LiteracyNCT03975972
Occupational Therapy-based Literacy Intervention and Classroom Based Literacy Intervention
A study testing Occupational Therapy Based Literacy Intervention in people with Literacy, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The purpose of this study is to determine the impact of a literacy focused occupational therapy intervention program versus standard classroom-based reading intervention on reading engagement and reading achievement in elementary school-aged children with emotional disturbances. Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Literacy
- What is being tested?
- Occupational Therapy Based Literacy Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2019to 20 Dec 2019
- 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 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants must be in grades 1-5 .
- Participants must be between the ages of 5-13 years of age: (the age is capped at a higher level due to the population this school serves where students may repeat a grade. So, the student may be older than most elementary aged children, but from a literacy perspective, they are functioning below their peers).
- Participants must be at least one grade level below peers in reading using assessment that is utilized in school.
- Participants must be able to speak English
Who cannot join
- Students who are unable to speak or read English due to assessments being in English
- Students who fall outside of the age criterion listed above
- Students that are on grade level with reading
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences in Reading Achievement When Using Occupational-therapy Based Strategies Versus Standard Classroom-based Reading Intervention for Elementary School Children-a Pilot Study.
The purpose of this study is to determine the impact of a literacy focused occupational therapy intervention program versus standard classroom-based reading intervention on reading engagement and reading achievement in elementary school-aged children with emotional disturbances.
Read the detailed description
The elementary school will assist with recruitment by sending recruitment packets home to parents/legal guardian of children to consent to participation in the study. Interested families will return the signed consent form to the researchers in a sealed envelope. These signed consent forms will be collected from the school by the researchers. For children where a 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 participating the study, a requirement to ensure that the child has a choice in partaking in the study.
Once all consents have been received, all consenting student participants will be placed in either a control group or intervention group based on the students' classroom teacher. Both the control group and intervention group will be assessed using the Inventory of Reading Occupations(IRO) to determine their access to reading materials and their perceived proficiency with the reading tasks. Both the control group and intervention group's reading level will be obtained from the classroom teacher using the results of the Independent Reading Level Assessment® Framework (IRLA) from the beginning of the school year.
The intervention group will be provided with a 12-question survey to determine reading interest to guide the 9-week literacy intervention plan and ensure that the literacy intervention plan is in line with the IRLA reading Program. The control group will receive literacy instruction as proposed by the IRLA reading program and will not receive a specific occupation-based literacy intervention plan. Both the control and intervention group will have the principal investigator and student researchers available to provide one-on-one support during literacy instruction, with the intervention group receiving a specific literacy intervention plan while the control group continues with the literacy instructional material provided within the IRLA assessment framework. At the end of 9-weeks, the control group and intervention group will be re-administered the Inventory of Reading Occupations(IRO) and an updated reading achievement will be obtained from teacher from the student's scores on the Independent Reading Level Assessment® Framework (IRLA) at the end of the 9-week intervention period. The control group and intervention group's IRO and IRLA scores will be analyzed to find out the differences between the groups in reading interest, perceived reading proficiency and reading achievement. The researchers will be available by phone or email throughout the entirety of the study should questions arise about the intervention.
- Conditions
- Literacy
- Being tested
- Occupational Therapy Based Literacy Intervention
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational Therapy Based Literacy InterventionOther
Use of an occupational therapy-based literacy intervention that utilizes student interest to guide a prescriptive literacy intervention. Addressing reading as an occupation and making the necessary modifications to the literacy task to allows for increased engagement in the task. Increased engagement in literacy tasks, allows for opportunities to work on literacy deficit areas to address proficiency with reading ability.
| Study group | Role | What they receive |
|---|---|---|
| Occupational Therapy Based Literacy Intervention | Experimental | For the intervention group, the results from the Inventory of Reading Occupations will be utilized to determine a prescriptive weekly intervention for each participant in the intervention group that will be provided to teachers based on student interest and literacy need. For the intervention group, each participant will be provided with a list of 12 questions that will be used to inform the intervention plan based on the interests of each participant within the intervention group. Collectively, the information from the 12 questions and the results of the Inventory of Reading Occupations will be used to determine a 9-week intervention plan for each participant within the intervention group. The researchers will work with the subjects twice per week, 30 minutes per session in the classroom using the prescriptive intervention that was determined from the assessments utilized. Receives: Other: Occupational Therapy Based Literacy Intervention |
| Standard Classroom Based Literacy Intervention | No intervention | The control group will receive the standard reading instruction provided within the school. With the control group, the researchers will provide occupational therapy support to classroom teachers. But, will provide this support using the materials that are standardly provided within the classroom for literacy instruction. The researchers will provide support to the classroom teachers to students in the control group twice per week for 30 mintues per session in the classroom. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading Achievement
The reading level of student using the reading assessment that is utilized by the school: Independent Reading Level Assessment Framework (IRLA)
Measured: 9 weeks
Secondary outcomes (1)
Literacy Engagement
The amount of methods that the students using to access text, literacy tasks that the student engages in and the student's perceived proficiency with methods of accessing text. The Inventory of Reading Occupations (IRO) will be used to determine these three areas.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start2 Sep 2019
- Primary completion13 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LiteracyStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 52 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, Ed.D, Principal investigator, SUNY Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975972
- Sponsor's protocol ID
- Study00003591
- Status last verified
- Oct 2020
- First submitted
- 4 Jun 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be made available to other researchers.
Publications
Grajo, L.C. & Candler, C. (2014). Children with reading difficulties: how occupational therapy can help. OT Practice, 19(13), 16-17.
