students who do not have access to a computer, internet, and Zoom access at home.
- 2. Students who do not speak, read, and write in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Newsletter using a virtual mode of deliveryNewsletter creation where topics in the newsletter are chosen by participants in the intervention group. | Other | Intervention Group |
Primary outcome
Reading Skills of Middle-School Aged Children
Time frame: These assessments will be administered at the start of the study and at the end of the study. Total timeframe from Time 1 to Time 2 is 7 weeks.
Reading skills will be assessed using the Gray Oral Reading Test 5 (GORT 5) and the Test of Orthographic Competency (TOC). The Gray Oral Reading Test 5 assesses oral reading skills of individuals ages 6-23 years old, in the areas of rate, accuracy, fluency, and comprehension. The Test of Orthographic Competence assesses reading skills of children ages 6-17 years old, looking at proficiency with letters, spelling, punctuation, abbreviations and special symbols.
1 secondary outcome
Literacy Engagement of Middle-School Aged Children
Time frame: This assessment will be administered at the start of the study and at the end of the study. Total timeframe from Time 1 to Time 2 is 7 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Background: PubMed 27089292Grajo LC, Candler C, Bowyer P, Schultz S, Thomson J, Fong K. Determining the Internal Validity of the Inventory of Reading Occupations: An Assessment Tool of Children's Reading Participation. Am J Occup Ther. 2016 May-Jun;70(3):7003220010p1-9. doi: 10.5014/ajot.2016.017582.
- BackgroundKim, A.-H., Vaughn, S., Klingner, J. K., Woodruff, A. L., Reutebuch, C. K., & Kouzekanani, K. (2006). Improving the reading comprehension of middle school students with disabilities through computer-assisted collaborative strategic reading. Remedial and Special Education, 27(4), 235-249. doi: 10.1177/07419325060270040401
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Turquessa Francis principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Newsletter using a virtual mode of delivery in people with Reading Problem, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading Skills of Middle-School Aged Children (time frame: These assessments will be administered at the start of the study and at the end of the study. Total timeframe from Time 1 to Time 2 is 7 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04511065, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.