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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03975972
Other study ID # Study00003591
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2, 2019
Est. completion date December 20, 2019

Study information

Verified date October 2020
Source State University of New York at Buffalo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date December 20, 2019
Est. primary completion date December 13, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 13 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Occupational Therapy Based Literacy Intervention
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.

Locations

Country Name City State
United States University at Buffalo Buffalo New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Reading Achievement The reading level of student using the reading assessment that is utilized by the school: Independent Reading Level Assessment Framework (IRLA) 9 weeks
Secondary 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. 9 weeks
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