Computer Based Newsletter and Literacy Engagement of Middle-school Students

June 20, 2022 updated by: Turquessa Francis, State University of New York at Buffalo

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14214
        • University at Buffalo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 13 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participants must be in After-school participants ages 10-13 years old and in grades 6-8.
  2. Have access to a computer: laptop, Chromebook, or desktop.
  3. Can identify and press all keys on a keyboard.
  4. Can use a mouse to navigate on a computer.
  5. Have internet access at home or center.
  6. Computer system has the capability to download Zoom.
  7. One grade equivalent or more below in areas of: fluency, rate, accuracy, or comprehension on Gray Oral Reading Test 5 (GORT 5).
  8. Standard score in the below average range on the Test of Orthographic Competence (TOC).
  9. Participants must speak, read, and write in English

Exclusion Criteria:

- 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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 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.
Other: Newsletter using a virtual mode of delivery
Newsletter creation where topics in the newsletter are chosen by participants in the intervention group.
NO_INTERVENTION: Control Group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York at Buffalo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Turquessa Francis, University at Buffalo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00004610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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