Grajo, L.C. & Candler, C. (2016). An occupation and participation approach to reading intervention (OPARI) part I: defining reading as an occupation. Journal of Occupational Therapy, Schools, & Early Intervention, 9(1), 74-85.
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 27089292
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Reading Achievement When Using Occupational-therapy Based Strategies Versus Standard Classroom-based Reading Intervention for Elementary School Children-a Pilot Study.
- ClinicalTrials.gov ID
- NCT03975972
- Acronym / sponsor ID
- Study00003591
- Conditions
- Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 5 Jun 2019 (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 determine the impact of a literacy focused occupational therapy intervention program versus standard classroom-based reading intervention on reading engagement and reading achievement in elementary school-aged children with emotional disturbances.
Detailed description
The elementary school will assist with recruitment by sending recruitment packets home to parents/legal guardian of children to consent to participation in the study. Interested families will return the signed consent form to the researchers in a sealed envelope. These signed consent forms will be collected from the school by the researchers. For children where a 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 participating the study, a requirement to ensure that the child has a choice in partaking in the study.
Once all consents have been received, all consenting student participants will be placed in either a control group or intervention group based on the students' classroom teacher. Both the control group and intervention group will be assessed using the Inventory of Reading Occupations(IRO) to determine their access to reading materials and their perceived proficiency with the reading tasks. Both the control group and intervention group's reading level will be obtained from the classroom teacher using the results of the Independent Reading Level Assessment® Framework (IRLA) from the beginning of the school year.
The intervention group will be provided with a 12-question survey to determine reading interest to guide the 9-week literacy intervention plan and ensure that the literacy intervention plan is in line with the IRLA reading Program. The control group will receive literacy instruction as proposed by the IRLA reading program and will not receive a specific occupation-based literacy intervention plan. Both the control and intervention group will have the principal investigator and student researchers available to provide one-on-one support during literacy instruction, with the intervention group receiving a specific literacy intervention plan while the control group continues with the literacy instructional material provided within the IRLA assessment framework. At the end of 9-weeks, the control group and intervention group will be re-administered the Inventory of Reading Occupations(IRO) and an updated reading achievement will be obtained from teacher from the student's scores on the Independent Reading Level Assessment® Framework (IRLA) at the end of the 9-week intervention period. The control group and intervention group's IRO and IRLA scores will be analyzed to find out the differences between the groups in reading interest, perceived reading proficiency and reading achievement. The researchers will be available by phone or email throughout the entirety of the study should questions arise about the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occupational Therapy Based Literacy Intervention | Experimental | Other: Occupational Therapy Based Literacy InterventionFor the intervention group, the results from the Inventory of Reading Occupations will be utilized to determine a prescriptive weekly intervention for each participant in the intervention group that will be provided to teachers based on student interest and literacy need. For the intervention group, each participant will be provided with a list of 12 questions that will be used to inform the intervention plan based on the interests of each participant within the intervention group. Collectively, the information from the 12 questions and the results of the Inventory of Reading Occupations will be used to determine a 9-week intervention plan for each participant within the intervention group. The researchers will work with the subjects twice per week, 30 minutes per session in the classroom using the prescriptive intervention that was determined from the assessments utilized. |
| Standard Classroom Based Literacy Intervention | No intervention | –The control group will receive the standard reading instruction provided within the school. With the control group, the researchers will provide occupational therapy support to classroom teachers. But, will provide this support using the materials that are standardly provided within the classroom for literacy instruction. The researchers will provide support to the classroom teachers to students in the control group twice per week for 30 mintues per session in the classroom. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participants must be in grades 1-5 .
- Participants must be between the ages of 5-13 years of age: (the age is capped at a higher level due to the population this school serves where students may repeat a grade. So, the student may be older than most elementary aged children, but from a literacy perspective, they are functioning below their peers).
- Participants must be at least one grade level below peers in reading using assessment that is utilized in school.
- Participants must be able to speak English
Key exclusion criteria (3 listed)
- Students who are unable to speak or read English due to assessments being in English
- Students who fall outside of the age criterion listed above
- Students that are on grade level with reading
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 |
|---|---|---|
| Occupational Therapy Based Literacy InterventionUse of an occupational therapy-based literacy intervention that utilizes student interest to guide a prescriptive literacy intervention. Addressing reading as an occupation and making the necessary modifications to the literacy task to allows for increased engagement in the task. Increased engagement in literacy tasks, allows for opportunities to work on literacy deficit areas to address proficiency with reading ability. | Other | Occupational Therapy Based Literacy Intervention |
Primary outcome
Reading Achievement
Time frame: 9 weeks
The reading level of student using the reading assessment that is utilized by the school: Independent Reading Level Assessment Framework (IRLA)
1 secondary outcome
Literacy Engagement
Time frame: 9 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 22 Oct 2020.
- BackgroundGrajo, L.C. & Candler, C. (2014). Children with reading difficulties: how occupational therapy can help. OT Practice, 19(13), 16-17.
- BackgroundGrajo, L.C. & Candler, C. (2016). An occupation and participation approach to reading intervention (OPARI) part I: defining reading as an occupation. Journal of Occupational Therapy, Schools, & Early Intervention, 9(1), 74-85.
- 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.
- American Occupational Therapy Association. The role of occupational therapy with literacy.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual Participant Data will not be made 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, Ed.D principal investigator
SUNY 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 Occupational Therapy Based Literacy Intervention in people with Literacy, 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 4 inclusion and 3 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 22 Oct 2020. 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 Achievement (time frame: 9 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 NCT03975972, which also lists 3 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 22 Oct 2020.